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Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (GSK580299) in Healthy Female Subjects 10-25 Years of Age.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00481767
Recruitment Status : Completed
First Posted : June 4, 2007
Results First Posted : March 24, 2011
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Human Papillomavirus (HPV) Infection
Interventions Biological: Cervarix
Drug: Placebo Al(OH)3
Enrollment 676
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Period Title: Overall Study
Started 450 226
Completed 418 205
Not Completed 32 21
Reason Not Completed
Withdrawal by Subject             16             11
Lost to Follow-up             16             10
Arm/Group Title Cervarix Group Placebo Group Total
Hide Arm/Group Description Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. Total of all reporting groups
Overall Number of Baseline Participants 450 226 676
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 450 participants 226 participants 676 participants
16.9  (4.36) 16.8  (4.16) 16.9  (4.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 450 participants 226 participants 676 participants
Female
450
 100.0%
226
 100.0%
676
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 450 participants 226 participants 676 participants
African/African american
431
  95.8%
219
  96.9%
650
  96.2%
Not specified
19
   4.2%
7
   3.1%
26
   3.8%
1.Primary Outcome
Title Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies
Hide Description

A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination.

The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.

Time Frame At Month 7
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 for whom immunogenicity data were available.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Overall Number of Participants Analyzed 212 98
Measure Type: Count of Participants
Unit of Measure: Participants
10-14 years anti-HPV-16 Number Analyzed 130 participants 59 participants
130
 100.0%
4
   6.8%
15-25 years anti-HPV-16 Number Analyzed 190 participants 97 participants
190
 100.0%
5
   5.2%
10-14 years anti-HPV-18 Number Analyzed 128 participants 56 participants
128
 100.0%
2
   3.6%
15-25 years anti-HPV-18 Number Analyzed 212 participants 98 participants
212
 100.0%
5
   5.1%
2.Primary Outcome
Title Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies
Hide Description

Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.

Time Frame At Month 7
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 for whom immunogenicity data were available.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Overall Number of Participants Analyzed 237 114
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
10-14 years anti-HPV-16 Number Analyzed 142 participants 65 participants
18591.3
(16433.0 to 21033.1)
4.8
(4.2 to 5.5)
15-25 years anti-HPV-16 Number Analyzed 237 participants 112 participants
10664.0
(9668.5 to 11762.0)
5.3
(4.6 to 6.1)
10-14 years anti-HPV-18 Number Analyzed 141 participants 66 participants
6409.8
(5563.4 to 7385.0)
3.9
(3.6 to 4.2)
15-25 years anti-HPV-18 Number Analyzed 235 participants 114 participants
3653.6
(3343.9 to 3991.9)
4.6
(4.0 to 5.3)
3.Secondary Outcome
Title Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies
Hide Description

A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination.

The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.

Time Frame At Month 2 and Month 12
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 for whom immunogenicity data were available.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Overall Number of Participants Analyzed 212 98
Measure Type: Count of Participants
Unit of Measure: Participants
10-14 years anti-HPV-16 Month 2 Number Analyzed 130 participants 59 participants
130
 100.0%
1
   1.7%
15-25 years anti-HPV-16 Month 2 Number Analyzed 190 participants 96 participants
190
 100.0%
3
   3.1%
10-14 years anti-HPV-16 Month 12 Number Analyzed 128 participants 59 participants
128
 100.0%
2
   3.4%
15-25 years anti-HPV-16 Month 12 Number Analyzed 184 participants 94 participants
184
 100.0%
7
   7.4%
10-14 years anti-HPV-18 Month 2 Number Analyzed 128 participants 55 participants
128
 100.0%
1
   1.8%
15-25 years anti-HPV-18 Month 2 Number Analyzed 212 participants 98 participants
212
 100.0%
4
   4.1%
10-14 years anti-HPV-18 Month 12 Number Analyzed 126 participants 56 participants
125
  99.2%
0
   0.0%
15-25 years anti-HPV-18 Month 12 Number Analyzed 205 participants 96 participants
205
 100.0%
6
   6.3%
4.Secondary Outcome
Title GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies
Hide Description

Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.

Time Frame At Month 2 and Month 12
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 for whom immunogenicity data were available.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Overall Number of Participants Analyzed 237 112
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
10-14 years anti-HPV-16 Month 2 Number Analyzed 142 participants 64 participants
5340.2
(4823.7 to 5912.0)
4.5
(4.0 to 5.0)
15-25 years anti-HPV-16 Month 2 Number Analyzed 237 participants 112 participants
3732.6
(3436.6 to 4054.1)
4.9
(4.3 to 5.5)
10-14 years anti-HPV-16 Month 12 Number Analyzed 139 participants 65 participants
4016.2
(3323.3 to 4853.7)
4.7
(4.2 to 5.3)
15-25 years anti-HPV-16 Month 12 Number Analyzed 229 participants 109 participants
2464.2
(2196.5 to 2764.5)
5.6
(4.7 to 6.6)
10-14 years anti-HPV-18 Month 2 Number Analyzed 141 participants 65 participants
3016.7
(2677.4 to 3398.9)
3.9
(3.6 to 4.3)
15-25 years anti-HPV-18 Month 2 Number Analyzed 235 participants 112 participants
2039.3
(1861.3 to 2234.4)
4.6
(4.0 to 5.3)
10-14 years anti-HPV-18 Month 12 Number Analyzed 138 participants 66 participants
1422.1
(1170.0 to 1728.4)
3.7
(3.5 to 3.9)
15-25 years anti-HPV-18 Month 12 Number Analyzed 227 participants 111 participants
855.9
(768.3 to 953.5)
4.6
(4.0 to 5.4)
5.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Solicited local symptoms assessed were pain and swelling at the injection site. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Grade 3 pain = pain that prevented normal activity.
Time Frame Within 7 days (Day 0-6) after 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 vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Overall Number of Participants Analyzed 450 226
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 450 participants 226 participants
309
  68.7%
116
  51.3%
Grade 3 Pain, Dose 1 Number Analyzed 450 participants 226 participants
2
   0.4%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 450 participants 226 participants
15
   3.3%
7
   3.1%
Grade 3 Swelling, Dose 1 Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 437 participants 217 participants
265
  60.6%
95
  43.8%
Grade 3 Pain, Dose 2 Number Analyzed 437 participants 217 participants
0
   0.0%
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 437 participants 217 participants
45
  10.3%
15
   6.9%
Grade 3 Swelling, Dose 2 Number Analyzed 437 participants 217 participants
0
   0.0%
0
   0.0%
Any Pain, Dose 3 Number Analyzed 411 participants 200 participants
200
  48.7%
66
  33.0%
Grade 3 Pain, Dose 3 Number Analyzed 411 participants 200 participants
0
   0.0%
0
   0.0%
Any Swelling, Dose 3 Number Analyzed 411 participants 200 participants
26
   6.3%
10
   5.0%
Grade 3 Swelling, Dose 3 Number Analyzed 411 participants 200 participants
0
   0.0%
0
   0.0%
Any Pain, Across doses Number Analyzed 450 participants 226 participants
375
  83.3%
166
  73.5%
Grade 3 Pain, Across doses Number Analyzed 450 participants 226 participants
2
   0.4%
0
   0.0%
Any Swelling, Across doses Number Analyzed 450 participants 226 participants
74
  16.4%
27
  11.9%
Grade 3 Swelling, Across doses Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Solicited general symptoms assessed were arthralgia (only joints that are distal from the injection site), fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time Frame Within 7 days (Day 0-6) after 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 vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Overall Number of Participants Analyzed 450 226
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia, Dose 1 Number Analyzed 450 participants 226 participants
19
   4.2%
10
   4.4%
Grade 3 Arthralgia, Dose 1 Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Arthralgia, Dose 1 Number Analyzed 450 participants 226 participants
7
   1.6%
2
   0.9%
Any Fatigue, Dose 1 Number Analyzed 450 participants 226 participants
34
   7.6%
12
   5.3%
Grade 3 Fatigue, Dose 1 Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Fatigue, Dose 1 Number Analyzed 450 participants 226 participants
21
   4.7%
3
   1.3%
Any Fever, Dose 1 Number Analyzed 450 participants 226 participants
72
  16.0%
43
  19.0%
Grade 3 Fever, Dose 1 Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Fever, Dose 1 Number Analyzed 450 participants 226 participants
34
   7.6%
17
   7.5%
Any Gastrointestinal, Dose 1 Number Analyzed 450 participants 226 participants
34
   7.6%
21
   9.3%
Grade 3 Gastrointestinal, Dose 1 Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Gastrointestinal, Dose 1 Number Analyzed 450 participants 226 participants
14
   3.1%
8
   3.5%
Any Headache, Dose 1 Number Analyzed 450 participants 226 participants
89
  19.8%
56
  24.8%
Grade 3 Headache, Dose 1 Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Headache, Dose 1 Number Analyzed 450 participants 226 participants
51
  11.3%
25
  11.1%
Any Myalgia, Dose 1 Number Analyzed 450 participants 226 participants
35
   7.8%
16
   7.1%
Grade 3 Myalgia, Dose 1 Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Myalgia, Dose 1 Number Analyzed 450 participants 226 participants
22
   4.9%
7
   3.1%
Any Rash, Dose 1 Number Analyzed 450 participants 226 participants
14
   3.1%
8
   3.5%
Grade 3 Rash, Dose 1 Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Rash, Dose 1 Number Analyzed 450 participants 226 participants
1
   0.2%
0
   0.0%
Any Urticaria, Dose 1 Number Analyzed 450 participants 226 participants
12
   2.7%
7
   3.1%
Grade 3 Urticaria, Dose 1 Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Urticaria, Dose 1 Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Any Arthralgia, Dose 2 Number Analyzed 437 participants 217 participants
47
  10.8%
17
   7.8%
Grade 3 Arthralgia, Dose 2 Number Analyzed 437 participants 217 participants
0
   0.0%
0
   0.0%
Related Arthralgia, Dose 2 Number Analyzed 437 participants 217 participants
4
   0.9%
2
   0.9%
Any Fatigue, Dose 2 Number Analyzed 437 participants 217 participants
62
  14.2%
25
  11.5%
Grade 3 Fatigue, Dose 2 Number Analyzed 437 participants 217 participants
0
   0.0%
0
   0.0%
Related Fatigue, Dose 2 Number Analyzed 437 participants 217 participants
17
   3.9%
4
   1.8%
Any Fever, Dose 2 Number Analyzed 437 participants 217 participants
82
  18.8%
33
  15.2%
Grade 3 Fever, Dose 2 Number Analyzed 437 participants 217 participants
0
   0.0%
0
   0.0%
Related Fever, Dose 2 Number Analyzed 437 participants 217 participants
19
   4.3%
8
   3.7%
Any Gastrointestinal, Dose 2 Number Analyzed 437 participants 217 participants
66
  15.1%
26
  12.0%
Grade 3 Gastrointestinal, Dose 2 Number Analyzed 437 participants 217 participants
0
   0.0%
0
   0.0%
Related Gastrointestinal, Dose 2 Number Analyzed 437 participants 217 participants
15
   3.4%
6
   2.8%
Any Headache, Dose 2 Number Analyzed 437 participants 217 participants
96
  22.0%
49
  22.6%
Grade 3 Headache, Dose 2 Number Analyzed 437 participants 217 participants
0
   0.0%
0
   0.0%
Related Headache, Dose 2 Number Analyzed 437 participants 217 participants
40
   9.2%
18
   8.3%
Any Myalgia, Dose 2 Number Analyzed 437 participants 217 participants
50
  11.4%
17
   7.8%
Grade 3 Myalgia, Dose 2 Number Analyzed 437 participants 217 participants
0
   0.0%
0
   0.0%
Related Myalgia, Dose 2 Number Analyzed 437 participants 217 participants
9
   2.1%
3
   1.4%
Any Rash, Dose 2 Number Analyzed 437 participants 217 participants
44
  10.1%
15
   6.9%
Grade 3 Rash, Dose 2 Number Analyzed 437 participants 217 participants
0
   0.0%
0
   0.0%
Related Rash, Dose 2 Number Analyzed 437 participants 217 participants
1
   0.2%
0
   0.0%
Any Urticaria, Dose 2 Number Analyzed 437 participants 217 participants
43
   9.8%
14
   6.5%
Grade 3 Urticaria, Dose 2 Number Analyzed 437 participants 217 participants
0
   0.0%
0
   0.0%
Related Urticaria, Dose 2 Number Analyzed 437 participants 217 participants
0
   0.0%
0
   0.0%
Any Arthralgia, Dose 3 Number Analyzed 411 participants 200 participants
28
   6.8%
10
   5.0%
Grade 3 Arthralgia, Dose 3 Number Analyzed 411 participants 200 participants
0
   0.0%
0
   0.0%
Related Arthralgia, Dose 3 Number Analyzed 411 participants 200 participants
0
   0.0%
0
   0.0%
Any Fatigue, Dose 3 Number Analyzed 411 participants 200 participants
34
   8.3%
13
   6.5%
Grade 3 Fatigue, Dose 3 Number Analyzed 411 participants 200 participants
0
   0.0%
0
   0.0%
Related Fatigue, Dose 3 Number Analyzed 411 participants 200 participants
4
   1.0%
3
   1.5%
Any Fever, Dose 3 Number Analyzed 411 participants 200 participants
81
  19.7%
33
  16.5%
Grade 3 Fever, Dose 3 Number Analyzed 411 participants 200 participants
0
   0.0%
0
   0.0%
Related Fever, Dose 3 Number Analyzed 411 participants 200 participants
20
   4.9%
9
   4.5%
Any Gastrointestinal, Dose 3 Number Analyzed 411 participants 200 participants
43
  10.5%
19
   9.5%
Grade 3 Gastrointestinal, Dose 3 Number Analyzed 411 participants 200 participants
0
   0.0%
0
   0.0%
Related Gastrointestinal, Dose 3 Number Analyzed 411 participants 200 participants
5
   1.2%
5
   2.5%
Any Headache, Dose 3 Number Analyzed 411 participants 200 participants
71
  17.3%
33
  16.5%
Grade 3 Headache, Dose 3 Number Analyzed 411 participants 200 participants
0
   0.0%
0
   0.0%
Related Headache, Dose 3 Number Analyzed 411 participants 200 participants
22
   5.4%
12
   6.0%
Any Myalgia, Dose 3 Number Analyzed 411 participants 200 participants
28
   6.8%
10
   5.0%
Grade 3 Myalgia, Dose 3 Number Analyzed 411 participants 200 participants
0
   0.0%
0
   0.0%
Related Myalgia, Dose 3 Number Analyzed 411 participants 200 participants
1
   0.2%
0
   0.0%
Any Rash, Dose 3 Number Analyzed 411 participants 200 participants
26
   6.3%
12
   6.0%
Grade 3 Rash, Dose 3 Number Analyzed 411 participants 200 participants
0
   0.0%
0
   0.0%
Related Rash, Dose 3 Number Analyzed 411 participants 200 participants
0
   0.0%
0
   0.0%
Any Urticaria, Dose 3 Number Analyzed 411 participants 200 participants
26
   6.3%
11
   5.5%
Grade 3 Urticaria, Dose 3 Number Analyzed 411 participants 200 participants
0
   0.0%
0
   0.0%
Related Urticaria, Dose 3 Number Analyzed 411 participants 200 participants
0
   0.0%
0
   0.0%
Any Arthralgia, Across doses Number Analyzed 450 participants 226 participants
77
  17.1%
32
  14.2%
Grade 3 Arthralgia, Across doses Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Arthralgia, Across doses Number Analyzed 450 participants 226 participants
10
   2.2%
4
   1.8%
Any Fatigue, Across doses Number Analyzed 450 participants 226 participants
111
  24.7%
42
  18.6%
Grade 3 Fatigue, Across doses Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Fatigue, Across doses Number Analyzed 450 participants 226 participants
39
   8.7%
9
   4.0%
Any Fever, Across doses Number Analyzed 450 participants 226 participants
147
  32.7%
70
  31.0%
Grade 3 Fever, Across doses Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Fever, Across doses Number Analyzed 450 participants 226 participants
57
  12.7%
27
  11.9%
Any Gastrointestinal, Across doses Number Analyzed 450 participants 226 participants
118
  26.2%
56
  24.8%
Grade 3 Gastrointestinal, Across doses Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Gastrointestinal, Across doses Number Analyzed 450 participants 226 participants
31
   6.9%
17
   7.5%
Any Headache, Across doses Number Analyzed 450 participants 226 participants
189
  42.0%
109
  48.2%
Grade 3 Headache, Across doses Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Headache, Across doses Number Analyzed 450 participants 226 participants
101
  22.4%
46
  20.4%
Any Myalgia, Across doses Number Analyzed 450 participants 226 participants
90
  20.0%
36
  15.9%
Grade 3 Myalgia, Across doses Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Myalgia, Across doses Number Analyzed 450 participants 226 participants
27
   6.0%
9
   4.0%
Any Rash, Across doses Number Analyzed 450 participants 226 participants
71
  15.8%
30
  13.3%
Grade 3 Rash, Across doses Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Rash, Across doses Number Analyzed 450 participants 226 participants
2
   0.4%
0
   0.0%
Any Urticaria, Across doses Number Analyzed 450 participants 226 participants
68
  15.1%
27
  11.9%
Grade 3 Urticaria, Across doses Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
Related Urticaria, Across doses Number Analyzed 450 participants 226 participants
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
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 = any unsolicited AE regardless of intensity and relationship to vaccination. Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.
Time Frame Within 30 days (Day 0-29) after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Overall Number of Participants Analyzed 450 226
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE(s)
235
  52.2%
142
  62.8%
Grade 3 AE(s)
5
   1.1%
1
   0.4%
Related AE(s)
3
   0.7%
4
   1.8%
8.Secondary Outcome
Title Number of Subjects With NOCDs and Other MSCs
Hide Description New onset of chronic diseases (NOCDs) assessed included autoimmune disorders, asthma, type I diabetes, allergies. Medically significant conditions (MSCs) assessed included AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame From Day 0 up to Month 7 and from Month 7 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Overall Number of Participants Analyzed 450 226
Measure Type: Count of Participants
Unit of Measure: Participants
NOCD(s) up to Month 7 Number Analyzed 450 participants 226 participants
10
   2.2%
8
   3.5%
NOCD(s) Month 7-12 Number Analyzed 421 participants 208 participants
1
   0.2%
3
   1.4%
MSC(s) up to Month 7 Number Analyzed 450 participants 226 participants
289
  64.2%
161
  71.2%
MSC(s) Month 7-12 Number Analyzed 421 participants 208 participants
121
  28.7%
68
  32.7%
9.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Day 0 up to Month 7 and from Month 7 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Overall Number of Participants Analyzed 450 226
Measure Type: Count of Participants
Unit of Measure: Participants
up to Month 7
12
   2.7%
10
   4.4%
up to Month 12
17
   3.8%
14
   6.2%
10.Secondary Outcome
Title Number of Subjects With Pregnancies and Their Outcomes
Hide Description Pregnancy outcomes were ectopic pregnancy, elective termination no apparent congenital anomaly, live infant no apparent congenital anomaly, premature live infant no apparent congenital anomaly, lost to follow-up and spontaneous abortion no apparent congenital anomaly.
Time Frame From Day 0 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented and who reported pregnancies (and their outcomes).
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Overall Number of Participants Analyzed 14 10
Measure Type: Count of Participants
Unit of Measure: Participants
Ectopic pregnancy
1
   7.1%
0
   0.0%
Elective termination
3
  21.4%
3
  30.0%
Live infant
5
  35.7%
5
  50.0%
Premature live infant
3
  21.4%
1
  10.0%
Lost to follow-up
1
   7.1%
0
   0.0%
Spontaneous abortion
1
   7.1%
1
  10.0%
11.Secondary Outcome
Title Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
Hide Description

Biochemical and haematological parameters assessed were:

Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC).

Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range.

N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.

Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Overall Number of Participants Analyzed 217 105
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 8 participants 4 participants
7
  87.5%
4
 100.0%
ALT, pre-vacc.ABOVE, Month 7 BELOW Number Analyzed 8 participants 4 participants
0
   0.0%
0
   0.0%
ALT, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 8 participants 4 participants
1
  12.5%
0
   0.0%
ALT, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 39 participants 17 participants
15
  38.5%
7
  41.2%
ALT, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 39 participants 17 participants
24
  61.5%
10
  58.8%
ALT, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 39 participants 17 participants
0
   0.0%
0
   0.0%
ALT, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 170 participants 84 participants
137
  80.6%
57
  67.9%
ALT, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 170 participants 84 participants
30
  17.6%
25
  29.8%
ALT, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 170 participants 84 participants
3
   1.8%
2
   2.4%
BAS, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 217 participants 105 participants
216
  99.5%
105
 100.0%
BAS, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 217 participants 105 participants
0
   0.0%
0
   0.0%
BAS, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 217 participants 105 participants
1
   0.5%
0
   0.0%
CREA, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 2 participants 1 participants
1
  50.0%
1
 100.0%
CREA, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 2 participants 1 participants
0
   0.0%
0
   0.0%
CREA, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 2 participants 1 participants
1
  50.0%
0
   0.0%
CREA, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 56 participants 30 participants
19
  33.9%
13
  43.3%
CREA, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 56 participants 30 participants
37
  66.1%
17
  56.7%
CREA, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 56 participants 30 participants
0
   0.0%
0
   0.0%
CREA, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 159 participants 74 participants
149
  93.7%
68
  91.9%
CREA, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 159 participants 74 participants
10
   6.3%
4
   5.4%
CREA, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 159 participants 74 participants
0
   0.0%
2
   2.7%
EOS, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 43 participants 28 participants
9
  20.9%
12
  42.9%
EOS, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 43 participants 28 participants
0
   0.0%
0
   0.0%
EOS, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 43 participants 28 participants
34
  79.1%
16
  57.1%
EOS, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 19 participants 10 participants
17
  89.5%
9
  90.0%
EOS, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 19 participants 10 participants
2
  10.5%
1
  10.0%
EOS, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 19 participants 10 participants
0
   0.0%
0
   0.0%
EOS, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 155 participants 67 participants
134
  86.5%
56
  83.6%
EOS, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 155 participants 67 participants
3
   1.9%
2
   3.0%
EOS, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 155 participants 67 participants
18
  11.6%
9
  13.4%
HC, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 75 participants 33 participants
16
  21.3%
7
  21.2%
HC, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 75 participants 33 participants
59
  78.7%
26
  78.8%
HC, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 75 participants 33 participants
0
   0.0%
0
   0.0%
HC, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 142 participants 72 participants
104
  73.2%
52
  72.2%
HC, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 142 participants 72 participants
38
  26.8%
20
  27.8%
HC, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 142 participants 72 participants
0
   0.0%
0
   0.0%
LYM, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 77 participants 41 participants
23
  29.9%
11
  26.8%
LYM, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 77 participants 41 participants
4
   5.2%
3
   7.3%
LYM, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 77 participants 41 participants
50
  64.9%
27
  65.9%
LYM, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 41 participants 19 participants
23
  56.1%
8
  42.1%
LYM, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 41 participants 19 participants
11
  26.8%
6
  31.6%
LYM, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 41 participants 19 participants
7
  17.1%
5
  26.3%
LYM, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 99 participants 45 participants
47
  47.5%
19
  42.2%
LYM, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 99 participants 45 participants
17
  17.2%
2
   4.4%
LYM, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 99 participants 45 participants
35
  35.4%
24
  53.3%
MON, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 48 participants 35 participants
17
  35.4%
4
  11.4%
MON, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 48 participants 35 participants
0
   0.0%
0
   0.0%
MON, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 48 participants 35 participants
31
  64.6%
31
  88.6%
MON, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 169 participants 70 participants
108
  63.9%
45
  64.3%
MON, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 169 participants 70 participants
0
   0.0%
0
   0.0%
MON, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 169 participants 70 participants
61
  36.1%
25
  35.7%
NEU, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 8 participants 3 participants
0
   0.0%
0
   0.0%
NEU, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 8 participants 3 participants
7
  87.5%
3
 100.0%
NEU, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 8 participants 3 participants
1
  12.5%
0
   0.0%
NEU, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 176 participants 91 participants
9
   5.1%
4
   4.4%
NEU, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 176 participants 91 participants
165
  93.8%
86
  94.5%
NEU, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 176 participants 91 participants
2
   1.1%
1
   1.1%
NEU, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 33 participants 11 participants
4
  12.1%
1
   9.1%
NEU, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 33 participants 11 participants
26
  78.8%
10
  90.9%
NEU, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 33 participants 11 participants
3
   9.1%
0
   0.0%
PLA, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 17 participants 6 participants
10
  58.8%
4
  66.7%
PLA, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 17 participants 6 participants
0
   0.0%
0
   0.0%
PLA, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 17 participants 6 participants
7
  41.2%
2
  33.3%
PLA. pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 2 participants 3 participants
1
  50.0%
0
   0.0%
PLA. pre-vacc. BELOW, Month 7 BELOW Number Analyzed 2 participants 3 participants
1
  50.0%
2
  66.7%
PLA. pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 2 participants 3 participants
0
   0.0%
1
  33.3%
PLA, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 198 participants 96 participants
194
  98.0%
96
 100.0%
PLA, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 198 participants 96 participants
0
   0.0%
0
   0.0%
PLA, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 198 participants 96 participants
4
   2.0%
0
   0.0%
RBC, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 29 participants 11 participants
10
  34.5%
3
  27.3%
RBC, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 29 participants 11 participants
19
  65.5%
8
  72.7%
RBC, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 29 participants 11 participants
0
   0.0%
0
   0.0%
RBC, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 188 participants 94 participants
176
  93.6%
89
  94.7%
RBC, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 188 participants 94 participants
12
   6.4%
5
   5.3%
RBC, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 188 participants 94 participants
0
   0.0%
0
   0.0%
WBC, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 9 participants 7 participants
6
  66.7%
6
  85.7%
WBC, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 9 participants 7 participants
0
   0.0%
0
   0.0%
WBC, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 9 participants 7 participants
3
  33.3%
1
  14.3%
WBC, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 21 participants 12 participants
5
  23.8%
6
  50.0%
WBC, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 21 participants 12 participants
16
  76.2%
6
  50.0%
WBC, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 21 participants 12 participants
0
   0.0%
0
   0.0%
WBC, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 187 participants 86 participants
158
  84.5%
72
  83.7%
WBC, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 187 participants 86 participants
26
  13.9%
13
  15.1%
WBC, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 187 participants 86 participants
3
   1.6%
1
   1.2%
12.Secondary Outcome
Title Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
Hide Description

Biochemical and haematological parameters assessed were:

Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC).

Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range.

N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.

Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Overall Number of Participants Analyzed 187 96
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 3 participants 3 participants
2
  66.7%
2
  66.7%
ALT, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 3 participants 3 participants
0
   0.0%
1
  33.3%
ALT, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 3 participants 3 participants
1
  33.3%
0
   0.0%
ALT, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 13 participants 11 participants
7
  53.8%
3
  27.3%
ALT, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 13 participants 11 participants
6
  46.2%
8
  72.7%
ALT, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 13 participants 11 participants
0
   0.0%
0
   0.0%
ALT, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 183 participants 85 participants
144
  78.7%
65
  76.5%
ALT, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 183 participants 85 participants
39
  21.3%
20
  23.5%
ALT, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 183 participants 85 participants
0
   0.0%
0
   0.0%
BAS, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 21 participants 12 participants
19
  90.5%
12
 100.0%
BAS, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 21 participants 12 participants
0
   0.0%
0
   0.0%
BAS, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 21 participants 12 participants
2
   9.5%
0
   0.0%
BAS, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 178 participants 87 participants
163
  91.6%
81
  93.1%
BAS, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 178 participants 87 participants
0
   0.0%
0
   0.0%
BAS, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 178 participants 87 participants
15
   8.4%
6
   6.9%
CREA, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 43 participants 14 participants
2
   4.7%
2
  14.3%
CREA, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 43 participants 14 participants
41
  95.3%
12
  85.7%
CREA, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 43 participants 14 participants
0
   0.0%
0
   0.0%
CREA, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 156 participants 85 participants
40
  25.6%
14
  16.5%
CREA, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 156 participants 85 participants
116
  74.4%
71
  83.5%
CREA, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 156 participants 85 participants
0
   0.0%
0
   0.0%
EOS, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 76 participants 39 participants
14
  18.4%
4
  10.3%
EOS, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 76 participants 39 participants
0
   0.0%
0
   0.0%
EOS, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 76 participants 39 participants
61
  80.3%
35
  89.7%
EOS, pre-vacc. ABOVE, Month 7 MISSING Number Analyzed 76 participants 39 participants
1
   1.3%
0
   0.0%
EOS, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 123 participants 60 participants
92
  74.8%
52
  86.7%
EOS, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 123 participants 60 participants
0
   0.0%
0
   0.0%
EOS, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 123 participants 60 participants
31
  25.2%
8
  13.3%
HC, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 1 participants 0 participants
1
 100.0%
0
HC, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 1 participants 0 participants
0
   0.0%
0
HC, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 1 participants 0 participants
0
   0.0%
0
HC, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 60 participants 35 participants
20
  33.3%
6
  17.1%
HC, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 60 participants 35 participants
40
  66.7%
29
  82.9%
HC, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 60 participants 35 participants
0
   0.0%
0
   0.0%
HC, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 138 participants 64 participants
118
  85.5%
51
  79.7%
HC, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 138 participants 64 participants
20
  14.5%
13
  20.3%
HC, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 138 participants 64 participants
0
   0.0%
0
   0.0%
LYM, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 20 participants 8 participants
12
  60.0%
7
  87.5%
LYM, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 20 participants 8 participants
0
   0.0%
0
   0.0%
LYM, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 20 participants 8 participants
8
  40.0%
1
  12.5%
LYM, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 179 participants 91 participants
166
  92.7%
81
  89.0%
LYM, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 179 participants 91 participants
3
   1.7%
0
   0.0%
LYM, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 179 participants 91 participants
10
   5.6%
10
  11.0%
MON, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 12 participants 7 participants
6
  50.0%
6
  85.7%
MON, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 12 participants 7 participants
0
   0.0%
0
   0.0%
MON, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 12 participants 7 participants
6
  50.0%
1
  14.3%
MON, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 187 participants 92 participants
180
  96.3%
85
  92.4%
MON, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 187 participants 92 participants
0
   0.0%
0
   0.0%
MON, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 187 participants 92 participants
7
   3.7%
7
   7.6%
NEU, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 36 participants 16 participants
13
  36.1%
9
  56.3%
NEU, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 36 participants 16 participants
22
  61.1%
7
  43.8%
NEU, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 36 participants 16 participants
0
   0.0%
0
   0.0%
NEU, pre-vacc. BELOW, Month 7 MISSING Number Analyzed 36 participants 16 participants
1
   2.8%
0
   0.0%
NEU, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 163 participants 83 participants
145
  89.0%
70
  84.3%
NEU, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 163 participants 83 participants
17
  10.4%
13
  15.7%
NEU, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 163 participants 83 participants
1
   0.6%
0
   0.0%
PLA, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 10 participants 3 participants
7
  70.0%
1
  33.3%
PLA, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 10 participants 3 participants
0
   0.0%
0
   0.0%
PLA, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 10 participants 3 participants
3
  30.0%
2
  66.7%
PLA, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 5 participants 0 participants
4
  80.0%
0
PLA, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 5 participants 0 participants
1
  20.0%
0
PLA, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 5 participants 0 participants
0
   0.0%
0
PLA, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 184 participants 96 participants
180
  97.8%
92
  95.8%
PLA, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 184 participants 96 participants
2
   1.1%
0
   0.0%
PLA, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 184 participants 96 participants
2
   1.1%
4
   4.2%
RBC, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 11 participants 7 participants
6
  54.5%
4
  57.1%
RBC, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 11 participants 7 participants
0
   0.0%
0
   0.0%
RBC, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 11 participants 7 participants
5
  45.5%
3
  42.9%
RBC, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 2 participants 1 participants
1
  50.0%
0
   0.0%
RBC, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 2 participants 1 participants
1
  50.0%
1
 100.0%
RBC, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 2 participants 1 participants
0
   0.0%
0
   0.0%
RBC, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 186 participants 91 participants
177
  95.2%
90
  98.9%
RBC, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 186 participants 91 participants
5
   2.7%
0
   0.0%
RBC, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 186 participants 91 participants
4
   2.2%
1
   1.1%
WBC, pre-vacc. ABOVE, Month 7 NORMAL Number Analyzed 17 participants 7 participants
13
  76.5%
6
  85.7%
WBC, pre-vacc. ABOVE, Month 7 BELOW Number Analyzed 17 participants 7 participants
0
   0.0%
0
   0.0%
WBC, pre-vacc. ABOVE, Month 7 ABOVE Number Analyzed 17 participants 7 participants
4
  23.5%
1
  14.3%
WBC, pre-vacc. BELOW, Month 7 NORMAL Number Analyzed 0 participants 2 participants
0
2
 100.0%
WBC, pre-vacc. BELOW, Month 7 BELOW Number Analyzed 0 participants 2 participants
0
0
   0.0%
WBC, pre-vacc. BELOW, Month 7 ABOVE Number Analyzed 0 participants 2 participants
0
0
   0.0%
WBC, pre-vacc. NORMAL, Month 7 NORMAL Number Analyzed 182 participants 90 participants
177
  97.3%
86
  95.6%
WBC, pre-vacc. NORMAL, Month 7 BELOW Number Analyzed 182 participants 90 participants
4
   2.2%
2
   2.2%
WBC, pre-vacc. NORMAL, Month 7 ABOVE Number Analyzed 182 participants 90 participants
1
   0.5%
2
   2.2%
13.Secondary Outcome
Title Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
Hide Description

Biochemical and haematological parameters assessed were:

Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC).

Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range.

N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.

Time Frame At Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Overall Number of Participants Analyzed 211 102
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 8 participants 4 participants
8
 100.0%
4
 100.0%
ALT, pre-vacc.ABOVE, Month 12 BELOW Number Analyzed 8 participants 4 participants
0
   0.0%
0
   0.0%
ALT, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 8 participants 4 participants
0
   0.0%
0
   0.0%
ALT, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 38 participants 17 participants
17
  44.7%
9
  52.9%
ALT, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 38 participants 17 participants
21
  55.3%
8
  47.1%
ALT, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 38 participants 17 participants
0
   0.0%
0
   0.0%
ALT, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 165 participants 81 participants
139
  84.2%
61
  75.3%
ALT, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 165 participants 81 participants
24
  14.5%
17
  21.0%
ALT, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 165 participants 81 participants
2
   1.2%
3
   3.7%
BAS, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 211 participants 102 participants
210
  99.5%
102
 100.0%
BAS, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 211 participants 102 participants
0
   0.0%
0
   0.0%
BAS, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 211 participants 102 participants
1
   0.5%
0
   0.0%
CREA, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 2 participants 1 participants
1
  50.0%
0
   0.0%
CREA, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 2 participants 1 participants
0
   0.0%
1
 100.0%
CREA, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 2 participants 1 participants
1
  50.0%
0
   0.0%
CREA, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 56 participants 29 participants
13
  23.2%
6
  20.7%
CREA, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 56 participants 29 participants
43
  76.8%
23
  79.3%
CREA, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 56 participants 29 participants
0
   0.0%
0
   0.0%
CREA, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 153 participants 72 participants
130
  85.0%
64
  88.9%
CREA, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 153 participants 72 participants
23
  15.0%
8
  11.1%
CREA, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 153 participants 72 participants
0
   0.0%
0
   0.0%
EOS, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 43 participants 28 participants
14
  32.6%
11
  39.3%
EOS, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 43 participants 28 participants
1
   2.3%
0
   0.0%
EOS, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 43 participants 28 participants
28
  65.1%
17
  60.7%
EOS, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 19 participants 10 participants
13
  68.4%
6
  60.0%
EOS, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 19 participants 10 participants
6
  31.6%
3
  30.0%
EOS, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 19 participants 10 participants
0
   0.0%
1
  10.0%
EOS, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 149 participants 64 participants
126
  84.6%
52
  81.3%
EOS, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 149 participants 64 participants
6
   4.0%
2
   3.1%
EOS, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 149 participants 64 participants
17
  11.4%
10
  15.6%
HC, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 71 participants 33 participants
15
  21.1%
10
  30.3%
HC, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 71 participants 33 participants
56
  78.9%
23
  69.7%
HC, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 71 participants 33 participants
0
   0.0%
0
   0.0%
HC, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 140 participants 69 participants
108
  77.1%
45
  65.2%
HC, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 140 participants 69 participants
32
  22.9%
24
  34.8%
HC, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 140 participants 69 participants
0
   0.0%
0
   0.0%
LYM, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 75 participants 41 participants
24
  32.0%
16
  39.0%
LYM, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 75 participants 41 participants
4
   5.3%
3
   7.3%
LYM, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 75 participants 41 participants
47
  62.7%
22
  53.7%
LYM, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 38 participants 19 participants
9
  23.7%
8
  42.1%
LYM, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 38 participants 19 participants
15
  39.5%
5
  26.3%
LYM, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 38 participants 19 participants
14
  36.8%
6
  31.6%
LYM, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 98 participants 42 participants
48
  49.0%
24
  57.1%
LYM, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 98 participants 42 participants
27
  27.6%
4
   9.5%
LYM, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 98 participants 42 participants
23
  23.5%
14
  33.3%
MON, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 45 participants 34 participants
13
  28.9%
10
  29.4%
MON, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 45 participants 34 participants
0
   0.0%
0
   0.0%
MON, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 45 participants 34 participants
32
  71.1%
24
  70.6%
MON, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 166 participants 68 participants
102
  61.4%
38
  55.9%
MON, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 166 participants 68 participants
0
   0.0%
0
   0.0%
MON, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 166 participants 68 participants
64
  38.6%
30
  44.1%
NEU, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 8 participants 3 participants
4
  50.0%
0
   0.0%
NEU, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 8 participants 3 participants
4
  50.0%
3
 100.0%
NEU, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 8 participants 3 participants
0
   0.0%
0
   0.0%
NEU, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 173 participants 88 participants
11
   6.4%
5
   5.7%
NEU, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 173 participants 88 participants
160
  92.5%
83
  94.3%
NEU, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 173 participants 88 participants
2
   1.2%
0
   0.0%
NEU, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 30 participants 11 participants
7
  23.3%
1
   9.1%
NEU, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 30 participants 11 participants
22
  73.3%
9
  81.8%
NEU, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 30 participants 11 participants
1
   3.3%
1
   9.1%
PLA, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 17 participants 6 participants
13
  76.5%
4
  66.7%
PLA, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 17 participants 6 participants
0
   0.0%
0
   0.0%
PLA, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 17 participants 6 participants
4
  23.5%
2
  33.3%
PLA. pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 2 participants 3 participants
1
  50.0%
1
  33.3%
PLA. pre-vacc. BELOW, Month 12 BELOW Number Analyzed 2 participants 3 participants
1
  50.0%
2
  66.7%
PLA. pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 2 participants 3 participants
0
   0.0%
0
   0.0%
PLA, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 192 participants 93 participants
188
  97.9%
93
 100.0%
PLA, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 198 participants 93 participants
3
   1.5%
0
   0.0%
PLA, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 198 participants 93 participants
1
   0.5%
0
   0.0%
RBC, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 27 participants 11 participants
8
  29.6%
5
  45.5%
RBC, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 27 participants 11 participants
19
  70.4%
6
  54.5%
RBC, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 27 participants 11 participants
0
   0.0%
0
   0.0%
RBC, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 184 participants 91 participants
169
  91.8%
80
  87.9%
RBC, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 184 participants 91 participants
15
   8.2%
11
  12.1%
RBC, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 184 participants 91 participants
0
   0.0%
0
   0.0%
WBC, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 8 participants 7 participants
6
  75.0%
7
 100.0%
WBC, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 8 participants 7 participants
0
   0.0%
0
   0.0%
WBC, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 8 participants 7 participants
2
  25.0%
0
   0.0%
WBC, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 19 participants 12 participants
10
  52.6%
5
  41.7%
WBC, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 19 participants 12 participants
9
  47.4%
7
  58.3%
WBC, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 19 participants 12 participants
0
   0.0%
0
   0.0%
WBC, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 184 participants 83 participants
156
  84.8%
64
  77.1%
WBC, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 184 participants 83 participants
22
  12.0%
16
  19.3%
WBC, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 184 participants 83 participants
6
   3.3%
3
   3.6%
14.Secondary Outcome
Title Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
Hide Description

Biochemical and haematological parameters assessed were:

Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC).

Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range.

N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.

Time Frame At Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description:
Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Overall Number of Participants Analyzed 194 100
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 3 participants 4 participants
2
  66.7%
2
  50.0%
ALT, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 3 participants 4 participants
0
   0.0%
1
  25.0%
ALT, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 3 participants 4 participants
1
  33.3%
1
  25.0%
ALT, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 13 participants 11 participants
12
  92.3%
8
  72.7%
ALT, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 13 participants 11 participants
1
   7.7%
3
  27.3%
ALT, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 13 participants 11 participants
0
   0.0%
0
   0.0%
ALT, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 190 participants 87 participants
166
  87.4%
73
  83.9%
ALT, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 190 participants 87 participants
24
  12.6%
13
  14.9%
ALT, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 190 participants 87 participants
0
   0.0%
1
   1.1%
BAS, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 23 participants 13 participants
21
  91.3%
12
  92.3%
BAS, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 23 participants 13 participants
0
   0.0%
0
   0.0%
BAS, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 23 participants 13 participants
2
   8.7%
1
   7.7%
BAS, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 183 participants 89 participants
174
  95.1%
81
  91.0%
BAS, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 183 participants 89 participants
0
   0.0%
0
   0.0%
BAS, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 183 participants 89 participants
9
   4.9%
8
   9.0%
CREA, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 42 participants 14 participants
2
   4.8%
0
   0.0%
CREA, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 42 participants 14 participants
40
  95.2%
14
 100.0%
CREA, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 42 participants 14 participants
0
   0.0%
0
   0.0%
CREA, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 164 participants 88 participants
48
  29.3%
19
  21.6%
CREA, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 164 participants 88 participants
116
  70.7%
69
  78.4%
CREA, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 164 participants 88 participants
0
   0.0%
0
   0.0%
EOS, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 79 participants 43 participants
22
  27.8%
10
  23.3%
EOS, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 79 participants 43 participants
0
   0.0%
0
   0.0%
EOS, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 79 participants 43 participants
57
  72.2%
33
  76.7%
EOS, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 127 participants 59 participants
93
  73.2%
48
  81.4%
EOS, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 127 participants 59 participants
0
   0.0%
0
   0.0%
EOS, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 127 participants 59 participants
34
  26.8%
11
  18.6%
HC, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 63 participants 38 participants
29
  46.0%
10
  26.3%
HC, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 63 participants 38 participants
34
  54.0%
28
  73.7%
HC, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 63 participants 38 participants
0
   0.0%
0
   0.0%
HC, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 143 participants 64 participants
107
  74.8%
48
  75.0%
HC, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 143 participants 64 participants
36
  25.2%
16
  25.0%
HC, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 143 participants 64 participants
0
   0.0%
0
   0.0%
LYM, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 18 participants 8 participants
9
  50.0%
3
  37.5%
LYM, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 18 participants 8 participants
0
   0.0%
0
   0.0%
LYM, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 18 participants 8 participants
9
  50.0%
5
  62.5%
LYM, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 188 participants 94 participants
168
  89.4%
81
  86.2%
LYM, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 188 participants 94 participants
0
   0.0%
2
   2.1%
LYM, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 188 participants 94 participants
20
  10.6%
11
  11.7%
MON, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 12 participants 7 participants
8
  66.7%
6
  85.7%
MON, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 12 participants 7 participants
0
   0.0%
0
   0.0%
MON, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 12 participants 7 participants
4
  33.3%
1
  14.3%
MON, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 194 participants 95 participants
184
  94.8%
88
  92.6%
MON, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 194 participants 95 participants
0
   0.0%
0
   0.0%
MON, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 194 participants 95 participants
10
   5.2%
7
   7.4%
NEU, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 36 participants 17 participants
18
  50.0%
6
  35.3%
NEU, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 36 participants 17 participants
18
  50.0%
11
  64.7%
NEU, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 36 participants 17 participants
0
   0.0%
0
   0.0%
NEU, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 170 participants 85 participants
138
  81.2%
72
  84.7%
NEU, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 170 participants 85 participants
32
  18.8%
13
  15.3%
NEU, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 170 participants 85 participants
0
   0.0%
0
   0.0%
PLA, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 10 participants 2 participants
8
  80.0%
1
  50.0%
PLA, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 10 participants 2 participants
0
   0.0%
0
   0.0%
PLA, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 10 participants 2 participants
2
  20.0%
1
  50.0%
PLA, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 5 participants 0 participants
5
 100.0%
0
PLA, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 5 participants 0 participants
0
   0.0%
0
PLA, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 5 participants 0 participants
0
   0.0%
0
PLA, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 191 participants 100 participants
185
  96.9%
96
  96.0%
PLA, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 191 participants 100 participants
1
   0.5%
2
   2.0%
PLA, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 191 participants 100 participants
5
   2.6%
2
   2.0%
RBC, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 10 participants 7 participants
5
  50.0%
3
  42.9%
RBC, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 10 participants 7 participants
0
   0.0%
0
   0.0%
RBC, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 10 participants 7 participants
5
  50.0%
4
  57.1%
RBC, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 3 participants 2 participants
2
  66.7%
0
   0.0%
RBC, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 3 participants 2 participants
1
  33.3%
2
 100.0%
RBC, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
RBC, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 193 participants 93 participants
182
  94.3%
91
  97.8%
RBC, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 193 participants 93 participants
6
   3.1%
2
   2.2%
RBC, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 193 participants 93 participants
5
   2.6%
0
   0.0%
WBC, pre-vacc. ABOVE, Month 12 NORMAL Number Analyzed 17 participants 6 participants
12
  70.6%
5
  83.3%
WBC, pre-vacc. ABOVE, Month 12 BELOW Number Analyzed 17 participants 6 participants
0
   0.0%
0
   0.0%
WBC, pre-vacc. ABOVE, Month 12 ABOVE Number Analyzed 17 participants 6 participants
5
  29.4%
1
  16.7%
WBC, pre-vacc. BELOW, Month 12 NORMAL Number Analyzed 0 participants 2 participants
0
2
 100.0%
WBC, pre-vacc. BELOW, Month 12 BELOW Number Analyzed 0 participants 2 participants
0
0
   0.0%
WBC, pre-vacc. BELOW, Month 12 ABOVE Number Analyzed 0 participants 2 participants
0
0
   0.0%
WBC, pre-vacc. NORMAL, Month 12 NORMAL Number Analyzed 189 participants 94 participants
165
  87.3%
85
  90.4%
WBC, pre-vacc. NORMAL, Month 12 BELOW Number Analyzed 189 participants 94 participants
14
   7.4%
5
   5.3%
WBC, pre-vacc. NORMAL, Month 12 ABOVE Number Analyzed 189 participants 94 participants
10
   5.3%
4
   4.3%
Time Frame Solicited local and general symptoms: within 7 days (Day 0-6) after vaccination; Unsolicited AEs: within 30 days (Day 0-29) after any vaccination; SAEs: during the whole study period (from Day 0 up to Month 12).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cervarix Group Placebo Group
Hide Arm/Group Description Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
All-Cause Mortality
Cervarix Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/450 (0.00%)      0/226 (0.00%)    
Hide Serious Adverse Events
Cervarix Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/450 (3.78%)      14/226 (6.19%)    
Endocrine disorders     
Goitre * 1  1/450 (0.22%)  0/226 (0.00%) 
Gastrointestinal disorders     
Abdominal pain lower * 1  1/450 (0.22%)  0/226 (0.00%) 
Haemorrhoids * 1  1/450 (0.22%)  0/226 (0.00%) 
Infections and infestations     
Malaria * 1  10/450 (2.22%)  11/226 (4.87%) 
Urinary tract infection * 1  0/450 (0.00%)  3/226 (1.33%) 
Pneumonia bacterial * 1  1/450 (0.22%)  1/226 (0.44%) 
Amoebiasis * 1  1/450 (0.22%)  0/226 (0.00%) 
Appendicitis * 1  1/450 (0.22%)  0/226 (0.00%) 
Burn infection * 1  0/450 (0.00%)  1/226 (0.44%) 
Dysentery * 1  1/450 (0.22%)  0/226 (0.00%) 
Gastroenteritis * 1  1/450 (0.22%)  0/226 (0.00%) 
Pelvic inflammatory disease * 1  1/450 (0.22%)  0/226 (0.00%) 
Pyomyositis * 1  1/450 (0.22%)  0/226 (0.00%) 
Tonsillitis bacterial * 1  1/450 (0.22%)  0/226 (0.00%) 
Tonsillitis * 1  0/450 (0.00%)  1/226 (0.44%) 
Injury, poisoning and procedural complications     
Femur fracture * 1  1/450 (0.22%)  0/226 (0.00%) 
Nervous system disorders     
Neuropathy vitamin b6 deficiency * 1  1/450 (0.22%)  0/226 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous complete * 1  1/450 (0.22%)  1/226 (0.44%) 
Ectopic pregnancy * 1  1/450 (0.22%)  0/226 (0.00%) 
Postpartum haemorrhage * 1  1/450 (0.22%)  0/226 (0.00%) 
Reproductive system and breast disorders     
Vaginal haemorrhage * 1  1/450 (0.22%)  0/226 (0.00%) 
1
Term from vocabulary, MedDRA 13.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cervarix Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   424/450 (94.22%)      208/226 (92.04%)    
Blood and lymphatic system disorders     
Iron deficiency anaemia  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Lymphadenitis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Cardiac disorders     
Palpitations  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Ear and labyrinth disorders     
Ear pain  1  5/450 (1.11%)  5 2/226 (0.88%)  2
Vertigo  1  13/450 (2.89%)  15 3/226 (1.33%)  4
Eye disorders     
Conjunctivitis  1  8/450 (1.78%)  8 1/226 (0.44%)  1
Conjunctivitis allergic  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Eye allergy  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Eye irritation  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Eye pain  1  4/450 (0.89%)  4 0/226 (0.00%)  0
Eye pruritus  1  2/450 (0.44%)  2 0/226 (0.00%)  0
Eyelid oedema  1  1/450 (0.22%)  1 1/226 (0.44%)  1
Lacrimation increased  1  1/450 (0.22%)  1 1/226 (0.44%)  1
Myopia  1  1/450 (0.22%)  1 2/226 (0.88%)  2
Visual impairment  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Gastrointestinal disorders     
Abdominal discomfort  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Abdominal pain  1  16/450 (3.56%)  17 7/226 (3.10%)  7
Abdominal pain upper  1  1/450 (0.22%)  1 2/226 (0.88%)  2
Constipation  1  0/450 (0.00%)  0 2/226 (0.88%)  2
Dental caries  1  6/450 (1.33%)  6 2/226 (0.88%)  2
Diarrhoea  1  6/450 (1.33%)  6 3/226 (1.33%)  3
Dyspepsia  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Enteritis  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Gastritis  1  4/450 (0.89%)  4 0/226 (0.00%)  0
Gastrointestinal disorder  1  118/450 (26.22%)  143 56/226 (24.78%)  66
Gastrooesophageal reflux disease  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Gingivitis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Glossitis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Haemorrhoids  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Hyperchlorhydria  1  2/450 (0.44%)  2 0/226 (0.00%)  0
Nausea  1  2/450 (0.44%)  2 2/226 (0.88%)  2
Oesophagitis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Peptic ulcer  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Stomatitis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Toothache  1  6/450 (1.33%)  6 3/226 (1.33%)  3
Vomiting  1  2/450 (0.44%)  2 0/226 (0.00%)  0
General disorders     
Asthenia  1  1/450 (0.22%)  1 1/226 (0.44%)  1
Chest discomfort  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Chest pain  1  5/450 (1.11%)  5 1/226 (0.44%)  1
Fatigue  1  111/450 (24.67%)  130 42/226 (18.58%)  50
Influenza like illness  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Injection site rash  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Oedema peripheral  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Pain  1  376/450 (83.56%)  779 168/226 (74.34%)  279
Pyrexia  1  147/450 (32.67%)  235 71/226 (31.42%)  110
Swelling  1  74/450 (16.44%)  86 27/226 (11.95%)  32
Immune system disorders     
Hypersensitivity  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Infections and infestations     
Abscess  1  2/450 (0.44%)  2 0/226 (0.00%)  0
Abscess limb  1  1/450 (0.22%)  1 1/226 (0.44%)  1
Adenoiditis  1  1/450 (0.22%)  1 1/226 (0.44%)  1
Amoebiasis  1  1/450 (0.22%)  1 3/226 (1.33%)  3
Arthritis bacterial  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Body tinea  1  7/450 (1.56%)  7 3/226 (1.33%)  3
Bronchitis  1  4/450 (0.89%)  4 4/226 (1.77%)  4
Bronchopneumonia  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Candidiasis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Cellulitis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Chlamydial infection  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Cutaneous larva migrans  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Fungal infection  1  2/450 (0.44%)  2 1/226 (0.44%)  1
Fungal skin infection  1  4/450 (0.89%)  4 2/226 (0.88%)  2
Gastroenteritis  1  3/450 (0.67%)  3 1/226 (0.44%)  1
Giardiasis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Gingival infection  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Helminthic infection  1  8/450 (1.78%)  8 1/226 (0.44%)  1
Hookworm infection  1  1/450 (0.22%)  1 1/226 (0.44%)  1
Hordeolum  1  1/450 (0.22%)  1 1/226 (0.44%)  1
Influenza  1  8/450 (1.78%)  8 1/226 (0.44%)  1
Malaria  1  56/450 (12.44%)  66 38/226 (16.81%)  44
Measles  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Nasopharyngitis  1  9/450 (2.00%)  10 12/226 (5.31%)  12
Otitis media  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Parasitic gastroenteritis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Paronychia  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Pelvic inflammatory disease  1  4/450 (0.89%)  5 1/226 (0.44%)  1
Pericoronitis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Pharyngitis  1  2/450 (0.44%)  2 0/226 (0.00%)  0
Pneumonia  1  2/450 (0.44%)  2 3/226 (1.33%)  3
Respiratory tract infection  1  1/450 (0.22%)  1 1/226 (0.44%)  1
Rhinitis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Sepsis  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Shigella infection  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Sinusitis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Subcutaneous abscess  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Tinea capitis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Tinea versicolour  1  1/450 (0.22%)  1 1/226 (0.44%)  1
Tonsillitis  1  4/450 (0.89%)  4 2/226 (0.88%)  2
Trichuriasis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Upper respiratory tract infection  1  10/450 (2.22%)  11 5/226 (2.21%)  5
Vaginal infection  1  2/450 (0.44%)  2 0/226 (0.00%)  0
Vaginitis bacterial  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Varicella  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Vulvitis  1  1/450 (0.22%)  1 2/226 (0.88%)  2
Vulvovaginal candidiasis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Injury, poisoning and procedural complications     
Arthropod sting  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Burns first degree  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Human bite  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Limb traumatic amputation  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Soft tissue injury  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Wound  1  2/450 (0.44%)  2 1/226 (0.44%)  1
Metabolism and nutrition disorders     
Hypoglycaemia  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  79/450 (17.56%)  97 36/226 (15.93%)  41
Back pain  1  4/450 (0.89%)  4 2/226 (0.88%)  2
Musculoskeletal chest pain  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Musculoskeletal pain  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Myalgia  1  90/450 (20.00%)  113 38/226 (16.81%)  46
Neck pain  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Pain in extremity  1  2/450 (0.44%)  2 2/226 (0.88%)  2
Torticollis  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Head discomfort  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Headache  1  201/450 (44.67%)  298 116/226 (51.33%)  157
Sensory disturbance  1  2/450 (0.44%)  2 0/226 (0.00%)  0
Psychiatric disorders     
Anxiety  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Insomnia  1  2/450 (0.44%)  2 1/226 (0.44%)  1
Renal and urinary disorders     
Dysuria  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Reproductive system and breast disorders     
Amenorrhoea  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Dysmenorrhoea  1  23/450 (5.11%)  25 10/226 (4.42%)  10
Genital discharge  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Menstruation delayed  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Metrorrhagia  1  1/450 (0.22%)  1 1/226 (0.44%)  1
Oligomenorrhoea  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Ovarian cyst  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Pelvic pain  1  3/450 (0.67%)  3 0/226 (0.00%)  0
Vaginal discharge  1  6/450 (1.33%)  6 4/226 (1.77%)  4
Vaginal haemorrhage  1  1/450 (0.22%)  1 1/226 (0.44%)  1
Vulvovaginal pruritus  1  1/450 (0.22%)  1 0/226 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchopneumopathy  1  0/450 (0.00%)  0 1/226 (0.44%)  1
Cough  1  13/450 (2.89%)  13