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Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule

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ClinicalTrials.gov Identifier: NCT00513409
Recruitment Status : Completed
First Posted : August 8, 2007
Results First Posted : August 11, 2009
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Investigator);   Primary Purpose: Prevention
Condition Infections, Streptococcal
Interventions Biological: Synflorix
Biological: Infanrix Hexa
Biological: Havrix
Enrollment 163
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Synflorix Booster Group Synflorix Catch-up Group
Hide Arm/Group Description Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2). Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Period Title: Overall Study
Started 84 79
Completed 82 73
Not Completed 2 6
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             0             2
Lost to Follow-up             0             1
Physician Decision             1             0
Visit 3 not done             1             2
Arm/Group Title Synflorix Booster Group Synflorix Catch-up Group Total
Hide Arm/Group Description Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2). Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2). Total of all reporting groups
Overall Number of Baseline Participants 84 79 163
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 84 participants 79 participants 163 participants
18.3  (0.44) 18.3  (0.50) 18.3  (0.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 79 participants 163 participants
Female
39
  46.4%
44
  55.7%
83
  50.9%
Male
45
  53.6%
35
  44.3%
80
  49.1%
1.Primary Outcome
Title Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)
Hide Description Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).
Time Frame Within 4 days after the administration of any study vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.
Arm/Group Title Synflorix Booster Group Synflorix Catch-up Group
Hide Arm/Group Description:
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Overall Number of Participants Analyzed 84 78
Measure Type: Number
Unit of Measure: subjects
Any symptoms 32 36
General symptoms 6 14
Local symptoms 30 32
2.Secondary Outcome
Title Number of Subjects Reporting Solicited Local Symptoms
Hide Description Solicited local symptoms assessed include pain, redness and swelling.
Time Frame Within 4 days after the administration of any study vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.
Arm/Group Title Synflorix Booster Group Synflorix Catch-up Group
Hide Arm/Group Description:
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Overall Number of Participants Analyzed 84 78
Measure Type: Number
Unit of Measure: subjects
Pain 57 63
Redness 49 52
Swelling 44 47
3.Secondary Outcome
Title Number of Subjects Reporting Solicited General Symptoms
Hide Description

Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.

Fever was defined as rectal temperature ≥ 38 degrees Celsius.

Time Frame Within 4 days after the administration of any study vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all subjects included in the Total Vaccinated Cohort, who returned the symptom sheet.
Arm/Group Title Synflorix Booster Group Synflorix Catch-up Group
Hide Arm/Group Description:
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Overall Number of Participants Analyzed 84 78
Measure Type: Number
Unit of Measure: subjects
Drowsiness 33 36
Fever 30 40
Irritability 56 55
Loss of appetite 35 37
4.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events
Hide Description An Adverse Event is 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.
Time Frame Within 31 days after the administration of any study vaccine dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Synflorix Booster Group Synflorix Catch-up Group
Hide Arm/Group Description:
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Overall Number of Participants Analyzed 84 79
Measure Type: Number
Unit of Measure: subjects
47 47
5.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study
Hide Description

A serious adverse event (SAE) is any untoward medical occurrence that:

results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Time Frame Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Synflorix Booster Group Synflorix Catch-up Group
Hide Arm/Group Description:
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Overall Number of Participants Analyzed 84 79
Measure Type: Number
Unit of Measure: subjects
1 0
6.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period
Hide Description

An SAE is any untoward medical occurrence that:

results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Time Frame Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Synflorix Booster Group Synflorix Catch-up Group
Hide Arm/Group Description:
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Overall Number of Participants Analyzed 84 79
Measure Type: Number
Unit of Measure: subjects
1 0
7.Secondary Outcome
Title Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Hide Description

Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL).

The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.

Time Frame Before (pre) and one month after (post) the administration of Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results
Arm/Group Title Synflorix Booster Group Synflorix Catch-up Group
Hide Arm/Group Description:
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Overall Number of Participants Analyzed 80 73
Measure Type: Number
Unit of Measure: subjects
Anti-1 Pre (N=79; 72) 43 1
Anti-1 Post (N=78; 70) 78 70
Anti-4 Pre (N=75; 73) 45 3
Anti-4 Post (N=77; 70) 77 70
Anti-5 Pre (N=76; 70) 58 7
Anti-5 Post (N=78; 70) 77 70
Anti-6A Pre (N=76; 72) 66 36
Anti-6A Post (N=77; 70) 71 64
Anti-6B Pre (N=76; 73) 55 1
Anti-6B Post (N=78; 70) 76 59
Anti-7F Pre (N=70; 68) 60 8
Anti-7F Post (N=78; 70) 77 70
Anti-9V Pre (N=78; 72) 71 6
Anti-9V Post (N=79; 70) 79 69
Anti-14 Pre (N=76; 71) 69 20
Anti-14 Post (N=79; 70) 79 70
Anti-18C Pre (N=77; 73) 68 5
Anti-18C Post (N=78; 70) 78 70
Anti-19A Pre (N=78; 73) 72 50
Anti-19A Post (N=78; 70) 78 70
Anti-19F Pre (N=80; 72) 76 19
Anti-19F Post (N=78; 70) 78 70
Anti-23F Pre (N=76; 71) 59 3
Anti-23F Post (N=78; 70) 78 66
8.Secondary Outcome
Title Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Hide Description

Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8

The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.

Time Frame Before (pre) and one month after (post) the administration of Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results
Arm/Group Title Synflorix Booster Group Synflorix Catch-up Group
Hide Arm/Group Description:
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Overall Number of Participants Analyzed 29 28
Measure Type: Number
Unit of Measure: subjects
Opsono-1 Pre (N=28; 25) 12 1
Opsono-1 Post (N=25; 25) 25 13
Opsono-4 Pre (N=17; 19) 7 1
Opsono-4 Post (N=24; 18) 24 18
Opsono-5 Pre (N=19; 23) 13 1
Opsono-5 Post (N=20; 25) 20 21
Opsono-6A Pre (N=20; 25) 12 2
Opsono-6A Post (N=19; 19) 14 12
Opsono-6B Pre (N=22; 25) 12 3
Opsono-6B Post (N=24; 27) 22 13
Opsono-7F Pre (N=17; 12) 16 4
Opsono-7F Post (N=25; 26) 25 26
Opsono-9V Pre (N=20; 17) 20 11
Opsono-9V Post (N=23; 23) 23 22
Opsono-14 Pre (N=16; 11) 14 5
Opsono-14 Post (N=21; 25) 21 25
Opsono-18C Pre (N=29; 28) 12 3
Opsono-18C Post (N=26; 27) 25 27
Opsono-19A Pre (N=18; 18) 0 0
Opsono-19A Post (N=23; 19) 14 5
Opsono-19F Pre (N=22; 23) 17 2
Opsono-19F Post (N=20; 21) 20 20
Opsono-23F Pre (N=21; 16) 18 8
Opsono-23F Post (N=25; 25) 25 25
9.Secondary Outcome
Title Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value
Hide Description Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Time Frame Before (pre) and one month after (post) the administration of Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results
Arm/Group Title Synflorix Booster Group Synflorix Catch-up Group
Hide Arm/Group Description:
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Overall Number of Participants Analyzed 77 70
Measure Type: Number
Unit of Measure: subjects
Pre (N= 73; 69) 72 44
Post (N= 77; 70) 77 70
10.Secondary Outcome
Title Anti-hepatitis A Virus Antibodies Concentration
Hide Description Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).
Time Frame Before (pre) and one month after (post) the administration of Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity,on subjects with available results
Arm/Group Title Synflorix Booster Group Synflorix Catch-up Group
Hide Arm/Group Description:
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Overall Number of Participants Analyzed 19 21
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Pre (N=18; 21)
30.3
(16.3 to 56.3)
539.9
(231.0 to 1261.9)
Post (N=19; 19)
495.5
(228.0 to 1076.7)
478.5
(199.4 to 1148.2)
11.Secondary Outcome
Title Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value
Hide Description Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.
Time Frame Before (pre) and one month after (post) the administration of Dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results.
Arm/Group Title Synflorix Booster Group Synflorix Catch-up Group
Hide Arm/Group Description:
Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
Overall Number of Participants Analyzed 19 21
Measure Type: Number
Unit of Measure: subjects
Pre (N=18; 21) 12 21
Post (N=19; 19) 18 19
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Synflorix Booster Group Synflorix Catch-up Group
Hide Arm/Group Description Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2). Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
All-Cause Mortality
Synflorix Booster Group Synflorix Catch-up Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Synflorix Booster Group Synflorix Catch-up Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/84 (1.19%)   0/79 (0.00%) 
Injury, poisoning and procedural complications     
Thermal burn *  1/84 (1.19%)  0/79 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Synflorix Booster Group Synflorix Catch-up Group
Affected / at Risk (%) Affected / at Risk (%)
Total   78/84 (92.86%)   75/79 (94.94%) 
Gastrointestinal disorders     
Diarrhoea *  6/84 (7.14%)  8/79 (10.13%) 
Vomiting *  5/84 (5.95%)  2/79 (2.53%) 
General disorders     
Injection site induration *  7/84 (8.33%)  7/79 (8.86%) 
Pain   57/84 (67.86%)  63/79 (79.75%) 
Redness   49/84 (58.33%)  52/79 (65.82%) 
Swelling   44/84 (52.38%)  47/79 (59.49%) 
Drowsiness   33/84 (39.29%)  36/79 (45.57%) 
Fever (Rectally)   30/84 (35.71%)  40/79 (50.63%) 
Irritability   56/84 (66.67%)  55/79 (69.62%) 
Loss of appetite   35/84 (41.67%)  37/79 (46.84%) 
Pyrexia *  4/84 (4.76%)  5/79 (6.33%) 
Infections and infestations     
Bronchitis *  15/84 (17.86%)  16/79 (20.25%) 
Nasopharyngitis *  6/84 (7.14%)  14/79 (17.72%) 
Rhinitis *  5/84 (5.95%)  4/79 (5.06%) 
Pharyngitis *  6/84 (7.14%)  8/79 (10.13%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-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
Publications:
Lagos R et al. 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) given as booster dose or 2-dose catch-up in Chilean children. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00513409     History of Changes
Other Study ID Numbers: 110031
First Submitted: August 7, 2007
First Posted: August 8, 2007
Results First Submitted: March 11, 2009
Results First Posted: August 11, 2009
Last Update Posted: December 18, 2018