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Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults

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ClinicalTrials.gov Identifier: NCT01755689
Recruitment Status : Completed
First Posted : December 24, 2012
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Meningococcal
Interventions Biological: Meningococcal vaccine GSK134612
Biological: Cervarix®
Biological: Boostrix®
Enrollment 1300
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Hide Arm/Group Description Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm. Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm. Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Period Title: Overall Study
Started 259 259 261 260 261
Completed 256 254 255 254 255
Not Completed 3 5 6 6 6
Reason Not Completed
Withdrawal by Subject             1             3             2             1             1
Migrated/moved from study area             0             1             1             1             1
Lost to Follow-up             1             0             1             0             2
Pregnancy             1             1             2             4             2
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group Total
Hide Arm/Group Description Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm. Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm. Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. Total of all reporting groups
Overall Number of Baseline Participants 259 259 261 260 261 1300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Participants
Number Analyzed 259 participants 259 participants 261 participants 260 participants 261 participants 1300 participants
16.3  (4.6) 16.6  (4.4) 16.6  (4.6) 16.6  (4.6) 16.6  (4.5) 16.5  (4.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 259 participants 259 participants 261 participants 260 participants 261 participants 1300 participants
Female
259
 100.0%
259
 100.0%
261
 100.0%
260
 100.0%
261
 100.0%
1300
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic ancestry Number Analyzed 259 participants 259 participants 261 participants 260 participants 261 participants 1300 participants
African Heritage / African American
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
0
   0.0%
1
   0.1%
Asian - South East Asian Heritage
86
  33.2%
86
  33.2%
86
  33.0%
86
  33.1%
86
  33.0%
430
  33.1%
White - Caucasian / European Heritage
87
  33.6%
86
  33.2%
87
  33.3%
87
  33.5%
88
  33.7%
435
  33.5%
Other
86
  33.2%
87
  33.6%
88
  33.7%
86
  33.1%
87
  33.3%
434
  33.4%
1.Primary Outcome
Title Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)
Hide Description The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers, tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement. This analysis was only performed on groups receiving Nimenrix vaccine.
Time Frame At one month after vaccination with Nimenrix (Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix.
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Nimenrix+Cervarix+Boostrix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 256 255 257
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
rSBA-MenA
5517.1
(4791.4 to 6352.6)
5523.5
(4913.2 to 6209.6)
4649.6
(4022.8 to 5374.0)
rSBA-MenC
4277.3
(3604.3 to 5076.1)
5091.0
(4338.6 to 5973.8)
3598.6
(3004.2 to 4310.7)
rSBA-MenW-135
14782.1
(12254.2 to 17831.5)
18068.3
(15381.6 to 21224.4)
11663.6
(9336.8 to 14570.2)
rSBA-MenY
11871.0
(10542.3 to 13367.2)
12758.9
(11569.6 to 14070.5)
11201.2
(9678.7 to 12963.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix (1,2,7-Month) Group, Nimenrix+Cervarix+Boostrix Group
Comments Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenA titers.
Type of Statistical Test Non-Inferiority
Comments The non-inferiority criteria: the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT Ratio
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.99 to 1.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix (1,2,7-Month) Group, Nimenrix+Cervarix (0,1,6-Month) Group
Comments Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenA titers.
Type of Statistical Test Non-Inferiority
Comments The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT Ratio
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.84 to 1.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix (1,2,7-Month) Group, Nimenrix+Cervarix+Boostrix Group
Comments Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenC titers.
Type of Statistical Test Non-Inferiority
Comments The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT Ratio
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.93 to 1.51
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix (1,2,7-Month) Group, Nimenrix+Cervarix (0,1,6-Month) Group
Comments Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenC titers.
Type of Statistical Test Non-Inferiority
Comments The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT Ratio
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.66 to 1.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix (1,2,7-Month) Group, Nimenrix+Cervarix+Boostrix Group
Comments Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenW-135 titers.
Type of Statistical Test Non-Inferiority
Comments The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT Ratio
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
0.97 to 1.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix (1,2,7-Month) Group, Nimenrix+Cervarix (0,1,6-Month) Group
Comments Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenW-135 titers.
Type of Statistical Test Non-Inferiority
Comments The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT Ratio
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.63 to 1.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix (1,2,7-Month) Group, Nimenrix+Cervarix+Boostrix Group
Comments Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenY titers.
Type of Statistical Test Non-Inferiority
Comments The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT Ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.89 to 1.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix (1,2,7-Month) Group, Nimenrix+Cervarix (0,1,6-Month) Group
Comments Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenY titers.
Type of Statistical Test Non-Inferiority
Comments The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT Ratio
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.80 to 1.12
Estimation Comments [Not Specified]
2.Primary Outcome
Title Anti-HPV-16 and Anti-HPV-18 Concentrations
Hide Description The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).
Time Frame At one month after vaccination with Cervarix (Month 7)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination.
Arm/Group Title Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 248 249 244 247
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Anti-HPV-16
12124.9
(10564.5 to 13915.7)
11672.1
(10173.5 to 13391.4)
9563.8
(8262.0 to 11070.7)
11470.7
(10018.5 to 13133.5)
Anti-HPV-18
5234.1
(4573.9 to 5989.6)
5655.0
(4978.5 to 6423.4)
4306.2
(3748.3 to 4947.1)
5110.0
(4487.0 to 5819.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix (0,1,6-Month) Group, Cervarix Group
Comments Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-16 titers.
Type of Statistical Test Non-Inferiority
Comments For HPV-16, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.81 to 1.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix (0,1,6-Month) Group, Cervarix Group
Comments Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-18 titers.
Type of Statistical Test Non-Inferiority
Comments For HPV-18, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.92 to 1.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix+Boostrix Group, Boostrix+Cervarix Group
Comments Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-16 titers.
Type of Statistical Test Non-Inferiority
Comments For HPV-16, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
1.01 to 1.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix+Boostrix Group, Boostrix+Cervarix Group
Comments Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-18 titers.
Type of Statistical Test Non-Inferiority
Comments For HPV-18, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
1.00 to 1.41
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL
Hide Description The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL). This analysis was only performed on the groups receiving Boostrix vaccine.
Time Frame At one month after Boostrix vaccination (Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.
Arm/Group Title Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 250 256
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D
235
  94.0%
248
  96.9%
Anti-T
249
  99.6%
256
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix+Boostrix Group, Boostrix+Cervarix Group
Comments The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-D titers.
Type of Statistical Test Non-Inferiority
Comments For anti-D the lower limit (LL) of the 2-sided standardised asymptotic 95% CI for the group difference (Nimenrix+Cervarix+Boostrix Group minus Boostrix +Cervarix Group) had to be greater than or equal to the pre-defined limit of -10%.
Method of Estimation Estimation Parameter Difference between groups
Estimated Value -2.88
Confidence Interval (2-Sided) 95%
-6.90 to 0.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix+Boostrix Group, Boostrix+Cervarix Group
Comments The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-T titers.
Type of Statistical Test Non-Inferiority
Comments For anti-T the LL of the 2-sided standardised asymptotic 95% CI for the group difference (Nimenrix+Cervarix+Boostrix Group minus Boostrix +Cervarix Group) had to be greater than or equal to the pre-defined limit of -10%.
Method of Estimation Estimation Parameter Difference between groups
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-2.23 to 1.08
Estimation Comments [Not Specified]
4.Primary Outcome
Title Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Hide Description The antibody concentrations were tabulated as GMCs and expressed as IU/mL. GMCs were only analyzed in subjects receiving Boostrix vaccination.
Time Frame At one month after Boostrix vaccination (Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.
Arm/Group Title Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 247 256
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-PT Number Analyzed 245 participants 254 participants
52.9
(46.4 to 60.4)
73.2
(65.0 to 82.5)
Anti-FHA Number Analyzed 247 participants 256 participants
278.7
(249.5 to 311.2)
472.4
(419.7 to 531.8)
Anti-PRN Number Analyzed 246 participants 256 participants
193.4
(159.0 to 235.1)
318.6
(262.4 to 386.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix+Boostrix Group, Boostrix+Cervarix Group
Comments Adjusted GMT ratio of the Nimenrix+Cervarix+Boostrix Group versus Boostrix+ Cervarix Group in terms of anti-PRN titers.
Type of Statistical Test Non-Inferiority
Comments For anti-PRN the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT Ratio
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
1.25 to 1.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix+Boostrix Group, Boostrix+Cervarix Group
Comments Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-FHA titers.
Type of Statistical Test Non-Inferiority
Comments For anti-FHA the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT Ratio
Estimated Value 1.65
Confidence Interval (2-Sided) 95%
1.42 to 1.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Nimenrix+Cervarix+Boostrix Group, Boostrix+Cervarix Group
Comments Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-PT titers.
Type of Statistical Test Non-Inferiority
Comments For anti-PT the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted GMT Ratio
Estimated Value 1.39
Confidence Interval (2-Sided) 95%
1.20 to 1.61
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128
Hide Description The number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8 and ≥ 1:128 prior to and one month after vaccination with Nimenrix vaccine.
Time Frame Prior to and one month after vaccination with Nimenrix (Months 0 and 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix.
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Nimenrix+Cervarix+Boostrix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 256 255 257
Measure Type: Count of Participants
Unit of Measure: Participants
rSBA-MenA ≥1:8, Month 0 Number Analyzed 256 participants 255 participants 255 participants
112
  43.8%
118
  46.3%
129
  50.6%
rSBA-MenC ≥1:8, Month 0 Number Analyzed 255 participants 255 participants 255 participants
34
  13.3%
29
  11.4%
40
  15.7%
rSBA-MenW-135 ≥1:8, Month 0 Number Analyzed 256 participants 255 participants 256 participants
23
   9.0%
24
   9.4%
22
   8.6%
rSBA-MenY ≥1:8, Month 0 Number Analyzed 255 participants 255 participants 256 participants
86
  33.7%
102
  40.0%
80
  31.3%
rSBA-MenA ≥1:128, Month 0 Number Analyzed 256 participants 255 participants 255 participants
78
  30.5%
86
  33.7%
82
  32.2%
rSBA-MenC ≥1:128, Month 0 Number Analyzed 255 participants 255 participants 255 participants
20
   7.8%
10
   3.9%
23
   9.0%
rSBA-MenW-135 ≥1:128, Month 0 Number Analyzed 256 participants 255 participants 256 participants
22
   8.6%
23
   9.0%
20
   7.8%
rSBA-MenY ≥1:128, Month 0 Number Analyzed 255 participants 255 participants 256 participants
84
  32.9%
99
  38.8%
74
  28.9%
rSBA-MenA ≥1:8, Month 1 Number Analyzed 256 participants 255 participants 257 participants
255
  99.6%
255
 100.0%
255
  99.2%
rSBA-MenC ≥1:8, Month 1 Number Analyzed 256 participants 255 participants 257 participants
254
  99.2%
253
  99.2%
253
  98.4%
rSBA-MenW-135 ≥1:8, Month 1 Number Analyzed 256 participants 255 participants 257 participants
253
  98.8%
255
 100.0%
250
  97.3%
rSBA-MenY ≥1:8, Month 1 Number Analyzed 256 participants 255 participants 257 participants
256
 100.0%
255
 100.0%
255
  99.2%
rSBA-MenA ≥1:128, Month 1 Number Analyzed 256 participants 255 participants 257 participants
255
  99.6%
255
 100.0%
255
  99.2%
rSBA-MenC ≥1:128, Month 1 Number Analyzed 256 participants 255 participants 257 participants
254
  99.2%
252
  98.8%
252
  98.1%
rSBA-MenW-135 ≥1:128, Month 1 Number Analyzed 256 participants 255 participants 257 participants
253
  98.8%
255
 100.0%
250
  97.3%
rSBA-MenY ≥1:128, Month 1 Number Analyzed 256 participants 255 participants 257 participants
256
 100.0%
255
 100.0%
255
  99.2%
6.Secondary Outcome
Title rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response
Hide Description

rSBA vaccine response for serogroups A, C, W-135 and Y was defined as:

  • For initially seronegative subjects (pre-vaccination titre below the cut-off of 1:8): number of subjects with rSBA antibody titres ≥ 1:32 one month after vaccination.
  • For initially seropositive subjects (pre-vaccination titre ≥ 1:8): number of subjects with rSBA antibody titres at least four times the pre-vaccination antibody titres, one month after vaccination.
Time Frame At one month after Nimenrix vaccination (Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix.
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Nimenrix+Cervarix+Boostrix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 256 255 256
Measure Type: Count of Participants
Unit of Measure: Participants
rSBA-MenA Number Analyzed 256 participants 255 participants 255 participants
240
  93.8%
235
  92.2%
230
  90.2%
rSBA-MenC Number Analyzed 255 participants 255 participants 255 participants
250
  98.0%
251
  98.4%
246
  96.5%
rSBA-MenW-135 Number Analyzed 256 participants 255 participants 256 participants
252
  98.4%
255
 100.0%
248
  96.9%
rSBA-MenY Number Analyzed 255 participants 255 participants 256 participants
245
  96.1%
253
  99.2%
251
  98.0%
7.Secondary Outcome
Title Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL
Hide Description The antibody concentrations were tabulated as GMCs and expressed as IU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group.
Time Frame Prior to and one month after vaccination with Nimenrix (Months 0 and 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after Nimenrix vaccination,only for Nimenrix+Cervarix (1,2,7-Month) Group.
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 255
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-T ≥ 0.1 IU/mL, Month 0
236
  92.5%
Anti-T ≥ 0.1 IU/mL, Month 1
255
 100.0%
Anti-T ≥ 1 IU/mL, Month 0
151
  59.2%
Anti-T ≥ 1 IU/mL, Month 1
253
  99.2%
8.Secondary Outcome
Title Anti-T Antibody Concentrations
Hide Description The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). This analysis was only performed for the Nimenrix+Cervarix (1,2,7-Month) Group.
Time Frame Prior to and one month after vaccination with Nimenrix (Months 0 and 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after Nimenrix vaccination,only for Nimenrix+Cervarix (1,2,7-Month) Group.
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 255
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-T, Month 0
1.2
(1.0 to 1.4)
Anti-T, Month 1
25.4
(22.8 to 28.3)
9.Secondary Outcome
Title Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL
Hide Description The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).
Time Frame Prior to the first dose and one month after the third dose of Cervarix [Month 0 and Month 7/Month 8 in Nimenrix+Cervarix (1,2,7-Month) Group]
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination.
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Boostrix+Cervarix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 246 248 249 244 247
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16, Month 0
17
   6.9%
29
  11.7%
32
  12.9%
29
  11.9%
22
   8.9%
Anti-HPV-16, Month 7/Month 8
245
  99.6%
248
 100.0%
249
 100.0%
244
 100.0%
247
 100.0%
Anti-HPV-18, Month 0
11
   4.5%
12
   4.8%
17
   6.8%
14
   5.7%
14
   5.7%
Anti-HPV-18, Month 7/Month 8
245
  99.6%
248
 100.0%
249
 100.0%
244
 100.0%
247
 100.0%
10.Secondary Outcome
Title Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies
Hide Description Seroconversion rate is defined as the appearance of antibodies (i.e. titers greater than or equal to the cut-off value) in the serum of subjects who are seronegative before vaccination. The antibody concentrations were calculated as GMCs and expressed as EU/mL.
Time Frame Prior to and one month after the third dose of Cervarix (Month 0 and Month 7/Month 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination.
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 235 236 232 230 233
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HPV-16, Month 0 Number Analyzed 229 participants 219 participants 217 participants 215 participants 225 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Anti-HPV-16, Month 7/Month 8 Number Analyzed 229 participants 219 participants 217 participants 215 participants 225 participants
228
  99.6%
219
 100.0%
217
 100.0%
215
 100.0%
225
 100.0%
Anti-HPV-18, Month 0 Number Analyzed 235 participants 236 participants 232 participants 230 participants 233 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Anti-HPV-18, Month 7/Month 8 Number Analyzed 235 participants 236 participants 232 participants 230 participants 233 participants
234
  99.6%
236
 100.0%
232
 100.0%
230
 100.0%
233
 100.0%
11.Secondary Outcome
Title Anti-HPV-16 and Anti-HPV-18 Concentrations
Hide Description The antibody concentrations were calculated as GMCs and expressed as EU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group.
Time Frame Prior to and one month after the third dose of Cervarix (Months 0 and 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination from the Nimenrix+Cervarix (1,2,7-Month) Group.
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 246
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Anti-HPV-16, Month 0
10.9
(10.2 to 11.6)
Anti-HPV-16, Month 8
11128.2
(9471.8 to 13074.4)
Anti-HPV-18, Month 0
9.8
(9.3 to 10.4)
Anti-HPV-18, Month 8
5357.0
(4550.2 to 6306.9)
12.Secondary Outcome
Title Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Hide Description

Booster responses to the PT, FHA and PRN antigens were defined as:

  • For initially seronegative subjects (antibody concentrations: < 2.046 IU/ml for anti-FHA, < 2.187 IU/ml for anti-PRN, < 2.693 IU/ml for anti-PT), antibody concentration ≥ 4*cut_off IU/ml at Month 1 post-vaccination;
  • For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration < 4*cut_off IU/ml : antibody concentration at Month 1 ≥ 4 fold the pre-vaccination antibody concentration;
  • For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration ≥ 4*cut_off IU/ml : antibody concentration at Month 1 ≥ 2 fold the pre-vaccination antibody concentration.
Time Frame At one month after Boostrix vaccination (Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.
Arm/Group Title Nimenrix+Boostrix+Cervarix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 247 256
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PT Number Analyzed 245 participants 254 participants
218
  89.0%
235
  92.5%
Anti-FHA Number Analyzed 247 participants 256 participants
240
  97.2%
247
  96.5%
Anti-PRN Number Analyzed 246 participants 256 participants
231
  93.9%
248
  96.9%
13.Secondary Outcome
Title Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL
Hide Description The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).
Time Frame Prior to and one month after Boostrix vaccination (Month 0 and Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.
Arm/Group Title Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 251 256
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D, Month 0 Number Analyzed 249 participants 254 participants
214
  85.9%
223
  87.8%
Anti-D, Month 1 Number Analyzed 250 participants 256 participants
250
 100.0%
256
 100.0%
Anti-T, Month 0 Number Analyzed 251 participants 256 participants
239
  95.2%
248
  96.9%
Anti-T, Month 1 Number Analyzed 250 participants 256 participants
250
 100.0%
256
 100.0%
14.Secondary Outcome
Title Anti-D and Anti-T Antibody Concentrations
Hide Description The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).
Time Frame Prior to and one month after Boostrix vaccination (Months 0 and 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.
Arm/Group Title Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 251 256
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-D, Month 0 Number Analyzed 249 participants 254 participants
0.5
(0.4 to 0.5)
0.5
(0.4 to 0.6)
Anti-D, Month 1 Number Analyzed 250 participants 256 participants
4.7
(4.2 to 5.2)
6.6
(5.9 to 7.4)
Anti-T, Month 0 Number Analyzed 251 participants 256 participants
1.3
(1.1 to 1.5)
1.3
(1.1 to 1.5)
Anti-T, Month 1 Number Analyzed 250 participants 256 participants
25.9
(23.4 to 28.8)
15.4
(14.1 to 16.9)
15.Secondary Outcome
Title Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value
Hide Description The antibody concentrations were calculated as GMCs and expressed as IU/mL. Anti-PT assay cut-off=2.693 IU/mL, anti-FHA assay cut-off=2.046 IU/mL, anti-PRN assay cut-off=2.187 IU/mL.
Time Frame Prior to and one month after Boostrix vaccination (Months 0 and 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.
Arm/Group Title Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 251 256
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PT, Month 0 Number Analyzed 249 participants 254 participants
156
  62.7%
153
  60.2%
Anti-PT, Month 1 Number Analyzed 245 participants 254 participants
240
  98.0%
252
  99.2%
Anti-FHA, Month 0 Number Analyzed 251 participants 256 participants
235
  93.6%
244
  95.3%
Anti-FHA, Month 1 Number Analyzed 247 participants 256 participants
247
 100.0%
256
 100.0%
Anti-PRN, Month 0 Number Analyzed 250 participants 256 participants
218
  87.2%
229
  89.5%
Anti-PRN, Month 1 Number Analyzed 246 participants 256 participants
246
 100.0%
256
 100.0%
16.Secondary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Symptoms were presented by vaccination site. Some groups do not have results for "Dose 2" because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented, who filled in their symptom sheets.
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 259 257 259 260 261
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain (Nimenrix), Dose 1 Number Analyzed 259 participants 257 participants 0 participants 260 participants 0 participants
152
  58.7%
140
  54.5%
156
  60.0%
Grade 3 Pain (Nimenrix), Dose 1 Number Analyzed 259 participants 257 participants 0 participants 260 participants 0 participants
4
   1.5%
3
   1.2%
7
   2.7%
Any Pain (Boostrix), Dose 1 Number Analyzed 0 participants 0 participants 0 participants 260 participants 261 participants
189
  72.7%
200
  76.6%
Grade 3 Pain (Boostrix), Dose 1 Number Analyzed 0 participants 0 participants 0 participants 260 participants 261 participants
21
   8.1%
15
   5.7%
Any Pain (Cervarix), Dose 1 Number Analyzed 0 participants 257 participants 259 participants 260 participants 261 participants
213
  82.9%
205
  79.2%
217
  83.5%
221
  84.7%
Grade 3 Pain (Cervarix), Dose 1 Number Analyzed 0 participants 257 participants 259 participants 260 participants 261 participants
8
   3.1%
11
   4.2%
23
   8.8%
18
   6.9%
Any Redness (Nimenrix), Dose 1 Number Analyzed 259 participants 257 participants 0 participants 260 participants 0 participants
57
  22.0%
42
  16.3%
54
  20.8%
Grade 3 Redness (Nimenrix), Dose 1 Number Analyzed 259 participants 257 participants 0 participants 260 participants 0 participants
4
   1.5%
2
   0.8%
0
   0.0%
Any Redness (Boostrix), Dose 1 Number Analyzed 0 participants 0 participants 0 participants 260 participants 261 participants
73
  28.1%
53
  20.3%
Grade 3 Redness (Boostrix), Dose 1 Number Analyzed 0 participants 0 participants 0 participants 260 participants 261 participants
2
   0.8%
4
   1.5%
Any Redness (Cervarix), Dose 1 Number Analyzed 0 participants 257 participants 259 participants 260 participants 261 participants
56
  21.8%
54
  20.8%
62
  23.8%
48
  18.4%
Grade 3 Redness (Cervarix), Dose 1 Number Analyzed 0 participants 257 participants 259 participants 260 participants 261 participants
0
   0.0%
0
   0.0%
1
   0.4%
0
   0.0%
Any Swelling (Nimenrix), Dose 1 Number Analyzed 259 participants 257 participants 0 participants 260 participants 0 participants
40
  15.4%
34
  13.2%
58
  22.3%
Grade 3 Swelling (Nimenrix), Dose 1 Number Analyzed 259 participants 257 participants 0 participants 260 participants 0 participants
1
   0.4%
1
   0.4%
5
   1.9%
Any Swelling (Boostrix), Dose 1 Number Analyzed 0 participants 0 participants 0 participants 260 participants 261 participants
79
  30.4%
58
  22.2%
Grade 3 Swelling (Boostrix), Dose 1 Number Analyzed 0 participants 0 participants 0 participants 260 participants 261 participants
5
   1.9%
7
   2.7%
Any Swelling (Cervarix), Dose 1 Number Analyzed 0 participants 257 participants 259 participants 260 participants 261 participants
42
  16.3%
37
  14.3%
64
  24.6%
55
  21.1%
Grade 3 Swelling (Cervarix), Dose 1 Number Analyzed 0 participants 257 participants 259 participants 260 participants 261 participants
1
   0.4%
1
   0.4%
1
   0.4%
5
   1.9%
Any Pain (Nimenrix), Dose 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Grade 3 Pain (Nimenrix), Dose 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Any Pain (Boostrix), Dose 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Grade 3 Pain (Boostrix), Dose 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Any Pain (Cervarix), Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
193
  74.8%
Grade 3 Pain (Cervarix), Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
15
   5.8%
Any Redness (Nimenrix), Dose 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Grade 3 Redness (Nimenrix), Dose 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Any Redness (Boostrix), Dose 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Grade 3 Redness (Boostrix), Dose 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Any Redness (Cervarix), Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
43
  16.7%
Grade 3 Redness (Cervarix), Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
Any Swelling (Nimenrix), Dose 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Grade 3 Swelling (Nimenrix), Dose 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Any Swelling (Boostrix), Dose 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Grade 3 Swelling (Boostrix), Dose 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Any Swelling (Cervarix), Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
41
  15.9%
Grade 3 Swelling (Cervarix), Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
1
   0.4%
Any Pain (Nimenrix), Across doses Number Analyzed 259 participants 257 participants 0 participants 260 participants 0 participants
152
  58.7%
140
  54.5%
156
  60.0%
Grade 3 Pain (Nimenrix), Across doses Number Analyzed 259 participants 257 participants 0 participants 260 participants 0 participants
4
   1.5%
3
   1.2%
7
   2.7%
Any Pain (Boostrix), Across doses Number Analyzed 0 participants 0 participants 0 participants 260 participants 261 participants
189
  72.7%
200
  76.6%
Grade 3 Pain (Boostrix), Across doses Number Analyzed 0 participants 0 participants 0 participants 260 participants 261 participants
21
   8.1%
15
   5.7%
Any Pain (Cervarix), Across doses Number Analyzed 258 participants 257 participants 259 participants 260 participants 261 participants
193
  74.8%
213
  82.9%
205
  79.2%
217
  83.5%
221
  84.7%
Grade 3 Pain (Cervarix), Across doses Number Analyzed 258 participants 257 participants 259 participants 260 participants 261 participants
15
   5.8%
8
   3.1%
11
   4.2%
23
   8.8%
18
   6.9%
Any Redness (Nimenrix), Across doses Number Analyzed 259 participants 257 participants 0 participants 260 participants 0 participants
57
  22.0%
42
  16.3%
54
  20.8%
Grade 3 Redness (Nimenrix), Across doses Number Analyzed 259 participants 257 participants 0 participants 260 participants 0 participants
4
   1.5%
2
   0.8%
0
   0.0%
Any Redness (Boostrix), Across doses Number Analyzed 0 participants 0 participants 0 participants 260 participants 261 participants
73
  28.1%
53
  20.3%
Grade 3 Redness (Boostrix), Across doses Number Analyzed 0 participants 0 participants 0 participants 260 participants 261 participants
2
   0.8%
4
   1.5%
Any Redness (Cervarix), Across doses Number Analyzed 258 participants 257 participants 259 participants 260 participants 261 participants
43
  16.7%
56
  21.8%
54
  20.8%
62
  23.8%
48
  18.4%
Grade 3 Redness (Cervarix), Across doses Number Analyzed 258 participants 257 participants 259 participants 260 participants 261 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
0
   0.0%
Any Swelling (Nimenrix), Across doses Number Analyzed 259 participants 257 participants 0 participants 260 participants 0 participants
40
  15.4%
34
  13.2%
58
  22.3%
Grade 3 Swelling (Nimenrix), Across doses Number Analyzed 259 participants 257 participants 0 participants 260 participants 0 participants
1
   0.4%
1
   0.4%
5
   1.9%
Any Swelling (Boostrix), Across doses Number Analyzed 0 participants 0 participants 0 participants 260 participants 261 participants
79
  30.4%
58
  22.2%
Grade 3 Swelling (Boostrix), Across doses Number Analyzed 0 participants 0 participants 0 participants 260 participants 261 participants
5
   1.9%
7
   2.7%
Any Swelling (Cervarix), Across doses Number Analyzed 258 participants 257 participants 259 participants 260 participants 261 participants
41
  15.9%
42
  16.3%
37
  14.3%
64
  24.6%
55
  21.1%
Grade 3 Swelling (Cervarix), Across doses Number Analyzed 258 participants 257 participants 259 participants 260 participants 261 participants
1
   0.4%
1
   0.4%
1
   0.4%
1
   0.4%
5
   1.9%
17.Secondary Outcome
Title Number of Subjects Reporting Solicited General Symptoms
Hide Description Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Some groups do not have results for "Dose 2" because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented, who filled in their symptom sheets.
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Boostrix+Cervarix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 259 257 259 260 261
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
23
   8.9%
18
   7.0%
13
   5.0%
36
  13.8%
23
   8.8%
Grade 3 Arthralgia, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
0
   0.0%
1
   0.4%
1
   0.4%
1
   0.4%
4
   1.5%
Related Arthralgia, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
23
   8.9%
18
   7.0%
13
   5.0%
34
  13.1%
23
   8.8%
Any Fatigue, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
87
  33.6%
95
  37.0%
85
  32.8%
110
  42.3%
101
  38.7%
Grade 3 Fatigue, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
2
   0.8%
4
   1.6%
2
   0.8%
8
   3.1%
5
   1.9%
Related Fatigue, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
82
  31.7%
92
  35.8%
79
  30.5%
103
  39.6%
99
  37.9%
Any Gastrointestinal, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
21
   8.1%
27
  10.5%
23
   8.9%
29
  11.2%
22
   8.4%
Grade 3 Gastrointestinal, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
1
   0.4%
1
   0.4%
0
   0.0%
2
   0.8%
0
   0.0%
Related Gastrointestinal, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
19
   7.3%
27
  10.5%
21
   8.1%
26
  10.0%
20
   7.7%
Any Headache, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
82
  31.7%
94
  36.6%
78
  30.1%
99
  38.1%
95
  36.4%
Grade 3 Headache, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
5
   1.9%
3
   1.2%
5
   1.9%
5
   1.9%
4
   1.5%
Related Headache, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
81
  31.3%
89
  34.6%
73
  28.2%
92
  35.4%
85
  32.6%
Any Myalgia, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
65
  25.1%
83
  32.3%
85
  32.8%
96
  36.9%
101
  38.7%
Grade 3 Myalgia, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
0
   0.0%
4
   1.6%
6
   2.3%
9
   3.5%
9
   3.4%
Related Myalgia, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
60
  23.2%
81
  31.5%
82
  31.7%
92
  35.4%
100
  38.3%
Any Rash, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
4
   1.5%
8
   3.1%
8
   3.1%
6
   2.3%
6
   2.3%
Grade 3 Rash, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Rash, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
1
   0.4%
6
   2.3%
7
   2.7%
6
   2.3%
4
   1.5%
Any Fever, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
24
   9.3%
32
  12.5%
15
   5.8%
38
  14.6%
27
  10.3%
Grade 3 Fever, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Fever, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
21
   8.1%
31
  12.1%
14
   5.4%
37
  14.2%
25
   9.6%
Any Urticaria, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
0
   0.0%
4
   1.6%
4
   1.5%
5
   1.9%
5
   1.9%
Grade 3 Urticaria, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Urticaria, Dose 1 Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
0
   0.0%
3
   1.2%
4
   1.5%
5
   1.9%
3
   1.1%
Any Arthralgia, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
18
   7.0%
Grade 3 Arthralgia, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
Related Arthralgia, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
18
   7.0%
Any Fatigue, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
61
  23.6%
Grade 3 Fatigue, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
2
   0.8%
Related Fatigue, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
58
  22.5%
Any Gastrointestinal, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
10
   3.9%
Grade 3 Gastrointestinal, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
1
   0.4%
Related Gastrointestinal, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
8
   3.1%
Any Headache, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
58
  22.5%
Grade 3 Headache, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
3
   1.2%
Related Headache, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
55
  21.3%
Any Myalgia, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
73
  28.3%
Grade 3 Myalgia, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
4
   1.6%
Related Myalgia, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
72
  27.9%
Any Rash, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
3
   1.2%
Grade 3 Rash, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
Related Rash, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
3
   1.2%
Any Fever, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
11
   4.3%
Grade 3 Fever, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
Related Fever, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
10
   3.9%
Any Urticaria, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
2
   0.8%
Grade 3 Urticaria, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
0
   0.0%
Related Urticaria, Dose 2 Number Analyzed 258 participants 0 participants 0 participants 0 participants 0 participants
2
   0.8%
Any Arthralgia, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
34
  13.1%
18
   7.0%
13
   5.0%
36
  13.8%
23
   8.8%
Grade 3 Arthralgia, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
0
   0.0%
1
   0.4%
1
   0.4%
1
   0.4%
4
   1.5%
Related Arthralgia, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
34
  13.1%
18
   7.0%
13
   5.0%
34
  13.1%
23
   8.8%
Any Fatigue, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
105
  40.5%
95
  37.0%
85
  32.8%
110
  42.3%
101
  38.7%
Grade 3 Fatigue, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
4
   1.5%
4
   1.6%
2
   0.8%
8
   3.1%
5
   1.9%
Related Fatigue, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
98
  37.8%
92
  35.8%
79
  30.5%
103
  39.6%
99
  37.9%
Any Gastrointestinal, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
26
  10.0%
27
  10.5%
23
   8.9%
29
  11.2%
22
   8.4%
Grade 3 Gastrointestinal, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
2
   0.8%
1
   0.4%
0
   0.0%
2
   0.8%
0
   0.0%
Related Gastrointestinal, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
23
   8.9%
27
  10.5%
21
   8.1%
26
  10.0%
20
   7.7%
Any Headache, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
101
  39.0%
94
  36.6%
78
  30.1%
99
  38.1%
95
  36.4%
Grade 3 Headache, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
8
   3.1%
3
   1.2%
5
   1.9%
5
   1.9%
4
   1.5%
Related Headache, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
99
  38.2%
89
  34.6%
73
  28.2%
92
  35.4%
85
  32.6%
Any Myalgia, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
95
  36.7%
83
  32.3%
85
  32.8%
96
  36.9%
101
  38.7%
Grade 3 Myalgia, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
4
   1.5%
4
   1.6%
6
   2.3%
9
   3.5%
9
   3.4%
Related Myalgia, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
91
  35.1%
81
  31.5%
82
  31.7%
92
  35.4%
100
  38.3%
Any Rash, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
7
   2.7%
8
   3.1%
8
   3.1%
6
   2.3%
6
   2.3%
Grade 3 Rash, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Rash, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
4
   1.5%
6
   2.3%
7
   2.7%
6
   2.3%
4
   1.5%
Any Fever, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
34
  13.1%
32
  12.5%
15
   5.8%
38
  14.6%
27
  10.3%
Grade 3 Fever, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Fever, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
30
  11.6%
31
  12.1%
14
   5.4%
37
  14.2%
25
   9.6%
Any Urticaria, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
2
   0.8%
4
   1.6%
4
   1.5%
5
   1.9%
5
   1.9%
Grade 3 Urticaria, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Urticaria, Across doses Number Analyzed 259 participants 257 participants 259 participants 260 participants 261 participants
2
   0.8%
3
   1.2%
4
   1.5%
5
   1.9%
3
   1.1%
18.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events AE(s)
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame During the 31-day (Days 0-30) period following vaccination with Nimenrix, Boostrix or the first dose of Cervarix
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 259 259 261 260 261
Measure Type: Count of Participants
Unit of Measure: Participants
37
  14.3%
35
  13.5%
35
  13.4%
42
  16.2%
39
  14.9%
19.Secondary Outcome
Title Number of Subjects With Serious Adverse Events SAE(s)
Hide Description SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame During the entire study period (from Month 0 to Month 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 259 259 261 260 261
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.2%
2
   0.8%
5
   1.9%
7
   2.7%
6
   2.3%
20.Secondary Outcome
Title Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
Hide Description pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame During the entire study period (from Month 0 to Month 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 259 259 261 260 261
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
21.Secondary Outcome
Title Number of Subjects With New Onset Chronic Illnesses (NOCIs)
Hide Description NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame During the entire study period (from Month 0 to Month 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Hide Arm/Group Description:
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Number of Participants Analyzed 259 259 261 260 261
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.2%
0
   0.0%
1
   0.4%
0
   0.0%
2
   0.8%
Time Frame Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Hide Arm/Group Description Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm. Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm. Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
All-Cause Mortality
Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/259 (0.00%)      0/259 (0.00%)      0/261 (0.00%)      0/260 (0.00%)      1/261 (0.38%)    
Hide Serious Adverse Events
Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/259 (1.16%)      2/259 (0.77%)      5/261 (1.92%)      7/260 (2.69%)      6/261 (2.30%)    
Congenital, familial and genetic disorders           
Atrial septal defect  1  0/259 (0.00%)  0 0/259 (0.00%)  0 0/261 (0.00%)  0 1/260 (0.38%)  1 0/261 (0.00%)  0
Infections and infestations           
Appendicitis  1  2/259 (0.77%)  2 0/259 (0.00%)  0 0/261 (0.00%)  0 1/260 (0.38%)  1 0/261 (0.00%)  0
Dengue fever  1  0/259 (0.00%)  0 1/259 (0.39%)  1 2/261 (0.77%)  2 2/260 (0.77%)  2 0/261 (0.00%)  0
Gastroenteritis  1  0/259 (0.00%)  0 0/259 (0.00%)  0 0/261 (0.00%)  0 1/260 (0.38%)  1 1/261 (0.38%)  1
Influenza  1  0/259 (0.00%)  0 0/259 (0.00%)  0 1/261 (0.38%)  1 0/260 (0.00%)  0 0/261 (0.00%)  0
Pelvic inflammatory disease  1  0/259 (0.00%)  0 0/259 (0.00%)  0 1/261 (0.38%)  1 0/260 (0.00%)  0 0/261 (0.00%)  0
Pharyngitis  1  0/259 (0.00%)  0 1/259 (0.39%)  1 0/261 (0.00%)  0 0/260 (0.00%)  0 0/261 (0.00%)  0
Injury, poisoning and procedural complications           
Stab wound  1  0/259 (0.00%)  0 0/259 (0.00%)  0 0/261 (0.00%)  0 0/260 (0.00%)  0 1/261 (0.38%)  1
Metabolism and nutrition disorders           
Underweight  1  0/259 (0.00%)  0 0/259 (0.00%)  0 0/261 (0.00%)  0 0/260 (0.00%)  0 1/261 (0.38%)  1
Musculoskeletal and connective tissue disorders           
Pain in extremity  1  0/259 (0.00%)  0 0/259 (0.00%)  0 0/261 (0.00%)  0 1/260 (0.38%)  1 0/261 (0.00%)  0
Nervous system disorders           
Migraine  1  0/259 (0.00%)  0 0/259 (0.00%)  0 0/261 (0.00%)  0 0/260 (0.00%)  0 1/261 (0.38%)  1
Pregnancy, puerperium and perinatal conditions           
Premature baby  1  0/259 (0.00%)  0 0/259 (0.00%)  0 0/261 (0.00%)  0 0/260 (0.00%)  0 1/261 (0.38%)  1
Abortion incomplete  1  0/259 (0.00%)  0 0/259 (0.00%)  0 0/261 (0.00%)  0 1/260 (0.38%)  1 0/261 (0.00%)  0
Abortion spontaneous  1  0/259 (0.00%)  0 0/259 (0.00%)  0 1/261 (0.38%)  1 0/260 (0.00%)  0 0/261 (0.00%)  0
Reproductive system and breast disorders           
Ovarian cyst  1  0/259 (0.00%)  0 0/259 (0.00%)  0 0/261 (0.00%)  0 0/260 (0.00%)  0 1/261 (0.38%)  1
Pelvic pain  1  0/259 (0.00%)  0 0/259 (0.00%)  0 0/261 (0.00%)  0 0/260 (0.00%)  0 1/261 (0.38%)  1
Respiratory, thoracic and mediastinal disorders           
Neonatal respiratory distress syndrome  1  0/259 (0.00%)  0 0/259 (0.00%)  0 0/261 (0.00%)  0 0/260 (0.00%)  0 1/261 (0.38%)  1
Skin and subcutaneous tissue disorders           
Dermatitis atopic  1  1/259 (0.39%)  1 0/259 (0.00%)  0 0/261 (0.00%)  0 0/260 (0.00%)  0 0/261 (0.00%)  0
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nimenrix+Cervarix (1,2,7-Month) Group Nimenrix+Cervarix (0,1,6-Month) Group Cervarix Group Nimenrix+Cervarix+Boostrix Group Boostrix+Cervarix Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   232/259 (89.58%)      228/259 (88.03%)      222/261 (85.06%)      236/260 (90.77%)      243/261 (93.10%)    
Gastrointestinal disorders           
Gastrointestinal disorder  1  26/259 (10.04%)  31 27/259 (10.42%)  27 23/261 (8.81%)  23 29/260 (11.15%)  29 22/261 (8.43%)  22
General disorders           
Fatigue  1  105/259 (40.54%)  148 95/259 (36.68%)  95 85/261 (32.57%)  85 110/260 (42.31%)  110 101/261 (38.70%)  101
Pain  1  217/259 (83.78%)  345 220/259 (84.94%)  220 205/261 (78.54%)  205 228/260 (87.69%)  228 233/261 (89.27%)  233
Pyrexia  1  35/259 (13.51%)  36 33/259 (12.74%)  34 16/261 (6.13%)  16 39/260 (15.00%)  39 28/261 (10.73%)  28
Swelling  1  62/259 (23.94%)  81 54/259 (20.85%)  54 37/261 (14.18%)  37 98/260 (37.69%)  98 70/261 (26.82%)  70
Musculoskeletal and connective tissue disorders           
Arthralgia  1  34/259 (13.13%)  41 18/259 (6.95%)  18 13/261 (4.98%)  13 36/260 (13.85%)  36 23/261 (8.81%)  23
Myalgia  1  95/259 (36.68%)  139 83/259 (32.05%)  83 85/261 (32.57%)  85 96/260 (36.92%)  96 101/261 (38.70%)  101
Nervous system disorders           
Headache  1  103/259 (39.77%)  147 98/259 (37.84%)  99 78/261 (29.89%)  78 102/260 (39.23%)  107 98/261 (37.55%)  101
Skin and subcutaneous tissue disorders           
Erythema  1  78/259 (30.12%)  100 68/259 (26.25%)  68 54/261 (20.69%)  54 90/260 (34.62%)  90 64/261 (24.52%)  64
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01755689    
Other Study ID Numbers: 113823
2012-001876-13 ( EudraCT Number )
First Submitted: December 13, 2012
First Posted: December 24, 2012
Results First Submitted: June 16, 2017
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018