Trial Outcomes & Findings for Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females (NCT NCT01031069)
NCT ID: NCT01031069
Last Updated: 2020-07-21
Results Overview
Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
873 participants
Primary outcome timeframe
During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
Results posted on
2020-07-21
Participant Flow
A number of 873 subjects were enrolled, out of which 173 subjects were excluded from all statistical analysis. 154 subjects were not administered any vaccine dose (146 screen failures subjects and 8 subjects that did not participate from Visit 1).
Screening involved: checking of inclusion/exclusion criteria, demographic data, history and physical examination, AF B sputum test and/or chest X-ray, blood sampling for HIV testing and safety, urine pregnancy testing, birth control and HIV, STI, STD counselling, checking records for concomitant medication/vaccination, subject card distribution.
Participant milestones
| Measure |
HIV+/Cervarix Group
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
129
|
128
|
144
|
145
|
|
Overall Study
COMPLETED
|
117
|
117
|
103
|
111
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
41
|
34
|
Reasons for withdrawal
| Measure |
HIV+/Cervarix Group
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Overall Study
Serious Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
18
|
18
|
|
Overall Study
Migrated/moved from study area
|
1
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
9
|
5
|
21
|
15
|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females
Baseline characteristics by cohort
| Measure |
HIV+/Cervarix Group
n=129 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
n=144 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
n=145 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
Total
n=546 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
20.4 Years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
20.1 Years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
19.3 Years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
19.6 Years
STANDARD_DEVIATION 3.0 • n=4 Participants
|
19.8 Years
STANDARD_DEVIATION 3.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
546 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African Heritage/African American
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
173 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
40 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
165 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian/European Heritage
|
33 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.
Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=127 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
115 Participants
|
58 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
24 Participants
|
19 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
25 Participants
|
6 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
98 Participants
|
56 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 3
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across Doses
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
18 Participants
|
13 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
16 Participants
|
11 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 3
|
87 Participants
|
60 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 3
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 3
|
17 Participants
|
18 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 3
|
19 Participants
|
10 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across Doses
|
120 Participants
|
85 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across Doses
|
11 Participants
|
6 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across Doses
|
41 Participants
|
34 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across Doses
|
38 Participants
|
20 Participants
|
—
|
—
|
|
Number of Human Immunodeficiency Virus Positive Subjects (HIV+) With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across Doses
|
2 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, myalgia, rash, temperature \[defined as axillary temperature higher than (\>) 37.5 degrees Celsius (°C)\] and urticaria. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \> 39.0 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=127 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Dose 1
|
19 Participants
|
13 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 1
|
50 Participants
|
47 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 1
|
30 Participants
|
29 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 1
|
30 Participants
|
21 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 1
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 1
|
19 Participants
|
15 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 1
|
61 Participants
|
48 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 1
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 1
|
39 Participants
|
27 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 1
|
49 Participants
|
34 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 1
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 1
|
35 Participants
|
25 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash, Dose 1
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash, Dose 1
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Across Doses
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Across Doses
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Across Doses
|
50 Participants
|
39 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Across Doses
|
27 Participants
|
23 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Across Doses
|
11 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Across Doses
|
65 Participants
|
39 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Across Doses
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash, Across Doses
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Across Doses
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Across Doses
|
18 Participants
|
10 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria, Across Doses
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria, Across Doses
|
10 Participants
|
8 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Across Doses
|
31 Participants
|
28 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash, Dose 1
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 1
|
9 Participants
|
5 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 1
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria, Dose 1
|
8 Participants
|
3 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria, Dose 1
|
6 Participants
|
3 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Dose 2
|
18 Participants
|
21 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 2
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Dose 2
|
11 Participants
|
14 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 2
|
38 Participants
|
40 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 2
|
20 Participants
|
25 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 2
|
15 Participants
|
17 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 2
|
11 Participants
|
11 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 2
|
48 Participants
|
37 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 2
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 2
|
30 Participants
|
20 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 2
|
36 Participants
|
26 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 2
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 2
|
25 Participants
|
19 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash, Dose 2
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 2
|
11 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 2
|
9 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria, Dose 2
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria, Dose 2
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Dose 3
|
17 Participants
|
15 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 3
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Dose 3
|
13 Participants
|
12 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 3
|
40 Participants
|
31 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 3
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 3
|
30 Participants
|
22 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 3
|
13 Participants
|
17 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 3
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 3
|
9 Participants
|
13 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 3
|
48 Participants
|
27 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 3
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 3
|
39 Participants
|
16 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 3
|
30 Participants
|
21 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 3
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 3
|
26 Participants
|
17 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash, Dose 3
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash, Dose 3
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 3
|
10 Participants
|
12 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 3
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 3
|
7 Participants
|
6 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria, Dose 3
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria, Dose 3
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Across Doses
|
41 Participants
|
38 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Across Doses
|
73 Participants
|
59 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Across Doses
|
41 Participants
|
35 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Across Doses
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Across Doses
|
88 Participants
|
63 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Across Doses
|
68 Participants
|
51 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Across Doses
|
52 Participants
|
37 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash, Across Doses
|
11 Participants
|
5 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash, Across Doses
|
5 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Across Doses
|
23 Participants
|
19 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria, Across Doses
|
13 Participants
|
9 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Dose 1
|
29 Participants
|
20 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 1
|
1 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=129 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any AE(s)
|
41 Participants
|
41 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
7 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related AE(s)
|
9 Participants
|
8 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)Population: The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.
SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=129 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV+ Subjects With Serious Adverse Events (SAEs)
|
6 Participants
|
6 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)Population: The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.
Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=129 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV+ Subjects With Medically Significant Conditions (MSCs)
|
17 Participants
|
27 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)Population: The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.
Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=129 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV+ Subjects With Potential Immune-mediated Diseases (pIMDs)
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported any pregnancies and outcomes of reported pregnancies.
Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.) no apparent congenital anomaly, elective termination (termin.) congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.) anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=4 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=2 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Live infant NO apparent congenital anomaly
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Live infant congenital anomaly
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Elective termin. NO apparent congenital anomaly
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Elective termin. congenital anomaly
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Ectopic pregnancy
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Spontaneous abortion NO apparent congen. anomaly
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Stillbirth congenital anomaly
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Lost to follow-up
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Pregnancy ongoing
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Missing
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Stillbirth NO apparent congenital anomaly
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 7 (30 days after the last vaccination dose at Month 6)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.
Among assessed haematological and biochemical parameters were: alanine aminotransferase \[ALAT\], basophilis \[BSPH\], creatinine \[CRT\], eosinophils \[ESPH\], haematocrit \[HTCR\], haemoglobin \[HGB\], lymphocytes \[LYMP\], monocytes \[MONO\], neutrophils \[NTPH\], platelets \[PLAT\], red blood cells \[RBC\] and white blood cells \[WBC\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=121 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=121 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
ALAT, Below
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
ALAT, Within
|
110 Participants
|
105 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
BSPH, Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
LYMP, Below
|
12 Participants
|
11 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
MONO, Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
RBC, Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
WBC, Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
WBC, Within
|
106 Participants
|
108 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
ALAT, Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
ALAT, Above
|
7 Participants
|
13 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
BSPH, Below
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
BSPH, Within
|
120 Participants
|
121 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
BSPH, Above
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
CRT, Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
CRT, Below
|
29 Participants
|
36 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
CRT, Within
|
91 Participants
|
84 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
CRT, Above
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
ESPH, Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
ESPH, Below
|
9 Participants
|
10 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
ESPH, Within
|
108 Participants
|
106 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
ESPH, Above
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
HTCR, Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
HTCR, Below
|
19 Participants
|
27 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
HTCR, Within
|
101 Participants
|
92 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
HTCR, Above
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
HGB, Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
HGB, Below
|
28 Participants
|
37 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
HGB, Within
|
92 Participants
|
83 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
HGB, Above
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
LYMP, Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
LYMP, Within
|
96 Participants
|
97 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
LYMP, Above
|
13 Participants
|
13 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
MONO, Below
|
4 Participants
|
7 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
MONO, Within
|
106 Participants
|
97 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
MONO, Above
|
11 Participants
|
17 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
NTPH, Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
NTPH, Below
|
16 Participants
|
17 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
NTPH, Within
|
97 Participants
|
93 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
NTPH, Above
|
8 Participants
|
11 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
PLAT, Unknown
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
PLAT, Below
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
PLAT, Within
|
118 Participants
|
114 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
PLAT, Above
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
RBC, Below
|
36 Participants
|
34 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
RBC, Within
|
82 Participants
|
84 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
RBC, Above
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
WBC, Below
|
10 Participants
|
9 Participants
|
—
|
—
|
|
Number of HIV+ Subjects With Haematological and Biochemical Parameter Abnormalities
WBC, Above
|
5 Participants
|
4 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 7 (30 days after the last vaccination dose at Month 6)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.
CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=121 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=121 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Month 7
|
554.0 cells/mm3
Interval 440.0 to 799.0
|
568.0 cells/mm3
Interval 457.0 to 773.4
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 7 (30 days after the last vaccination dose at Month 6)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.
HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=96 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=95 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
HIV Viral Load (VL) in HIV+ Subjects at Month 7
|
1.9 HIV copies/mL
Interval 1.3 to 3.8
|
2.5 HIV copies/mL
Interval 1.3 to 3.8
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 7 (30 days after the last vaccination dose at Month 6)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.
HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification \[WHO, 2009\].
Outcome measures
| Measure |
HIV+/Cervarix Group
n=129 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV+ Subjects by World Health Organization (WHO) HIV Clinical Staging
Clinical Stage 1
|
113 Participants
|
114 Participants
|
—
|
—
|
|
Number of HIV+ Subjects by World Health Organization (WHO) HIV Clinical Staging
Clinical Stage 2
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV+ Subjects by World Health Organization (WHO) HIV Clinical Staging
Clinical Stage 3
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects by World Health Organization (WHO) HIV Clinical Staging
Clinical Stage 4
|
1 Participants
|
4 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 7 (30 days after the last vaccination dose at Month 6)Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom Month 7 data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity at Month 7 were available.
Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \[PBNA\], in HIV+ subjects. Between-group comparisons to assess non-inferiority were performed on the ATP cohort for immunogenicity (by PBNA, regardless of HPV serostatus at baseline).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=79 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=83 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Adapted According-to-protocol (ATP) Cohort for Immunogenicity
Anti-HPV-16
|
23436.1 Titers
Interval 18186.4 to 30201.1
|
7507.0 Titers
Interval 5378.1 to 10478.6
|
—
|
—
|
|
Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Adapted According-to-protocol (ATP) Cohort for Immunogenicity
Anti-HPV-18
|
12490.9 Titers
Interval 9681.7 to 16115.2
|
1459.6 Titers
Interval 965.4 to 2206.7
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 7 (30 days after the last vaccination dose at Month 6)Population: The analysis was performed on the TVC for analysis of immunogenicity, which included vaccinated subjects for whom data concerning immunogenicity endpoint measures were available at Month 7.
Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \[PBNA\], in HIV+ subjects. Between-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=108 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=109 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Total Vaccinated Cohort (TVC)
Anti-HPV-16
|
21106.6 Titers
Interval 15961.3 to 27910.6
|
7533.7 Titers
Interval 5616.7 to 10105.0
|
—
|
—
|
|
Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV+ Subjects, Based on Total Vaccinated Cohort (TVC)
Anti-HPV-18
|
11580.5 Titers
Interval 8851.5 to 15150.9
|
1451.9 Titers
Interval 1009.0 to 2089.2
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.
Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=141 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=144 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across Doses
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
127 Participants
|
91 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
10 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
32 Participants
|
21 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
23 Participants
|
14 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
108 Participants
|
92 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
6 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
29 Participants
|
29 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
24 Participants
|
27 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 3
|
94 Participants
|
82 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 3
|
10 Participants
|
6 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 3
|
28 Participants
|
19 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 3
|
29 Participants
|
19 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across Doses
|
133 Participants
|
119 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across Doses
|
22 Participants
|
8 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across Doses
|
52 Participants
|
42 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across Doses
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across Doses
|
47 Participants
|
39 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, myalgia, rash, temperature \[defined as axillary temperature higher than (\>) 37.5 degrees Celsius (°C)\] and urticaria. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature \> 39.0 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=141 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=144 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Dose 1
|
9 Participants
|
11 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Across Doses
|
20 Participants
|
18 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria, Across Doses
|
4 Participants
|
6 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Across Doses
|
28 Participants
|
26 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Across Doses
|
45 Participants
|
33 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 3
|
29 Participants
|
15 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 3
|
7 Participants
|
9 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 3
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 3
|
6 Participants
|
6 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 3
|
33 Participants
|
25 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 3
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 3
|
26 Participants
|
17 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 3
|
26 Participants
|
28 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 3
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 3
|
22 Participants
|
21 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash, Dose 3
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash, Dose 3
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 3
|
9 Participants
|
10 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 3
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 3
|
7 Participants
|
6 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria, Dose 3
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria, Dose 3
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Across Doses
|
31 Participants
|
34 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Across Doses
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Across Doses
|
65 Participants
|
56 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Across Doses
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Across Doses
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Across Doses
|
17 Participants
|
17 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Across Doses
|
69 Participants
|
67 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Across Doses
|
7 Participants
|
5 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Across Doses
|
51 Participants
|
40 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Across Doses
|
64 Participants
|
53 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Across Doses
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Across Doses
|
44 Participants
|
40 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash, Across Doses
|
5 Participants
|
8 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash, Across Doses
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash, Across Doses
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Across Doses
|
22 Participants
|
24 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Across Doses
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Across Doses
|
16 Participants
|
16 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria, Across Doses
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria, Across Doses
|
4 Participants
|
6 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria, Dose 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Dose 1
|
17 Participants
|
21 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 1
|
45 Participants
|
34 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 1
|
29 Participants
|
17 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 1
|
19 Participants
|
14 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 1
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 1
|
8 Participants
|
11 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 1
|
45 Participants
|
45 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 1
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 1
|
29 Participants
|
22 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 1
|
44 Participants
|
36 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 1
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 1
|
28 Participants
|
21 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash, Dose 1
|
2 Participants
|
6 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash, Dose 1
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 1
|
11 Participants
|
8 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 1
|
7 Participants
|
5 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Urticaria, Dose 1
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Urticaria, Dose 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria, Dose 1
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Dose 2
|
14 Participants
|
12 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Dose 2
|
9 Participants
|
5 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 2
|
34 Participants
|
34 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue, Dose 2
|
19 Participants
|
19 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 2
|
9 Participants
|
15 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 2
|
7 Participants
|
6 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache, Dose 2
|
35 Participants
|
31 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache, Dose 2
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache, Dose 2
|
23 Participants
|
19 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Myalgia, Dose 2
|
36 Participants
|
26 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Myalgia, Dose 2
|
28 Participants
|
19 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash, Dose 2
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash, Dose 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash, Dose 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 2
|
10 Participants
|
10 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 2
|
5 Participants
|
8 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Urticaria, Dose 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Arthralgia, Dose 3
|
9 Participants
|
14 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 3
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Arthralgia, Dose 3
|
9 Participants
|
11 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue, Dose 3
|
32 Participants
|
20 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 3
|
1 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=144 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=145 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV- Subjects With Unsolicited Adverse Events (AEs)
Any AE(s)
|
26 Participants
|
32 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Unsolicited Adverse Events (AEs)
Grade 3 AE(s)
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Number of HIV- Subjects With Unsolicited Adverse Events (AEs)
Related AE(s)
|
4 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)Population: The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.
SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=144 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=145 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV- Subjects With Serious Adverse Events (SAEs)
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)Population: The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.
Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=144 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=145 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV- Subjects With Medically Significant Conditions (MSCs)
|
7 Participants
|
14 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 7 (from Day 0 up to 30 days after the last vaccination dose at Month 6)Population: The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.
Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=144 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=145 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV- Subjects With Potential Immune-mediated Disease (pIMDs)
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 up to Month 24)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported any pregnancies and outcomes of reported pregnancies.
Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.) no apparent congenital anomaly, elective termination (termin.) congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.) anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=10 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=8 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
n=3 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
n=7 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Spontaneous abortion NO apparent congen. anomaly
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Live infant NO apparent congenital anomaly
|
8 Participants
|
7 Participants
|
3 Participants
|
7 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Live infant congenital anomaly
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Elective termin. NO apparent congenital anomaly
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Elective termin. congenital anomaly
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Ectopic pregnancy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Stillbirth NO apparent congenital anomaly
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Stillbirth congenital anomaly
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Lost to follow-up
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Pregnancy ongoing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Day 0, Week 6, Week 10, Month 6, Month 7\*, Month 12, Month 18 and Month 24. \* Month 7 data for HIV+/Cervarix and HIV+/Gardasil groups are also reported in the Primary outcome measure.
Among assessed haematological and biochemical parameters were: alanine aminotransferase \[ALAT\], basophils \[BSPH\], creatinine \[CRT\], eosinophils \[ESPH\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=129 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
n=144 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
n=145 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 12, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Week 10, Below
|
2 Participants
|
8 Participants
|
27 Participants
|
26 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 6, Above
|
8 Participants
|
9 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 18, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 24, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Week 6, Below
|
35 Participants
|
28 Participants
|
36 Participants
|
28 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 7, Below
|
29 Participants
|
36 Participants
|
22 Participants
|
17 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 18, Within
|
93 Participants
|
98 Participants
|
98 Participants
|
102 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Day 0, Above
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Week 10, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 24, Above
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Day 0, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Week 10, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 7, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 12, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 18, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 24, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Day 0, Below
|
15 Participants
|
18 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Week 6, Below
|
10 Participants
|
13 Participants
|
7 Participants
|
6 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Week 10, Below
|
11 Participants
|
12 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 6, Below
|
9 Participants
|
13 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 7, Below
|
9 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 18, Below
|
4 Participants
|
9 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 24, Below
|
7 Participants
|
15 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Week 6, Within
|
109 Participants
|
102 Participants
|
115 Participants
|
126 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 6, Within
|
103 Participants
|
108 Participants
|
118 Participants
|
124 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 7, Within
|
108 Participants
|
106 Participants
|
103 Participants
|
112 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 18, Within
|
111 Participants
|
106 Participants
|
96 Participants
|
105 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Day 0, Above
|
6 Participants
|
8 Participants
|
11 Participants
|
8 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 12, Above
|
7 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Day 0, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Week 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Week 10, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 7, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 18, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 24, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Day 0, Below
|
9 Participants
|
4 Participants
|
33 Participants
|
35 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Week 6, Below
|
4 Participants
|
5 Participants
|
35 Participants
|
32 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 6, Below
|
3 Participants
|
4 Participants
|
25 Participants
|
27 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 7, Below
|
4 Participants
|
3 Participants
|
20 Participants
|
23 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 12, Below
|
6 Participants
|
1 Participants
|
20 Participants
|
22 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 18, Below
|
2 Participants
|
2 Participants
|
23 Participants
|
17 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 24, Below
|
0 Participants
|
1 Participants
|
14 Participants
|
14 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Day 0, Within
|
109 Participants
|
118 Participants
|
109 Participants
|
106 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Week 6, Within
|
119 Participants
|
115 Participants
|
97 Participants
|
106 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Week 10, Within
|
117 Participants
|
110 Participants
|
104 Participants
|
109 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 6, Within
|
112 Participants
|
110 Participants
|
101 Participants
|
102 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 7, Within
|
110 Participants
|
105 Participants
|
94 Participants
|
98 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 12, Within
|
104 Participants
|
112 Participants
|
86 Participants
|
95 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 18, Within
|
115 Participants
|
109 Participants
|
85 Participants
|
98 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 24, Within
|
112 Participants
|
110 Participants
|
87 Participants
|
95 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Day 0, Above
|
11 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Week 6, Above
|
5 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Week 10, Above
|
8 Participants
|
9 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 7, Above
|
7 Participants
|
13 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 12, Above
|
12 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 18, Above
|
4 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ALAT, Month 24, Above
|
4 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Day 0, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Week 6, Unknown
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Week 10, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 7, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 12, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 18, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 24, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Day 0, Below
|
0 Participants
|
1 Participants
|
21 Participants
|
20 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Week 6, Below
|
0 Participants
|
1 Participants
|
8 Participants
|
7 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Week 10, Below
|
0 Participants
|
0 Participants
|
15 Participants
|
17 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 6, Below
|
0 Participants
|
0 Participants
|
12 Participants
|
13 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 7, Below
|
0 Participants
|
0 Participants
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 12, Below
|
0 Participants
|
0 Participants
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 18, Below
|
0 Participants
|
0 Participants
|
10 Participants
|
12 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 24, Below
|
0 Participants
|
0 Participants
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Day 0, Within
|
129 Participants
|
127 Participants
|
123 Participants
|
125 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Week 6, Within
|
128 Participants
|
125 Participants
|
127 Participants
|
131 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Week 10, Within
|
127 Participants
|
124 Participants
|
119 Participants
|
119 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 6, Within
|
123 Participants
|
122 Participants
|
116 Participants
|
120 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 7, Within
|
120 Participants
|
121 Participants
|
109 Participants
|
116 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 12, Within
|
121 Participants
|
119 Participants
|
102 Participants
|
111 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 18, Within
|
120 Participants
|
117 Participants
|
99 Participants
|
104 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 24, Within
|
115 Participants
|
117 Participants
|
96 Participants
|
102 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Day 0, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Week 6, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Week 10, Above
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 6, Above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 7, Above
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 12, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 18, Above
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
BSPH, Month 24, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Day 0, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Week 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Week 10, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 7, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 12, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Day 0, Below
|
31 Participants
|
26 Participants
|
27 Participants
|
21 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Week 10, Below
|
33 Participants
|
30 Participants
|
27 Participants
|
29 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 6, Below
|
33 Participants
|
32 Participants
|
25 Participants
|
26 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 12, Below
|
25 Participants
|
23 Participants
|
24 Participants
|
22 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 18, Below
|
25 Participants
|
17 Participants
|
11 Participants
|
12 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 24, Below
|
27 Participants
|
30 Participants
|
17 Participants
|
17 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Day 0, Within
|
97 Participants
|
100 Participants
|
115 Participants
|
123 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Week 6, Within
|
93 Participants
|
97 Participants
|
101 Participants
|
113 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Week 10, Within
|
95 Participants
|
96 Participants
|
108 Participants
|
107 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 6, Within
|
89 Participants
|
89 Participants
|
103 Participants
|
107 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 7, Within
|
91 Participants
|
84 Participants
|
93 Participants
|
107 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 12, Within
|
94 Participants
|
91 Participants
|
83 Participants
|
95 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 24, Within
|
88 Participants
|
85 Participants
|
86 Participants
|
93 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Week 6, Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 6, Above
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 7, Above
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 12, Above
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
CRT, Month 18, Above
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Week 6, Unknown
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 12, Below
|
9 Participants
|
10 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Day 0, Within
|
108 Participants
|
102 Participants
|
130 Participants
|
133 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Week 10, Within
|
112 Participants
|
108 Participants
|
125 Participants
|
130 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 12, Within
|
105 Participants
|
104 Participants
|
98 Participants
|
107 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 24, Within
|
103 Participants
|
99 Participants
|
99 Participants
|
99 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Week 6, Above
|
9 Participants
|
11 Participants
|
13 Participants
|
7 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Week 10, Above
|
5 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 6, Above
|
11 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 7, Above
|
4 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 18, Above
|
6 Participants
|
2 Participants
|
8 Participants
|
8 Participants
|
|
Number of Subjects With Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine and Eosinophils Parameters
ESPH, Month 24, Above
|
5 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Day 0, Week 6, Week 10, Month 6, Month 7\*, Month 12, Month 18 and Month 24. \* Month 7 data for HIV+/Cervarix and HIV+/Gardasil groups are also reported in the Primary outcome measure.
Among assessed haematological parameters were: haematocrit \[HTCR\], haemoglobin \[HGB\], lymphocytes \[LYMP\] and monocytes \[MONO\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=129 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
n=144 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
n=145 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Week 6, Unknown
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Day 0, Above
|
11 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 7, Below
|
12 Participants
|
11 Participants
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Week 6, Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 7, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 12, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 18, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 24, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Day 0, Below
|
32 Participants
|
23 Participants
|
24 Participants
|
24 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 18, Below
|
30 Participants
|
22 Participants
|
17 Participants
|
16 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 7, Within
|
101 Participants
|
92 Participants
|
102 Participants
|
108 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Week 6, Above
|
0 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Week 10, Above
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Week 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Week 10, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 12, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 18, Below
|
4 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 24, Below
|
8 Participants
|
9 Participants
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Week 6, Within
|
109 Participants
|
109 Participants
|
113 Participants
|
121 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Week 10, Within
|
101 Participants
|
102 Participants
|
110 Participants
|
124 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 6, Within
|
98 Participants
|
104 Participants
|
106 Participants
|
115 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Week 6, Above
|
13 Participants
|
6 Participants
|
10 Participants
|
12 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Day 0, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Week 6, Below
|
4 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Week 10, Within
|
116 Participants
|
108 Participants
|
129 Participants
|
127 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Week 10, Above
|
8 Participants
|
15 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 6, Above
|
13 Participants
|
14 Participants
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 7, Above
|
11 Participants
|
17 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 12, Above
|
15 Participants
|
13 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 18, Above
|
10 Participants
|
12 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 24, Above
|
12 Participants
|
13 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 24, Below
|
27 Participants
|
27 Participants
|
28 Participants
|
26 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 7, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 12, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 18, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 24, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Day 0, Below
|
38 Participants
|
37 Participants
|
40 Participants
|
45 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Week 6, Below
|
38 Participants
|
35 Participants
|
40 Participants
|
50 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Week 10, Below
|
38 Participants
|
35 Participants
|
37 Participants
|
38 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 6, Below
|
38 Participants
|
36 Participants
|
45 Participants
|
38 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 7, Below
|
28 Participants
|
37 Participants
|
36 Participants
|
38 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 12, Below
|
29 Participants
|
35 Participants
|
39 Participants
|
39 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 18, Below
|
34 Participants
|
32 Participants
|
32 Participants
|
35 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Day 0, Within
|
88 Participants
|
89 Participants
|
104 Participants
|
98 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Week 6, Within
|
88 Participants
|
88 Participants
|
97 Participants
|
88 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Week 10, Within
|
89 Participants
|
90 Participants
|
98 Participants
|
97 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 6, Within
|
85 Participants
|
86 Participants
|
83 Participants
|
96 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 7, Within
|
92 Participants
|
83 Participants
|
79 Participants
|
86 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 12, Within
|
91 Participants
|
83 Participants
|
69 Participants
|
79 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 18, Within
|
84 Participants
|
82 Participants
|
77 Participants
|
82 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 24, Within
|
88 Participants
|
89 Participants
|
75 Participants
|
84 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Day 0, Above
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Week 6, Above
|
2 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Week 10, Above
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 6, Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 7, Above
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 12, Above
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 18, Above
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 24, Above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Day 0, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Week 6, Unknown
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Week 10, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 7, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 18, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 24, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Day 0, Below
|
7 Participants
|
9 Participants
|
11 Participants
|
6 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Week 6, Below
|
6 Participants
|
11 Participants
|
12 Participants
|
6 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Week 10, Below
|
11 Participants
|
9 Participants
|
13 Participants
|
6 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 6, Below
|
6 Participants
|
8 Participants
|
9 Participants
|
11 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 12, Below
|
6 Participants
|
10 Participants
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Day 0, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Day 0, Within
|
105 Participants
|
105 Participants
|
120 Participants
|
132 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Week 10, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 7, Within
|
96 Participants
|
97 Participants
|
103 Participants
|
111 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 12, Within
|
104 Participants
|
95 Participants
|
92 Participants
|
98 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 18, Within
|
105 Participants
|
103 Participants
|
94 Participants
|
106 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 24, Within
|
98 Participants
|
97 Participants
|
88 Participants
|
101 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Day 0, Above
|
17 Participants
|
14 Participants
|
13 Participants
|
7 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Week 10, Above
|
16 Participants
|
16 Participants
|
12 Participants
|
6 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 6, Above
|
19 Participants
|
11 Participants
|
13 Participants
|
8 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 7, Above
|
13 Participants
|
13 Participants
|
6 Participants
|
8 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Week 6, Below
|
22 Participants
|
17 Participants
|
18 Participants
|
13 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Week 10, Below
|
30 Participants
|
22 Participants
|
11 Participants
|
7 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 6, Below
|
26 Participants
|
27 Participants
|
13 Participants
|
17 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 7, Below
|
19 Participants
|
27 Participants
|
13 Participants
|
14 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 12, Below
|
24 Participants
|
25 Participants
|
15 Participants
|
17 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 24, Below
|
24 Participants
|
24 Participants
|
21 Participants
|
17 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Day 0, Within
|
96 Participants
|
102 Participants
|
120 Participants
|
118 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Week 6, Within
|
106 Participants
|
105 Participants
|
119 Participants
|
125 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Week 10, Within
|
97 Participants
|
103 Participants
|
123 Participants
|
126 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 12, Above
|
11 Participants
|
14 Participants
|
10 Participants
|
12 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 6, Within
|
97 Participants
|
95 Participants
|
115 Participants
|
117 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 12, Within
|
95 Participants
|
94 Participants
|
93 Participants
|
100 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 18, Within
|
91 Participants
|
92 Participants
|
90 Participants
|
101 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 24, Within
|
91 Participants
|
92 Participants
|
82 Participants
|
93 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Day 0, Above
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 18, Above
|
12 Participants
|
10 Participants
|
10 Participants
|
7 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
LYMP, Month 24, Above
|
9 Participants
|
11 Participants
|
9 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 6, Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 7, Above
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 12, Above
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 18, Above
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HTCR, Month 24, Above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Day 0, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
HGB, Month 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Week 10, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 7, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 12, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 18, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 24, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Day 0, Below
|
7 Participants
|
4 Participants
|
10 Participants
|
17 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Week 10, Below
|
4 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 6, Below
|
3 Participants
|
5 Participants
|
0 Participants
|
7 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 7, Below
|
4 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 12, Below
|
2 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 18, Below
|
3 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 24, Below
|
5 Participants
|
5 Participants
|
7 Participants
|
10 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Day 0, Within
|
111 Participants
|
117 Participants
|
133 Participants
|
126 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Week 6, Within
|
117 Participants
|
112 Participants
|
129 Participants
|
133 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 6, Within
|
107 Participants
|
104 Participants
|
113 Participants
|
121 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 7, Within
|
106 Participants
|
97 Participants
|
107 Participants
|
118 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 12, Within
|
104 Participants
|
101 Participants
|
101 Participants
|
113 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 18, Within
|
108 Participants
|
99 Participants
|
101 Participants
|
109 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Month 24, Within
|
98 Participants
|
99 Participants
|
95 Participants
|
99 Participants
|
|
Number of Subjects With Relevant Abnormalities in Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters
MONO, Week 6, Above
|
7 Participants
|
10 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Week 6, Week 10, Month 6, Month 7, Month 12, Month 18 and Month 24Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Day 0, Week 6, Week 10, Month 6, Month 7\*, Month 12, Month 18 and Month 24. \* Month 7 data for HIV+/Cervarix and HIV+/Gardasil groups are also reported in the Primary outcome measure.
Among assessed haematological parameters were: neutrophils \[NTPH\], platelets \[PLAT\], red blood cells \[RBC\] and white blood cells \[WBC\]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=129 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
n=144 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
n=145 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 18, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 24, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Week 6, Unknown
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Week 10, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 7, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Day 0, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Week 6, Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Week 10, Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 7, Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 18, Within
|
106 Participants
|
107 Participants
|
100 Participants
|
107 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 12, Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Week 6, Below
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 7, Below
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 7, Within
|
118 Participants
|
114 Participants
|
110 Participants
|
121 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 24, Within
|
109 Participants
|
110 Participants
|
97 Participants
|
103 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Day 0, Above
|
6 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Week 6, Above
|
3 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Week 10, Above
|
5 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 6, Above
|
5 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 7, Above
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 12, Above
|
5 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 18, Above
|
1 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Week 10, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 18, Unknown
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 24, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Week 6, Below
|
44 Participants
|
36 Participants
|
14 Participants
|
12 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 7, Below
|
36 Participants
|
34 Participants
|
15 Participants
|
19 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 18, Below
|
38 Participants
|
31 Participants
|
9 Participants
|
13 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Week 6, Within
|
81 Participants
|
85 Participants
|
118 Participants
|
120 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 12, Within
|
79 Participants
|
86 Participants
|
88 Participants
|
100 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 18, Within
|
81 Participants
|
80 Participants
|
97 Participants
|
96 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Week 6, Above
|
3 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 18, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Week 6, Within
|
118 Participants
|
111 Participants
|
124 Participants
|
135 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 7, Within
|
106 Participants
|
108 Participants
|
106 Participants
|
120 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 6, Above
|
5 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 7, Above
|
5 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 12, Above
|
4 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 18, Above
|
3 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Day 0, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 6, Within
|
79 Participants
|
81 Participants
|
111 Participants
|
117 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 12, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Day 0, Below
|
14 Participants
|
12 Participants
|
11 Participants
|
7 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Week 6, Below
|
16 Participants
|
13 Participants
|
8 Participants
|
13 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Week 10, Below
|
18 Participants
|
17 Participants
|
12 Participants
|
10 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 6, Below
|
18 Participants
|
14 Participants
|
15 Participants
|
14 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 7, Below
|
16 Participants
|
17 Participants
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 12, Below
|
19 Participants
|
16 Participants
|
12 Participants
|
11 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 18, Below
|
15 Participants
|
15 Participants
|
9 Participants
|
14 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 24, Below
|
14 Participants
|
11 Participants
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Day 0, Within
|
106 Participants
|
99 Participants
|
117 Participants
|
122 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Week 6, Within
|
101 Participants
|
95 Participants
|
107 Participants
|
116 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Week 10, Within
|
103 Participants
|
100 Participants
|
104 Participants
|
113 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 6, Within
|
100 Participants
|
98 Participants
|
98 Participants
|
104 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 7, Within
|
97 Participants
|
93 Participants
|
92 Participants
|
106 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 12, Within
|
92 Participants
|
93 Participants
|
84 Participants
|
94 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 18, Within
|
98 Participants
|
89 Participants
|
86 Participants
|
92 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 24, Within
|
92 Participants
|
95 Participants
|
83 Participants
|
89 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Day 0, Above
|
9 Participants
|
17 Participants
|
16 Participants
|
16 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Week 6, Above
|
11 Participants
|
18 Participants
|
20 Participants
|
10 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Week 10, Above
|
7 Participants
|
10 Participants
|
19 Participants
|
13 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 6, Above
|
5 Participants
|
11 Participants
|
15 Participants
|
16 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 7, Above
|
8 Participants
|
11 Participants
|
13 Participants
|
10 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 12, Above
|
10 Participants
|
10 Participants
|
12 Participants
|
13 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 18, Above
|
8 Participants
|
13 Participants
|
15 Participants
|
11 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
NTPH, Month 24, Above
|
9 Participants
|
11 Participants
|
11 Participants
|
12 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 18, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 24, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Day 0, Below
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Week 10, Below
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 6, Below
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 12, Below
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 18, Below
|
3 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 24, Below
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Day 0, Within
|
123 Participants
|
122 Participants
|
133 Participants
|
138 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Week 6, Within
|
124 Participants
|
119 Participants
|
130 Participants
|
137 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Week 10, Within
|
122 Participants
|
124 Participants
|
131 Participants
|
132 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 6, Within
|
116 Participants
|
118 Participants
|
127 Participants
|
131 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 12, Within
|
113 Participants
|
114 Participants
|
103 Participants
|
111 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 18, Within
|
117 Participants
|
110 Participants
|
106 Participants
|
111 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
PLAT, Month 24, Above
|
5 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Day 0, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Week 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 7, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 12, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Day 0, Below
|
43 Participants
|
38 Participants
|
18 Participants
|
13 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Week 10, Below
|
48 Participants
|
37 Participants
|
11 Participants
|
8 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 6, Below
|
40 Participants
|
39 Participants
|
14 Participants
|
12 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 12, Below
|
39 Participants
|
31 Participants
|
19 Participants
|
14 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 24, Below
|
38 Participants
|
34 Participants
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Day 0, Within
|
83 Participants
|
87 Participants
|
118 Participants
|
123 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Week 10, Within
|
78 Participants
|
87 Participants
|
120 Participants
|
122 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 7, Within
|
82 Participants
|
84 Participants
|
100 Participants
|
100 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 24, Within
|
74 Participants
|
83 Participants
|
91 Participants
|
98 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Day 0, Above
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Week 10, Above
|
2 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 6, Above
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 7, Above
|
3 Participants
|
3 Participants
|
0 Participants
|
6 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 12, Above
|
3 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 18, Above
|
2 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
RBC, Month 24, Above
|
3 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Day 0, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Week 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Week 10, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 6, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 7, Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 12, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 24, Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Day 0, Below
|
8 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Week 6, Below
|
9 Participants
|
11 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Week 10, Below
|
9 Participants
|
9 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 6, Below
|
12 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 7, Below
|
10 Participants
|
9 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 12, Below
|
14 Participants
|
13 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 18, Below
|
12 Participants
|
10 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 24, Below
|
11 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Day 0, Within
|
118 Participants
|
116 Participants
|
135 Participants
|
140 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Week 10, Within
|
116 Participants
|
113 Participants
|
131 Participants
|
129 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 6, Within
|
106 Participants
|
116 Participants
|
122 Participants
|
128 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 12, Within
|
103 Participants
|
103 Participants
|
100 Participants
|
115 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 24, Within
|
102 Participants
|
107 Participants
|
94 Participants
|
101 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Day 0, Above
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Week 6, Above
|
1 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Week 10, Above
|
3 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells Parameters
WBC, Month 24, Above
|
2 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 up to Month 24)Population: The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.
SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=129 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
n=144 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
n=145 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of Subjects With SAEs
|
9 Participants
|
9 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)Population: The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.
Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=129 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
n=144 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
n=145 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of Subjects With Medically Significant Conditions (MSCs)
|
25 Participants
|
37 Participants
|
10 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Month 18 (from Day 0 up to 12 months after the last vaccination dose at Month 6)Population: The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.
Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=129 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
n=144 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
n=145 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Months 12, 18 and 24Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Months 12, 18 and 24.
CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=122 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=119 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Months 12, 18 and 24
CD4+ cell counts, Month 12
|
584.5 cells/mm3
Interval 498.0 to 832.0
|
602.0 cells/mm3
Interval 445.0 to 835.0
|
—
|
—
|
|
Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Months 12, 18 and 24
CD4+ cell counts, Month 18
|
621.0 cells/mm3
Interval 472.0 to 789.0
|
572.0 cells/mm3
Interval 443.0 to 770.0
|
—
|
—
|
|
Cluster of Differentiation 4 (CD4+) Cell Count in HIV+ Subjects at Months 12, 18 and 24
CD4+ cell counts, Month 24
|
568.0 cells/mm3
Interval 447.0 to 738.0
|
598.0 cells/mm3
Interval 441.0 to 834.0
|
—
|
—
|
SECONDARY outcome
Timeframe: At Months 12, 18 and 24Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Months 12, 18 and 24.
HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=94 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=96 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
HIV Viral Load (VL) in HIV+ Subjects at Months 12, 18 and 24
HIV viral load, Month 12
|
1.6 HIV copies/mL
Interval 1.3 to 3.2
|
2.3 HIV copies/mL
Interval 1.3 to 3.7
|
—
|
—
|
|
HIV Viral Load (VL) in HIV+ Subjects at Months 12, 18 and 24
HIV viral load, Month 18
|
1.7 HIV copies/mL
Interval 1.3 to 3.2
|
2.2 HIV copies/mL
Interval 1.3 to 3.8
|
—
|
—
|
|
HIV Viral Load (VL) in HIV+ Subjects at Months 12, 18 and 24
HIV viral load, Month 24
|
1.6 HIV copies/mL
Interval 1.3 to 2.8
|
2.1 HIV copies/mL
Interval 1.3 to 3.8
|
—
|
—
|
SECONDARY outcome
Timeframe: At Months 12, 18 and 24Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Months 12, 18 and 24.
HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification \[WHO, 2009\].
Outcome measures
| Measure |
HIV+/Cervarix Group
n=129 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Number of HIV+ Subjects by WHO HIV Clinical Staging
Clinical stage 1, Month 12
|
113 Participants
|
112 Participants
|
—
|
—
|
|
Number of HIV+ Subjects by WHO HIV Clinical Staging
Clinical stage 2, Month 12
|
7 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects by WHO HIV Clinical Staging
Clinical stage 3, Month 12
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV+ Subjects by WHO HIV Clinical Staging
Clinical stage 4, Month 12
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV+ Subjects by WHO HIV Clinical Staging
Clinical stage 1, Month 18
|
112 Participants
|
110 Participants
|
—
|
—
|
|
Number of HIV+ Subjects by WHO HIV Clinical Staging
Clinical stage 2, Month 18
|
7 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects by WHO HIV Clinical Staging
Clinical stage 3, Month 18
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV+ Subjects by WHO HIV Clinical Staging
Clinical stage 4, Month 18
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Number of HIV+ Subjects by WHO HIV Clinical Staging
Clinical stage 1, Month 24
|
107 Participants
|
110 Participants
|
—
|
—
|
|
Number of HIV+ Subjects by WHO HIV Clinical Staging
Clinical stage 2, Month 24
|
7 Participants
|
1 Participants
|
—
|
—
|
|
Number of HIV+ Subjects by WHO HIV Clinical Staging
Clinical stage 3, Month 24
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of HIV+ Subjects by WHO HIV Clinical Staging
Clinical stage 4, Month 24
|
2 Participants
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 7 (30 days after the last vaccination dose at Month 6)Population: The analysis was performed on the TVC for analysis of immunogenicity, which included vaccinated subjects for whom data concerning immunogenicity endpoint measures were available at Month 7.
Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay \[PBNA\], for HIV- subjects. Between-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=105 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=112 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV- Subjects, Based on TVC
Anti-HPV-16
|
60550.6 Titers
Interval 44040.1 to 83250.9
|
19634.8 Titers
Interval 14410.8 to 26752.4
|
—
|
—
|
|
Pseudovirion-Based Neutralization Assay (PBNA) Titers of Anti-HPV-16/18 Antibodies in HIV- Subjects, Based on TVC
Anti-HPV-18
|
32118.1 Titers
Interval 23195.8 to 44472.3
|
5773.4 Titers
Interval 4205.2 to 7926.4
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Week 6, Week 10, Month 7, Month 12, Month 18 and Month 24Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-HPV-16 and anti-HPV-18 antibody concentrations in serum, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 19 ELISA units per milliliter (EU/mL) and 18 EU/mL respectively, as assessed by Enzyme-linked immunosorbent assay (ELISA), in all (HIV+ and HIV-) subjects.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=81 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=84 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
n=77 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
n=80 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
anti-HPV-16, Month 7
|
4896.0 EU/mL
Interval 4002.2 to 5989.3
|
2145.2 EU/mL
Interval 1647.8 to 2792.7
|
15493.0 EU/mL
Interval 12537.0 to 19146.0
|
5960.9 EU/mL
Interval 5028.9 to 7065.7
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
anti-HPV-16, Month 24
|
664.6 EU/mL
Interval 499.9 to 883.7
|
243.5 EU/mL
Interval 173.9 to 341.0
|
1893.6 EU/mL
Interval 1443.8 to 2483.7
|
601.9 EU/mL
Interval 481.8 to 752.1
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
anti-HPV-18, Week 6
|
205.6 EU/mL
Interval 146.3 to 288.7
|
53.2 EU/mL
Interval 36.4 to 77.6
|
277.3 EU/mL
Interval 217.5 to 353.5
|
60.4 EU/mL
Interval 47.5 to 76.8
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
anti-HPV-18, Month 7
|
2540.8 EU/mL
Interval 2085.9 to 3094.9
|
493.8 EU/mL
Interval 356.6 to 683.8
|
6779.3 EU/mL
Interval 5382.6 to 8538.5
|
1516.5 EU/mL
Interval 1232.9 to 1865.2
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
anti-HPV-18, Month 12
|
676.9 EU/mL
Interval 520.1 to 880.9
|
116.2 EU/mL
Interval 82.2 to 164.2
|
1747.7 EU/mL
Interval 1329.4 to 2297.6
|
338.3 EU/mL
Interval 261.2 to 438.1
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
anti-HPV-18, Month 24
|
295.2 EU/mL
Interval 216.9 to 401.7
|
52.4 EU/mL
Interval 37.2 to 73.8
|
761.9 EU/mL
Interval 576.6 to 1006.7
|
116.2 EU/mL
Interval 88.8 to 151.9
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
anti-HPV-16, Day 0
|
17.2 EU/mL
Interval 13.3 to 22.2
|
15.0 EU/mL
Interval 12.0 to 18.9
|
10.2 EU/mL
Interval 9.4 to 11.0
|
10.9 EU/mL
Interval 9.5 to 12.5
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
anti-HPV-16, Week 6
|
452.9 EU/mL
Interval 302.3 to 678.5
|
280.2 EU/mL
Interval 182.5 to 430.1
|
390.6 EU/mL
Interval 298.3 to 511.6
|
303.2 EU/mL
Interval 228.0 to 403.3
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
anti-HPV-16, Week 10
|
2191.2 EU/mL
Interval 1775.7 to 2704.0
|
1565.5 EU/mL
Interval 1197.5 to 2046.6
|
4512.7 EU/mL
Interval 3771.5 to 5399.7
|
2993.2 EU/mL
Interval 2459.1 to 3643.3
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
anti-HPV-16, Month 12
|
1392.3 EU/mL
Interval 1077.5 to 1799.0
|
608.8 EU/mL
Interval 445.4 to 832.1
|
4389.3 EU/mL
Interval 3400.5 to 5665.7
|
1772.2 EU/mL
Interval 1473.3 to 2131.7
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
anti-HPV-16, Month 18
|
861.3 EU/mL
Interval 662.3 to 1119.9
|
311.4 EU/mL
Interval 226.3 to 428.4
|
2294.1 EU/mL
Interval 1785.0 to 2948.4
|
798.0 EU/mL
Interval 646.6 to 984.8
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
anti-HPV-18, Day 0
|
13.4 EU/mL
Interval 11.2 to 16.0
|
10.7 EU/mL
Interval 9.3 to 12.3
|
9.3 EU/mL
Interval 8.9 to 9.8
|
9.2 EU/mL
Interval 8.9 to 9.5
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
anti-HPV-18, Week 10
|
1432.4 EU/mL
Interval 1136.9 to 1804.6
|
277.2 EU/mL
Interval 200.8 to 382.8
|
3174.4 EU/mL
Interval 2596.2 to 3881.4
|
666.1 EU/mL
Interval 549.8 to 806.9
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by Enzyme-linked Immunosorbent Assay (ELISA) in Serum
anti-HPV-18, Month 18
|
408.7 EU/mL
Interval 310.4 to 538.2
|
55.6 EU/mL
Interval 39.6 to 78.0
|
895.5 EU/mL
Interval 679.6 to 1179.9
|
160.1 EU/mL
Interval 123.7 to 207.1
|
SECONDARY outcome
Timeframe: At Day 0, Week 6, Week 10, Month 7, Month 12, Month 18 and Month 24Population: The analysis was performed on the Adapted ATP cohort for immunogenicity, which included post-menarcheal subjects who volunteered for this procedure, met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
Anti-HPV-16 and anti-HPV-18 antibody concentrations in CVS, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 0 EU/mL, as assessed by ELISA, in post-menarcheal subjects who volunteered for this procedure.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=12 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=18 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
n=3 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
n=5 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
anti-HPV-16, Month 7
|
23.6 EU/mL
Interval 3.4 to 163.0
|
5.4 EU/mL
Interval 1.6 to 17.6
|
104.2 EU/mL
Interval 40.3 to 269.4
|
53.5 EU/mL
Interval 3.0 to 945.1
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
anti-HPV-16, Month 24
|
8.1 EU/mL
Interval 1.3 to 50.3
|
4.3 EU/mL
Interval 1.4 to 12.9
|
49.0 EU/mL
Interval 4.5 to 534.2
|
1.0 EU/mL
The confidence interval could not be calculated, as there was only one participant analyzed.
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
anti-HPV-16, Day 0
|
1.5 EU/mL
Interval 0.8 to 2.6
|
1.4 EU/mL
Interval 0.7 to 2.8
|
1.0 EU/mL
Interval 1.0 to 1.0
|
1.0 EU/mL
Interval 1.0 to 1.0
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
anti-HPV-16, Week 6
|
31.5 EU/mL
Interval 4.7 to 211.5
|
3.1 EU/mL
Interval 0.8 to 11.6
|
27.1 EU/mL
Interval 8.7 to 84.2
|
2.7 EU/mL
Interval 0.4 to 16.5
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
anti-HPV-16, Week 10
|
38.8 EU/mL
Interval 6.1 to 245.0
|
15.7 EU/mL
Interval 5.4 to 45.2
|
—
|
159.8 EU/mL
The confidence interval could not be calculated, as there was only one participant analyzed.
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
anti-HPV-16, Month 12
|
18.7 EU/mL
Interval 3.2 to 109.0
|
6.8 EU/mL
Interval 2.1 to 22.3
|
107.6 EU/mL
Interval 29.1 to 398.1
|
34.7 EU/mL
The confidence interval could not be calculated, as there was only one participant analyzed.
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
anti-HPV-18, Day 0
|
1.2 EU/mL
Interval 0.8 to 1.9
|
1.0 EU/mL
Interval 1.0 to 1.0
|
1.0 EU/mL
Interval 1.0 to 1.0
|
1.0 EU/mL
Interval 1.0 to 1.0
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
anti-HPV-18, Week 6
|
16.8 EU/mL
Interval 2.5 to 113.1
|
1.7 EU/mL
Interval 0.5 to 5.2
|
3.0 EU/mL
Interval 0.0 to 312.7
|
1.0 EU/mL
Interval 1.0 to 1.0
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
anti-HPV-18, Week 10
|
22.9 EU/mL
Interval 3.4 to 152.2
|
2.3 EU/mL
Interval 0.9 to 5.8
|
—
|
21.6 EU/mL
The confidence interval could not be calculated, as there was only one participant analyzed.
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
anti-HPV-18, Month 7
|
10.1 EU/mL
Interval 1.8 to 58.2
|
2.2 EU/mL
Interval 1.0 to 4.8
|
44.2 EU/mL
Interval 14.3 to 136.9
|
16.3 EU/mL
Interval 1.0 to 265.0
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
anti-HPV-18, Month 12
|
23.9 EU/mL
Interval 8.0 to 72.0
|
2.4 EU/mL
Interval 0.9 to 6.8
|
32.7 EU/mL
Interval 17.2 to 62.1
|
16.3 EU/mL
The confidence interval could not be calculated, as there was only one participant analyzed.
|
|
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations by ELISA in Cervicovaginal Secretion (CVS)
anti-HPV-18, Month 24
|
8.8 EU/mL
Interval 1.6 to 48.5
|
1.5 EU/mL
Interval 0.8 to 3.0
|
13.8 EU/mL
Interval 1.3 to 149.2
|
1.0 EU/mL
The confidence interval could not be calculated, as there was only one participant analyzed.
|
SECONDARY outcome
Timeframe: At Day 0, Week 6, Week 10, Month 7 and Month 12Population: The analysis was performed on the Adapted ATP cohort for immunogenicity,which included subjects in a subset of approximately 100 subjects(50 HIV+ and 50 HIV-),who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
B-cell memory was assessed by Enzyme Linked Immuno Spot (ELISPOT) assay. The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=16 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=12 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
n=20 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
n=20 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Frequency of Specific B-cells for HPV-16/18 Antigens
HPV-16, Month 12
|
256.5 B-cells/million cells
Interval 75.5 to 891.5
|
121.0 B-cells/million cells
Interval 64.5 to 315.0
|
414.5 B-cells/million cells
Interval 94.5 to 640.5
|
256.0 B-cells/million cells
Interval 218.0 to 449.0
|
|
Frequency of Specific B-cells for HPV-16/18 Antigens
HPV-16, Day 0
|
1.0 B-cells/million cells
Interval 1.0 to 1.0
|
1.0 B-cells/million cells
Interval 1.0 to 61.0
|
1.0 B-cells/million cells
Interval 1.0 to 1.0
|
1.0 B-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Specific B-cells for HPV-16/18 Antigens
HPV-18, Day 0
|
1.0 B-cells/million cells
Interval 1.0 to 1.0
|
1.0 B-cells/million cells
Interval 1.0 to 1.0
|
1.0 B-cells/million cells
Interval 1.0 to 1.0
|
1.0 B-cells/million cells
Interval 1.0 to 1.0
|
|
Frequency of Specific B-cells for HPV-16/18 Antigens
HPV-16, Week 6
|
91.0 B-cells/million cells
Interval 1.0 to 154.0
|
1.0 B-cells/million cells
Interval 1.0 to 1.0
|
22.0 B-cells/million cells
Interval 1.0 to 154.0
|
1.0 B-cells/million cells
Interval 1.0 to 204.0
|
|
Frequency of Specific B-cells for HPV-16/18 Antigens
HPV-18, Week 6
|
39.5 B-cells/million cells
Interval 1.0 to 693.0
|
1.0 B-cells/million cells
Interval 1.0 to 45.5
|
155.0 B-cells/million cells
Interval 1.0 to 345.0
|
33.0 B-cells/million cells
Interval 1.0 to 80.0
|
|
Frequency of Specific B-cells for HPV-16/18 Antigens
HPV-16, Week 10
|
558.0 B-cells/million cells
Interval 95.5 to 989.5
|
198.0 B-cells/million cells
Interval 1.0 to 391.0
|
494.0 B-cells/million cells
Interval 90.5 to 834.0
|
150.5 B-cells/million cells
Interval 33.5 to 726.5
|
|
Frequency of Specific B-cells for HPV-16/18 Antigens
HPV-18, Week 10
|
150.0 B-cells/million cells
Interval 31.0 to 471.0
|
1.0 B-cells/million cells
Interval 1.0 to 42.0
|
211.0 B-cells/million cells
Interval 84.0 to 656.0
|
29.5 B-cells/million cells
Interval 1.0 to 222.0
|
|
Frequency of Specific B-cells for HPV-16/18 Antigens
HPV-16, Month 7
|
624.0 B-cells/million cells
Interval 457.0 to 1196.0
|
213.0 B-cells/million cells
Interval 165.0 to 632.0
|
1504.0 B-cells/million cells
Interval 481.0 to 3026.0
|
448.0 B-cells/million cells
Interval 257.0 to 890.0
|
|
Frequency of Specific B-cells for HPV-16/18 Antigens
HPV-18, Month 7
|
332.0 B-cells/million cells
Interval 153.0 to 494.0
|
1.0 B-cells/million cells
Interval 1.0 to 392.0
|
513.5 B-cells/million cells
Interval 111.5 to 1292.0
|
65.0 B-cells/million cells
Interval 1.0 to 158.0
|
|
Frequency of Specific B-cells for HPV-16/18 Antigens
HPV-18, Month 12
|
101.0 B-cells/million cells
Interval 1.0 to 525.0
|
1.0 B-cells/million cells
Interval 1.0 to 159.0
|
250.5 B-cells/million cells
Interval 1.0 to 481.5
|
58.0 B-cells/million cells
Interval 1.0 to 101.0
|
SECONDARY outcome
Timeframe: At Day 0, Week 6, Week 10, Month 7 and Month 12Population: The analysis was performed on the Adapted ATP cohort for immunogenicity,which included subjects in a subset of approximately 100 subjects(50 HIV+ and 50 HIV-) who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.
The combinations of cytokines expressed were CD4/8-all doubles, CD4/8-d-cluster of differentiation 40 Ligand (CD40L), CD4/8-d-interferon gamma (IFNG), CD4/8-interleukin-2 (IL-2), CD4/8-d-tumour necrosis alpha (TNFA), as assessed by Intracellular cytokine staining (ICS). The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=17 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=15 Participants
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
n=21 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
n=19 Participants
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-All doubles,Anti-HPV-16,Day 0
|
41.0 CD4 cells/million T-cells
Interval 1.0 to 118.0
|
101.0 CD4 cells/million T-cells
Interval 43.0 to 215.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 28.0
|
54.5 CD4 cells/million T-cells
Interval 1.0 to 88.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-All doubles,Anti-HPV-18,Month 7
|
1866.0 CD4 cells/million T-cells
Interval 1267.0 to 2875.0
|
840.5 CD4 cells/million T-cells
Interval 518.0 to 1641.0
|
2084.5 CD4 cells/million T-cells
Interval 911.0 to 4110.0
|
669.0 CD4 cells/million T-cells
Interval 470.0 to 1035.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-CD40L, Anti-HPV-16, Day 0
|
22.0 CD4 cells/million T-cells
Interval 1.0 to 118.0
|
99.0 CD4 cells/million T-cells
Interval 60.0 to 215.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 58.0
|
46.0 CD4 cells/million T-cells
Interval 1.0 to 81.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-CD40L, Anti-HPV-16, Week 10
|
2893.5 CD4 cells/million T-cells
Interval 988.0 to 5006.0
|
1440.0 CD4 cells/million T-cells
Interval 882.0 to 1814.0
|
1678.0 CD4 cells/million T-cells
Interval 917.0 to 4306.0
|
1239.0 CD4 cells/million T-cells
Interval 562.0 to 2362.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-CD40L, Anti-HPV-18, Month 12
|
1668.0 CD4 cells/million T-cells
Interval 807.0 to 2427.0
|
808.5 CD4 cells/million T-cells
Interval 295.0 to 1914.0
|
1641.0 CD4 cells/million T-cells
Interval 984.0 to 2767.0
|
394.0 CD4 cells/million T-cells
Interval 155.0 to 913.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IFNG, Anti-HPV-18, Month 12
|
402.0 CD4 cells/million T-cells
Interval 191.0 to 585.0
|
253.5 CD4 cells/million T-cells
Interval 92.0 to 415.0
|
273.0 CD4 cells/million T-cells
Interval 88.0 to 406.0
|
98.0 CD4 cells/million T-cells
Interval 1.0 to 154.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IL-2, Anti-HPV-16, Week 6
|
361.0 CD4 cells/million T-cells
Interval 235.5 to 966.0
|
300.0 CD4 cells/million T-cells
Interval 234.0 to 827.0
|
245.5 CD4 cells/million T-cells
Interval 137.0 to 468.0
|
454.5 CD4 cells/million T-cells
Interval 228.0 to 816.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IL-2, Anti-HPV-18, Month 12
|
1170.0 CD4 cells/million T-cells
Interval 683.0 to 2375.0
|
601.5 CD4 cells/million T-cells
Interval 230.0 to 1568.0
|
1342.0 CD4 cells/million T-cells
Interval 825.0 to 2794.0
|
337.0 CD4 cells/million T-cells
Interval 243.0 to 636.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-TNFA, Anti-HPV-18, Week 6
|
234.0 CD4 cells/million T-cells
Interval 66.0 to 579.0
|
204.0 CD4 cells/million T-cells
Interval 94.0 to 539.0
|
162.5 CD4 cells/million T-cells
Interval 75.5 to 247.0
|
156.5 CD4 cells/million T-cells
Interval 72.0 to 398.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-TNFA, Anti-HPV-18, Week 10
|
1493.5 CD4 cells/million T-cells
Interval 592.0 to 2341.0
|
443.0 CD4 cells/million T-cells
Interval 248.0 to 1432.0
|
899.0 CD4 cells/million T-cells
Interval 415.0 to 2310.0
|
334.5 CD4 cells/million T-cells
Interval 203.0 to 958.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-TNFA, Anti-HPV-16, Month 7
|
2688.0 CD4 cells/million T-cells
Interval 1399.0 to 3994.0
|
1109.0 CD4 cells/million T-cells
Interval 670.0 to 2066.0
|
2621.0 CD4 cells/million T-cells
Interval 1062.0 to 3652.5
|
1215.0 CD4 cells/million T-cells
Interval 792.0 to 1665.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-TNFA, Anti-HPV-16, Month 12
|
1937.0 CD4 cells/million T-cells
Interval 883.0 to 3961.0
|
1011.5 CD4 cells/million T-cells
Interval 681.0 to 2066.0
|
2344.0 CD4 cells/million T-cells
Interval 1053.0 to 3741.0
|
646.0 CD4 cells/million T-cells
Interval 344.0 to 1219.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-TNFA, Anti-HPV-18, Month 12
|
1264.0 CD4 cells/million T-cells
Interval 707.0 to 2500.0
|
527.0 CD4 cells/million T-cells
Interval 174.0 to 1684.0
|
1480.0 CD4 cells/million T-cells
Interval 703.0 to 2619.0
|
358.0 CD4 cells/million T-cells
Interval 186.0 to 617.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-All doubles,Anti-HPV-18, Day 0
|
6.0 CD4 cells/million T-cells
Interval 1.0 to 50.0
|
23.0 CD4 cells/million T-cells
Interval 1.0 to 60.0
|
21.0 CD4 cells/million T-cells
Interval 1.0 to 54.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 35.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-All doubles,Anti-HPV-16,Week 6
|
2.0 CD4 cells/million T-cells
Interval 1.0 to 34.5
|
13.0 CD4 cells/million T-cells
Interval 1.0 to 70.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 14.5
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 3.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-All doubles,Anti-HPV-16,Month 7
|
51.0 CD4 cells/million T-cells
Interval 18.0 to 69.0
|
9.5 CD4 cells/million T-cells
Interval 1.0 to 33.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 74.5
|
2.0 CD4 cells/million T-cells
Interval 1.0 to 54.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-All doubles,Anti-HPV-18,Month 7
|
41.0 CD4 cells/million T-cells
Interval 1.0 to 159.0
|
30.0 CD4 cells/million T-cells
Interval 3.0 to 49.0
|
15.5 CD4 cells/million T-cells
Interval 1.0 to 106.5
|
24.0 CD4 cells/million T-cells
Interval 1.0 to 54.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-CD40L, Anti-HPV-18, Day 0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 29.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 19.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 33.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 16.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-CD40L, Anti-HPV-18, Week 6
|
9.5 CD4 cells/million T-cells
Interval 1.0 to 27.5
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 17.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 23.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 36.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IL-2, Anti-HPV-18, Week 6
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 23.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IL-2, Anti-HPV-16, Month 7
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 23.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 17.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 37.5
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IL-2, Anti-HPV-18, Month 7
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 29.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IL-2, Anti-HPV-16, Month 12
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 27.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-TNFA, Anti-HPV-18, Day 0
|
6.0 CD4 cells/million T-cells
Interval 1.0 to 50.0
|
7.0 CD4 cells/million T-cells
Interval 1.0 to 54.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 33.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 34.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-TNFA, Anti-HPV-16, Week 10
|
1.5 CD4 cells/million T-cells
Interval 1.0 to 32.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 24.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 31.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 26.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-TNFA, Anti-HPV-18, Week 10
|
17.5 CD4 cells/million T-cells
Interval 1.0 to 34.0
|
14.0 CD4 cells/million T-cells
Interval 1.0 to 61.0
|
5.0 CD4 cells/million T-cells
Interval 1.0 to 42.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 34.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-TNFA, Anti-HPV-16, Month 7
|
34.0 CD4 cells/million T-cells
Interval 1.0 to 41.0
|
13.0 CD4 cells/million T-cells
Interval 1.0 to 33.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 49.0
|
2.0 CD4 cells/million T-cells
Interval 1.0 to 33.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-TNFA, Anti-HPV-18, Month 7
|
41.0 CD4 cells/million T-cells
Interval 1.0 to 111.0
|
26.5 CD4 cells/million T-cells
Interval 15.0 to 58.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 58.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 32.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-All doubles,Anti-HPV-16, Month 12
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 23.0
|
34.0 CD4 cells/million T-cells
Interval 1.0 to 79.0
|
23.0 CD4 cells/million T-cells
Interval 1.0 to 49.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 24.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-All doubles,Anti-HPV-18, Month 12
|
25.0 CD4 cells/million T-cells
Interval 1.0 to 92.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 29.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 37.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 24.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-CD40L, Anti-HPV-16, Day 0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 29.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 6.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 10.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 7.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-CD40L, Anti-HPV-16, Week 6
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 24.5
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 32.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 18.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-All doubles,Anti-HPV-18,Day 0
|
7.0 CD4 cells/million T-cells
Interval 1.0 to 116.0
|
87.0 CD4 cells/million T-cells
Interval 18.0 to 184.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 82.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 98.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-All doubles,Anti-HPV-16,Week 6
|
445.5 CD4 cells/million T-cells
Interval 262.0 to 1028.0
|
345.5 CD4 cells/million T-cells
Interval 227.0 to 1034.0
|
298.0 CD4 cells/million T-cells
Interval 173.0 to 540.5
|
661.0 CD4 cells/million T-cells
Interval 234.0 to 982.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-All doubles,Anti-HPV-18,Week 6
|
396.0 CD4 cells/million T-cells
Interval 163.0 to 832.0
|
309.5 CD4 cells/million T-cells
Interval 203.0 to 852.0
|
237.0 CD4 cells/million T-cells
Interval 81.0 to 421.5
|
320.5 CD4 cells/million T-cells
Interval 117.0 to 524.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-All doubles,Anti-HPV-16,Week 10
|
2955.5 CD4 cells/million T-cells
Interval 1075.0 to 5200.0
|
1449.0 CD4 cells/million T-cells
Interval 922.0 to 1778.0
|
1767.0 CD4 cells/million T-cells
Interval 916.0 to 4428.0
|
1268.5 CD4 cells/million T-cells
Interval 648.0 to 2453.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-All doubles,Anti-HPV-18,Week 10
|
2036.5 CD4 cells/million T-cells
Interval 951.0 to 3123.0
|
602.0 CD4 cells/million T-cells
Interval 498.0 to 2079.0
|
1243.0 CD4 cells/million T-cells
Interval 587.0 to 3400.0
|
515.5 CD4 cells/million T-cells
Interval 414.0 to 1178.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-All doubles,Anti-HPV-16,Month 7
|
3693.0 CD4 cells/million T-cells
Interval 1870.0 to 5153.0
|
1679.5 CD4 cells/million T-cells
Interval 1052.0 to 2734.0
|
3414.5 CD4 cells/million T-cells
Interval 1424.5 to 4520.0
|
1505.0 CD4 cells/million T-cells
Interval 995.0 to 2205.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-All doubles, Anti-HPV-16, Month 12
|
2328.0 CD4 cells/million T-cells
Interval 1225.0 to 4614.0
|
1288.0 CD4 cells/million T-cells
Interval 976.0 to 2485.0
|
2543.0 CD4 cells/million T-cells
Interval 1232.0 to 4264.0
|
830.0 CD4 cells/million T-cells
Interval 367.0 to 1386.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-All doubles, Anti-HPV-18, Month 12
|
1654.0 CD4 cells/million T-cells
Interval 836.0 to 2634.0
|
808.5 CD4 cells/million T-cells
Interval 295.0 to 1932.0
|
1641.0 CD4 cells/million T-cells
Interval 985.0 to 2939.0
|
428.0 CD4 cells/million T-cells
Interval 162.0 to 938.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-CD40L, Anti-HPV-18, Day 0
|
36.0 CD4 cells/million T-cells
Interval 1.0 to 81.0
|
89.0 CD4 cells/million T-cells
Interval 1.0 to 176.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 54.0
|
13.5 CD4 cells/million T-cells
Interval 1.0 to 100.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-CD40L, Anti-HPV-16, Week 6
|
426.0 CD4 cells/million T-cells
Interval 258.5 to 999.5
|
326.5 CD4 cells/million T-cells
Interval 196.0 to 1034.0
|
298.0 CD4 cells/million T-cells
Interval 209.5 to 540.0
|
582.0 CD4 cells/million T-cells
Interval 223.0 to 967.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-CD40L, Anti-HPV-18, Week 6
|
403.5 CD4 cells/million T-cells
Interval 144.0 to 835.0
|
296.0 CD4 cells/million T-cells
Interval 216.0 to 840.0
|
242.5 CD4 cells/million T-cells
Interval 36.5 to 393.0
|
310.0 CD4 cells/million T-cells
Interval 95.0 to 521.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-CD40L, Anti-HPV-18, Week 10
|
2015.0 CD4 cells/million T-cells
Interval 944.0 to 3021.0
|
564.5 CD4 cells/million T-cells
Interval 507.0 to 2045.0
|
1051.0 CD4 cells/million T-cells
Interval 631.0 to 3317.0
|
474.5 CD4 cells/million T-cells
Interval 385.0 to 811.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-CD40L, Anti-HPV-16, Month 7
|
3658.0 CD4 cells/million T-cells
Interval 1804.0 to 5070.0
|
1619.5 CD4 cells/million T-cells
Interval 1071.0 to 2600.0
|
3290.0 CD4 cells/million T-cells
Interval 1464.5 to 4387.5
|
1389.0 CD4 cells/million T-cells
Interval 949.0 to 2133.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-CD40L, Anti-HPV-18, Month 7
|
1839.0 CD4 cells/million T-cells
Interval 1066.0 to 2893.0
|
833.5 CD4 cells/million T-cells
Interval 518.0 to 1605.0
|
2014.0 CD4 cells/million T-cells
Interval 979.0 to 3878.5
|
647.0 CD4 cells/million T-cells
Interval 442.0 to 981.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-CD40L, Anti-HPV-16, Month 12
|
2266.0 CD4 cells/million T-cells
Interval 1178.0 to 4558.0
|
1278.0 CD4 cells/million T-cells
Interval 955.0 to 2478.0
|
2519.0 CD4 cells/million T-cells
Interval 1232.0 to 4190.0
|
862.0 CD4 cells/million T-cells
Interval 353.0 to 1197.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IFNG, Anti-HPV-16, Day 0
|
27.0 CD4 cells/million T-cells
Interval 1.0 to 63.0
|
30.0 CD4 cells/million T-cells
Interval 1.0 to 51.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 45.0
|
39.0 CD4 cells/million T-cells
Interval 1.0 to 61.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IFNG, Anti-HPV-18, Day 0
|
4.0 CD4 cells/million T-cells
Interval 1.0 to 42.0
|
51.0 CD4 cells/million T-cells
Interval 1.0 to 59.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 54.0
|
21.0 CD4 cells/million T-cells
Interval 1.0 to 46.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IFNG, Anti-HPV-16, Week 6
|
222.5 CD4 cells/million T-cells
Interval 117.0 to 393.0
|
116.0 CD4 cells/million T-cells
Interval 75.0 to 222.0
|
42.5 CD4 cells/million T-cells
Interval 1.0 to 127.5
|
241.5 CD4 cells/million T-cells
Interval 71.0 to 404.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IFNG, Anti-HPV-18, Week 6
|
98.0 CD4 cells/million T-cells
Interval 25.0 to 361.0
|
104.5 CD4 cells/million T-cells
Interval 35.0 to 211.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 44.0
|
129.5 CD4 cells/million T-cells
Interval 1.0 to 182.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IFNG, Anti-HPV-16, Week 10
|
1220.0 CD4 cells/million T-cells
Interval 554.0 to 1478.0
|
450.0 CD4 cells/million T-cells
Interval 245.0 to 527.0
|
332.0 CD4 cells/million T-cells
Interval 282.0 to 1251.0
|
442.0 CD4 cells/million T-cells
Interval 160.0 to 935.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IFNG, Anti-HPV-18, Week 10
|
694.0 CD4 cells/million T-cells
Interval 342.0 to 1207.0
|
326.5 CD4 cells/million T-cells
Interval 121.0 to 455.0
|
222.0 CD4 cells/million T-cells
Interval 124.0 to 569.0
|
202.0 CD4 cells/million T-cells
Interval 122.0 to 279.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IFNG, Anti-HPV-16, Month 7
|
1513.0 CD4 cells/million T-cells
Interval 891.0 to 1993.0
|
585.5 CD4 cells/million T-cells
Interval 190.0 to 846.0
|
731.0 CD4 cells/million T-cells
Interval 267.5 to 1245.0
|
495.0 CD4 cells/million T-cells
Interval 319.0 to 859.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IFNG, Anti-HPV-18, Month 7
|
694.0 CD4 cells/million T-cells
Interval 409.0 to 868.0
|
306.0 CD4 cells/million T-cells
Interval 171.0 to 382.0
|
414.5 CD4 cells/million T-cells
Interval 245.5 to 616.5
|
198.0 CD4 cells/million T-cells
Interval 126.0 to 435.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IFNG, Anti-HPV-16, Month 12
|
452.0 CD4 cells/million T-cells
Interval 368.0 to 1097.0
|
432.0 CD4 cells/million T-cells
Interval 202.0 to 835.0
|
621.0 CD4 cells/million T-cells
Interval 239.0 to 1042.0
|
302.0 CD4 cells/million T-cells
Interval 129.0 to 555.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IL-2, Anti-HPV-16, Day 0
|
43.0 CD4 cells/million T-cells
Interval 1.0 to 81.0
|
30.0 CD4 cells/million T-cells
Interval 7.0 to 121.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 58.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 21.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IL-2, Anti-HPV-18, Day 0
|
46.0 CD4 cells/million T-cells
Interval 1.0 to 115.0
|
37.0 CD4 cells/million T-cells
Interval 1.0 to 102.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 31.0
|
13.5 CD4 cells/million T-cells
Interval 1.0 to 57.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IL-2, Anti-HPV-18, Week 6
|
364.5 CD4 cells/million T-cells
Interval 161.0 to 858.0
|
193.5 CD4 cells/million T-cells
Interval 94.0 to 687.0
|
227.5 CD4 cells/million T-cells
Interval 131.5 to 379.5
|
286.0 CD4 cells/million T-cells
Interval 129.0 to 413.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IL-2, Anti-HPV-16, Week 10
|
2503.0 CD4 cells/million T-cells
Interval 938.0 to 4606.0
|
1221.0 CD4 cells/million T-cells
Interval 678.0 to 1584.0
|
1542.0 CD4 cells/million T-cells
Interval 776.0 to 3499.0
|
929.5 CD4 cells/million T-cells
Interval 435.0 to 2128.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IL-2, Anti-HPV-18, Week 10
|
1668.5 CD4 cells/million T-cells
Interval 635.0 to 2183.0
|
555.5 CD4 cells/million T-cells
Interval 349.0 to 1687.0
|
1183.0 CD4 cells/million T-cells
Interval 456.0 to 2311.0
|
411.0 CD4 cells/million T-cells
Interval 245.0 to 891.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IL-2, Anti-HPV-16, Month 7
|
2847.0 CD4 cells/million T-cells
Interval 1557.0 to 4064.0
|
1318.5 CD4 cells/million T-cells
Interval 672.0 to 2141.0
|
2608.5 CD4 cells/million T-cells
Interval 1147.5 to 3875.0
|
1128.0 CD4 cells/million T-cells
Interval 697.0 to 1574.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IL-2, Anti-HPV-18, Month 7
|
1522.0 CD4 cells/million T-cells
Interval 914.0 to 2285.0
|
615.0 CD4 cells/million T-cells
Interval 472.0 to 1234.0
|
1442.0 CD4 cells/million T-cells
Interval 811.0 to 3471.0
|
537.0 CD4 cells/million T-cells
Interval 341.0 to 643.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-IL-2, Anti-HPV-16, Month 12
|
1792.0 CD4 cells/million T-cells
Interval 1076.0 to 4087.0
|
1040.5 CD4 cells/million T-cells
Interval 804.0 to 1972.0
|
1861.0 CD4 cells/million T-cells
Interval 1861.0 to 3754.0
|
723.0 CD4 cells/million T-cells
Interval 330.0 to 1255.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-TNFA, Anti-HPV-16, Day 0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 58.0
|
71.0 CD4 cells/million T-cells
Interval 1.0 to 252.0
|
32.0 CD4 cells/million T-cells
Interval 1.0 to 74.0
|
34.0 CD4 cells/million T-cells
Interval 1.0 to 76.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-TNFA, Anti-HPV-18, Day 0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 52.0
|
35.0 CD4 cells/million T-cells
Interval 1.0 to 131.0
|
25.0 CD4 cells/million T-cells
Interval 1.0 to 39.0
|
15.5 CD4 cells/million T-cells
Interval 1.0 to 83.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-TNFA, Anti-HPV-16, Week 6
|
326.5 CD4 cells/million T-cells
Interval 49.5 to 714.0
|
171.0 CD4 cells/million T-cells
Interval 133.0 to 701.0
|
237.0 CD4 cells/million T-cells
Interval 89.5 to 325.0
|
337.5 CD4 cells/million T-cells
Interval 183.0 to 648.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-TNFA, Anti-HPV-16, Week 10
|
2086.0 CD4 cells/million T-cells
Interval 519.0 to 4016.0
|
903.5 CD4 cells/million T-cells
Interval 606.0 to 1355.0
|
1260.0 CD4 cells/million T-cells
Interval 764.0 to 3094.0
|
865.5 CD4 cells/million T-cells
Interval 453.0 to 2100.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD4-d-TNFA, Anti-HPV-18, Month 7
|
1366.0 CD4 cells/million T-cells
Interval 1126.0 to 2449.0
|
598.0 CD4 cells/million T-cells
Interval 362.0 to 1522.0
|
1614.0 CD4 cells/million T-cells
Interval 760.5 to 3463.5
|
505.0 CD4 cells/million T-cells
Interval 330.0 to 683.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-All doubles,Anti-HPV-16, Day 0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 40.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 43.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 28.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 29.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-All doubles,Anti-HPV-18,Week 6
|
37.5 CD4 cells/million T-cells
Interval 9.0 to 66.5
|
2.0 CD4 cells/million T-cells
Interval 1.0 to 42.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 42.5
|
30.5 CD4 cells/million T-cells
Interval 1.0 to 74.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-All doubles,Anti-HPV-16,Week 10
|
41.0 CD4 cells/million T-cells
Interval 1.0 to 75.0
|
3.5 CD4 cells/million T-cells
Interval 1.0 to 36.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 54.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 29.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-All doubles,Anti-HPV-18,Week 10
|
11.0 CD4 cells/million T-cells
Interval 1.0 to 60.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 60.0
|
5.0 CD4 cells/million T-cells
Interval 1.0 to 84.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 41.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-CD40L, Anti-HPV-16, Week 10
|
18.5 CD4 cells/million T-cells
Interval 1.0 to 73.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 29.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 41.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 27.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-CD40L, Anti-HPV-18, Week 10
|
10.5 CD4 cells/million T-cells
Interval 1.0 to 34.0
|
2.5 CD4 cells/million T-cells
Interval 1.0 to 34.0
|
26.0 CD4 cells/million T-cells
Interval 1.0 to 72.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 30.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-CD40L, Anti-HPV-16, Month 7
|
26.0 CD4 cells/million T-cells
Interval 1.0 to 63.0
|
3.0 CD4 cells/million T-cells
Interval 1.0 to 20.0
|
2.0 CD4 cells/million T-cells
Interval 1.0 to 52.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 36.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-CD40L, Anti-HPV-18, Month 7
|
4.0 CD4 cells/million T-cells
Interval 1.0 to 42.0
|
15.0 CD4 cells/million T-cells
Interval 1.0 to 31.0
|
38.0 CD4 cells/million T-cells
Interval 1.0 to 92.0
|
4.0 CD4 cells/million T-cells
Interval 1.0 to 33.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-CD40L, Anti-HPV-16, Month 12
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 73.0
|
31.0 CD4 cells/million T-cells
Interval 7.0 to 39.0
|
3.0 CD4 cells/million T-cells
Interval 1.0 to 30.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 24.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-CD40L, Anti-HPV-18, Month 12
|
23.0 CD4 cells/million T-cells
Interval 1.0 to 59.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 8.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 39.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 24.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IFNG, Anti-HPV-16, Day 0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 29.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 43.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 28.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 2.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IFNG, Anti-HPV-18, Day 0
|
6.0 CD4 cells/million T-cells
Interval 1.0 to 33.0
|
19.0 CD4 cells/million T-cells
Interval 1.0 to 47.0
|
21.0 CD4 cells/million T-cells
Interval 1.0 to 54.0
|
4.0 CD4 cells/million T-cells
Interval 1.0 to 35.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IFNG, Anti-HPV-16, Week 6
|
2.5 CD4 cells/million T-cells
Interval 1.0 to 39.5
|
17.5 CD4 cells/million T-cells
Interval 1.0 to 78.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 14.5
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 11.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IFNG, Anti-HPV-18, Week 6
|
27.5 CD4 cells/million T-cells
Interval 1.0 to 55.5
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 47.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 42.5
|
35.5 CD4 cells/million T-cells
Interval 1.0 to 84.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IFNG, Anti-HPV-16, Week 10
|
34.0 CD4 cells/million T-cells
Interval 1.0 to 99.0
|
25.0 CD4 cells/million T-cells
Interval 1.0 to 30.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 38.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 29.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IFNG, Anti-HPV-18, Week 10
|
3.0 CD4 cells/million T-cells
Interval 1.0 to 68.0
|
7.5 CD4 cells/million T-cells
Interval 1.0 to 34.0
|
24.0 CD4 cells/million T-cells
Interval 1.0 to 76.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IFNG, Anti-HPV-16, Month 7
|
46.0 CD4 cells/million T-cells
Interval 1.0 to 68.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 26.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 74.5
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 50.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IFNG, Anti-HPV-18, Month 7
|
41.0 CD4 cells/million T-cells
Interval 1.0 to 68.0
|
21.0 CD4 cells/million T-cells
Interval 1.0 to 41.0
|
4.0 CD4 cells/million T-cells
Interval 1.0 to 90.5
|
3.0 CD4 cells/million T-cells
Interval 1.0 to 52.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IFNG, Anti-HPV-16, Month 12
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 31.0
|
25.0 CD4 cells/million T-cells
Interval 1.0 to 57.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 39.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 24.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IFNG, Anti-HPV-18, Month 12
|
23.0 CD4 cells/million T-cells
Interval 1.0 to 92.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 31.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 7.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 4.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IL-2, Anti-HPV-16, Day 0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 16.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IL-2, Anti-HPV-18, Day 0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IL-2, Anti-HPV-16, Week 6
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IL-2, Anti-HPV-16, Week 10
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 32.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IL-2, Anti-HPV-18, Week 10
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 26.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 25.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-IL-2, Anti-HPV-18, Month 12
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 48.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 19.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-TNFA, Anti-HPV-16, Day 0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 10.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 35.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 29.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-TNFA, Anti-HPV-16, Week 6
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 46.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 35.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 1.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 31.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-TNFA, Anti-HPV-18, Week 6
|
19.0 CD4 cells/million T-cells
Interval 1.0 to 50.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 57.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 28.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 26.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-TNFA, Anti-HPV-16, Month 12
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 26.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 54.0
|
28.0 CD4 cells/million T-cells
Interval 1.0 to 49.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 42.0
|
|
Frequency of Cluster of Differentiation 4/8 [CD4+/CD8+] T-cell Response
CD8-d-TNFA, Anti-HPV-18, Month 12
|
30.0 CD4 cells/million T-cells
Interval 24.0 to 62.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 28.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 48.0
|
1.0 CD4 cells/million T-cells
Interval 1.0 to 40.0
|
Adverse Events
HIV+/Cervarix Group
Serious events: 9 serious events
Other events: 123 other events
Deaths: 0 deaths
HIV+/Gardasil Group
Serious events: 9 serious events
Other events: 109 other events
Deaths: 1 deaths
HIV-/Cervarix Group
Serious events: 4 serious events
Other events: 136 other events
Deaths: 0 deaths
HIV-/Gardasil Group
Serious events: 1 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV+/Cervarix Group
n=129 participants at risk
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 participants at risk
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
n=144 participants at risk
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
n=145 participants at risk
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.6%
2/128 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Dengue fever
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Meningitis tuberculous
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Pneumonia
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Tonsillitis
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Vaginitis gardnerella
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Viral infection
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Renal and urinary disorders
Renal failure
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Immune system disorders
Hypersensitivity
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Psychiatric disorders
Dissociative disorder
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
Other adverse events
| Measure |
HIV+/Cervarix Group
n=129 participants at risk
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV+/Gardasil Group
n=128 participants at risk
HIV seropositive female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Cervarix Group
n=144 participants at risk
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Cervarix vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
HIV-/Gardasil Group
n=145 participants at risk
HIV seronegative female subjects, between and including 15 and 25 years of age, who received 3 doses of Gardasil vaccine, administered intramuscularly in the deltoid muscle of the non-dominant arm, according to a three-dose schedule: at Day 0, Week 6, Month 6.
|
|---|---|---|---|---|
|
Infections and infestations
Pharyngitis
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.6%
2/128 • Number of events 3 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.4%
2/145 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.6%
2/128 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Administration site pruritus
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Administration site swelling
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
2/129 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
2.3%
3/128 • Number of events 3 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
31.8%
41/129 • Number of events 64 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
29.7%
38/128 • Number of events 56 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
21.5%
31/144 • Number of events 40 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
23.4%
34/145 • Number of events 47 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Asthenia
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.6%
2/128 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Bacterial vaginosis
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Bartholinitis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Eye disorders
Blindness
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Investigations
Blood pressure increased
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Body tinea
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Reproductive system and breast disorders
Breast mass
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Investigations
Cd4 lymphocytes decreased
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Cervicitis gonococcal
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Chest pain
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Conjunctivitis
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Cystitis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Gastrointestinal disorders
Dental caries
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Psychiatric disorders
Depression
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Dermatophytosis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Discomfort
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Nervous system disorders
Dizziness
|
1.6%
2/129 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.6%
2/128 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.3%
3/129 • Number of events 3 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
2.8%
4/144 • Number of events 5 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.4%
2/145 • Number of events 3 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Renal and urinary disorders
Dysuria
|
0.78%
1/129 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
31.8%
41/129 • Number of events 59 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
26.6%
34/128 • Number of events 50 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
36.1%
52/144 • Number of events 89 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
29.0%
42/145 • Number of events 69 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Fatigue
|
56.6%
73/129 • Number of events 128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
46.1%
59/128 • Number of events 118 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
45.1%
65/144 • Number of events 111 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
38.6%
56/145 • Number of events 88 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Nervous system disorders
Formication
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Furuncle
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
31.8%
41/129 • Number of events 58 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
27.3%
35/128 • Number of events 55 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
19.4%
28/144 • Number of events 35 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
17.9%
26/145 • Number of events 38 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Nervous system disorders
Headache
|
68.2%
88/129 • Number of events 165 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
49.2%
63/128 • Number of events 116 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
48.6%
70/144 • Number of events 115 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
46.2%
67/145 • Number of events 104 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Hepatitis c
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Nervous system disorders
Hypoaesthesia
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Vascular disorders
Hypotension
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Influenza
|
1.6%
2/129 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.4%
2/145 • Number of events 3 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Injection site erythema
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Injection site haematoma
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Injection site pain
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Injection site rash
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Malaise
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
52.7%
68/129 • Number of events 115 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
39.8%
51/128 • Number of events 81 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
44.4%
64/144 • Number of events 106 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
37.2%
54/145 • Number of events 91 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
2/129 • Number of events 4 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
3.1%
4/128 • Number of events 5 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.4%
2/144 • Number of events 3 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
4.1%
6/145 • Number of events 7 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Oral herpes
|
1.6%
2/129 • Number of events 3 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.6%
2/128 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.4%
2/144 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Pain
|
93.8%
121/129 • Number of events 303 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
66.4%
85/128 • Number of events 174 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
92.4%
133/144 • Number of events 329 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
82.1%
119/145 • Number of events 265 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.6%
2/128 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Peripheral swelling
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
2/129 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Pyrexia
|
18.6%
24/129 • Number of events 32 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
15.6%
20/128 • Number of events 22 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
16.0%
23/144 • Number of events 31 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
17.2%
25/145 • Number of events 29 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.5%
11/129 • Number of events 11 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
3.9%
5/128 • Number of events 6 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
3.5%
5/144 • Number of events 6 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
5.5%
8/145 • Number of events 10 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.3%
3/129 • Number of events 3 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Immune system disorders
Seasonal allergy
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Sinusitis
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.4%
2/145 • Number of events 3 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Skin infection
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
General disorders
Swelling
|
29.5%
38/129 • Number of events 60 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
16.4%
21/128 • Number of events 28 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
32.6%
47/144 • Number of events 76 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
26.9%
39/145 • Number of events 60 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Cardiac disorders
Tachycardia
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Tonsillitis
|
1.6%
2/129 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.4%
2/144 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Gastrointestinal disorders
Toothache
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Nervous system disorders
Tremor
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
3/129 • Number of events 3 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
2.3%
3/128 • Number of events 3 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
1.4%
2/144 • Number of events 2 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
2.8%
4/145 • Number of events 5 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Urethritis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.9%
14/129 • Number of events 17 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
7.0%
9/128 • Number of events 11 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
2.8%
4/144 • Number of events 6 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
4.1%
6/145 • Number of events 7 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Varicella
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/145 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Ear and labyrinth disorders
Vertigo
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Investigations
Viral load increased
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/129 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.78%
1/128 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.69%
1/144 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.78%
1/129 • Number of events 1 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
1.6%
2/129 • Number of events 3 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/128 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/144 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
0.00%
0/145 • Solicited local and general symptoms: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after vaccination; Unsolicited AEs: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after vaccination; SAEs: during the whole study period (from Day 0 up to Month 24).
|
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