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Trial record 14 of 91 for:    cervarix

Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix TM) in HIV Infected Females

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00586339
Recruitment Status : Completed
First Posted : January 4, 2008
Results First Posted : March 22, 2012
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: Cervarix TM
Biological: Placebo Control
Enrollment 150
Recruitment Details HIV+ subjects were randomised to receive either Cervarix or Aluminium Hydroxide vaccines; HIV- subjects were not randomised and all received Cervarix vaccine.
Pre-assignment Details Enrolment was staggered as follows: 1) Enrolment 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) Enrolment of remaining HIV+/HIV- subjects.
Arm/Group Title HIV+/Cervarix Group HIV+/Aluminium Hydroxide Group HIV-/Cervarix Group
Hide Arm/Group Description Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule. Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule. Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Period Title: Overall Study
Started 61 59 30
Completed 54 52 24
Not Completed 7 7 6
Reason Not Completed
Lost to Follow-up             6             4             5
Withdrawal by Subject             1             3             1
Arm/Group Title HIV+/Cervarix Group HIV+/Aluminium Hydroxide Group HIV-/Cervarix Group Total
Hide Arm/Group Description Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule. Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule. Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule. Total of all reporting groups
Overall Number of Baseline Participants 61 59 30 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 59 participants 30 participants 150 participants
21.6  (2.21) 22.7  (1.70) 21.3  (1.65) 21.9  (1.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 59 participants 30 participants 150 participants
Female
61
 100.0%
59
 100.0%
30
 100.0%
150
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
African heritage/African American Number Analyzed 61 participants 59 participants 30 participants 150 participants
61
 100.0%
59
 100.0%
30
 100.0%
150
 100.0%
1.Primary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Hide Description

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.

Time Frame Within 7 days (Days 0-6) after each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title HIV+/Cervarix Group HIV+/Aluminium Hydroxide Group HIV-/Cervarix Group
Hide Arm/Group Description:
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 61 59 30
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
46
  75.4%
18
  30.5%
19
  63.3%
Grade 3 Pain, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
2
   3.3%
0
   0.0%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
6
   9.8%
0
   0.0%
4
  13.3%
Grade 3 Swelling, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
1
   1.6%
0
   0.0%
2
   6.7%
Any Pain, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
29
  54.7%
12
  23.5%
21
  72.4%
Grade 3 Pain, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
1
   3.4%
Any Swelling, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
5
   9.4%
0
   0.0%
8
  27.6%
Grade 3 Swelling, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
2
   6.9%
Any Pain, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
27
  56.3%
6
  13.6%
19
  73.1%
Grade 3 Pain, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
1
   2.1%
0
   0.0%
0
   0.0%
Any Swelling, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
12
  25.0%
2
   4.5%
3
  11.5%
Grade 3 Swelling, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
0
   0.0%
0
   0.0%
1
   3.8%
Any Pain, Across doses Number Analyzed 61 participants 59 participants 30 participants
52
  85.2%
27
  45.8%
28
  93.3%
Grade 3 Pain, Across doses Number Analyzed 61 participants 59 participants 30 participants
3
   4.9%
0
   0.0%
1
   3.3%
Any Swelling, Across doses Number Analyzed 61 participants 59 participants 30 participants
19
  31.1%
2
   3.4%
12
  40.0%
Grade 3 Swelling, Across doses Number Analyzed 61 participants 59 participants 30 participants
1
   1.6%
0
   0.0%
4
  13.3%
2.Primary Outcome
Title Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Hide Description

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.

Time Frame Within 7 days (Days 0-6) after each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title HIV+/Cervarix Group HIV+/Aluminium Hydroxide Group HIV-/Cervarix Group
Hide Arm/Group Description:
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 61 59 30
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
3
   4.9%
4
   6.8%
2
   6.7%
Grade 3 Arthralgia, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Arthralgia, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
1
   1.6%
1
   1.7%
2
   6.7%
Any Fatigue, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
12
  19.7%
13
  22.0%
7
  23.3%
Grade 3 Fatigue, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
1
   1.7%
0
   0.0%
Related Fatigue, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
9
  14.8%
9
  15.3%
5
  16.7%
Any Fever, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
1
   1.6%
2
   3.4%
0
   0.0%
Grade 3 Fever, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
1
   1.7%
0
   0.0%
Related Fever, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Gastrointestinal, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
5
   8.2%
7
  11.9%
9
  30.0%
Grade 3 Gastrointestinal, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Gastrointestinal, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
2
   3.3%
2
   3.4%
2
   6.7%
Any Headache, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
13
  21.3%
16
  27.1%
11
  36.7%
Grade 3 Headache, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Headache, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
5
   8.2%
4
   6.8%
1
   3.3%
Any Myalgia, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
2
   3.3%
1
   1.7%
4
  13.3%
Grade 3 Myalgia, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Myalgia, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
1
   1.6%
1
   1.7%
3
  10.0%
Any Rash, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
2
   3.4%
0
   0.0%
Grade 3 Rash, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Rash, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
1
   1.7%
0
   0.0%
Any Urticaria, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Urticaria, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Urticaria, Dose 1 Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Arthralgia, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Arthralgia, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Arthralgia, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Fatigue, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
4
   7.5%
6
  11.8%
4
  13.8%
Grade 3 Fatigue, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Fatigue, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
4
   7.5%
4
   7.8%
4
  13.8%
Any Fever, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Fever, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Fever, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Gastrointestinal, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
10
  18.9%
2
   3.9%
4
  13.8%
Grade 3 Gastrointestinal, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
1
   1.9%
0
   0.0%
0
   0.0%
Related Gastrointestinal, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
3
   5.7%
1
   2.0%
0
   0.0%
Any Headache, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
11
  20.8%
9
  17.6%
4
  13.8%
Grade 3 Headache, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Headache, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
5
   9.4%
2
   3.9%
1
   3.4%
Any Myalgia, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
1
   2.0%
3
  10.3%
Grade 3 Myalgia, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Myalgia, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
1
   2.0%
3
  10.3%
Any Rash, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
1
   3.4%
Grade 3 Rash, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Rash, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Urticaria, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Urticaria, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Urticaria, Dose 2 Number Analyzed 53 participants 51 participants 29 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Arthralgia, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
1
   2.1%
0
   0.0%
0
   0.0%
Grade 3 Arthralgia, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Arthralgia, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
1
   2.1%
0
   0.0%
0
   0.0%
Any Fatigue, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
4
   8.3%
1
   2.3%
4
  15.4%
Grade 3 Fatigue, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Fatigue, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
4
   8.3%
1
   2.3%
4
  15.4%
Any Fever, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
1
   2.1%
1
   2.3%
2
   7.7%
Grade 3 Fever, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Fever, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
1
   2.1%
0
   0.0%
0
   0.0%
Any Gastrointestinal, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
3
   6.3%
2
   4.5%
6
  23.1%
Grade 3 Gastrointestinal, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Gastrointestinal, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
1
   2.1%
0
   0.0%
3
  11.5%
Any Headache, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
2
   4.2%
7
  15.9%
6
  23.1%
Grade 3 Headache, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Headache, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
1
   2.1%
3
   6.8%
2
   7.7%
Any Myalgia, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
1
   2.1%
1
   2.3%
1
   3.8%
Grade 3 Myalgia, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Myalgia, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
1
   2.1%
1
   2.3%
1
   3.8%
Any Rash, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
1
   2.1%
0
   0.0%
0
   0.0%
Grade 3 Rash, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Rash, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Urticaria, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Urticaria, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Urticaria, Dose 3 Number Analyzed 48 participants 44 participants 26 participants
0
   0.0%
0
   0.0%
0
   0.0%
Any Arthralgia, Across doses Number Analyzed 61 participants 59 participants 30 participants
4
   6.6%
4
   6.8%
2
   6.7%
Grade 3 Arthralgia, Across doses Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Arthralgia, Across doses Number Analyzed 61 participants 59 participants 30 participants
2
   3.3%
1
   1.7%
2
   6.7%
Any Fatigue, Across doses Number Analyzed 61 participants 59 participants 30 participants
18
  29.5%
16
  27.1%
8
  26.7%
Grade 3 Fatigue, Across doses Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
1
   1.7%
0
   0.0%
Related Fatigue, Across doses Number Analyzed 61 participants 59 participants 30 participants
15
  24.6%
12
  20.3%
7
  23.3%
Any Fever, Across doses Number Analyzed 61 participants 59 participants 30 participants
2
   3.3%
3
   5.1%
2
   6.7%
Grade 3 Fever, Across doses Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
1
   1.7%
0
   0.0%
Related Fever, Across doses Number Analyzed 61 participants 59 participants 30 participants
1
   1.6%
0
   0.0%
0
   0.0%
Any Gastrointestinal, Across doses Number Analyzed 61 participants 59 participants 30 participants
15
  24.6%
11
  18.6%
13
  43.3%
Grade 3 Gastrointestinal, Across doses Number Analyzed 61 participants 59 participants 30 participants
1
   1.6%
0
   0.0%
0
   0.0%
Related Gastrointestinal, Across doses Number Analyzed 61 participants 59 participants 30 participants
5
   8.2%
3
   5.1%
4
  13.3%
Any Headache, Across doses Number Analyzed 61 participants 59 participants 30 participants
23
  37.7%
26
  44.1%
16
  53.3%
Grade 3 Headache, Across doses Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Headache, Across doses Number Analyzed 61 participants 59 participants 30 participants
10
  16.4%
9
  15.3%
3
  10.0%
Any Myalgia, Across doses Number Analyzed 61 participants 59 participants 30 participants
3
   4.9%
3
   5.1%
7
  23.3%
Grade 3 Myalgia, Across doses Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Myalgia, Across doses Number Analyzed 61 participants 59 participants 30 participants
2
   3.3%
3
   5.1%
7
  23.3%
Any Rash, Across doses Number Analyzed 61 participants 59 participants 30 participants
1
   1.6%
2
   3.4%
1
   3.3%
Grade 3 Rash, Across doses Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Rash, Across doses Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
1
   1.7%
0
   0.0%
Any Urticaria, Across doses Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Grade 3 Urticaria, Across doses Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
Related Urticaria, Across doses Number Analyzed 61 participants 59 participants 30 participants
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any 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.
Time Frame Within 30 days (Days 0-29) after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title HIV+/Cervarix Group HIV+/Aluminium Hydroxide Group HIV-/Cervarix Group
Hide Arm/Group Description:
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 61 59 30
Measure Type: Count of Participants
Unit of Measure: Participants
Any unsolicited AE(s)
53
  86.9%
46
  78.0%
26
  86.7%
Grade 3 unsolicited AE(s)
1
   1.6%
1
   1.7%
0
   0.0%
Related unsolicited AE(s)
16
  26.2%
3
   5.1%
7
  23.3%
4.Primary Outcome
Title Number of Subjects With Medically Significant Conditions (MSCs)
Hide Description

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.

Time Frame From Day 0 up to Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title HIV+/Cervarix Group HIV+/Aluminium Hydroxide Group HIV-/Cervarix Group
Hide Arm/Group Description:
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 61 59 30
Measure Type: Count of Participants
Unit of Measure: Participants
18
  29.5%
21
  35.6%
5
  16.7%
5.Primary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Day 0 up to Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title HIV+/Cervarix Group HIV+/Aluminium Hydroxide Group HIV-/Cervarix Group
Hide Arm/Group Description:
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 61 59 30
Measure Type: Count of Participants
Unit of Measure: Participants
3
   4.9%
2
   3.4%
1
   3.3%
6.Primary Outcome
Title Number of Subjects With Medically Significant Conditions
Hide Description

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.

Time Frame From Day 0 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title HIV+/Cervarix Group HIV+/Aluminium Hydroxide Group HIV-/Cervarix Group
Hide Arm/Group Description:
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 61 59 30
Measure Type: Count of Participants
Unit of Measure: Participants
19
  31.1%
21
  35.6%
5
  16.7%
7.Primary Outcome
Title Number of Subjects Reporting Serious Adverse Events
Hide Description SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Day 0 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title HIV+/Cervarix Group HIV+/Aluminium Hydroxide Group HIV-/Cervarix Group
Hide Arm/Group Description:
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 61 59 30
Measure Type: Count of Participants
Unit of Measure: Participants
3
   4.9%
2
   3.4%
1
   3.3%
8.Primary Outcome
Title Number of Subjects With Pregnancies and Their Outcome
Hide Description Pregnancy outcome with live infant having no apparent congenital anomaly.
Time Frame From Day 0 up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title HIV+/Cervarix Group HIV+/Aluminium Hydroxide Group HIV-/Cervarix Group
Hide Arm/Group Description:
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 0 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
9.Primary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed
Hide Description Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) 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). Parameters presented in this table are haemoglobin (Hgb) and haematocrit (Hct).
Time Frame At Day 7 and at Months 1, 2, 4, 6 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title HIV+/Cervarix Group HIV+/Aluminium Hydroxide Group HIV-/Cervarix Group
Hide Arm/Group Description:
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 60 57 29
Measure Type: Count of Participants
Unit of Measure: Participants
Hgb [pre-vacc Normal; post-vacc Normal] Day 7
13
  21.7%
11
  19.3%
13
  44.8%
Hgb [pre-vacc Normal; post-vacc Below] Day 7
1
   1.7%
3
   5.3%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Normal] Month 1
46
  76.7%
43
  75.4%
23
  79.3%
Hgb [pre-vacc Normal; post-vacc Below] Month 1
3
   5.0%
5
   8.8%
2
   6.9%
Hgb [pre-vacc Normal; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Normal] Month 2
46
  76.7%
43
  75.4%
24
  82.8%
Hgb [pre-vacc Normal; post-vacc Below] Month 2
1
   1.7%
4
   7.0%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Above] Month 2
0
   0.0%
1
   1.8%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Normal] Month 4
46
  76.7%
43
  75.4%
23
  79.3%
Hgb [pre-vacc Normal; post-vacc Below] Month 4
1
   1.7%
3
   5.3%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Normal] Month 6
42
  70.0%
39
  68.4%
23
  79.3%
Hgb [pre-vacc Normal; post-vacc Below] Month 6
5
   8.3%
6
  10.5%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Normal] Month 7
43
  71.7%
38
  66.7%
22
  75.9%
Hgb [pre-vacc Normal; post-vacc Below] Month 7
3
   5.0%
7
  12.3%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Normal; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Low; post-vacc Normal] Day 7
0
   0.0%
0
   0.0%
1
   3.4%
Hgb [pre-vacc Low; post-vacc Below] Day 7
1
   1.7%
1
   1.8%
1
   3.4%
Hgb [pre-vacc Low; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Low; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Low; post-vacc Normal] Month 1
1
   1.7%
6
  10.5%
3
  10.3%
Hgb [pre-vacc Low; post-vacc Below] Month 1
10
  16.7%
3
   5.3%
1
   3.4%
Hgb [pre-vacc Low; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Low; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Low; post-vacc Normal] Month 2
3
   5.0%
2
   3.5%
3
  10.3%
Hgb [pre-vacc Low; post-vacc Below] Month 2
8
  13.3%
7
  12.3%
1
   3.4%
Hgb [pre-vacc Low; post-vacc Above] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Low; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Low; post-vacc Normal] Month 4
5
   8.3%
4
   7.0%
2
   6.9%
Hgb [pre-vacc Low; post-vacc Below] Month 4
5
   8.3%
4
   7.0%
1
   3.4%
Hgb [pre-vacc Low; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Low; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Low; post-vacc Normal] Month 6
6
  10.0%
3
   5.3%
2
   6.9%
Hgb [pre-vacc Low; post-vacc Below] Month 6
4
   6.7%
6
  10.5%
1
   3.4%
Hgb [pre-vacc Low; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Low; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Low; post-vacc Normal] Month 7
4
   6.7%
2
   3.5%
2
   6.9%
Hgb [pre-vacc Low; post-vacc Below] Month 7
6
  10.0%
6
  10.5%
1
   3.4%
Hgb [pre-vacc Low; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
Hgb [pre-vacc Low; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Normal; post-vacc Normal] Day 7
11
  18.3%
11
  19.3%
13
  44.8%
Hct [pre-vacc Normal; post-vacc Below] Day 7
3
   5.0%
3
   5.3%
1
   3.4%
Hct [pre-vacc Normal; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Normal; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Normal; post-vacc Normal] Month 1
42
  70.0%
37
  64.9%
22
  75.9%
Hct [pre-vacc Normal; post-vacc Below] Month 1
2
   3.3%
6
  10.5%
4
  13.8%
Hct [pre-vacc Normal; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Normal; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Normal; post-vacc Normal] Month 2
37
  61.7%
36
  63.2%
24
  82.8%
Hct [pre-vacc Normal; post-vacc Below] Month 2
5
   8.3%
6
  10.5%
1
   3.4%
Hct [pre-vacc Normal; post-vacc Above] Month 2
0
   0.0%
1
   1.8%
0
   0.0%
Hct [pre-vacc Normal; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Normal; post-vacc Normal] Month 4
38
  63.3%
36
  63.2%
24
  82.8%
Hct [pre-vacc Normal; post-vacc Below] Month 4
4
   6.7%
5
   8.8%
0
   0.0%
Hct [pre-vacc Normal; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Normal; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Normal; post-vacc Normal] Month 6
36
  60.0%
33
  57.9%
22
  75.9%
Hct [pre-vacc Normal; post-vacc Below] Month 6
6
  10.0%
7
  12.3%
1
   3.4%
Hct [pre-vacc Normal; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
1
   3.4%
Hct [pre-vacc Normal; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Normal; post-vacc Normal] Month 7
34
  56.7%
30
  52.6%
20
  69.0%
Hct [pre-vacc Normal; post-vacc Below] Month 7
7
  11.7%
10
  17.5%
2
   6.9%
Hct [pre-vacc Normal; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
1
   3.4%
Hct [pre-vacc Normal; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Low; post-vacc Normal] Day 7
0
   0.0%
0
   0.0%
1
   3.4%
Hct [pre-vacc Low; post-vacc Below] Day 7
1
   1.7%
1
   1.8%
0
   0.0%
Hct [pre-vacc Low; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Low; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Low; post-vacc Normal] Month 1
4
   6.7%
2
   3.5%
1
   3.4%
Hct [pre-vacc Low; post-vacc Below] Month 1
12
  20.0%
11
  19.3%
2
   6.9%
Hct [pre-vacc Low; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Low; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Low; post-vacc Normal] Month 2
4
   6.7%
3
   5.3%
2
   6.9%
Hct [pre-vacc Low; post-vacc Below] Month 2
12
  20.0%
10
  17.5%
1
   3.4%
Hct [pre-vacc Low; post-vacc Above] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Low; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Low; post-vacc Normal] Month 4
6
  10.0%
3
   5.3%
1
   3.4%
Hct [pre-vacc Low; post-vacc Below] Month 4
9
  15.0%
9
  15.8%
1
   3.4%
Hct [pre-vacc Low; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Low; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Low; post-vacc Normal] Month 6
8
  13.3%
4
   7.0%
2
   6.9%
Hct [pre-vacc Low; post-vacc Below] Month 6
7
  11.7%
9
  15.8%
0
   0.0%
Hct [pre-vacc Low; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Low; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Low; post-vacc Normal] Month 7
8
  13.3%
3
   5.3%
2
   6.9%
Hct [pre-vacc Low; post-vacc Below] Month 7
7
  11.7%
9
  15.8%
0
   0.0%
Hct [pre-vacc Low; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc Low; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Normal] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Below] Month 1
0
   0.0%
1
   1.8%
0
   0.0%
Hct [pre-vacc High; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Normal] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Below] Month 2
0
   0.0%
1
   1.8%
0
   0.0%
Hct [pre-vacc High; post-vacc Above] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Normal] Month 4
0
   0.0%
1
   1.8%
0
   0.0%
Hct [pre-vacc High; post-vacc Below] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Normal] Month 6
0
   0.0%
1
   1.8%
0
   0.0%
Hct [pre-vacc High; post-vacc Below] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Normal] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Below] Month 7
0
   0.0%
1
   1.8%
0
   0.0%
Hct [pre-vacc High; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
Hct [pre-vacc High; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
10.Primary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed
Hide Description

Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) 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).

Parameters presented in this table are red blood cells (RBC) and platelets (PLA).

Time Frame At Day 7 and at Months 1, 2, 4, 6 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title HIV+/Cervarix Group HIV+/Aluminium Hydroxide Group HIV-/Cervarix Group
Hide Arm/Group Description:
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 60 57 29
Measure Type: Count of Participants
Unit of Measure: Participants
RBC [pre-vacc Normal; post-vacc Normal] Day 7
14
  23.3%
12
  21.1%
15
  51.7%
RBC [pre-vacc Normal; post-vacc Below] Day 7
1
   1.7%
2
   3.5%
0
   0.0%
RBC [pre-vacc Normal; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Normal; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Normal; post-vacc Normal] Month 1
46
  76.7%
44
  77.2%
25
  86.2%
RBC [pre-vacc Normal; post-vacc Below] Month 1
5
   8.3%
4
   7.0%
4
  13.8%
RBC [pre-vacc Normal; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Normal; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Normal; post-vacc Normal] Month 2
44
  73.3%
45
  78.9%
28
  96.6%
RBC [pre-vacc Normal; post-vacc Below] Month 2
5
   8.3%
3
   5.3%
0
   0.0%
RBC [pre-vacc Normal; post-vacc Above] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Normal; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Normal; post-vacc Normal] Month 4
43
  71.7%
40
  70.2%
25
  86.2%
RBC [pre-vacc Normal; post-vacc Below] Month 4
6
  10.0%
6
  10.5%
1
   3.4%
RBC [pre-vacc Normal; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Normal; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Normal; post-vacc Normal] Month 6
40
  66.7%
40
  70.2%
25
  86.2%
RBC [pre-vacc Normal; post-vacc Below] Month 6
9
  15.0%
5
   8.8%
1
   3.4%
RBC [pre-vacc Normal; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Normal; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Normal; post-vacc Normal] Month 7
43
  71.7%
37
  64.9%
24
  82.8%
RBC [pre-vacc Normal; post-vacc Below] Month 7
5
   8.3%
8
  14.0%
1
   3.4%
RBC [pre-vacc Normal; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Normal; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Normal] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Below] Day 7
0
   0.0%
1
   1.8%
0
   0.0%
RBC [pre-vacc Low; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Normal] Month 1
4
   6.7%
4
   7.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Below] Month 1
5
   8.3%
5
   8.8%
0
   0.0%
RBC [pre-vacc Low; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Normal] Month 2
3
   5.0%
1
   1.8%
0
   0.0%
RBC [pre-vacc Low; post-vacc Below] Month 2
6
  10.0%
8
  14.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Above] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Normal] Month 4
4
   6.7%
4
   7.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Below] Month 4
4
   6.7%
4
   7.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Normal] Month 6
3
   5.0%
4
   7.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Below] Month 6
5
   8.3%
5
   8.8%
0
   0.0%
RBC [pre-vacc Low; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Normal] Month 7
2
   3.3%
4
   7.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Below] Month 7
6
  10.0%
4
   7.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
RBC [pre-vacc Low; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Normal] Day 7
13
  21.7%
14
  24.6%
15
  51.7%
PLA [pre-vacc Normal; post-vacc Below] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Normal] Month 1
56
  93.3%
54
  94.7%
29
 100.0%
PLA [pre-vacc Normal; post-vacc Below] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Missing] Month 1
0
   0.0%
1
   1.8%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Normal] Month 2
51
  85.0%
54
  94.7%
28
  96.6%
PLA [pre-vacc Normal; post-vacc Below] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Above] Month 2
2
   3.3%
1
   1.8%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Missing] Month 2
1
   1.7%
0
   0.0%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Normal] Month 4
52
  86.7%
51
  89.5%
26
  89.7%
PLA [pre-vacc Normal; post-vacc Below] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Above] Month 4
0
   0.0%
1
   1.8%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Missing] Month 4
1
   1.7%
0
   0.0%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Normal] Month 6
53
  88.3%
52
  91.2%
26
  89.7%
PLA [pre-vacc Normal; post-vacc Below] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Normal] Month 7
51
  85.0%
50
  87.7%
25
  86.2%
PLA [pre-vacc Normal; post-vacc Below] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Above] Month 7
1
   1.7%
1
   1.8%
0
   0.0%
PLA [pre-vacc Normal; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Normal] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Below] Month 1
1
   1.7%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Normal] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Below] Month 2
1
   1.7%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Above] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Normal] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Below] Month 4
1
   1.7%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Normal] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Below] Month 6
1
   1.7%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Normal] Month 7
1
   1.7%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Below] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc Low; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Normal] Day 7
0
   0.0%
1
   1.8%
0
   0.0%
PLA [pre-vacc High; post-vacc Below] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Above] Day 7
2
   3.3%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Normal] Month 1
1
   1.7%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Below] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Above] Month 1
2
   3.3%
2
   3.5%
0
   0.0%
PLA [pre-vacc High; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Normal] Month 2
3
   5.0%
2
   3.5%
0
   0.0%
PLA [pre-vacc High; post-vacc Below] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Above] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Normal] Month 4
2
   3.3%
1
   1.8%
0
   0.0%
PLA [pre-vacc High; post-vacc Below] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Above] Month 4
1
   1.7%
1
   1.8%
0
   0.0%
PLA [pre-vacc High; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Normal] Month 6
3
   5.0%
1
   1.8%
0
   0.0%
PLA [pre-vacc High; post-vacc Below] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Above] Month 6
0
   0.0%
1
   1.8%
0
   0.0%
PLA [pre-vacc High; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Normal] Month 7
2
   3.3%
1
   1.8%
0
   0.0%
PLA [pre-vacc High; post-vacc Below] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
PLA [pre-vacc High; post-vacc Above] Month 7
1
   1.7%
1
   1.8%
0
   0.0%
PLA [pre-vacc High; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
11.Primary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Hide Description

Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) 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).

Parameters presented in this table are white blood cells (WBC) and neutrophils (NEU).

Time Frame At Day 7 and at Months 1, 2, 4, 6 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title HIV+/Cervarix Group HIV+/Aluminium Hydroxide Group HIV-/Cervarix Group
Hide Arm/Group Description:
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 60 57 29
Measure Type: Count of Participants
Unit of Measure: Participants
WBC [pre-vacc Normal; post-vacc Normal] Day 7
9
  15.0%
12
  21.1%
12
  41.4%
WBC [pre-vacc Normal; post-vacc Below] Day 7
4
   6.7%
2
   3.5%
1
   3.4%
WBC [pre-vacc Normal; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Normal; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Normal; post-vacc Normal] Month 1
39
  65.0%
43
  75.4%
23
  79.3%
WBC [pre-vacc Normal; post-vacc Below] Month 1
7
  11.7%
6
  10.5%
3
  10.3%
WBC [pre-vacc Normal; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Normal; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Normal; post-vacc Normal] Month 2
38
  63.3%
41
  71.9%
24
  82.8%
WBC [pre-vacc Normal; post-vacc Below] Month 2
6
  10.0%
9
  15.8%
2
   6.9%
WBC [pre-vacc Normal; post-vacc Above] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Normal; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Normal; post-vacc Normal] Month 4
37
  61.7%
41
  71.9%
22
  75.9%
WBC [pre-vacc Normal; post-vacc Below] Month 4
6
  10.0%
7
  12.3%
2
   6.9%
WBC [pre-vacc Normal; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Normal; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Normal; post-vacc Normal] Month 6
35
  58.3%
38
  66.7%
21
  72.4%
WBC [pre-vacc Normal; post-vacc Below] Month 6
8
  13.3%
8
  14.0%
2
   6.9%
WBC [pre-vacc Normal; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
1
   3.4%
WBC [pre-vacc Normal; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Normal; post-vacc Normal] Month 7
34
  56.7%
38
  66.7%
21
  72.4%
WBC [pre-vacc Normal; post-vacc Below] Month 7
8
  13.3%
8
  14.0%
2
   6.9%
WBC [pre-vacc Normal; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Normal; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Low; post-vacc Normal] Day 7
1
   1.7%
1
   1.8%
1
   3.4%
WBC [pre-vacc Low; post-vacc Below] Day 7
1
   1.7%
0
   0.0%
1
   3.4%
WBC [pre-vacc Low; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Low; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Low; post-vacc Normal] Month 1
9
  15.0%
5
   8.8%
2
   6.9%
WBC [pre-vacc Low; post-vacc Below] Month 1
5
   8.3%
3
   5.3%
1
   3.4%
WBC [pre-vacc Low; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Low; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Low; post-vacc Normal] Month 2
10
  16.7%
5
   8.8%
0
   0.0%
WBC [pre-vacc Low; post-vacc Below] Month 2
4
   6.7%
2
   3.5%
2
   6.9%
WBC [pre-vacc Low; post-vacc Above] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Low; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Low; post-vacc Normal] Month 4
8
  13.3%
2
   3.5%
1
   3.4%
WBC [pre-vacc Low; post-vacc Below] Month 4
6
  10.0%
4
   7.0%
1
   3.4%
WBC [pre-vacc Low; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Low; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Low; post-vacc Normal] Month 6
6
  10.0%
5
   8.8%
0
   0.0%
WBC [pre-vacc Low; post-vacc Below] Month 6
8
  13.3%
3
   5.3%
2
   6.9%
WBC [pre-vacc Low; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Low; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Low; post-vacc Normal] Month 7
6
  10.0%
3
   5.3%
1
   3.4%
WBC [pre-vacc Low; post-vacc Below] Month 7
8
  13.3%
4
   7.0%
1
   3.4%
WBC [pre-vacc Low; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
WBC [pre-vacc Low; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Normal; post-vacc Normal] Day 7
9
  15.0%
11
  19.3%
12
  41.4%
NEU [pre-vacc Normal; post-vacc Below] Day 7
4
   6.7%
3
   5.3%
1
   3.4%
NEU [pre-vacc Normal; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Normal; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Normal; post-vacc Normal] Month 1
36
  60.0%
36
  63.2%
21
  72.4%
NEU [pre-vacc Normal; post-vacc Below] Month 1
11
  18.3%
5
   8.8%
4
  13.8%
NEU [pre-vacc Normal; post-vacc Above] Month 1
1
   1.7%
0
   0.0%
0
   0.0%
NEU [pre-vacc Normal; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Normal; post-vacc Normal] Month 2
38
  63.3%
35
  61.4%
22
  75.9%
NEU [pre-vacc Normal; post-vacc Below] Month 2
8
  13.3%
6
  10.5%
3
  10.3%
NEU [pre-vacc Normal; post-vacc Above] Month 2
0
   0.0%
1
   1.8%
0
   0.0%
NEU [pre-vacc Normal; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Normal; post-vacc Normal] Month 4
36
  60.0%
30
  52.6%
19
  65.5%
NEU [pre-vacc Normal; post-vacc Below] Month 4
9
  15.0%
10
  17.5%
4
  13.8%
NEU [pre-vacc Normal; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Normal; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Normal; post-vacc Normal] Month 6
33
  55.0%
33
  57.9%
19
  65.5%
NEU [pre-vacc Normal; post-vacc Below] Month 6
12
  20.0%
5
   8.8%
4
  13.8%
NEU [pre-vacc Normal; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Normal; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Normal; post-vacc Normal] Month 7
35
  58.3%
32
  56.1%
18
  62.1%
NEU [pre-vacc Normal; post-vacc Below] Month 7
9
  15.0%
6
  10.5%
4
  13.8%
NEU [pre-vacc Normal; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Normal; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Low; post-vacc Normal] Day 7
0
   0.0%
1
   1.8%
0
   0.0%
NEU [pre-vacc Low; post-vacc Below] Day 7
2
   3.3%
0
   0.0%
2
   6.9%
NEU [pre-vacc Low; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Low; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Low; post-vacc Normal] Month 1
7
  11.7%
6
  10.5%
1
   3.4%
NEU [pre-vacc Low; post-vacc Below] Month 1
5
   8.3%
10
  17.5%
3
  10.3%
NEU [pre-vacc Low; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Low; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Low; post-vacc Normal] Month 2
6
  10.0%
7
  12.3%
0
   0.0%
NEU [pre-vacc Low; post-vacc Below] Month 2
6
  10.0%
8
  14.0%
3
  10.3%
NEU [pre-vacc Low; post-vacc Above] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Low; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Low; post-vacc Normal] Month 4
6
  10.0%
7
  12.3%
1
   3.4%
NEU [pre-vacc Low; post-vacc Below] Month 4
6
  10.0%
7
  12.3%
2
   6.9%
NEU [pre-vacc Low; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Low; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Low; post-vacc Normal] Month 6
5
   8.3%
6
  10.5%
0
   0.0%
NEU [pre-vacc Low; post-vacc Below] Month 6
7
  11.7%
10
  17.5%
3
  10.3%
NEU [pre-vacc Low; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Low; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Low; post-vacc Normal] Month 7
5
   8.3%
6
  10.5%
0
   0.0%
NEU [pre-vacc Low; post-vacc Below] Month 7
7
  11.7%
9
  15.8%
3
  10.3%
NEU [pre-vacc Low; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
NEU [pre-vacc Low; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
12.Primary Outcome
Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Hide Description

Laboratory parameters assessed were alanine aminotransferase (ALAT), creatinine (CREA), white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), haemoglobin (Hgb), haematocrit (Hct) 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).

Parameters presented in this table are lymphocytes (LYM) and monocytes (MON).

Time Frame At Day 7 and at Months 1, 2, 4, 6 and 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title HIV+/Cervarix Group HIV+/Aluminium Hydroxide Group HIV-/Cervarix Group
Hide Arm/Group Description:
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Overall Number of Participants Analyzed 60 57 29
Measure Type: Count of Participants
Unit of Measure: Participants
LYM [pre-vacc Normal; post-vacc Normal] Day 7
12
  20.0%
14
  24.6%
14
  48.3%
LYM [pre-vacc Normal; post-vacc Below] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Normal; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Normal; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Normal; post-vacc Normal] Month 1
52
  86.7%
55
  96.5%
27
  93.1%
LYM [pre-vacc Normal; post-vacc Below] Month 1
2
   3.3%
0
   0.0%
0
   0.0%
LYM [pre-vacc Normal; post-vacc Above] Month 1
0
   0.0%
1
   1.8%
0
   0.0%
LYM [pre-vacc Normal; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Normal; post-vacc Normal] Month 2
50
  83.3%
54
  94.7%
26
  89.7%
LYM [pre-vacc Normal; post-vacc Below] Month 2
1
   1.7%
2
   3.5%
0
   0.0%
LYM [pre-vacc Normal; post-vacc Above] Month 2
1
   1.7%
0
   0.0%
0
   0.0%
LYM [pre-vacc Normal; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Normal; post-vacc Normal] Month 4
49
  81.7%
50
  87.7%
23
  79.3%
LYM [pre-vacc Normal; post-vacc Below] Month 4
2
   3.3%
3
   5.3%
0
   0.0%
LYM [pre-vacc Normal; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
1
   3.4%
LYM [pre-vacc Normal; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Normal; post-vacc Normal] Month 6
48
  80.0%
52
  91.2%
22
  75.9%
LYM [pre-vacc Normal; post-vacc Below] Month 6
3
   5.0%
1
   1.8%
0
   0.0%
LYM [pre-vacc Normal; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
2
   6.9%
LYM [pre-vacc Normal; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Normal; post-vacc Normal] Month 7
48
  80.0%
49
  86.0%
22
  75.9%
LYM [pre-vacc Normal; post-vacc Below] Month 7
2
   3.3%
3
   5.3%
0
   0.0%
LYM [pre-vacc Normal; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
1
   3.4%
LYM [pre-vacc Normal; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Normal] Day 7
2
   3.3%
1
   1.8%
1
   3.4%
LYM [pre-vacc Low; post-vacc Below] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Normal] Month 1
3
   5.0%
1
   1.8%
1
   3.4%
LYM [pre-vacc Low; post-vacc Below] Month 1
2
   3.3%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Normal] Month 2
4
   6.7%
1
   1.8%
1
   3.4%
LYM [pre-vacc Low; post-vacc Below] Month 2
1
   1.7%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Above] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Normal] Month 4
3
   5.0%
1
   1.8%
1
   3.4%
LYM [pre-vacc Low; post-vacc Below] Month 4
2
   3.3%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Normal] Month 6
3
   5.0%
1
   1.8%
1
   3.4%
LYM [pre-vacc Low; post-vacc Below] Month 6
2
   3.3%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Normal] Month 7
3
   5.0%
1
   1.8%
1
   3.4%
LYM [pre-vacc Low; post-vacc Below] Month 7
2
   3.3%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc Low; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Normal] Day 7
1
   1.7%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Below] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Normal] Month 1
1
   1.7%
0
   0.0%
1
   3.4%
LYM [pre-vacc High; post-vacc Below] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Normal] Month 2
1
   1.7%
0
   0.0%
1
   3.4%
LYM [pre-vacc High; post-vacc Below] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Above] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Normal] Month 4
1
   1.7%
0
   0.0%
1
   3.4%
LYM [pre-vacc High; post-vacc Below] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Normal] Month 6
1
   1.7%
0
   0.0%
1
   3.4%
LYM [pre-vacc High; post-vacc Below] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Normal] Month 7
1
   1.7%
0
   0.0%
1
   3.4%
LYM [pre-vacc High; post-vacc Below] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
LYM [pre-vacc High; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Normal; post-vacc Normal] Day 7
13
  21.7%
14
  24.6%
15
  51.7%
MON [pre-vacc Normal; post-vacc Below] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Normal; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Normal; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Normal; post-vacc Normal] Month 1
56
  93.3%
54
  94.7%
28
  96.6%
MON [pre-vacc Normal; post-vacc Below] Month 1
1
   1.7%
1
   1.8%
1
   3.4%
MON [pre-vacc Normal; post-vacc Above] Month 1
0
   0.0%
1
   1.8%
0
   0.0%
MON [pre-vacc Normal; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Normal; post-vacc Normal] Month 2
52
  86.7%
55
  96.5%
28
  96.6%
MON [pre-vacc Normal; post-vacc Below] Month 2
2
   3.3%
1
   1.8%
0
   0.0%
MON [pre-vacc Normal; post-vacc Above] Month 2
1
   1.7%
0
   0.0%
0
   0.0%
MON [pre-vacc Normal; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Normal; post-vacc Normal] Month 4
51
  85.0%
52
  91.2%
26
  89.7%
MON [pre-vacc Normal; post-vacc Below] Month 4
3
   5.0%
1
   1.8%
0
   0.0%
MON [pre-vacc Normal; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Normal; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Normal; post-vacc Normal] Month 6
53
  88.3%
52
  91.2%
26
  89.7%
MON [pre-vacc Normal; post-vacc Below] Month 6
1
   1.7%
1
   1.8%
0
   0.0%
MON [pre-vacc Normal; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Normal; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Normal; post-vacc Normal] Month 7
50
  83.3%
50
  87.7%
24
  82.8%
MON [pre-vacc Normal; post-vacc Below] Month 7
3
   5.0%
2
   3.5%
1
   3.4%
MON [pre-vacc Normal; post-vacc Above] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Normal; post-vacc Missing] Month 7
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Normal] Day 7
2
   3.3%
1
   1.8%
0
   0.0%
MON [pre-vacc Low; post-vacc Below] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Above] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Missing] Day 7
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Normal] Month 1
2
   3.3%
1
   1.8%
0
   0.0%
MON [pre-vacc Low; post-vacc Below] Month 1
1
   1.7%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Above] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Missing] Month 1
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Normal] Month 2
3
   5.0%
1
   1.8%
0
   0.0%
MON [pre-vacc Low; post-vacc Below] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Above] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Missing] Month 2
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Normal] Month 4
2
   3.3%
1
   1.8%
0
   0.0%
MON [pre-vacc Low; post-vacc Below] Month 4
1
   1.7%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Above] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Missing] Month 4
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Normal] Month 6
1
   1.7%
1
   1.8%
0
   0.0%
MON [pre-vacc Low; post-vacc Below] Month 6
2
   3.3%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Above] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Missing] Month 6
0
   0.0%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Normal] Month 7
1
   1.7%
1
   1.8%
0
   0.0%
MON [pre-vacc Low; post-vacc Below] Month 7
2
   3.3%
0
   0.0%
0
   0.0%
MON [pre-vacc Low; post-vacc Above] Month 7
0
   0.0%