Trial Outcomes & Findings for Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix) in HIV Infected Females (NCT NCT00586339)
NCT ID: NCT00586339
Last Updated: 2020-01-03
Results Overview
CD4+ cell count categories, at baseline, assessed were: (i) below (\<) 200 CD4+ cells per cubic millimeter (mm\^3), (ii) between 200 and 500 CD4+ cells/mm\^3 and (iii) above (\>) 500 CD4+ cells/mm\^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
At Month 10 and Month 12
Results posted on
2020-01-03
Participant Flow
HIV+ subjects were randomised to receive either Cervarix or Aluminium Hydroxide vaccines; HIV- subjects were not randomised and all received Cervarix vaccine.
Enrollment was staggered as follows: 1) Enrollment of Human immunodeficiency virus positive (HIV+) subjects with cluster of differentiation 4 (CD4+) cell count \>200 cells per cubic millimeter (cells/mm\^3) and HIV negative (HIV-) subjects (up to 30 subjects) for blinded safety evaluation; 2) Enrollment of remaining HIV+/HIV- subjects.
Participant milestones
| Measure |
HIV+/Cervarix Group
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Overall Study
STARTED
|
61
|
59
|
30
|
|
Overall Study
COMPLETED
|
54
|
52
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
6
|
Reasons for withdrawal
| Measure |
HIV+/Cervarix Group
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
1
|
|
Overall Study
Migrated/moved from study area
|
3
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
1
|
Baseline Characteristics
Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix) in HIV Infected Females
Baseline characteristics by cohort
| Measure |
HIV+/Cervarix Group
n=61 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=59 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=30 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African heritage/African American
|
61 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Age, Continuous
|
21.6 Years
STANDARD_DEVIATION 2.21 • n=5 Participants
|
22.7 Years
STANDARD_DEVIATION 1.70 • n=7 Participants
|
21.3 Years
STANDARD_DEVIATION 1.65 • n=5 Participants
|
21.9 Years
STANDARD_DEVIATION 1.85 • n=4 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who had their symptom sheet filled in and for whom data were available.
Solicited local symptoms assessed were pain and swelling. Any = occurrence of any solicited local regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Solicited local symptoms were assessed as related to the study vaccination.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=61 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=59 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=30 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
46 Participants
|
18 Participants
|
19 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
6 Participants
|
0 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
29 Participants
|
12 Participants
|
21 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
5 Participants
|
0 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 3
|
27 Participants
|
6 Participants
|
19 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 3
|
12 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain, Across doses
|
52 Participants
|
27 Participants
|
28 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across doses
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across doses
|
19 Participants
|
2 Participants
|
12 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
1 Participants
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who had their symptom sheet filled in and for whom data were available.
Solicited general symptoms assessed were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], gastrointestinal, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Urticaria = Urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as causally related to the vaccination.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=61 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=59 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=30 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Myalgia, Dose 3
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Myalgia, Dose 3
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Rash, Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Headache, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Headache, Dose 2
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Myalgia, Dose 2
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Myalgia, Dose 2
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Rash, Dose 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Rash, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Rash, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Urticaria, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Urticaria, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Urticaria, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Arthralgia, Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Arthralgia, Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Fatigue, Dose 3
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Fatigue, Dose 3
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Fever, Dose 3
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Fever, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Fever, Dose 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Gastrointestinal, Dose 3
|
3 Participants
|
2 Participants
|
6 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Gastrointestinal, Dose 3
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Headache, Dose 3
|
2 Participants
|
7 Participants
|
6 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Headache, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Headache, Dose 3
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Rash, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Rash, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Urticaria, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Urticaria, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Urticaria, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Arthralgia, Across doses
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Arthralgia, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Arthralgia, Across doses
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Fatigue, Across doses
|
18 Participants
|
16 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Fatigue, Across doses
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Fatigue, Across doses
|
15 Participants
|
12 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Fever, Across doses
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Fever, Across doses
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Fever, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Gastrointestinal, Across doses
|
15 Participants
|
11 Participants
|
13 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Gastrointestinal, Across doses
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Headache, Across doses
|
23 Participants
|
26 Participants
|
16 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Headache, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Headache, Across doses
|
10 Participants
|
9 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Myalgia, Across doses
|
3 Participants
|
3 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Myalgia, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Myalgia, Across doses
|
2 Participants
|
3 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Rash, Across doses
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Rash, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Rash, Across doses
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Urticaria, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Urticaria, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Urticaria, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Arthralgia, Dose 1
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Arthralgia, Dose 1
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Fatigue, Dose 1
|
12 Participants
|
13 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Fatigue, Dose 1
|
9 Participants
|
9 Participants
|
5 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Fever, Dose 1
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Fever, Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Fever, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Gastrointestinal, Dose 1
|
5 Participants
|
7 Participants
|
9 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Gastrointestinal, Dose 1
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Headache, Dose 1
|
13 Participants
|
16 Participants
|
11 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Headache, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Headache, Dose 1
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Myalgia, Dose 1
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Myalgia, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Myalgia, Dose 1
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Rash, Dose 1
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Rash, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Rash, Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Urticaria, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Urticaria, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Urticaria, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Arthralgia, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Arthralgia, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Arthralgia, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Fatigue, Dose 2
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Fatigue, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Fatigue, Dose 2
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Fever, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Fever, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Fever, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Gastrointestinal, Dose 2
|
10 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Related Gastrointestinal, Dose 2
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Any Headache, Dose 2
|
11 Participants
|
9 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Within 30 days after any vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=61 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=59 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=30 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms
Any unsolicited AE(s)
|
53 Participants
|
46 Participants
|
26 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms
Grade 3 unsolicited AE(s)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms
Related unsolicited AE(s)
|
16 Participants
|
3 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: From Day 0 up to Month 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Medically significant conditions (MSCs) were collected regardless of causal relationship to vaccination and intensity. Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=61 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=59 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=30 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects With Medically Significant Conditions (MSCs) From Day 0 up to Month 7
|
18 Participants
|
21 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From Day 0 up to Month 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=61 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=59 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=30 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs) From Day 0 up to Month 7
|
3 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Day 0 up to Month 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported pregnancies and outcomes of reported pregnancies.
The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. The outcome of the reported pregnancy was a live infant with no apparent congenital anomaly.
Outcome measures
| Measure |
HIV+/Cervarix Group
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=1 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies From Day 0 up to Month 7
|
—
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: From Day 0 up to Month 12Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=61 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=59 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=30 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Reporting SAEs From Day 0 up to Month 12
|
3 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Day 0 up to Month 12Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
MSCs were collected regardless of causal relationship to vaccination and intensity. Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=61 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=59 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=30 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects With MSCs From Day 0 up to Month 12
|
19 Participants
|
21 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From Day 0 up to Month 12Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported pregnancies and outcomes of reported pregnancies.
The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. The outcome of the reported pregnancy was a live infant with no apparent congenital anomaly.
Outcome measures
| Measure |
HIV+/Cervarix Group
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=1 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies From Day 0 up to Month 12
|
—
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: At Day 7 and at Months 1, 2, 4, 6 and 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.
Haematological laboratory parameters assessed were red blood cells (RBC) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=56 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=55 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=29 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Normal] Month 4
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Below] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Below] Month 4
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Below] Month 6
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Normal] Month 7
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Normal] Day 7
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Below] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Normal] Month 7
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Below] Month 7
|
6 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Normal] Month 1
|
46 Participants
|
44 Participants
|
25 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Missing] Month 4
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Normal] Month 6
|
53 Participants
|
52 Participants
|
26 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Below] Month 4
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Normal] Month 6
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Below] Month 6
|
5 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Normal] Month 7
|
43 Participants
|
37 Participants
|
24 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Below] Month 7
|
5 Participants
|
8 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Normal] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Below] Day 7
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Normal] Month 1
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Below] Month 1
|
5 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Normal] Month 2
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Below] Month 2
|
6 Participants
|
8 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Above] Month 4
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Low; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Normal] Day 7
|
13 Participants
|
14 Participants
|
15 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Normal] Month 1
|
56 Participants
|
54 Participants
|
29 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Below] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Missing] Month 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Normal] Month 2
|
51 Participants
|
54 Participants
|
28 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Below] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Above] Month 2
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Missing] Month 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Normal] Month 4
|
52 Participants
|
51 Participants
|
26 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Below] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Below] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Above] Month 7
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Normal] Month 7
|
51 Participants
|
50 Participants
|
25 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Below] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Normal; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Normal] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Below] Month 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Normal] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Below] Month 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Normal] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Below] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Above] Day 7
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Normal] Month 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Normal] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Below] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Above] Month 1
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Below] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc Low; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Normal] Month 2
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Below] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Normal] Month 4
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Below] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Above] Month 4
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Normal] Month 6
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Below] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Above] Month 6
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Normal] Month 7
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Above] Month 7
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
PLA [pre-vacc High; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Normal] Day 7
|
14 Participants
|
12 Participants
|
15 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Below] Day 7
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Below] Month 1
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Normal] Month 2
|
44 Participants
|
45 Participants
|
28 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Below] Month 2
|
5 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Normal] Month 4
|
43 Participants
|
40 Participants
|
25 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Below] Month 4
|
6 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Normal] Month 6
|
40 Participants
|
40 Participants
|
25 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7
RBC [pre-vacc Normal; post-vacc Below] Month 6
|
9 Participants
|
5 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At Day 7 and Months 1, 2, 4, 6 and 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.
Haematological laboratory parameters assessed were white blood cells (WBC) and neutrophils (NEU). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=48 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=50 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=26 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Below] Month 1
|
7 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Normal] Month 2
|
38 Participants
|
41 Participants
|
24 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Below] Day 7
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Below] Month 4
|
9 Participants
|
10 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Normal] Month 7
|
35 Participants
|
32 Participants
|
18 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Normal] Month 6
|
6 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Below] Month 6
|
8 Participants
|
8 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Normal] Day 7
|
9 Participants
|
12 Participants
|
12 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Below] Day 7
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Normal] Month 1
|
39 Participants
|
43 Participants
|
23 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Below] Month 2
|
6 Participants
|
9 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Normal] Month 7
|
34 Participants
|
38 Participants
|
21 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Below] Month 7
|
8 Participants
|
8 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Normal] Month 4
|
37 Participants
|
41 Participants
|
22 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Below] Month 4
|
6 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Normal; post-vacc Normal] Month 6
|
35 Participants
|
38 Participants
|
21 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Normal] Month 2
|
10 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Below] Month 2
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Normal] Day 7
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Below] Day 7
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Normal] Month 1
|
9 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Below] Month 1
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Above] Month 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Normal] Month 4
|
8 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Below] Month 4
|
6 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Normal] Month 2
|
38 Participants
|
35 Participants
|
22 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Below] Month 2
|
8 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Above] Month 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Normal] Month 4
|
36 Participants
|
30 Participants
|
19 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Normal] Month 6
|
33 Participants
|
33 Participants
|
19 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Below] Month 6
|
12 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Below] Month 6
|
8 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Normal] Month 7
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Below] Month 7
|
8 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
WBC [pre-vacc Low; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Normal] Day 7
|
9 Participants
|
11 Participants
|
12 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Below] Month 7
|
9 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Normal] Day 7
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Below] Day 7
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Normal] Month 1
|
7 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Normal] Month 7
|
5 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Below] Month 7
|
7 Participants
|
9 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Normal] Month 1
|
36 Participants
|
36 Participants
|
21 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Normal; post-vacc Below] Month 1
|
11 Participants
|
5 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Below] Month 1
|
5 Participants
|
10 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Normal] Month 2
|
6 Participants
|
7 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Below] Month 2
|
6 Participants
|
8 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Normal] Month 4
|
6 Participants
|
7 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Below] Month 4
|
6 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Normal] Month 6
|
5 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7
NEU [pre-vacc Low; post-vacc Below] Month 6
|
7 Participants
|
10 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: At Day 7 and at Months 1, 2, 4, 6 and 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.
Haematological laboratory parameters assessed were lymphocytes (LYM) and monocytes (MON). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=57 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=56 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=29 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Below] Month 2
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Normal] Month 4
|
49 Participants
|
50 Participants
|
23 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Below] Month 4
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Normal] Month 4
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Normal] Month 7
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Below] Month 7
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Normal] Day 7
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Below] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Normal] Month 1
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Below] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Normal] Month 2
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Normal] Month 6
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Below] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Normal] Month 7
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Below] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Normal] Month 1
|
56 Participants
|
54 Participants
|
28 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Below] Month 1
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Above] Month 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Above] Month 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Normal] Month 4
|
51 Participants
|
52 Participants
|
26 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Below] Month 6
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Normal] Month 7
|
50 Participants
|
50 Participants
|
24 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Normal] Day 7
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Normal] Month 1
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Below] Month 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Normal] Month 2
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Below] Month 4
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Normal] Month 6
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Below] Month 7
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Normal] Day 7
|
12 Participants
|
14 Participants
|
14 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Below] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Above] Month 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Normal] Month 1
|
52 Participants
|
55 Participants
|
27 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Below] Month 1
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Normal] Month 2
|
50 Participants
|
54 Participants
|
26 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Above] Month 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Below] Month 4
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Normal] Month 6
|
53 Participants
|
52 Participants
|
26 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Below] Month 7
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Normal] Month 2
|
52 Participants
|
55 Participants
|
28 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Below] Month 2
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Normal] Month 6
|
48 Participants
|
52 Participants
|
22 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Below] Month 6
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Normal] Month 7
|
48 Participants
|
49 Participants
|
22 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Below] Month 7
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Normal; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Normal] Day 7
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Below] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Below] Month 1
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Normal] Month 1
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Normal] Month 2
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Below] Month 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Below] Month 4
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Normal] Month 6
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Below] Month 6
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc Low; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Below] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Normal] Month 4
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Below] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
LYM [pre-vacc High; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Normal] Day 7
|
13 Participants
|
14 Participants
|
15 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Below] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Normal; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Below] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Below] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Normal] Month 4
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Below] Month 6
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Normal] Month 7
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
MON [pre-vacc Low; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 7 and Months 1, 2, 4, 6 and 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.
Haematological laboratory parameters assessed were haemoglobin (Hgb) and haematocrit (Hct). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=49 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=48 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=26 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Below] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Normal] Day 7
|
13 Participants
|
11 Participants
|
13 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Below] Day 7
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Below] Month 1
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Normal] Month 2
|
46 Participants
|
43 Participants
|
24 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Above] Month 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Normal] Month 4
|
46 Participants
|
43 Participants
|
23 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Normal] Month 7
|
43 Participants
|
38 Participants
|
22 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Below] Day 7
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Normal] Month 1
|
1 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Normal] Month 2
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Below] Month 4
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Normal] Month 6
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Below] Month 6
|
4 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Below] Day 7
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Normal] Month 1
|
42 Participants
|
37 Participants
|
22 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Below] Month 1
|
2 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Normal] Month 2
|
37 Participants
|
36 Participants
|
24 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Below] Month 2
|
5 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Above] Month 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Normal] Month 4
|
38 Participants
|
36 Participants
|
24 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Below] Month 4
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Normal] Month 6
|
36 Participants
|
33 Participants
|
22 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Below] Month 6
|
6 Participants
|
7 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Normal] Month 7
|
34 Participants
|
30 Participants
|
20 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Below] Month 7
|
7 Participants
|
10 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Normal] Day 7
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Below] Day 7
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Normal] Month 1
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Below] Month 1
|
12 Participants
|
11 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Normal] Month 2
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Below] Month 2
|
12 Participants
|
10 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Normal] Month 4
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Below] Month 4
|
9 Participants
|
9 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Normal] Month 6
|
8 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Below] Month 6
|
7 Participants
|
9 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Normal] Month 7
|
8 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Below] Month 7
|
7 Participants
|
9 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Normal] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Below] Month 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Normal] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Below] Month 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Normal] Month 6
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Below] Month 1
|
10 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Below] Month 2
|
8 Participants
|
7 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Normal] Month 4
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Normal] Month 7
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Below] Month 7
|
6 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Normal] Day 7
|
11 Participants
|
11 Participants
|
13 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Normal; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc Low; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Normal] Month 4
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Below] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Normal] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Below] Month 7
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hct [pre-vacc High; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Normal] Month 1
|
46 Participants
|
43 Participants
|
23 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Below] Month 2
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Below] Month 4
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Normal] Month 6
|
42 Participants
|
39 Participants
|
23 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Below] Month 6
|
5 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Normal; post-vacc Below] Month 7
|
3 Participants
|
7 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Normal] Day 7
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Hgb [pre-vacc Low; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 7 and at Months 1, 2, 4, 6 and 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.
Haematological and biochemical laboratory parameters assessed were eosinophils (EOS), basophils (BAS) and creatinine (CREA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=60 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=57 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=29 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Normal] Day 7
|
13 Participants
|
13 Participants
|
15 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Below] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Normal] Month 1
|
53 Participants
|
52 Participants
|
28 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Below] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Above] Month 1
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Normal] Month 2
|
51 Participants
|
51 Participants
|
26 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Below] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Above] Month 4
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Below] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Above] Month 6
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Below] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Normal] Day 7
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Below] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Normal] Month 2
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Below] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Above] Month 2
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Normal] Month 4
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Below] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Above] Month 4
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Normal] Month 6
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Above] Month 6
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Above] Month 7
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Normal] Day 7
|
15 Participants
|
15 Participants
|
15 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Below] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Normal] Month 1
|
60 Participants
|
57 Participants
|
29 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Below] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Normal] Month 2
|
58 Participants
|
57 Participants
|
28 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Below] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Normal] Month 4
|
57 Participants
|
54 Participants
|
26 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Normal] Month 6
|
57 Participants
|
54 Participants
|
26 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Below] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Normal] Month 7
|
56 Participants
|
53 Participants
|
25 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Below] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Below] Day 7
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Normal] Month 1
|
24 Participants
|
29 Participants
|
17 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Normal] Month 2
|
26 Participants
|
30 Participants
|
15 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Below] Month 2
|
1 Participants
|
7 Participants
|
6 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Normal] Month 4
|
24 Participants
|
26 Participants
|
17 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Normal] Month 6
|
20 Participants
|
22 Participants
|
17 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Below] Month 6
|
6 Participants
|
12 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Normal] Month 7
|
22 Participants
|
24 Participants
|
15 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Below] Month 7
|
3 Participants
|
11 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Normal] Day 7
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Below] Day 7
|
6 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Above] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Normal] Month 1
|
5 Participants
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Below] Month 1
|
27 Participants
|
13 Participants
|
6 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Normal] Month 2
|
8 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Below] Month 2
|
23 Participants
|
15 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Normal] Month 4
|
6 Participants
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Below] Month 6
|
21 Participants
|
13 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Normal] Month 7
|
7 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Below] Month 7
|
24 Participants
|
13 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Below] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Normal] Month 7
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Below] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Below] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
BAS [pre-vacc Normal; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Normal] Day 7
|
6 Participants
|
4 Participants
|
11 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Below] Month 1
|
4 Participants
|
8 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Normal; post-vacc Below] Month 4
|
2 Participants
|
9 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Below] Month 4
|
25 Participants
|
12 Participants
|
5 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Normal] Month 6
|
10 Participants
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
CREA [pre-vacc Low; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Above] Day 7
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Above] Month 2
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Normal] Month 4
|
48 Participants
|
49 Participants
|
25 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Below] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Normal] Month 7
|
50 Participants
|
49 Participants
|
24 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Normal] Month 6
|
50 Participants
|
51 Participants
|
25 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc Normal; post-vacc Above] Month 7
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Below] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Above] Day 7
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Normal] Month 1
|
5 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
EOS [pre-vacc High; post-vacc Above] Month 1
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Day 7 and Months 1, 2, 4, 6 and 7Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.
Biochemical laboratory parameter assessed was alanine aminotransferase (ALAT). By pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=50 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=46 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=26 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Below] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Above] Month 2
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Normal] Month 4
|
9 Participants
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Normal] Day 7
|
10 Participants
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Below] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Above] Day 7
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Normal] Month 1
|
48 Participants
|
45 Participants
|
25 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Below] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Above] Month 1
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Normal] Month 2
|
47 Participants
|
40 Participants
|
24 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Below] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Above] Month 2
|
1 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Normal] Month 4
|
44 Participants
|
42 Participants
|
23 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Below] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Above] Month 4
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Normal] Month 6
|
46 Participants
|
41 Participants
|
21 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Below] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Above] Month 6
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Normal] Month 7
|
40 Participants
|
40 Participants
|
22 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Below] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Normal] Month 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Below] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Above] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Normal] Month 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Below] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Above] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Missing] Month 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Normal] Month 4
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Above] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Normal] Month 6
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Below] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Above] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Normal] Month 7
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Below] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Above] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Normal] Day 7
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Below] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Above] Day 7
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Missing] Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Normal] Month 1
|
6 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Below] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Above] Month 1
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Missing] Month 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Normal] Month 2
|
9 Participants
|
8 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Below] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Above] Month 4
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Below] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Above] Month 6
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Missing] Month 6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Normal] Month 7
|
7 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Below] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Above] Month 7
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Missing] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Normal; post-vacc Above] Month 7
|
6 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc Low; post-vacc Below] Month 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Normal] Month 6
|
7 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
ALAT [pre-vacc High; post-vacc Missing] Month 7
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Month 10 and Month 12Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.
Haematological laboratory parameters assessed were neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=51 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=50 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=24 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc High; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Normal; post-vacc Normal] Month 10
|
32 Participants
|
30 Participants
|
16 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Normal; post-vacc Below] Month 10
|
11 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Normal; post-vacc Above] Month 10
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Normal; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Low; post-vacc Normal] Month 10
|
6 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Low; post-vacc Below] Month 10
|
6 Participants
|
10 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Low; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Low; post-vacc Below] Month 12
|
9 Participants
|
11 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Low; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Low; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Normal; post-vacc Normal] Month 10
|
48 Participants
|
47 Participants
|
24 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Normal; post-vacc Below] Month 10
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Normal; post-vacc Above] Month 10
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Normal; post-vacc Missing] Month 10
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Normal; post-vacc Normal] Month 12
|
50 Participants
|
49 Participants
|
24 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Normal; post-vacc Below] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Normal; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Normal; post-vacc Missing] Month 12
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Low; post-vacc Normal] Month 10
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Low; post-vacc Below] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Low; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Low; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Low; post-vacc Normal] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Low; post-vacc Below] Month 12
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Low; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc Low; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc High; post-vacc Below] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc High; post-vacc Above] Month 10
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc High; post-vacc Below] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc High; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc High; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Normal; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Normal; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Normal; post-vacc Below] Month 12
|
7 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Normal; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Normal; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Low; post-vacc Normal] Month 10
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Low; post-vacc Below] Month 10
|
6 Participants
|
6 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Low; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Low; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Low; post-vacc Normal] Month 12
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Low; post-vacc Below] Month 12
|
7 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Low; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Low; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Normal; post-vacc Normal] Month 10
|
35 Participants
|
36 Participants
|
19 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Normal; post-vacc Below] Month 10
|
7 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Normal; post-vacc Above] Month 10
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Normal; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Normal; post-vacc Normal] Month 12
|
34 Participants
|
35 Participants
|
17 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Normal; post-vacc Below] Month 12
|
7 Participants
|
10 Participants
|
5 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Normal; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Normal; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Low; post-vacc Normal] Month 10
|
6 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Low; post-vacc Normal] Month 12
|
6 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Low; post-vacc Below] Month 12
|
7 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Low; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Normal; post-vacc Normal] Month 12
|
29 Participants
|
32 Participants
|
17 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Normal; post-vacc Below] Month 12
|
13 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Normal; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Normal; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Low; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
NEU [pre-vacc Low; post-vacc Normal] Month 12
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc High; post-vacc Normal] Month 10
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
PLA [pre-vacc High; post-vacc Normal] Month 12
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Normal; post-vacc Normal] Month 10
|
40 Participants
|
34 Participants
|
23 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Normal; post-vacc Below] Month 10
|
8 Participants
|
9 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
RBC [pre-vacc Normal; post-vacc Normal] Month 12
|
40 Participants
|
40 Participants
|
24 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Low; post-vacc Below] Month 10
|
7 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Low; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Low; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
WBC [pre-vacc Low; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At Month 10 and Month 12Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.
Haematological and biochemical laboratory parameters assessed were alanine aminotransferase (ALAT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocrit (Hct), haemoglobin (Hgb), lymphocytes (LYM) and monocytes (MON). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=55 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=52 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=24 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
BAS [pre-vacc Normal; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Normal; post-vacc Below] Month 10
|
4 Participants
|
11 Participants
|
4 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Normal; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Normal; post-vacc Normal] Month 10
|
44 Participants
|
40 Participants
|
20 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Normal; post-vacc Below] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Normal; post-vacc Above] Month 10
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Normal; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Normal; post-vacc Normal] Month 12
|
38 Participants
|
39 Participants
|
20 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Normal; post-vacc Below] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Normal; post-vacc Above] Month 12
|
6 Participants
|
6 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Low; post-vacc Normal] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Low; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Low; post-vacc Below] Month 12
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Low; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc High; post-vacc Below] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc High; post-vacc Normal] Month 12
|
8 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
BAS [pre-vacc Normal; post-vacc Normal] Month 10
|
55 Participants
|
50 Participants
|
24 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
BAS [pre-vacc Normal; post-vacc Below] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
BAS [pre-vacc Normal; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Normal; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Normal; post-vacc Normal] Month 12
|
18 Participants
|
24 Participants
|
13 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Low; post-vacc Below] Month 10
|
20 Participants
|
13 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Low ; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Low; post-vacc Normal] Month 12
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc Normal; post-vacc Below] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc Normal ; post-vacc Above] Month 10
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc Normal; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc Normal; post-vacc Normal] Month 12
|
46 Participants
|
49 Participants
|
24 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc Normal; post-vacc Above] Month 12
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc Normal; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc High; post-vacc Below] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc High; post-vacc Above] Month 12
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Normal; post-vacc Normal] Month 10
|
35 Participants
|
31 Participants
|
20 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Normal; post-vacc Below] Month 10
|
6 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Normal; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Low; post-vacc Normal] Month 10
|
6 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Low; post-vacc Below] Month 10
|
8 Participants
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Low ; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Low; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Low; post-vacc Normal] Month 12
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Low; post-vacc Below] Month 12
|
9 Participants
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc High; post-vacc Normal] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc High; post-vacc Below] Month 10
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc High; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc High; post-vacc Below] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc High; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc High; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Normal; post-vacc Normal] Month 10
|
44 Participants
|
38 Participants
|
21 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Normal; post-vacc Below] Month 10
|
2 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Normal ; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Normal; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Normal; post-vacc Normal] Month 12
|
43 Participants
|
42 Participants
|
21 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Normal; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Low; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Normal; post-vacc Below] Month 10
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Normal; post-vacc Below] Month 12
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Normal; post-vacc Above] Month 12
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Low; post-vacc Normal] Month 10
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Low; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Low; post-vacc Normal] Month 12
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Low; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc High; post-vacc Below] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc High; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc High; post-vacc Below] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc High; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Normal; post-vacc Normal] Month 10
|
50 Participants
|
48 Participants
|
24 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Normal; post-vacc Below] Month 10
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Normal; post-vacc Below] Month 12
|
1 Participants
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Normal; post-vacc Above] Month 12
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Low; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Low; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Low; post-vacc Normal] Month 12
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Low; post-vacc Below] Month 12
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Low; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Low; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Low; post-vacc Below] Month 10
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Low; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Low; post-vacc Normal] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Low; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc High; post-vacc Normal] Month 10
|
8 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc High; post-vacc Above] Month 10
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Low; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc High; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc High; post-vacc Below] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc High; post-vacc Above] Month 12
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc High; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
BAS [pre-vacc Normal; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
BAS [pre-vacc Normal; post-vacc Normal] Month 12
|
54 Participants
|
52 Participants
|
24 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
BAS [pre-vacc Normal; post-vacc Below] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
BAS [pre-vacc Normal; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Normal; post-vacc Normal] Month 10
|
20 Participants
|
22 Participants
|
15 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Normal; post-vacc Below] Month 12
|
6 Participants
|
10 Participants
|
6 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Normal; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Normal; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Low; post-vacc Normal] Month 10
|
11 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Low; post-vacc Below] Month 12
|
26 Participants
|
14 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Low; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
CREA [pre-vacc Low; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Normal; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc Normal; post-vacc Normal] Month 10
|
46 Participants
|
46 Participants
|
22 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc Normal; post-vacc Below] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc High; post-vacc Normal] Month 10
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc High; post-vacc Above] Month 10
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc High; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc High; post-vacc Normal] Month 12
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc High; post-vacc Below] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
EOS [pre-vacc High; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Normal ; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Normal; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Normal; post-vacc Normal] Month 12
|
32 Participants
|
32 Participants
|
22 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Normal; post-vacc Below] Month 12
|
9 Participants
|
8 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Normal; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Low; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc Low; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc High; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hct [pre-vacc High; post-vacc Normal] Month 12
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Normal; post-vacc Below] Month 12
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Normal; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Low; post-vacc Normal] Month 10
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Low; post-vacc Below] Month 10
|
7 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Low ; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Low; post-vacc Normal] Month 12
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Low; post-vacc Below] Month 12
|
5 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Low; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
Hgb [pre-vacc Low; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Normal; post-vacc Normal] Month 10
|
46 Participants
|
48 Participants
|
21 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Normal; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Normal; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Normal; post-vacc Normal] Month 12
|
45 Participants
|
48 Participants
|
21 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Normal; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Low; post-vacc Below] Month 10
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Low; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Low; post-vacc Below] Month 12
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc Low; post-vacc Above] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc High; post-vacc Normal] Month 10
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc High; post-vacc Missing] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc High; post-vacc Normal] Month 12
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
LYM [pre-vacc High; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Normal; post-vacc Above] Month 10
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Normal; post-vacc Normal] Month 12
|
50 Participants
|
45 Participants
|
24 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Normal; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Low; post-vacc Normal] Month 10
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
MON [pre-vacc Low; post-vacc Below] Month 10
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12
ALAT [pre-vacc Normal; post-vacc Missing] Month 12
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7Population: The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.
The number of CD4+ cells per cubic millimeter (mm\^3) in all HIV+ subjects at pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7 is reported.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=61 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=59 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Cluster of Differention 4 (CD4+) Cells Per Cubic Millimeter in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7
Pre-vaccination (Day 0)
|
451.0 cells/mm^3
Interval 310.0 to 596.0
|
458.0 cells/mm^3
Interval 363.0 to 611.0
|
—
|
|
Number of Cluster of Differention 4 (CD4+) Cells Per Cubic Millimeter in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7
Month 2
|
436.0 cells/mm^3
Interval 322.0 to 591.0
|
438.0 cells/mm^3
Interval 320.0 to 580.0
|
—
|
|
Number of Cluster of Differention 4 (CD4+) Cells Per Cubic Millimeter in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7
Month 7
|
419.0 cells/mm^3
Interval 327.0 to 593.0
|
464.0 cells/mm^3
Interval 359.0 to 602.0
|
—
|
|
Number of Cluster of Differention 4 (CD4+) Cells Per Cubic Millimeter in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7
Month 1
|
464.0 cells/mm^3
Interval 346.0 to 578.5
|
426.0 cells/mm^3
Interval 352.0 to 584.0
|
—
|
|
Number of Cluster of Differention 4 (CD4+) Cells Per Cubic Millimeter in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7
Month 4
|
469.0 cells/mm^3
Interval 346.0 to 596.0
|
423.0 cells/mm^3
Interval 308.0 to 563.0
|
—
|
|
Number of Cluster of Differention 4 (CD4+) Cells Per Cubic Millimeter in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7
Month 6
|
452.0 cells/mm^3
Interval 339.0 to 625.0
|
426.0 cells/mm^3
Interval 334.0 to 550.0
|
—
|
PRIMARY outcome
Timeframe: At Month 10 and Month 12Population: The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.
The number of CD4+ cells per cubic millimeter (mm\^3) in all HIV+ subjects at Month 10 and Month 12 is reported.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=55 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=52 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of CD4+ Cells Per Cubic Millimeter in All HIV+ Subjects at Month 10 and Month 12
Month 10
|
427.0 cells/mm^3
Interval 347.0 to 621.0
|
442.0 cells/mm^3
Interval 318.0 to 549.0
|
—
|
|
Number of CD4+ Cells Per Cubic Millimeter in All HIV+ Subjects at Month 10 and Month 12
Month 12
|
450.5 cells/mm^3
Interval 328.0 to 534.0
|
453.0 cells/mm^3
Interval 332.0 to 636.0
|
—
|
PRIMARY outcome
Timeframe: At pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7Population: The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.
The viral load was calculated by estimating the amount of virus in blood samples and it was given in number of Ribonucleic acid copies per milliliter (in log10) \[RNA copies/mL (in log10)\].
Outcome measures
| Measure |
HIV+/Cervarix Group
n=61 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=59 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
HIV Viral Load in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7
Month 6
|
4.6 RNA copies/mL (in log10)
Interval 3.7 to 5.0
|
4.5 RNA copies/mL (in log10)
Interval 3.8 to 4.9
|
—
|
|
HIV Viral Load in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7
Month 7
|
4.5 RNA copies/mL (in log10)
Interval 3.8 to 5.0
|
4.5 RNA copies/mL (in log10)
Interval 3.9 to 4.9
|
—
|
|
HIV Viral Load in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7
Pre-vaccination (Day 0)
|
4.4 RNA copies/mL (in log10)
Interval 3.7 to 4.8
|
4.4 RNA copies/mL (in log10)
Interval 3.7 to 4.7
|
—
|
|
HIV Viral Load in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7
Month 1
|
4.4 RNA copies/mL (in log10)
Interval 3.7 to 4.9
|
4.2 RNA copies/mL (in log10)
Interval 3.6 to 4.9
|
—
|
|
HIV Viral Load in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7
Month 2
|
4.4 RNA copies/mL (in log10)
Interval 3.6 to 5.1
|
4.6 RNA copies/mL (in log10)
Interval 4.1 to 4.8
|
—
|
|
HIV Viral Load in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7
Month 4
|
4.5 RNA copies/mL (in log10)
Interval 3.8 to 4.8
|
4.5 RNA copies/mL (in log10)
Interval 4.0 to 4.9
|
—
|
PRIMARY outcome
Timeframe: At Month 10 and Month 12Population: The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.
The viral load was calculated by estimating the amount of virus in blood samples and was given in number of RNA copies/mL (in log 10).
Outcome measures
| Measure |
HIV+/Cervarix Group
n=54 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=52 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
HIV Viral Load in All HIV+ Subjects at Month 10 and Month 12
Month 10
|
4.5 RNA copies/mL (in log10)
Interval 4.0 to 4.9
|
4.5 RNA copies/mL (in log10)
Interval 3.8 to 5.0
|
—
|
|
HIV Viral Load in All HIV+ Subjects at Month 10 and Month 12
Month 12
|
4.5 RNA copies/mL (in log10)
Interval 3.8 to 4.9
|
4.5 RNA copies/mL (in log10)
Interval 3.6 to 4.8
|
—
|
PRIMARY outcome
Timeframe: At Months 1, 2, 4, 6 and 7Population: The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.
CD4+ cell count categories, at baseline, assessed were (i) below (\<) 200 CD4+ cells per cubic millimeter (mm\^3), (ii) between 200 and 500 CD4+ cells/mm\^3 and (iii) above 500 CD4+ cells/mm\^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=60 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=57 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 2] Month 1
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 3] Month 1
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 4] Month 1
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 1] Month 1
|
31 Participants
|
33 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 2] Month 1
|
2 Participants
|
2 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 1] Month 4
|
23 Participants
|
20 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 3] Month 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 1] Month 6
|
23 Participants
|
19 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 1] Month 7
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 2] Month 7
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 3] Month 7
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 3] Month 1
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 4] Month 7
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 1] Month 7
|
28 Participants
|
28 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 2] Month 7
|
2 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 3] Month 7
|
2 Participants
|
4 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 4] Month 1
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 1] Month 1
|
23 Participants
|
20 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 2] Month 1
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 3] Month 1
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 4] Month 1
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 1] Month 2
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 2] Month 2
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 3] Month 2
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 4] Month 2
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 1] Month 2
|
30 Participants
|
33 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 2] Month 2
|
2 Participants
|
3 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 3] Month 2
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 4] Month 2
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 1] Month 2
|
22 Participants
|
19 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 2] Month 2
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 3] Month 2
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 4] Mth 2
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 1] Month 4
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 2] Month 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 3] Month 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 4] Month 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 1] Month 4
|
28 Participants
|
27 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 2] Month 4
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 3] Month 4
|
2 Participants
|
5 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 4] Month 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 2] Month 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 4] Month 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 1] Month 6
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 2] Month 6
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 3] Month 6
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 4] Month 6
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 1] Month 6
|
28 Participants
|
28 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 2] Month 6
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 3] Month 6
|
2 Participants
|
5 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 4] Month 6
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 2] Month 6
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 3] Month 6
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 4] Month 6
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
200-500 CD4+cells/mm^3 [stage 4] Month 7
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 1] Month 7
|
21 Participants
|
19 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 2] Month 7
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 3] Month 7
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
>500 CD4+cells/mm^3 [stage 4] Month 7
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7
<200 CD4+cells/mm^3 [stage 1] Month 1
|
2 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: At Month 10 and Month 12Population: The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.
CD4+ cell count categories, at baseline, assessed were: (i) below (\<) 200 CD4+ cells per cubic millimeter (mm\^3), (ii) between 200 and 500 CD4+ cells/mm\^3 and (iii) above (\>) 500 CD4+ cells/mm\^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=55 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=52 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
<200 CD4+cells/mm^3 [stage 1] Month 10
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
<200 CD4+cells/mm^3 [stage 2] Month 10
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
<200 CD4+cells/mm^3 [stage 3] Month 10
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
<200 CD4+cells/mm^3 [stage 4] Month 10
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
200-500 CD4+cells/mm^3 [stage 1] Month 10
|
26 Participants
|
25 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
200-500 CD4+cells/mm^3 [stage 2] Month 10
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
200-500 CD4+cells/mm^3 [stage 3] Month 10
|
4 Participants
|
4 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
200-500 CD4+cells/mm^3 [stage 4] Month 10
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
>500 CD4+cells/mm^3 [stage 1] Month 10
|
21 Participants
|
18 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
>500 CD4+cells/mm^3 [stage 2] Month 10
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
>500 CD4+cells/mm^3 [stage 3] Month 10
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
>500 CD4+cells/mm^3 [stage 4] Month 10
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
<200 CD4+cells/mm^3 [stage 1] Month 12
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
<200 CD4+cells/mm^3 [stage 2] Month 12
|
2 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
<200 CD4+cells/mm^3 [stage 3] Month 12
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
<200 CD4+cells/mm^3 [stage 4] Month 12
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
200-500 CD4+cells/mm^3 [stage 1] Month 12
|
24 Participants
|
23 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
200-500 CD4+cells/mm^3 [stage 2] Month 12
|
3 Participants
|
2 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
200-500 CD4+cells/mm^3 [stage 3] Month 12
|
4 Participants
|
6 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
200-500 CD4+cells/mm^3 [stage 4] Month 12
|
0 Participants
|
1 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
>500 CD4+cells/mm^3 [stage 1] Month 12
|
20 Participants
|
17 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
>500 CD4+cells/mm^3 [stage 2] Month 12
|
1 Participants
|
2 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
>500 CD4+cells/mm^3 [stage 3] Month 12
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12
>500 CD4+cells/mm^3 [stage 4] Month 12
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: At pre-vaccination (Day 0) and Months 2 and 7Population: The analysis was performed on the ATP cohort for immunogenicity (Month 7), which included all evaluable subjects up to Month 7 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 EL.U/mL and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject whose antibody titers are below the cut-off value. Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the According-to-Protocol (ATP) cohort for immunogenicity regardless of baseline serostatus.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=43 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=40 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=24 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7
anti-HPV-16, At Day 0
|
35 Participants
|
30 Participants
|
14 Participants
|
|
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7
anti-HPV-16, At Month 2
|
41 Participants
|
31 Participants
|
24 Participants
|
|
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7
anti-HPV-16, At Month 7
|
42 Participants
|
31 Participants
|
24 Participants
|
|
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7
anti-HPV-18, At Day 0
|
27 Participants
|
24 Participants
|
11 Participants
|
|
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7
anti-HPV-18, At Month 2
|
42 Participants
|
26 Participants
|
24 Participants
|
|
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7
anti-HPV-18, At Month 7
|
43 Participants
|
25 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: At Month 12Population: The analysis was performed on ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject whose antibody titers are below the cut-off value. Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=42 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=37 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=22 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Month 12
anti-HPV-16, At Month 12
|
41 Participants
|
28 Participants
|
22 Participants
|
|
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Month 12
anti-HPV-18, At Month 12
|
42 Participants
|
24 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: At pre-vaccination (Day 0) and Months 2 and 7Population: The analysis was performed on the ATP cohort for immunogenicity (Month 7), which included all evaluable subjects up to Month 7 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.
Concentrations are expressed as geometric mean antibody concentrations (GMCs) and are given in EL.U/mL. The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay are 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=43 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=40 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=24 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Concentrations for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7
anti-HPV-16, At Day 0
|
29.7 EL.U/mL
Interval 20.1 to 43.7
|
25.7 EL.U/mL
Interval 16.6 to 39.9
|
21.8 EL.U/mL
Interval 10.9 to 43.3
|
|
Concentrations for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7
anti-HPV-16, At Month 2
|
2245.2 EL.U/mL
Interval 1634.2 to 3084.5
|
32.9 EL.U/mL
Interval 19.3 to 56.0
|
6166.8 EL.U/mL
Interval 4079.5 to 9322.2
|
|
Concentrations for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7
anti-HPV-16, At Month 7
|
3583.1 EL.U/mL
Interval 2759.9 to 4651.9
|
27.2 EL.U/mL
Interval 17.6 to 42.0
|
7871.9 EL.U/mL
Interval 6185.3 to 10018.4
|
|
Concentrations for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7
anti-HPV-18, At Day 0
|
13.2 EL.U/mL
Interval 9.0 to 19.3
|
12.5 EL.U/mL
Interval 8.2 to 19.1
|
11.1 EL.U/mL
Interval 5.8 to 21.2
|
|
Concentrations for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7
anti-HPV-18, At Month 2
|
1339.3 EL.U/mL
Interval 901.6 to 1989.5
|
16.9 EL.U/mL
Interval 10.1 to 28.3
|
2380.2 EL.U/mL
Interval 1718.7 to 3296.2
|
|
Concentrations for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7
anti-HPV-18, At Month 7
|
1952.1 EL.U/mL
Interval 1466.3 to 2598.7
|
14.5 EL.U/mL
Interval 9.2 to 22.9
|
3755.3 EL.U/mL
Interval 2608.4 to 5406.5
|
PRIMARY outcome
Timeframe: At Month 12Population: The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.
Concentrations are expressed as geometric mean antibody concentrations (GMCs) and are given in EL.U/mL. The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay are 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=42 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=37 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=22 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Concentrations for HPV-16 and HPV-18 Antibodies at Month 12
anti-HPV-16, At Month 12
|
748.1 EL.U/mL
Interval 520.0 to 1076.3
|
20.7 EL.U/mL
Interval 13.9 to 30.9
|
2793.6 EL.U/mL
Interval 2087.8 to 3738.0
|
|
Concentrations for HPV-16 and HPV-18 Antibodies at Month 12
anti-HPV-18, At Month 12
|
343.1 EL.U/mL
Interval 236.2 to 498.2
|
13.0 EL.U/mL
Interval 8.5 to 19.7
|
1021.3 EL.U/mL
Interval 627.4 to 1662.6
|
PRIMARY outcome
Timeframe: At pre-vaccination (Day 0)Population: The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.
The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (\>) 0 as measured by Flow cytometry.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=42 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=37 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=22 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Cell Mediated Immune (CMI) Response (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Day 0
VLP-18, =0
|
5 Participants
|
15 Participants
|
6 Participants
|
|
Cell Mediated Immune (CMI) Response (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Day 0
VLP-16, =0
|
8 Participants
|
13 Participants
|
10 Participants
|
|
Cell Mediated Immune (CMI) Response (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Day 0
VLP-16, >0
|
14 Participants
|
13 Participants
|
6 Participants
|
|
Cell Mediated Immune (CMI) Response (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Day 0
VLP-16, Missing
|
20 Participants
|
11 Participants
|
6 Participants
|
|
Cell Mediated Immune (CMI) Response (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Day 0
VLP-18, >0
|
16 Participants
|
11 Participants
|
10 Participants
|
|
Cell Mediated Immune (CMI) Response (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Day 0
VLP-18, Missing
|
21 Participants
|
11 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: At Month 2Population: The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.
The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (\>) 0 as measured by Flow cytometry.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=42 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=37 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=22 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 2
VLP-16, =0
|
8 Participants
|
9 Participants
|
2 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 2
VLP-16, >0
|
20 Participants
|
7 Participants
|
11 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 2
VLP-16, Missing
|
14 Participants
|
21 Participants
|
9 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 2
VLP-18, =0
|
11 Participants
|
9 Participants
|
2 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 2
VLP-18, >0
|
17 Participants
|
8 Participants
|
11 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 2
VLP-18, Missing
|
14 Participants
|
20 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: At Month 7Population: The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.
The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (\>) 0 as measured by Flow cytometry.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=42 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=37 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=22 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 7
VLP-16, =0
|
2 Participants
|
9 Participants
|
1 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 7
VLP-16, >0
|
24 Participants
|
16 Participants
|
21 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 7
VLP-16, Missing
|
16 Participants
|
12 Participants
|
0 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 7
VLP-18, =0
|
0 Participants
|
15 Participants
|
1 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 7
VLP-18, >0
|
25 Participants
|
11 Participants
|
19 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 7
VLP-18, Missing
|
17 Participants
|
11 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: At Month 12Population: The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.
The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (\>) 0 as measured by Flow cytometry.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=42 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=37 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=22 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 12
VLP-18, Missing
|
16 Participants
|
13 Participants
|
4 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 12
VLP-16, =0
|
8 Participants
|
9 Participants
|
2 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 12
VLP-16, >0
|
21 Participants
|
16 Participants
|
18 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 12
VLP-16, Missing
|
13 Participants
|
12 Participants
|
2 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 12
VLP-18, =0
|
13 Participants
|
10 Participants
|
3 Participants
|
|
CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 12
VLP-18, >0
|
13 Participants
|
14 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: At pre-vaccination (Day 0) and at Months 2, 7 and 12Population: The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.
The CMI response is the measure of the cytokines production \[i.e. Cluster of Differentiation 40 Ligand (CD40L), Interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α)\] by HPV-antigen specific T lymphocytes and measured by Intracellular Cytokine Staining (ICS) assay. The results were expressed as a frequency of positive CD4 or CD8 T-cell producing at least 1 cytokine within the CD4 or CD8 T-cell sub-population. All doubles = T cell expressing at least 2 cytokines.
Outcome measures
| Measure |
HIV+/Cervarix Group
n=36 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=32 Participants
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=18 Participants
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-CD40L [HPV-18], At Month 7
|
2247.5 T cells/million cells
Interval 1154.0 to 4510.0
|
108.5 T cells/million cells
Interval 50.5 to 185.0
|
1524.5 T cells/million cells
Interval 706.0 to 2327.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-CD40L [HPV-18], At Month 12
|
1484.0 T cells/million cells
Interval 739.5 to 3045.0
|
178.0 T cells/million cells
Interval 90.0 to 250.0
|
1587.0 T cells/million cells
Interval 782.0 to 2596.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-TNF-α [HPV-16], At Day 0
|
148.0 T cells/million cells
Interval 61.0 to 226.0
|
132.0 T cells/million cells
Interval 50.0 to 221.0
|
185.0 T cells/million cells
Interval 127.0 to 261.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-ALL DOUBLES [HPV-16], At Day 0
|
256.0 T cells/million cells
Interval 119.0 to 390.0
|
154.0 T cells/million cells
Interval 96.0 to 235.0
|
259.0 T cells/million cells
Interval 160.0 to 377.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-ALL DOUBLES [HPV-16], At Month 2
|
4082.0 T cells/million cells
Interval 2997.0 to 6209.0
|
154.5 T cells/million cells
Interval 94.0 to 293.0
|
1691.0 T cells/million cells
Interval 1247.0 to 2809.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-ALL DOUBLES [HPV-16], At Month 7
|
4717.5 T cells/million cells
Interval 2050.5 to 9242.5
|
177.5 T cells/million cells
Interval 106.0 to 302.0
|
3121.5 T cells/million cells
Interval 1726.0 to 4538.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-ALL DOUBLES [HPV-16], At Month 12
|
3063.5 T cells/million cells
Interval 1294.0 to 5294.5
|
184.5 T cells/million cells
Interval 136.0 to 326.5
|
2490.0 T cells/million cells
Interval 1247.0 to 4499.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-ALL DOUBLES [HPV-18], At Day 0
|
218.0 T cells/million cells
Interval 131.0 to 281.0
|
114.0 T cells/million cells
Interval 82.0 to 188.0
|
273.0 T cells/million cells
Interval 135.0 to 387.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-ALL DOUBLES [HPV-18], At Month 2
|
2658.0 T cells/million cells
Interval 1157.0 to 4197.0
|
156.5 T cells/million cells
Interval 98.0 to 231.0
|
1065.0 T cells/million cells
Interval 624.0 to 1681.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-ALL DOUBLES [HPV-18], At Month 7
|
2917.5 T cells/million cells
Interval 1365.0 to 5976.0
|
143.5 T cells/million cells
Interval 88.5 to 227.5
|
1834.0 T cells/million cells
Interval 973.0 to 2827.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-ALL DOUBLES [HPV-18], At Month 12
|
1694.5 T cells/million cells
Interval 783.0 to 3401.0
|
220.0 T cells/million cells
Interval 121.0 to 285.5
|
1783.0 T cells/million cells
Interval 939.0 to 2891.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-CD40L [HPV-16], At Day 0
|
200.0 T cells/million cells
Interval 97.0 to 277.0
|
101.0 T cells/million cells
Interval 50.0 to 170.0
|
208.0 T cells/million cells
Interval 119.0 to 239.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-CD40L [HPV-16], At Month 2
|
3940.0 T cells/million cells
Interval 2653.0 to 5999.0
|
125.5 T cells/million cells
Interval 82.0 to 229.0
|
1437.0 T cells/million cells
Interval 1165.0 to 2649.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-CD40L [HPV-16], At Month 7
|
3400.5 T cells/million cells
Interval 1743.0 to 6893.0
|
143.5 T cells/million cells
Interval 50.0 to 182.0
|
2303.0 T cells/million cells
Interval 1483.0 to 3871.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-CD40L [HPV-16], At Month 12
|
2569.0 T cells/million cells
Interval 1209.5 to 4946.5
|
162.5 T cells/million cells
Interval 81.5 to 320.0
|
2201.0 T cells/million cells
Interval 930.0 to 4090.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-CD40L [HPV-18], At Day 0
|
150.0 T cells/million cells
Interval 110.0 to 225.0
|
98.0 T cells/million cells
Interval 45.0 to 147.0
|
222.0 T cells/million cells
Interval 82.0 to 306.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-CD40L [HPV-18], At Month 2
|
2467.0 T cells/million cells
Interval 911.0 to 3549.0
|
142.5 T cells/million cells
Interval 75.0 to 195.0
|
974.0 T cells/million cells
Interval 509.0 to 1598.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-IFN-γ [HPV-16], At Day 0
|
57.0 T cells/million cells
Interval 31.0 to 161.0
|
57.0 T cells/million cells
Interval 7.0 to 85.0
|
66.0 T cells/million cells
Interval 50.0 to 102.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-IFN-γ [HPV-16], At Month 2
|
1748.0 T cells/million cells
Interval 890.0 to 2632.0
|
50.0 T cells/million cells
Interval 7.0 to 85.0
|
760.0 T cells/million cells
Interval 535.0 to 956.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4- IFN-γ [HPV-16], At Month 7
|
1807.0 T cells/million cells
Interval 741.5 to 3483.0
|
51.0 T cells/million cells
Interval 7.0 to 111.0
|
900.5 T cells/million cells
Interval 763.0 to 1718.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4- IFN-γ [HPV-16], At Month 12
|
735.0 T cells/million cells
Interval 365.0 to 1290.5
|
49.5 T cells/million cells
Interval 19.0 to 97.5
|
592.0 T cells/million cells
Interval 320.0 to 895.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-IFN-γ [HPV-18], At Day 0
|
25.0 T cells/million cells
Interval 7.0 to 99.0
|
40.0 T cells/million cells
Interval 7.0 to 58.0
|
54.0 T cells/million cells
Interval 34.0 to 72.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-IFN-γ [HPV-18], At Month 2
|
1045.0 T cells/million cells
Interval 422.0 to 1619.0
|
43.5 T cells/million cells
Interval 7.0 to 77.0
|
407.0 T cells/million cells
Interval 285.0 to 532.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4- IFN-γ [HPV-18], At Month 7
|
915.0 T cells/million cells
Interval 453.0 to 2156.5
|
31.5 T cells/million cells
Interval 7.0 to 68.5
|
626.5 T cells/million cells
Interval 415.0 to 917.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4- IFN-γ [HPV-18], At Month 12
|
341.5 T cells/million cells
Interval 226.5 to 1052.0
|
39.0 T cells/million cells
Interval 7.0 to 91.5
|
436.0 T cells/million cells
Interval 291.0 to 587.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-IL-2 [HPV-16], At Day 0
|
187.0 T cells/million cells
Interval 97.0 to 285.0
|
104.0 T cells/million cells
Interval 42.0 to 150.0
|
176.0 T cells/million cells
Interval 105.0 to 313.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-IL-2 [HPV-16], At Month 2
|
3716.0 T cells/million cells
Interval 2951.0 to 5879.0
|
79.0 T cells/million cells
Interval 44.0 to 148.0
|
1601.0 T cells/million cells
Interval 1030.0 to 2493.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4- IL-2 [HPV-16], At Month 7
|
4329.0 T cells/million cells
Interval 1939.0 to 8847.0
|
113.5 T cells/million cells
Interval 52.5 to 175.0
|
2830.5 T cells/million cells
Interval 1509.0 to 4251.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4- IL-2 [HPV-16], At Month 12
|
2946.0 T cells/million cells
Interval 983.5 to 4840.5
|
135.5 T cells/million cells
Interval 62.0 to 235.5
|
2366.0 T cells/million cells
Interval 1075.0 to 4397.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-IL-2 [HPV-18], At Day 0
|
132.0 T cells/million cells
Interval 50.0 to 225.0
|
76.0 T cells/million cells
Interval 43.0 to 106.0
|
206.0 T cells/million cells
Interval 109.0 to 301.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-IL-2 [HPV-18], At Month 2
|
2527.0 T cells/million cells
Interval 1153.0 to 3850.0
|
103.5 T cells/million cells
Interval 55.0 to 158.0
|
921.0 T cells/million cells
Interval 587.0 to 1428.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4- IL-2 [HPV-18], At Month 7
|
2664.0 T cells/million cells
Interval 1258.0 to 5289.0
|
87.5 T cells/million cells
Interval 57.0 to 153.5
|
1572.5 T cells/million cells
Interval 900.0 to 2678.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4- IL-2 [HPV-18], At Month 12
|
1533.5 T cells/million cells
Interval 713.5 to 3229.0
|
134.0 T cells/million cells
Interval 57.0 to 206.5
|
1633.0 T cells/million cells
Interval 741.0 to 2787.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-TNF-α [HPV-16], At Month 2
|
3131.0 T cells/million cells
Interval 1811.0 to 4864.0
|
105.0 T cells/million cells
Interval 55.0 to 215.0
|
1332.0 T cells/million cells
Interval 980.0 to 1894.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-TNF-α [HPV-16], At Month 7
|
4315.0 T cells/million cells
Interval 1815.5 to 8347.5
|
154.0 T cells/million cells
Interval 58.0 to 247.5
|
2479.0 T cells/million cells
Interval 1426.0 to 3988.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-TNF-α [HPV-16], At Month 12
|
2662.5 T cells/million cells
Interval 1088.0 to 4675.0
|
135.5 T cells/million cells
Interval 81.5 to 257.0
|
2133.0 T cells/million cells
Interval 1125.0 to 4064.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-TNF-α [HPV-18], At Day 0
|
150.0 T cells/million cells
Interval 92.0 to 211.0
|
84.0 T cells/million cells
Interval 72.0 to 148.0
|
229.0 T cells/million cells
Interval 65.0 to 295.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-TNF-α [HPV-18], At Month 2
|
2319.0 T cells/million cells
Interval 1065.0 to 3666.0
|
94.5 T cells/million cells
Interval 56.0 to 173.0
|
982.0 T cells/million cells
Interval 505.0 to 1198.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-TNF-α [HPV-18], At Month 7
|
2689.0 T cells/million cells
Interval 1236.5 to 5303.5
|
109.0 T cells/million cells
Interval 58.5 to 168.5
|
1526.5 T cells/million cells
Interval 869.0 to 2682.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD4-TNF-α [HPV-18], At Month 12
|
1542.5 T cells/million cells
Interval 627.5 to 3175.5
|
138.0 T cells/million cells
Interval 59.5 to 198.5
|
1650.0 T cells/million cells
Interval 860.0 to 2541.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-ALL DOUBLES [HPV-16], At Day 0
|
43.0 T cells/million cells
Interval 16.0 to 79.0
|
40.0 T cells/million cells
Interval 11.0 to 58.0
|
26.0 T cells/million cells
Interval 11.0 to 73.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-ALL DOUBLES [HPV-16], At Month 2
|
65.0 T cells/million cells
Interval 34.0 to 107.0
|
40.5 T cells/million cells
Interval 11.0 to 90.0
|
48.0 T cells/million cells
Interval 34.0 to 118.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-ALL DOUBLES [HPV-16], At Month 7
|
38.0 T cells/million cells
Interval 24.5 to 94.0
|
32.5 T cells/million cells
Interval 11.0 to 76.0
|
48.0 T cells/million cells
Interval 26.0 to 71.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-ALL DOUBLES [HPV-16], At Month 12
|
53.5 T cells/million cells
Interval 11.0 to 118.5
|
37.0 T cells/million cells
Interval 11.0 to 72.0
|
45.0 T cells/million cells
Interval 11.0 to 58.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-ALL DOUBLES [HPV-18], At Day 0
|
51.0 T cells/million cells
Interval 29.5 to 89.0
|
11.0 T cells/million cells
Interval 11.0 to 58.0
|
31.0 T cells/million cells
Interval 11.0 to 63.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-ALL DOUBLES [HPV-18], At Month 2
|
65.0 T cells/million cells
Interval 11.0 to 85.0
|
39.5 T cells/million cells
Interval 11.0 to 91.0
|
62.0 T cells/million cells
Interval 32.0 to 85.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-ALL DOUBLES [HPV-18], At Month 7
|
40.0 T cells/million cells
Interval 15.5 to 100.0
|
35.5 T cells/million cells
Interval 11.0 to 63.0
|
44.0 T cells/million cells
Interval 11.0 to 74.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-ALL DOUBLES [HPV-18], At Month 12
|
39.5 T cells/million cells
Interval 11.0 to 128.5
|
35.0 T cells/million cells
Interval 11.0 to 75.0
|
21.0 T cells/million cells
Interval 11.0 to 47.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-CD40L [HPV-16], At Day 0
|
7.0 T cells/million cells
Interval 7.0 to 31.0
|
7.0 T cells/million cells
Interval 7.0 to 7.0
|
7.0 T cells/million cells
Interval 7.0 to 34.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-CD40L [HPV-16], At Month 2
|
28.0 T cells/million cells
Interval 7.0 to 55.0
|
7.0 T cells/million cells
Interval 7.0 to 27.0
|
7.0 T cells/million cells
Interval 7.0 to 44.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-CD40L [HPV-16], At Month 7
|
26.5 T cells/million cells
Interval 7.0 to 38.5
|
7.0 T cells/million cells
Interval 7.0 to 20.0
|
24.0 T cells/million cells
Interval 7.0 to 49.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-CD40L [HPV-16], At Month 12
|
7.0 T cells/million cells
Interval 7.0 to 15.5
|
7.0 T cells/million cells
Interval 7.0 to 32.0
|
7.0 T cells/million cells
Interval 7.0 to 7.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-CD40L [HPV-18], At Day 0
|
18.5 T cells/million cells
Interval 7.0 to 36.5
|
7.0 T cells/million cells
Interval 7.0 to 7.0
|
7.0 T cells/million cells
Interval 7.0 to 27.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8- CD40L [HPV-18], At Month 2
|
7.0 T cells/million cells
Interval 7.0 to 42.0
|
7.0 T cells/million cells
Interval 7.0 to 43.0
|
38.0 T cells/million cells
Interval 7.0 to 60.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-CD40L [HPV-18], At Month 7
|
7.0 T cells/million cells
Interval 7.0 to 29.0
|
7.0 T cells/million cells
Interval 7.0 to 7.0
|
7.0 T cells/million cells
Interval 7.0 to 57.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-CD40L [HPV-18], At Month 12
|
7.0 T cells/million cells
Interval 7.0 to 23.0
|
7.0 T cells/million cells
Interval 7.0 to 7.0
|
7.0 T cells/million cells
Interval 7.0 to 7.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IFN-γ [HPV-16], At Day 0
|
35.5 T cells/million cells
Interval 7.0 to 73.5
|
25.0 T cells/million cells
Interval 7.0 to 54.0
|
7.0 T cells/million cells
Interval 7.0 to 42.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IFN-γ [HPV-16], At Month 2
|
39.0 T cells/million cells
Interval 24.0 to 103.0
|
7.0 T cells/million cells
Interval 7.0 to 80.0
|
39.0 T cells/million cells
Interval 22.0 to 62.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IFN-γ [HPV-16], At Month 7
|
25.0 T cells/million cells
Interval 7.0 to 76.0
|
23.5 T cells/million cells
Interval 7.0 to 66.0
|
28.5 T cells/million cells
Interval 7.0 to 55.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IFN-γ [HPV-16], At Month 12
|
47.5 T cells/million cells
Interval 7.0 to 106.0
|
28.5 T cells/million cells
Interval 7.0 to 43.0
|
26.0 T cells/million cells
Interval 7.0 to 50.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IFN-γ [HPV-18], At Day 0
|
39.0 T cells/million cells
Interval 7.0 to 85.0
|
7.0 T cells/million cells
Interval 7.0 to 47.0
|
9.0 T cells/million cells
Interval 7.0 to 41.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IFN-γ [HPV-18], At Month 2
|
37.0 T cells/million cells
Interval 7.0 to 78.0
|
27.5 T cells/million cells
Interval 7.0 to 84.0
|
53.0 T cells/million cells
Interval 23.0 to 68.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IFN-γ [HPV-18], At Month 7
|
33.0 T cells/million cells
Interval 8.5 to 82.0
|
22.0 T cells/million cells
Interval 7.0 to 59.0
|
38.0 T cells/million cells
Interval 7.0 to 59.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IFN-γ [HPV-18], At Month 12
|
29.0 T cells/million cells
Interval 7.0 to 96.5
|
31.0 T cells/million cells
Interval 7.0 to 54.0
|
7.0 T cells/million cells
Interval 7.0 to 23.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IL-2 [HPV-16], At Day 0
|
7.0 T cells/million cells
Interval 7.0 to 29.0
|
7.0 T cells/million cells
Interval 7.0 to 25.0
|
7.0 T cells/million cells
Interval 7.0 to 34.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IL-2 [HPV-16], At Month 2
|
24.0 T cells/million cells
Interval 7.0 to 35.0
|
20.0 T cells/million cells
Interval 7.0 to 34.0
|
32.0 T cells/million cells
Interval 7.0 to 62.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IL-2 [HPV-16], At Month 7
|
20.5 T cells/million cells
Interval 7.0 to 33.0
|
7.0 T cells/million cells
Interval 7.0 to 7.0
|
28.5 T cells/million cells
Interval 7.0 to 55.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IL-2 [HPV-16], At Month 12
|
7.0 T cells/million cells
Interval 7.0 to 38.5
|
7.5 T cells/million cells
Interval 7.0 to 33.0
|
7.0 T cells/million cells
Interval 7.0 to 27.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IL-2 [HPV-18], At Day 0
|
7.0 T cells/million cells
Interval 7.0 to 30.5
|
7.0 T cells/million cells
Interval 7.0 to 7.0
|
7.0 T cells/million cells
Interval 7.0 to 32.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IL-2 [HPV-18], At Month 2
|
7.0 T cells/million cells
Interval 7.0 to 37.0
|
7.0 T cells/million cells
Interval 7.0 to 24.0
|
11.0 T cells/million cells
Interval 7.0 to 44.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IL-2 [HPV-18], At Month 7
|
7.0 T cells/million cells
Interval 7.0 to 7.0
|
7.0 T cells/million cells
Interval 7.0 to 7.0
|
17.5 T cells/million cells
Interval 7.0 to 41.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-IL-2 [HPV-18], At Month 12
|
7.0 T cells/million cells
Interval 7.0 to 7.0
|
7.0 T cells/million cells
Interval 7.0 to 17.0
|
7.0 T cells/million cells
Interval 7.0 to 38.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-TNF-α [HPV-16], At Day 0
|
26.0 T cells/million cells
Interval 7.0 to 71.0
|
34.0 T cells/million cells
Interval 7.0 to 54.0
|
7.0 T cells/million cells
Interval 7.0 to 36.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-TNF-α [HPV-16], At Month 2
|
34.0 T cells/million cells
Interval 7.0 to 52.0
|
28.5 T cells/million cells
Interval 7.0 to 65.0
|
30.0 T cells/million cells
Interval 7.0 to 55.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-TNF-α [HPV-16], At Month 7
|
25.5 T cells/million cells
Interval 7.0 to 53.5
|
15.5 T cells/million cells
Interval 7.0 to 66.0
|
28.5 T cells/million cells
Interval 7.0 to 50.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-TNF-α [HPV-16], At Month 12
|
35.5 T cells/million cells
Interval 7.0 to 97.0
|
9.0 T cells/million cells
Interval 7.0 to 38.0
|
26.0 T cells/million cells
Interval 7.0 to 50.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-TNF-α [HPV-18], At Day 0
|
21.5 T cells/million cells
Interval 7.0 to 55.0
|
7.0 T cells/million cells
Interval 7.0 to 46.0
|
7.0 T cells/million cells
Interval 7.0 to 41.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-TNF-α [HPV-18], At Month 2
|
38.0 T cells/million cells
Interval 7.0 to 66.0
|
7.0 T cells/million cells
Interval 7.0 to 54.0
|
28.0 T cells/million cells
Interval 7.0 to 50.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-TNF-α [HPV-18], At Month 7
|
28.5 T cells/million cells
Interval 7.0 to 73.5
|
25.5 T cells/million cells
Interval 7.0 to 57.0
|
22.0 T cells/million cells
Interval 7.0 to 59.0
|
|
CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
CD8-TNF-α [HPV-18], At Month 12
|
28.0 T cells/million cells
Interval 7.0 to 101.0
|
18.0 T cells/million cells
Interval 7.0 to 68.0
|
7.0 T cells/million cells
Interval 7.0 to 7.0
|
Adverse Events
HIV+/Cervarix Group
Serious events: 3 serious events
Other events: 61 other events
Deaths: 0 deaths
HIV+/Aluminium Hydroxide Group
Serious events: 2 serious events
Other events: 55 other events
Deaths: 0 deaths
HIV-/Cervarix Group
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HIV+/Cervarix Group
n=61 participants at risk
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=59 participants at risk
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=30 participants at risk
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Nervous system disorders
Migraine
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Pneumonia bacterial
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
Other adverse events
| Measure |
HIV+/Cervarix Group
n=61 participants at risk
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.
|
HIV+/Aluminium Hydroxide Group
n=59 participants at risk
Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide \[Al(OH)3\], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
HIV-/Cervarix Group
n=30 participants at risk
Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
|
|---|---|---|---|
|
Infections and infestations
Otitis media
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
General disorders
Pyrexia
|
3.3%
2/61 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
5.1%
3/59 • Number of events 3 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
6.7%
2/30 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.9%
3/61 • Number of events 3 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.4%
2/59 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
10.0%
3/30 • Number of events 3 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Paronychia
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Pharyngitis
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.4%
2/59 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
General disorders
Pain
|
85.2%
52/61 • Number of events 102 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
45.8%
27/59 • Number of events 36 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
93.3%
28/30 • Number of events 59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
General disorders
Swelling
|
31.1%
19/61 • Number of events 23 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.4%
2/59 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
40.0%
12/30 • Number of events 15 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
General disorders
Fatigue
|
29.5%
18/61 • Number of events 20 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
27.1%
16/59 • Number of events 20 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
26.7%
8/30 • Number of events 15 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
2/61 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.4%
2/59 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Psychiatric disorders
Acute stress disorder
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
2/61 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.6%
4/61 • Number of events 4 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
8.5%
5/59 • Number of events 5 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
6.7%
2/30 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.2%
5/61 • Number of events 5 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
6.8%
4/59 • Number of events 4 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
10.0%
3/30 • Number of events 3 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Reproductive system and breast disorders
Breast pain
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Bronchitis
|
3.3%
2/61 • Number of events 3 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Candidiasis
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Investigations
Cd4 lymphocytes decreased
|
3.3%
2/61 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Eye disorders
Conjunctivitis
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.1%
8/61 • Number of events 8 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
8.5%
5/59 • Number of events 5 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
13.3%
4/30 • Number of events 4 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Gastrointestinal disorders
Diarrhoea
|
6.6%
4/61 • Number of events 4 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
10.2%
6/59 • Number of events 7 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Nervous system disorders
Dizziness
|
6.6%
4/61 • Number of events 4 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
6.8%
4/59 • Number of events 5 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
6.7%
2/30 • Number of events 3 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
6.7%
2/30 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Ear and labyrinth disorders
Ear pain
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.4%
2/59 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
5.1%
3/59 • Number of events 3 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Eye disorders
Eye swelling
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Face injury
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Gastroenteritis
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
24.6%
15/61 • Number of events 18 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
18.6%
11/59 • Number of events 11 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
43.3%
13/30 • Number of events 19 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Nervous system disorders
Headache
|
50.8%
31/61 • Number of events 40 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
55.9%
33/59 • Number of events 48 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
60.0%
18/30 • Number of events 25 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.4%
2/59 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Herpes virus infection
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Herpes zoster
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Influenza
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
General disorders
Influenza like illness
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
General disorders
Injection site erythema
|
11.5%
7/61 • Number of events 8 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
13.3%
4/30 • Number of events 6 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
General disorders
Injection site induration
|
6.6%
4/61 • Number of events 4 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
13.3%
4/30 • Number of events 4 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
General disorders
Injection site mass
|
4.9%
3/61 • Number of events 3 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
General disorders
Injection site pruritus
|
4.9%
3/61 • Number of events 3 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
6.7%
2/30 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Measles
|
3.3%
2/61 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.4%
2/59 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Reproductive system and breast disorders
Metrorrhagia
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.6%
4/61 • Number of events 4 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
5.1%
3/59 • Number of events 4 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
23.3%
7/30 • Number of events 8 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
3.3%
2/61 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
3/61 • Number of events 3 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
10.2%
6/59 • Number of events 6 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
10.0%
3/30 • Number of events 3 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.3%
2/61 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Investigations
Neutrophil count decreased
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
General disorders
Oedema peripheral
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Oral herpes
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
2/61 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Rhinitis
|
4.9%
3/61 • Number of events 3 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Sexually transmitted disease
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Sinusitis
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Subcutaneous abscess
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Tinea infection
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Surgical and medical procedures
Tooth extraction
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Upper respiratory tract infection
|
16.4%
10/61 • Number of events 11 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
16.9%
10/59 • Number of events 10 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
23.3%
7/30 • Number of events 7 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.4%
2/59 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
6.7%
2/30 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Varicella
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
General disorders
Vessel puncture site pain
|
3.3%
2/61 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
8.2%
5/61 • Number of events 5 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
6.8%
4/59 • Number of events 4 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulvovaginal human papilloma virus infection
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/59 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
1.6%
1/61 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.4%
2/59 • Number of events 2 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
3.3%
1/30 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.00%
0/61 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
1.7%
1/59 • Number of events 1 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
0.00%
0/30 • Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER