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Trial Outcomes & Findings for Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (GSK580299) in Healthy Female Subjects 10-25 Years of Age. (NCT NCT00481767)

NCT ID: NCT00481767

Last Updated: 2020-11-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

676 participants

Primary outcome timeframe

At Month 7

Results posted on

2020-11-17

Participant Flow

Participant milestones

Participant milestones
Measure
Cervarix Group
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.
Placebo 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 Study
STARTED
450
226
Overall Study
COMPLETED
418
205
Overall Study
NOT COMPLETED
32
21

Reasons for withdrawal

Reasons for withdrawal
Measure
Cervarix Group
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.
Placebo 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 Study
Withdrawal by Subject
16
11
Overall Study
Lost to Follow-up
16
10

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cervarix Group
n=450 Participants
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.
Placebo Group
n=226 Participants
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
n=676 Participants
Total of all reporting groups
Age, Continuous
16.9 Years
STANDARD_DEVIATION 4.36 • n=5 Participants
16.8 Years
STANDARD_DEVIATION 4.16 • n=7 Participants
16.9 Years
STANDARD_DEVIATION 4.29 • n=5 Participants
Sex: Female, Male
Female
450 Participants
n=5 Participants
226 Participants
n=7 Participants
676 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race/Ethnicity, Customized
African/African american
431 Participants
n=5 Participants
219 Participants
n=7 Participants
650 Participants
n=5 Participants
Race/Ethnicity, Customized
Not specified
19 Participants
n=5 Participants
7 Participants
n=7 Participants
26 Participants
n=5 Participants

PRIMARY outcome

Timeframe: At Month 7

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

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.

Outcome measures

Outcome measures
Measure
Cervarix Group
n=212 Participants
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.
Placebo Group
n=98 Participants
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.
Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies
10-14 years anti-HPV-16
130 Participants
4 Participants
Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies
15-25 years anti-HPV-16
190 Participants
5 Participants
Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies
10-14 years anti-HPV-18
128 Participants
2 Participants
Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies
15-25 years anti-HPV-18
212 Participants
5 Participants

PRIMARY outcome

Timeframe: At Month 7

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

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.

Outcome measures

Outcome measures
Measure
Cervarix Group
n=237 Participants
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.
Placebo Group
n=114 Participants
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.
Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies
10-14 years anti-HPV-16
18591.3 EL.U/mL
Interval 16433.0 to 21033.1
4.8 EL.U/mL
Interval 4.2 to 5.5
Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies
15-25 years anti-HPV-16
10664.0 EL.U/mL
Interval 9668.5 to 11762.0
5.3 EL.U/mL
Interval 4.6 to 6.1
Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies
10-14 years anti-HPV-18
6409.8 EL.U/mL
Interval 5563.4 to 7385.0
3.9 EL.U/mL
Interval 3.6 to 4.2
Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies
15-25 years anti-HPV-18
3653.6 EL.U/mL
Interval 3343.9 to 3991.9
4.6 EL.U/mL
Interval 4.0 to 5.3

SECONDARY outcome

Timeframe: At Month 2 and Month 12

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

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.

Outcome measures

Outcome measures
Measure
Cervarix Group
n=212 Participants
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.
Placebo Group
n=98 Participants
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.
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies
15-25 years anti-HPV-16 Month 12
184 Participants
7 Participants
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies
10-14 years anti-HPV-16 Month 2
130 Participants
1 Participants
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies
15-25 years anti-HPV-16 Month 2
190 Participants
3 Participants
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies
10-14 years anti-HPV-16 Month 12
128 Participants
2 Participants
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies
10-14 years anti-HPV-18 Month 2
128 Participants
1 Participants
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies
15-25 years anti-HPV-18 Month 2
212 Participants
4 Participants
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies
10-14 years anti-HPV-18 Month 12
125 Participants
0 Participants
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies
15-25 years anti-HPV-18 Month 12
205 Participants
6 Participants

SECONDARY outcome

Timeframe: At Month 2 and Month 12

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

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.

Outcome measures

Outcome measures
Measure
Cervarix Group
n=237 Participants
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.
Placebo Group
n=112 Participants
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.
GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies
10-14 years anti-HPV-16 Month 2
5340.2 EL.U/mL
Interval 4823.7 to 5912.0
4.5 EL.U/mL
Interval 4.0 to 5.0
GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies
15-25 years anti-HPV-16 Month 2
3732.6 EL.U/mL
Interval 3436.6 to 4054.1
4.9 EL.U/mL
Interval 4.3 to 5.5
GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies
10-14 years anti-HPV-16 Month 12
4016.2 EL.U/mL
Interval 3323.3 to 4853.7
4.7 EL.U/mL
Interval 4.2 to 5.3
GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies
15-25 years anti-HPV-16 Month 12
2464.2 EL.U/mL
Interval 2196.5 to 2764.5
5.6 EL.U/mL
Interval 4.7 to 6.6
GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies
10-14 years anti-HPV-18 Month 2
3016.7 EL.U/mL
Interval 2677.4 to 3398.9
3.9 EL.U/mL
Interval 3.6 to 4.3
GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies
15-25 years anti-HPV-18 Month 2
2039.3 EL.U/mL
Interval 1861.3 to 2234.4
4.6 EL.U/mL
Interval 4.0 to 5.3
GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies
10-14 years anti-HPV-18 Month 12
1422.1 EL.U/mL
Interval 1170.0 to 1728.4
3.7 EL.U/mL
Interval 3.5 to 3.9
GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies
15-25 years anti-HPV-18 Month 12
855.9 EL.U/mL
Interval 768.3 to 953.5
4.6 EL.U/mL
Interval 4.0 to 5.4

SECONDARY outcome

Timeframe: Within 7 days (Day 0-6) after each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

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.

Outcome measures

Outcome measures
Measure
Cervarix Group
n=450 Participants
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.
Placebo Group
n=226 Participants
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.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
309 Participants
116 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
2 Participants
0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
15 Participants
7 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
0 Participants
0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
265 Participants
95 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
0 Participants
0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
45 Participants
15 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
0 Participants
0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 3
200 Participants
66 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 3
0 Participants
0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 3
26 Participants
10 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 3
0 Participants
0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across doses
375 Participants
166 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across doses
2 Participants
0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across doses
74 Participants
27 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across doses
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Within 7 days (Day 0-6) after each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

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.

Outcome measures

Outcome measures
Measure
Cervarix Group
n=450 Participants
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.
Placebo Group
n=226 Participants
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.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 1
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 1
22 Participants
7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash, Dose 1
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria, Dose 1
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Across doses
90 Participants
36 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Dose 1
19 Participants
10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 1
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Dose 1
7 Participants
2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 1
34 Participants
12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 1
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 1
21 Participants
3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 1
72 Participants
43 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 1
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 1
34 Participants
17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 1
34 Participants
21 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 1
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 1
14 Participants
8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 1
89 Participants
56 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 1
51 Participants
25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 1
35 Participants
16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 1
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash, Dose 1
14 Participants
8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash, Dose 1
1 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria, Dose 1
12 Participants
7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria, Dose 1
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Dose 2
47 Participants
17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 2
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Dose 2
4 Participants
2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 2
62 Participants
25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 2
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 2
17 Participants
4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 2
82 Participants
33 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 2
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 2
19 Participants
8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 2
66 Participants
26 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 2
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 2
15 Participants
6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 2
96 Participants
49 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 2
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 2
40 Participants
18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 2
50 Participants
17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 2
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 2
9 Participants
3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash, Dose 2
44 Participants
15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash, Dose 2
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash, Dose 2
1 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria, Dose 2
43 Participants
14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria, Dose 2
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria, Dose 2
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Dose 3
28 Participants
10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 3
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Dose 3
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 3
34 Participants
13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 3
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 3
4 Participants
3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Dose 3
81 Participants
33 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Dose 3
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Dose 3
20 Participants
9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 3
43 Participants
19 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 3
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 3
5 Participants
5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 3
71 Participants
33 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 3
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 3
22 Participants
12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 3
28 Participants
10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 3
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 3
1 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash, Dose 3
26 Participants
12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash, Dose 3
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash, Dose 3
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria, Dose 3
26 Participants
11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria, Dose 3
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria, Dose 3
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Across doses
77 Participants
32 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Across doses
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Across doses
10 Participants
4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Across doses
111 Participants
42 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Across doses
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Across doses
39 Participants
9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Across doses
147 Participants
70 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Across doses
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Across doses
57 Participants
27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Across doses
118 Participants
56 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Across doses
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Across doses
31 Participants
17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Across doses
189 Participants
109 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Across doses
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Across doses
101 Participants
46 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Across doses
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Across doses
27 Participants
9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash, Across doses
71 Participants
30 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash, Across doses
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash, Across doses
2 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria, Across doses
68 Participants
27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria, Across doses
0 Participants
0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria, Across doses
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Within 30 days (Day 0-29) after any vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

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.

Outcome measures

Outcome measures
Measure
Cervarix Group
n=450 Participants
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.
Placebo Group
n=226 Participants
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.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AE(s)
235 Participants
142 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
5 Participants
1 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AE(s)
3 Participants
4 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Month 7 and from Month 7 up to Month 12

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

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.

Outcome measures

Outcome measures
Measure
Cervarix Group
n=450 Participants
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.
Placebo Group
n=226 Participants
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.
Number of Subjects With NOCDs and Other MSCs
NOCD(s) up to Month 7
10 Participants
8 Participants
Number of Subjects With NOCDs and Other MSCs
NOCD(s) Month 7-12
1 Participants
3 Participants
Number of Subjects With NOCDs and Other MSCs
MSC(s) up to Month 7
289 Participants
161 Participants
Number of Subjects With NOCDs and Other MSCs
MSC(s) Month 7-12
121 Participants
68 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Month 7 and from Month 7 up to Month 12

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

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.

Outcome measures

Outcome measures
Measure
Cervarix Group
n=450 Participants
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.
Placebo Group
n=226 Participants
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.
Number of Subjects With Serious Adverse Events (SAEs)
up to Month 7
12 Participants
10 Participants
Number of Subjects With Serious Adverse Events (SAEs)
up to Month 12
17 Participants
14 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Month 12

Population: 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).

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.

Outcome measures

Outcome measures
Measure
Cervarix Group
n=14 Participants
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.
Placebo Group
n=10 Participants
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.
Number of Subjects With Pregnancies and Their Outcomes
Ectopic pregnancy
1 Participants
0 Participants
Number of Subjects With Pregnancies and Their Outcomes
Elective termination
3 Participants
3 Participants
Number of Subjects With Pregnancies and Their Outcomes
Live infant
5 Participants
5 Participants
Number of Subjects With Pregnancies and Their Outcomes
Premature live infant
3 Participants
1 Participants
Number of Subjects With Pregnancies and Their Outcomes
Lost to follow-up
1 Participants
0 Participants
Number of Subjects With Pregnancies and Their Outcomes
Spontaneous abortion
1 Participants
1 Participants

SECONDARY outcome

Timeframe: At Month 7

Population: The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.

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.

Outcome measures

Outcome measures
Measure
Cervarix Group
n=217 Participants
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.
Placebo Group
n=105 Participants
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.
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA. pre-vacc. BELOW, Month 7 NORMAL
1 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA. pre-vacc. BELOW, Month 7 BELOW
1 Participants
2 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA. pre-vacc. BELOW, Month 7 ABOVE
0 Participants
1 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. NORMAL, Month 7 NORMAL
194 Participants
96 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. NORMAL, Month 7 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. NORMAL, Month 7 ABOVE
4 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. BELOW, Month 7 NORMAL
10 Participants
3 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. BELOW, Month 7 BELOW
19 Participants
8 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. BELOW, Month 7 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. NORMAL, Month 7 NORMAL
176 Participants
89 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. NORMAL, Month 7 BELOW
12 Participants
5 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. NORMAL, Month 7 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. ABOVE, Month 7 NORMAL
6 Participants
6 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. ABOVE, Month 7 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. ABOVE, Month 7 ABOVE
3 Participants
1 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. BELOW, Month 7 NORMAL
5 Participants
6 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. BELOW, Month 7 BELOW
16 Participants
6 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. BELOW, Month 7 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. NORMAL, Month 7 NORMAL
158 Participants
72 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. NORMAL, Month 7 BELOW
26 Participants
13 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. BELOW, Month 7 BELOW
24 Participants
10 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. ABOVE, Month 7 NORMAL
7 Participants
4 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc.ABOVE, Month 7 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. ABOVE, Month 7 ABOVE
1 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. BELOW, Month 7 NORMAL
15 Participants
7 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. BELOW, Month 7 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. NORMAL, Month 7 NORMAL
137 Participants
57 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. NORMAL, Month 7 BELOW
30 Participants
25 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. NORMAL, Month 7 ABOVE
3 Participants
2 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. NORMAL, Month 7 NORMAL
216 Participants
105 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. NORMAL, Month 7 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. NORMAL, Month 7 ABOVE
1 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. ABOVE, Month 7 NORMAL
1 Participants
1 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. ABOVE, Month 7 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. ABOVE, Month 7 ABOVE
1 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. BELOW, Month 7 NORMAL
19 Participants
13 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. BELOW, Month 7 BELOW
37 Participants
17 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. BELOW, Month 7 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. NORMAL, Month 7 NORMAL
149 Participants
68 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. NORMAL, Month 7 BELOW
10 Participants
4 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. NORMAL, Month 7 ABOVE
0 Participants
2 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. ABOVE, Month 7 NORMAL
9 Participants
12 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. ABOVE, Month 7 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. ABOVE, Month 7 ABOVE
34 Participants
16 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. BELOW, Month 7 NORMAL
17 Participants
9 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. BELOW, Month 7 BELOW
2 Participants
1 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. BELOW, Month 7 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. NORMAL, Month 7 NORMAL
134 Participants
56 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. NORMAL, Month 7 BELOW
3 Participants
2 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. NORMAL, Month 7 ABOVE
18 Participants
9 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. BELOW, Month 7 NORMAL
16 Participants
7 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. BELOW, Month 7 BELOW
59 Participants
26 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. BELOW, Month 7 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. NORMAL, Month 7 NORMAL
104 Participants
52 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. NORMAL, Month 7 BELOW
38 Participants
20 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. NORMAL, Month 7 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. ABOVE, Month 7 NORMAL
23 Participants
11 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. ABOVE, Month 7 BELOW
4 Participants
3 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. ABOVE, Month 7 ABOVE
50 Participants
27 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. BELOW, Month 7 NORMAL
23 Participants
8 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. BELOW, Month 7 BELOW
11 Participants
6 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. BELOW, Month 7 ABOVE
7 Participants
5 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. NORMAL, Month 7 NORMAL
47 Participants
19 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. NORMAL, Month 7 BELOW
17 Participants
2 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. NORMAL, Month 7 ABOVE
35 Participants
24 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. ABOVE, Month 7 NORMAL
17 Participants
4 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. ABOVE, Month 7 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. ABOVE, Month 7 ABOVE
31 Participants
31 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. NORMAL, Month 7 NORMAL
108 Participants
45 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. NORMAL, Month 7 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. NORMAL, Month 7 ABOVE
61 Participants
25 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. ABOVE, Month 7 NORMAL
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. ABOVE, Month 7 BELOW
7 Participants
3 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. ABOVE, Month 7 ABOVE
1 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. BELOW, Month 7 NORMAL
9 Participants
4 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. BELOW, Month 7 BELOW
165 Participants
86 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. BELOW, Month 7 ABOVE
2 Participants
1 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. NORMAL, Month 7 NORMAL
4 Participants
1 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. NORMAL, Month 7 BELOW
26 Participants
10 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. NORMAL, Month 7 ABOVE
3 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. ABOVE, Month 7 NORMAL
10 Participants
4 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. ABOVE, Month 7 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. ABOVE, Month 7 ABOVE
7 Participants
2 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. NORMAL, Month 7 ABOVE
3 Participants
1 Participants

SECONDARY outcome

Timeframe: At Month 7

Population: The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.

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.

Outcome measures

Outcome measures
Measure
Cervarix Group
n=187 Participants
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.
Placebo Group
n=96 Participants
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.
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. BELOW, Month 7 NORMAL
4 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. BELOW, Month 7 BELOW
1 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. BELOW, Month 7 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. NORMAL, Month 7 NORMAL
177 Participants
90 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. NORMAL, Month 7 BELOW
5 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. NORMAL, Month 7 ABOVE
4 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. ABOVE, Month 7 NORMAL
13 Participants
6 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. ABOVE, Month 7 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. ABOVE, Month 7 ABOVE
4 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. BELOW, Month 7 NORMAL
0 Participants
2 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. BELOW, Month 7 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. BELOW, Month 7 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. NORMAL, Month 7 NORMAL
177 Participants
86 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. NORMAL, Month 7 BELOW
4 Participants
2 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. NORMAL, Month 7 ABOVE
1 Participants
2 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. ABOVE, Month 7 NORMAL
2 Participants
2 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. ABOVE, Month 7 BELOW
0 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. ABOVE, Month 7 ABOVE
1 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. BELOW, Month 7 NORMAL
7 Participants
3 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. BELOW, Month 7 BELOW
6 Participants
8 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. BELOW, Month 7 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. NORMAL, Month 7 NORMAL
144 Participants
65 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. NORMAL, Month 7 BELOW
39 Participants
20 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. NORMAL, Month 7 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. ABOVE, Month 7 NORMAL
19 Participants
12 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. ABOVE, Month 7 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. ABOVE, Month 7 ABOVE
2 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. NORMAL, Month 7 NORMAL
163 Participants
81 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. NORMAL, Month 7 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. NORMAL, Month 7 ABOVE
15 Participants
6 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. BELOW, Month 7 NORMAL
2 Participants
2 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. BELOW, Month 7 BELOW
41 Participants
12 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. BELOW, Month 7 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. NORMAL, Month 7 NORMAL
40 Participants
14 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. NORMAL, Month 7 BELOW
116 Participants
71 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. NORMAL, Month 7 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. ABOVE, Month 7 NORMAL
14 Participants
4 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. ABOVE, Month 7 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. ABOVE, Month 7 ABOVE
61 Participants
35 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. ABOVE, Month 7 MISSING
1 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. NORMAL, Month 7 NORMAL
92 Participants
52 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. NORMAL, Month 7 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. NORMAL, Month 7 ABOVE
31 Participants
8 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. ABOVE, Month 7 NORMAL
1 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. ABOVE, Month 7 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. ABOVE, Month 7 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. BELOW, Month 7 NORMAL
20 Participants
6 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. BELOW, Month 7 BELOW
40 Participants
29 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. BELOW, Month 7 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. NORMAL, Month 7 NORMAL
118 Participants
51 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. NORMAL, Month 7 BELOW
20 Participants
13 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. NORMAL, Month 7 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. ABOVE, Month 7 NORMAL
12 Participants
7 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. ABOVE, Month 7 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. ABOVE, Month 7 ABOVE
8 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. NORMAL, Month 7 NORMAL
166 Participants
81 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. NORMAL, Month 7 BELOW
3 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. NORMAL, Month 7 ABOVE
10 Participants
10 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. ABOVE, Month 7 NORMAL
6 Participants
6 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. ABOVE, Month 7 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. ABOVE, Month 7 ABOVE
6 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. NORMAL, Month 7 NORMAL
180 Participants
85 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. NORMAL, Month 7 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. NORMAL, Month 7 ABOVE
7 Participants
7 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. BELOW, Month 7 NORMAL
13 Participants
9 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. BELOW, Month 7 BELOW
22 Participants
7 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. BELOW, Month 7 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. BELOW, Month 7 MISSING
1 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. NORMAL, Month 7 NORMAL
145 Participants
70 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. NORMAL, Month 7 BELOW
17 Participants
13 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. NORMAL, Month 7 ABOVE
1 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. ABOVE, Month 7 NORMAL
7 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. ABOVE, Month 7 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. ABOVE, Month 7 ABOVE
3 Participants
2 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. BELOW, Month 7 BELOW
1 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. BELOW, Month 7 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. NORMAL, Month 7 NORMAL
180 Participants
92 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. NORMAL, Month 7 BELOW
2 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. NORMAL, Month 7 ABOVE
2 Participants
4 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. ABOVE, Month 7 NORMAL
6 Participants
4 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. ABOVE, Month 7 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. ABOVE, Month 7 ABOVE
5 Participants
3 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. BELOW, Month 7 NORMAL
1 Participants
0 Participants

SECONDARY outcome

Timeframe: At Month 12

Population: The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.

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.

Outcome measures

Outcome measures
Measure
Cervarix Group
n=211 Participants
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.
Placebo Group
n=102 Participants
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.
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. ABOVE, Month 12 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. BELOW, Month 12 NORMAL
17 Participants
9 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. BELOW, Month 12 BELOW
21 Participants
8 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. ABOVE, Month 12 ABOVE
1 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. BELOW, Month 12 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. NORMAL, Month 12 NORMAL
139 Participants
61 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. NORMAL, Month 12 BELOW
24 Participants
17 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. NORMAL, Month 12 ABOVE
2 Participants
3 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. NORMAL, Month 12 NORMAL
210 Participants
102 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. NORMAL, Month 12 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. NORMAL, Month 12 ABOVE
1 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. ABOVE, Month 12 NORMAL
1 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. ABOVE, Month 12 BELOW
0 Participants
1 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. BELOW, Month 12 NORMAL
13 Participants
6 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. BELOW, Month 12 BELOW
43 Participants
23 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. BELOW, Month 12 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. NORMAL, Month 12 NORMAL
130 Participants
64 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. NORMAL, Month 12 BELOW
23 Participants
8 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. NORMAL, Month 12 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. ABOVE, Month 12 NORMAL
14 Participants
11 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. ABOVE, Month 12 BELOW
1 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. ABOVE, Month 12 ABOVE
28 Participants
17 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. NORMAL, Month 12 BELOW
6 Participants
2 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. BELOW, Month 12 NORMAL
13 Participants
6 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. BELOW, Month 12 BELOW
6 Participants
3 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. BELOW, Month 12 ABOVE
0 Participants
1 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. NORMAL, Month 12 NORMAL
126 Participants
52 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. NORMAL, Month 12 ABOVE
17 Participants
10 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. ABOVE, Month 12 NORMAL
8 Participants
4 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc.ABOVE, Month 12 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. BELOW, Month 12 NORMAL
15 Participants
10 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. BELOW, Month 12 BELOW
56 Participants
23 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. BELOW, Month 12 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. NORMAL, Month 12 NORMAL
169 Participants
80 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. NORMAL, Month 12 BELOW
15 Participants
11 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. NORMAL, Month 12 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. ABOVE, Month 12 NORMAL
6 Participants
7 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. ABOVE, Month 12 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. ABOVE, Month 12 ABOVE
2 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. BELOW, Month 12 NORMAL
10 Participants
5 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. BELOW, Month 12 BELOW
9 Participants
7 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. BELOW, Month 12 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. NORMAL, Month 12 NORMAL
156 Participants
64 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. NORMAL, Month 12 BELOW
22 Participants
16 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. NORMAL, Month 12 ABOVE
6 Participants
3 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. NORMAL, Month 12 NORMAL
108 Participants
45 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. NORMAL, Month 12 BELOW
32 Participants
24 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. NORMAL, Month 12 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. ABOVE, Month 12 NORMAL
24 Participants
16 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. ABOVE, Month 12 BELOW
4 Participants
3 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. ABOVE, Month 12 ABOVE
47 Participants
22 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. BELOW, Month 12 NORMAL
9 Participants
8 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. BELOW, Month 12 BELOW
15 Participants
5 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. BELOW, Month 12 ABOVE
14 Participants
6 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. NORMAL, Month 12 NORMAL
48 Participants
24 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. NORMAL, Month 12 BELOW
27 Participants
4 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. NORMAL, Month 12 ABOVE
23 Participants
14 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. ABOVE, Month 12 NORMAL
13 Participants
10 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. ABOVE, Month 12 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. ABOVE, Month 12 ABOVE
32 Participants
24 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. NORMAL, Month 12 NORMAL
102 Participants
38 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. NORMAL, Month 12 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. NORMAL, Month 12 ABOVE
64 Participants
30 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. ABOVE, Month 12 NORMAL
4 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. ABOVE, Month 12 BELOW
4 Participants
3 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. ABOVE, Month 12 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. BELOW, Month 12 NORMAL
11 Participants
5 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. BELOW, Month 12 BELOW
160 Participants
83 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. BELOW, Month 12 ABOVE
2 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. NORMAL, Month 12 NORMAL
7 Participants
1 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. NORMAL, Month 12 BELOW
22 Participants
9 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. NORMAL, Month 12 ABOVE
1 Participants
1 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. ABOVE, Month 12 NORMAL
13 Participants
4 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. ABOVE, Month 12 BELOW
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. ABOVE, Month 12 ABOVE
4 Participants
2 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA. pre-vacc. BELOW, Month 12 NORMAL
1 Participants
1 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA. pre-vacc. BELOW, Month 12 BELOW
1 Participants
2 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA. pre-vacc. BELOW, Month 12 ABOVE
0 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. NORMAL, Month 12 NORMAL
188 Participants
93 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. NORMAL, Month 12 BELOW
3 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. NORMAL, Month 12 ABOVE
1 Participants
0 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. BELOW, Month 12 NORMAL
8 Participants
5 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. BELOW, Month 12 BELOW
19 Participants
6 Participants
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. BELOW, Month 12 ABOVE
0 Participants
0 Participants

SECONDARY outcome

Timeframe: At Month 12

Population: The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.

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.

Outcome measures

Outcome measures
Measure
Cervarix Group
n=194 Participants
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.
Placebo Group
n=100 Participants
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.
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. NORMAL, Month 12 BELOW
1 Participants
2 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. NORMAL, Month 12 ABOVE
5 Participants
2 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. ABOVE, Month 12 NORMAL
2 Participants
2 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. ABOVE, Month 12 BELOW
0 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. ABOVE, Month 12 ABOVE
1 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. BELOW, Month 12 NORMAL
12 Participants
8 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. BELOW, Month 12 BELOW
1 Participants
3 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. BELOW, Month 12 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. NORMAL, Month 12 NORMAL
166 Participants
73 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. NORMAL, Month 12 BELOW
24 Participants
13 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
ALT, pre-vacc. NORMAL, Month 12 ABOVE
0 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. ABOVE, Month 12 NORMAL
21 Participants
12 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. ABOVE, Month 12 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. ABOVE, Month 12 ABOVE
2 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. NORMAL, Month 12 NORMAL
174 Participants
81 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. NORMAL, Month 12 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
BAS, pre-vacc. NORMAL, Month 12 ABOVE
9 Participants
8 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. BELOW, Month 12 NORMAL
2 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. BELOW, Month 12 BELOW
40 Participants
14 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. BELOW, Month 12 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. NORMAL, Month 12 NORMAL
48 Participants
19 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. NORMAL, Month 12 BELOW
116 Participants
69 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
CREA, pre-vacc. NORMAL, Month 12 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. ABOVE, Month 12 NORMAL
22 Participants
10 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. ABOVE, Month 12 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. ABOVE, Month 12 ABOVE
57 Participants
33 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. NORMAL, Month 12 NORMAL
93 Participants
48 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. NORMAL, Month 12 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
EOS, pre-vacc. NORMAL, Month 12 ABOVE
34 Participants
11 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. BELOW, Month 12 NORMAL
29 Participants
10 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. BELOW, Month 12 BELOW
34 Participants
28 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. BELOW, Month 12 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. NORMAL, Month 12 NORMAL
107 Participants
48 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. NORMAL, Month 12 BELOW
36 Participants
16 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
HC, pre-vacc. NORMAL, Month 12 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. ABOVE, Month 12 NORMAL
9 Participants
3 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. ABOVE, Month 12 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. ABOVE, Month 12 ABOVE
9 Participants
5 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. NORMAL, Month 12 NORMAL
168 Participants
81 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. NORMAL, Month 12 BELOW
0 Participants
2 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
LYM, pre-vacc. NORMAL, Month 12 ABOVE
20 Participants
11 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. ABOVE, Month 12 NORMAL
8 Participants
6 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. ABOVE, Month 12 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. ABOVE, Month 12 ABOVE
4 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. NORMAL, Month 12 NORMAL
184 Participants
88 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. NORMAL, Month 12 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
MON, pre-vacc. NORMAL, Month 12 ABOVE
10 Participants
7 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. BELOW, Month 12 NORMAL
18 Participants
6 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. BELOW, Month 12 BELOW
18 Participants
11 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. BELOW, Month 12 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. NORMAL, Month 12 NORMAL
138 Participants
72 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. NORMAL, Month 12 BELOW
32 Participants
13 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
NEU, pre-vacc. NORMAL, Month 12 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. ABOVE, Month 12 NORMAL
8 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. ABOVE, Month 12 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. ABOVE, Month 12 ABOVE
2 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. BELOW, Month 12 NORMAL
5 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. BELOW, Month 12 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. BELOW, Month 12 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
PLA, pre-vacc. NORMAL, Month 12 NORMAL
185 Participants
96 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. ABOVE, Month 12 NORMAL
5 Participants
3 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. ABOVE, Month 12 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. ABOVE, Month 12 ABOVE
5 Participants
4 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. BELOW, Month 12 NORMAL
2 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. BELOW, Month 12 BELOW
1 Participants
2 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. BELOW, Month 12 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. NORMAL, Month 12 NORMAL
182 Participants
91 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. NORMAL, Month 12 BELOW
6 Participants
2 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
RBC, pre-vacc. NORMAL, Month 12 ABOVE
5 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. ABOVE, Month 12 NORMAL
12 Participants
5 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. ABOVE, Month 12 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. ABOVE, Month 12 ABOVE
5 Participants
1 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. BELOW, Month 12 NORMAL
0 Participants
2 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. BELOW, Month 12 BELOW
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. BELOW, Month 12 ABOVE
0 Participants
0 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. NORMAL, Month 12 NORMAL
165 Participants
85 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. NORMAL, Month 12 BELOW
14 Participants
5 Participants
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
WBC, pre-vacc. NORMAL, Month 12 ABOVE
10 Participants
4 Participants

Adverse Events

Cervarix Group

Serious events: 17 serious events
Other events: 433 other events
Deaths: 0 deaths

Placebo Group

Serious events: 14 serious events
Other events: 216 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Cervarix Group
n=450 participants at risk
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.
Placebo Group
n=226 participants at risk
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.
Infections and infestations
Malaria
2.2%
10/450 • 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).
4.9%
11/226 • 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).
Infections and infestations
Urinary tract infection
0.00%
0/450 • 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).
1.3%
3/226 • 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).
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
0.22%
1/450 • 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).
0.44%
1/226 • 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).
Infections and infestations
Pneumonia bacterial
0.22%
1/450 • 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).
0.44%
1/226 • 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).
Gastrointestinal disorders
Abdominal pain lower
0.22%
1/450 • 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).
0.00%
0/226 • 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).
Infections and infestations
Amoebiasis
0.22%
1/450 • 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).
0.00%
0/226 • 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).
Infections and infestations
Appendicitis
0.22%
1/450 • 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).
0.00%
0/226 • 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).
Infections and infestations
Burn infection
0.00%
0/450 • 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).
0.44%
1/226 • 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).
Infections and infestations
Dysentery
0.22%
1/450 • 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).
0.00%
0/226 • 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).
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
0.22%
1/450 • 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).
0.00%
0/226 • 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).
Injury, poisoning and procedural complications
Femur fracture
0.22%
1/450 • 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).
0.00%
0/226 • 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).
Infections and infestations
Gastroenteritis
0.22%
1/450 • 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).
0.00%
0/226 • 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).
Endocrine disorders
Goitre
0.22%
1/450 • 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).
0.00%
0/226 • 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).
Gastrointestinal disorders
Haemorrhoids
0.22%
1/450 • 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).
0.00%
0/226 • 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).
Nervous system disorders
Neuropathy vitamin b6 deficiency
0.22%
1/450 • 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).
0.00%
0/226 • 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).
Infections and infestations
Pelvic inflammatory disease
0.22%
1/450 • 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).
0.00%
0/226 • 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).
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
0.22%
1/450 • 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).
0.00%
0/226 • 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).
Infections and infestations
Pyomyositis
0.22%
1/450 • 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).
0.00%
0/226 • 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).
Infections and infestations
Tonsillitis bacterial
0.22%
1/450 • 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).
0.00%
0/226 • 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).
Infections and infestations
Tonsillitis
0.00%
0/450 • 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).
0.44%
1/226 • 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).
Reproductive system and breast disorders
Vaginal haemorrhage
0.22%
1/450 • 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).
0.00%
0/226 • 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).

Other adverse events

Other adverse events
Measure
Cervarix Group
n=450 participants at risk
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.
Placebo Group
n=226 participants at risk
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.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Fungal infection
0.44%
2/450 • Number of events 2 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Fungal skin infection
0.89%
4/450 • Number of events 4 • 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).
0.88%
2/226 • Number of events 2 • 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).
Gastrointestinal disorders
Gastritis
0.89%
4/450 • Number of events 4 • 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).
0.00%
0/226 • 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).
Infections and infestations
Gastroenteritis
0.67%
3/450 • Number of events 3 • 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).
0.44%
1/226 • Number of events 1 • 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).
Gastrointestinal disorders
Gastrointestinal disorder
26.2%
118/450 • Number of events 143 • 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).
24.8%
56/226 • Number of events 66 • 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).
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Reproductive system and breast disorders
Genital discharge
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Gastrointestinal disorders
Abdominal pain
3.6%
16/450 • Number of events 17 • 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).
3.1%
7/226 • Number of events 7 • 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).
Gastrointestinal disorders
Abdominal pain upper
0.22%
1/450 • Number of events 1 • 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).
0.88%
2/226 • Number of events 2 • 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).
Infections and infestations
Abscess
0.44%
2/450 • Number of events 2 • 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).
0.00%
0/226 • 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).
Infections and infestations
Abscess limb
0.22%
1/450 • Number of events 1 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Adenoiditis
0.22%
1/450 • Number of events 1 • 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).
0.44%
1/226 • Number of events 1 • 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).
Reproductive system and breast disorders
Amenorrhoea
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Amoebiasis
0.22%
1/450 • Number of events 1 • 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).
1.3%
3/226 • Number of events 3 • 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).
Psychiatric disorders
Anxiety
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Musculoskeletal and connective tissue disorders
Arthralgia
17.6%
79/450 • Number of events 97 • 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).
15.9%
36/226 • Number of events 41 • 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).
Infections and infestations
Arthritis bacterial
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Injury, poisoning and procedural complications
Arthropod sting
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
General disorders
Asthenia
0.22%
1/450 • Number of events 1 • 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).
0.44%
1/226 • Number of events 1 • 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).
Musculoskeletal and connective tissue disorders
Back pain
0.89%
4/450 • Number of events 4 • 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).
0.88%
2/226 • Number of events 2 • 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).
Infections and infestations
Body tinea
1.6%
7/450 • Number of events 7 • 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).
1.3%
3/226 • Number of events 3 • 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).
Infections and infestations
Bronchitis
0.89%
4/450 • Number of events 4 • 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).
1.8%
4/226 • Number of events 4 • 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).
Infections and infestations
Bronchopneumonia
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Injury, poisoning and procedural complications
Burns first degree
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Infections and infestations
Candidiasis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Infections and infestations
Cellulitis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
General disorders
Chest discomfort
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
General disorders
Chest pain
1.1%
5/450 • Number of events 5 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Chlamydial infection
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Eye disorders
Conjunctivitis
1.8%
8/450 • Number of events 8 • 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).
0.44%
1/226 • Number of events 1 • 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).
Eye disorders
Conjunctivitis allergic
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Gastrointestinal disorders
Constipation
0.00%
0/450 • 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).
0.88%
2/226 • Number of events 2 • 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).
Respiratory, thoracic and mediastinal disorders
Cough
2.9%
13/450 • Number of events 13 • 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).
3.1%
7/226 • Number of events 8 • 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).
Infections and infestations
Cutaneous larva migrans
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Gastrointestinal disorders
Dental caries
1.3%
6/450 • Number of events 6 • 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).
0.88%
2/226 • Number of events 2 • 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).
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Gastrointestinal disorders
Diarrhoea
1.3%
6/450 • Number of events 6 • 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).
1.3%
3/226 • Number of events 3 • 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).
Nervous system disorders
Dizziness
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Reproductive system and breast disorders
Dysmenorrhoea
5.1%
23/450 • Number of events 25 • 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).
4.4%
10/226 • Number of events 10 • 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).
Gastrointestinal disorders
Dyspepsia
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Renal and urinary disorders
Dysuria
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Ear and labyrinth disorders
Ear pain
1.1%
5/450 • Number of events 5 • 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).
0.88%
2/226 • Number of events 2 • 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).
Skin and subcutaneous tissue disorders
Eczema
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Gastrointestinal disorders
Enteritis
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Eye disorders
Eye allergy
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Eye disorders
Eye irritation
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Eye disorders
Eye pain
0.89%
4/450 • Number of events 4 • 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).
0.00%
0/226 • 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).
Eye disorders
Eye pruritus
0.44%
2/450 • Number of events 2 • 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).
0.00%
0/226 • 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).
Eye disorders
Eyelid oedema
0.22%
1/450 • Number of events 1 • 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).
0.44%
1/226 • Number of events 1 • 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).
General disorders
Fatigue
24.7%
111/450 • Number of events 130 • 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).
18.6%
42/226 • Number of events 50 • 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).
Infections and infestations
Giardiasis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Infections and infestations
Gingival infection
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Gastrointestinal disorders
Gingivitis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Gastrointestinal disorders
Glossitis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Gastrointestinal disorders
Haemorrhoids
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Nervous system disorders
Head discomfort
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Nervous system disorders
Headache
44.7%
201/450 • Number of events 298 • 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).
51.3%
116/226 • Number of events 157 • 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).
Infections and infestations
Helminthic infection
1.8%
8/450 • Number of events 8 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Hookworm infection
0.22%
1/450 • Number of events 1 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Hordeolum
0.22%
1/450 • Number of events 1 • 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).
0.44%
1/226 • Number of events 1 • 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).
Vascular disorders
Hot flush
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Injury, poisoning and procedural complications
Human bite
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Gastrointestinal disorders
Hyperchlorhydria
0.44%
2/450 • Number of events 2 • 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).
0.00%
0/226 • 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).
Immune system disorders
Hypersensitivity
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Vascular disorders
Hypotension
0.67%
3/450 • Number of events 3 • 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).
0.88%
2/226 • Number of events 2 • 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).
Infections and infestations
Influenza
1.8%
8/450 • Number of events 8 • 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).
0.44%
1/226 • Number of events 1 • 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).
General disorders
Influenza like illness
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
General disorders
Injection site rash
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Psychiatric disorders
Insomnia
0.44%
2/450 • Number of events 2 • 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).
0.44%
1/226 • Number of events 1 • 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).
Blood and lymphatic system disorders
Iron deficiency anaemia
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Eye disorders
Lacrimation increased
0.22%
1/450 • Number of events 1 • 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).
0.44%
1/226 • Number of events 1 • 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).
Injury, poisoning and procedural complications
Limb traumatic amputation
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Blood and lymphatic system disorders
Lymphadenitis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Infections and infestations
Malaria
12.4%
56/450 • Number of events 66 • 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).
16.8%
38/226 • Number of events 44 • 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).
Infections and infestations
Measles
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Reproductive system and breast disorders
Menstruation delayed
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Reproductive system and breast disorders
Metrorrhagia
0.22%
1/450 • Number of events 1 • 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).
0.44%
1/226 • Number of events 1 • 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).
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Musculoskeletal and connective tissue disorders
Myalgia
20.0%
90/450 • Number of events 113 • 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).
16.8%
38/226 • Number of events 46 • 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).
Eye disorders
Myopia
0.22%
1/450 • Number of events 1 • 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).
0.88%
2/226 • Number of events 2 • 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).
Infections and infestations
Nasopharyngitis
2.0%
9/450 • Number of events 10 • 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).
5.3%
12/226 • Number of events 12 • 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).
Gastrointestinal disorders
Nausea
0.44%
2/450 • Number of events 2 • 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).
0.88%
2/226 • Number of events 2 • 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).
Musculoskeletal and connective tissue disorders
Neck pain
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
General disorders
Oedema peripheral
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Gastrointestinal disorders
Oesophagitis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Reproductive system and breast disorders
Oligomenorrhoea
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
1.8%
8/450 • Number of events 9 • 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).
2.7%
6/226 • Number of events 6 • 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).
Vascular disorders
Orthostatic hypotension
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Otitis media
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Rhinitis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Reproductive system and breast disorders
Ovarian cyst
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
General disorders
Pain
83.6%
376/450 • Number of events 779 • 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).
74.3%
168/226 • Number of events 279 • 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).
Musculoskeletal and connective tissue disorders
Pain in extremity
0.44%
2/450 • Number of events 2 • 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).
0.88%
2/226 • Number of events 2 • 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).
Cardiac disorders
Palpitations
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Infections and infestations
Parasitic gastroenteritis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Infections and infestations
Paronychia
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Pelvic inflammatory disease
0.89%
4/450 • Number of events 5 • 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).
0.44%
1/226 • Number of events 1 • 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).
Reproductive system and breast disorders
Pelvic pain
0.67%
3/450 • Number of events 3 • 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).
0.00%
0/226 • 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).
Gastrointestinal disorders
Peptic ulcer
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Infections and infestations
Pericoronitis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Infections and infestations
Pharyngitis
0.44%
2/450 • Number of events 2 • 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).
0.00%
0/226 • 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).
Vascular disorders
Phlebitis
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Skin and subcutaneous tissue disorders
Pigmentation disorder
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Pneumonia
0.44%
2/450 • Number of events 2 • 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).
1.3%
3/226 • Number of events 3 • 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).
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
General disorders
Pyrexia
32.7%
147/450 • Number of events 235 • 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).
31.4%
71/226 • Number of events 110 • 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).
Skin and subcutaneous tissue disorders
Rash
15.8%
71/450 • Number of events 84 • 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).
14.6%
33/226 • Number of events 38 • 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).
Skin and subcutaneous tissue disorders
Rash papular
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Infections and infestations
Respiratory tract infection
0.22%
1/450 • Number of events 1 • 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).
0.44%
1/226 • Number of events 1 • 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).
Nervous system disorders
Sensory disturbance
0.44%
2/450 • Number of events 2 • 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).
0.00%
0/226 • 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).
Infections and infestations
Sepsis
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Shigella infection
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Sinusitis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Skin and subcutaneous tissue disorders
Skin disorder
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Skin and subcutaneous tissue disorders
Skin exfoliation
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Injury, poisoning and procedural complications
Soft tissue injury
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Gastrointestinal disorders
Stomatitis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Infections and infestations
Subcutaneous abscess
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
General disorders
Swelling
16.4%
74/450 • Number of events 86 • 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).
11.9%
27/226 • Number of events 32 • 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).
Infections and infestations
Tinea capitis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Infections and infestations
Tinea versicolour
0.22%
1/450 • Number of events 1 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Tonsillitis
0.89%
4/450 • Number of events 4 • 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).
0.88%
2/226 • Number of events 2 • 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).
Gastrointestinal disorders
Toothache
1.3%
6/450 • Number of events 6 • 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).
1.3%
3/226 • Number of events 3 • 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).
Musculoskeletal and connective tissue disorders
Torticollis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Infections and infestations
Trichuriasis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Infections and infestations
Upper respiratory tract infection
2.2%
10/450 • Number of events 11 • 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).
2.2%
5/226 • Number of events 5 • 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).
Skin and subcutaneous tissue disorders
Urticaria
15.1%
68/450 • Number of events 81 • 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).
12.4%
28/226 • Number of events 33 • 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).
Reproductive system and breast disorders
Vaginal discharge
1.3%
6/450 • Number of events 6 • 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).
1.8%
4/226 • Number of events 4 • 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).
Reproductive system and breast disorders
Vaginal haemorrhage
0.22%
1/450 • Number of events 1 • 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).
0.44%
1/226 • Number of events 1 • 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).
Infections and infestations
Vaginal infection
0.44%
2/450 • Number of events 2 • 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).
0.00%
0/226 • 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).
Infections and infestations
Vaginitis bacterial
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Infections and infestations
Varicella
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Ear and labyrinth disorders
Vertigo
2.9%
13/450 • Number of events 15 • 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).
1.3%
3/226 • Number of events 4 • 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).
Eye disorders
Visual impairment
0.00%
0/450 • 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).
0.44%
1/226 • Number of events 1 • 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).
Gastrointestinal disorders
Vomiting
0.44%
2/450 • Number of events 2 • 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).
0.00%
0/226 • 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).
Infections and infestations
Vulvitis
0.22%
1/450 • Number of events 1 • 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).
0.88%
2/226 • Number of events 2 • 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).
Infections and infestations
Vulvovaginal candidiasis
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Reproductive system and breast disorders
Vulvovaginal pruritus
0.22%
1/450 • Number of events 1 • 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).
0.00%
0/226 • 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).
Injury, poisoning and procedural complications
Wound
0.44%
2/450 • Number of events 2 • 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).
0.44%
1/226 • Number of events 1 • 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).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

  • Principal investigator is a sponsor employee 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.
  • Publication restrictions are in place

Restriction type: OTHER