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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00586339
First Posted: January 4, 2008
Last Update Posted: October 26, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: February 16, 2012  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
HIV+/Cervarix Group 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.
HIV+/Aluminium Hydroxide Group 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.
HIV-/Cervarix Group 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.

Participant Flow:   Overall Study
    HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group
STARTED   61   59   30 
COMPLETED   54   52   24 
NOT COMPLETED   7   7   6 
Lost to Follow-up                6                4                5 
Withdrawal by Subject                1                3                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HIV+/Cervarix Group 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.
HIV+/Aluminium Hydroxide Group 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.
HIV-/Cervarix Group 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 Total of all reporting groups

Baseline Measures
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   59   30   150 
Age 
[Units: Years]
Mean (Standard Deviation)
 21.6  (2.21)   22.7  (1.70)   21.3  (1.65)   21.9  (1.85) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
       
African heritage/African American   61   59   30   150 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms   [ Time Frame: Within 7 days (Days 0-6) after each dose and across doses ]

Measure Type Primary
Measure Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Reporting Groups
  Description
HIV+/Cervarix Group 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.
HIV+/Aluminium Hydroxide Group 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.
HIV-/Cervarix Group 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.

Measured Values
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group 
Participants Analyzed 
[Units: Participants]
 61   59   30 
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms 
[Units: Participants]
Count of Participants
     
Any Pain, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Pain, Dose 1   46   18   19 
Grade 3 Pain, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Pain, Dose 1   2   0   0 
Any Swelling, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Swelling, Dose 1   6   0   4 
Grade 3 Swelling, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Swelling, Dose 1   1   0   2 
Any Pain, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Any Pain, Dose 2   29   12   21 
Grade 3 Pain, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Grade 3 Pain, Dose 2   0   0   1 
Any Swelling, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Any Swelling, Dose 2   5   0   8 
Grade 3 Swelling, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Grade 3 Swelling, Dose 2   0   0   2 
Any Pain, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Any Pain, Dose 3   27   6   19 
Grade 3 Pain, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Grade 3 Pain, Dose 3   1   0   0 
Any Swelling, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Any Swelling, Dose 3   12   2   3 
Grade 3 Swelling, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Grade 3 Swelling, Dose 3   0   0   1 
Any Pain, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Pain, Across doses   52   27   28 
Grade 3 Pain, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Pain, Across doses   3   0   1 
Any Swelling, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Swelling, Across doses   19   2   12 
Grade 3 Swelling, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Swelling, Across doses   1   0   4 

No statistical analysis provided for Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms



2.  Primary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms   [ Time Frame: Within 7 days (Days 0-6) after each dose and across doses ]

Measure Type Primary
Measure Title Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Reporting Groups
  Description
HIV+/Cervarix Group 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.
HIV+/Aluminium Hydroxide Group 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.
HIV-/Cervarix Group 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.

Measured Values
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group 
Participants Analyzed 
[Units: Participants]
 61   59   30 
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms 
[Units: Participants]
Count of Participants
     
Any Arthralgia, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Arthralgia, Dose 1   3   4   2 
Grade 3 Arthralgia, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Arthralgia, Dose 1   0   0   0 
Related Arthralgia, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Arthralgia, Dose 1   1   1   2 
Any Fatigue, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Fatigue, Dose 1   12   13   7 
Grade 3 Fatigue, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Fatigue, Dose 1   0   1   0 
Related Fatigue, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Fatigue, Dose 1   9   9   5 
Any Fever, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Fever, Dose 1   1   2   0 
Grade 3 Fever, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Fever, Dose 1   0   1   0 
Related Fever, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Fever, Dose 1   0   0   0 
Any Gastrointestinal, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Gastrointestinal, Dose 1   5   7   9 
Grade 3 Gastrointestinal, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Gastrointestinal, Dose 1   0   0   0 
Related Gastrointestinal, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Gastrointestinal, Dose 1   2   2   2 
Any Headache, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Headache, Dose 1   13   16   11 
Grade 3 Headache, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Headache, Dose 1   0   0   0 
Related Headache, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Headache, Dose 1   5   4   1 
Any Myalgia, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Myalgia, Dose 1   2   1   4 
Grade 3 Myalgia, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Myalgia, Dose 1   0   0   0 
Related Myalgia, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Myalgia, Dose 1   1   1   3 
Any Rash, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Rash, Dose 1   0   2   0 
Grade 3 Rash, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Rash, Dose 1   0   0   0 
Related Rash, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Rash, Dose 1   0   1   0 
Any Urticaria, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Urticaria, Dose 1   0   0   0 
Grade 3 Urticaria, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Urticaria, Dose 1   0   0   0 
Related Urticaria, Dose 1       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Urticaria, Dose 1   0   0   0 
Any Arthralgia, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Any Arthralgia, Dose 2   0   0   0 
Grade 3 Arthralgia, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Grade 3 Arthralgia, Dose 2   0   0   0 
Related Arthralgia, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Related Arthralgia, Dose 2   0   0   0 
Any Fatigue, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Any Fatigue, Dose 2   4   6   4 
Grade 3 Fatigue, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Grade 3 Fatigue, Dose 2   0   0   0 
Related Fatigue, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Related Fatigue, Dose 2   4   4   4 
Any Fever, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Any Fever, Dose 2   0   0   0 
Grade 3 Fever, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Grade 3 Fever, Dose 2   0   0   0 
Related Fever, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Related Fever, Dose 2   0   0   0 
Any Gastrointestinal, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Any Gastrointestinal, Dose 2   10   2   4 
Grade 3 Gastrointestinal, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Grade 3 Gastrointestinal, Dose 2   1   0   0 
Related Gastrointestinal, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Related Gastrointestinal, Dose 2   3   1   0 
Any Headache, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Any Headache, Dose 2   11   9   4 
Grade 3 Headache, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Grade 3 Headache, Dose 2   0   0   0 
Related Headache, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Related Headache, Dose 2   5   2   1 
Any Myalgia, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Any Myalgia, Dose 2   0   1   3 
Grade 3 Myalgia, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Grade 3 Myalgia, Dose 2   0   0   0 
Related Myalgia, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Related Myalgia, Dose 2   0   1   3 
Any Rash, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Any Rash, Dose 2   0   0   1 
Grade 3 Rash, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Grade 3 Rash, Dose 2   0   0   0 
Related Rash, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Related Rash, Dose 2   0   0   0 
Any Urticaria, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Any Urticaria, Dose 2   0   0   0 
Grade 3 Urticaria, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Grade 3 Urticaria, Dose 2   0   0   0 
Related Urticaria, Dose 2       
Participants Analyzed 
[Units: Participants]
 53   51   29 
Related Urticaria, Dose 2   0   0   0 
Any Arthralgia, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Any Arthralgia, Dose 3   1   0   0 
Grade 3 Arthralgia, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Grade 3 Arthralgia, Dose 3   0   0   0 
Related Arthralgia, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Related Arthralgia, Dose 3   1   0   0 
Any Fatigue, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Any Fatigue, Dose 3   4   1   4 
Grade 3 Fatigue, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Grade 3 Fatigue, Dose 3   0   0   0 
Related Fatigue, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Related Fatigue, Dose 3   4   1   4 
Any Fever, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Any Fever, Dose 3   1   1   2 
Grade 3 Fever, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Grade 3 Fever, Dose 3   0   0   0 
Related Fever, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Related Fever, Dose 3   1   0   0 
Any Gastrointestinal, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Any Gastrointestinal, Dose 3   3   2   6 
Grade 3 Gastrointestinal, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Grade 3 Gastrointestinal, Dose 3   0   0   0 
Related Gastrointestinal, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Related Gastrointestinal, Dose 3   1   0   3 
Any Headache, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Any Headache, Dose 3   2   7   6 
Grade 3 Headache, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Grade 3 Headache, Dose 3   0   0   0 
Related Headache, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Related Headache, Dose 3   1   3   2 
Any Myalgia, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Any Myalgia, Dose 3   1   1   1 
Grade 3 Myalgia, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Grade 3 Myalgia, Dose 3   0   0   0 
Related Myalgia, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Related Myalgia, Dose 3   1   1   1 
Any Rash, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Any Rash, Dose 3   1   0   0 
Grade 3 Rash, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Grade 3 Rash, Dose 3   0   0   0 
Related Rash, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Related Rash, Dose 3   0   0   0 
Any Urticaria, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Any Urticaria, Dose 3   0   0   0 
Grade 3 Urticaria, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Grade 3 Urticaria, Dose 3   0   0   0 
Related Urticaria, Dose 3       
Participants Analyzed 
[Units: Participants]
 48   44   26 
Related Urticaria, Dose 3   0   0   0 
Any Arthralgia, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Arthralgia, Across doses   4   4   2 
Grade 3 Arthralgia, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Arthralgia, Across doses   0   0   0 
Related Arthralgia, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Arthralgia, Across doses   2   1   2 
Any Fatigue, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Fatigue, Across doses   18   16   8 
Grade 3 Fatigue, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Fatigue, Across doses   0   1   0 
Related Fatigue, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Fatigue, Across doses   15   12   7 
Any Fever, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Fever, Across doses   2   3   2 
Grade 3 Fever, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Fever, Across doses   0   1   0 
Related Fever, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Fever, Across doses   1   0   0 
Any Gastrointestinal, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Gastrointestinal, Across doses   15   11   13 
Grade 3 Gastrointestinal, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Gastrointestinal, Across doses   1   0   0 
Related Gastrointestinal, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Gastrointestinal, Across doses   5   3   4 
Any Headache, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Headache, Across doses   23   26   16 
Grade 3 Headache, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Headache, Across doses   0   0   0 
Related Headache, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Headache, Across doses   10   9   3 
Any Myalgia, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Myalgia, Across doses   3   3   7 
Grade 3 Myalgia, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Myalgia, Across doses   0   0   0 
Related Myalgia, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Myalgia, Across doses   2   3   7 
Any Rash, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Rash, Across doses   1   2   1 
Grade 3 Rash, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Rash, Across doses   0   0   0 
Related Rash, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Rash, Across doses   0   1   0 
Any Urticaria, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Any Urticaria, Across doses   0   0   0 
Grade 3 Urticaria, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Grade 3 Urticaria, Across doses   0   0   0 
Related Urticaria, Across doses       
Participants Analyzed 
[Units: Participants]
 61   59   30 
Related Urticaria, Across doses   0   0   0 

No statistical analysis provided for Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms



3.  Primary:   Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms   [ Time Frame: Within 30 days (Days 0-29) after vaccination ]

Measure Type Primary
Measure Title Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Reporting Groups
  Description
HIV+/Cervarix Group 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.
HIV+/Aluminium Hydroxide Group 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.
HIV-/Cervarix Group 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.

Measured Values
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group 
Participants Analyzed 
[Units: Participants]
 61   59   30 
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms 
[Units: Participants]
Count of Participants
     
Any unsolicited AE(s)   53   46   26 
Grade 3 unsolicited AE(s)   1   1   0 
Related unsolicited AE(s)   16   3   7 

No statistical analysis provided for Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms



4.  Primary:   Number of Subjects With Medically Significant Conditions (MSCs)   [ Time Frame: From Day 0 up to Month 7 ]

Measure Type Primary
Measure Title Number of Subjects With Medically Significant Conditions (MSCs)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Reporting Groups
  Description
HIV+/Cervarix Group 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.
HIV+/Aluminium Hydroxide Group 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.
HIV-/Cervarix Group 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.

Measured Values
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group 
Participants Analyzed 
[Units: Participants]
 61   59   30 
Number of Subjects With Medically Significant Conditions (MSCs) 
[Units: Participants]
Count of Participants
 18   21   5 

No statistical analysis provided for Number of Subjects With Medically Significant Conditions (MSCs)



5.  Primary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: From Day 0 up to Month 7 ]

Measure Type Primary
Measure Title Number of Subjects Reporting Serious Adverse Events (SAEs)
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Reporting Groups
  Description
HIV+/Cervarix Group 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.
HIV+/Aluminium Hydroxide Group 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.
HIV-/Cervarix Group 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.

Measured Values
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group 
Participants Analyzed 
[Units: Participants]
 61   59   30 
Number of Subjects Reporting Serious Adverse Events (SAEs) 
[Units: Participants]
Count of Participants
 3   2   1 

No statistical analysis provided for Number of Subjects Reporting Serious Adverse Events (SAEs)



6.  Primary:   Number of Subjects With Medically Significant Conditions   [ Time Frame: From Day 0 up to Month 12 ]

Measure Type Primary
Measure Title Number of Subjects With Medically Significant Conditions
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Reporting Groups
  Description
HIV+/Cervarix Group 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.
HIV+/Aluminium Hydroxide Group 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.
HIV-/Cervarix Group 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.

Measured Values
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group 
Participants Analyzed 
[Units: Participants]
 61   59   30 
Number of Subjects With Medically Significant Conditions 
[Units: Participants]
Count of Participants
 19   21   5 

No statistical analysis provided for Number of Subjects With Medically Significant Conditions



7.  Primary:   Number of Subjects Reporting Serious Adverse Events   [ Time Frame: From Day 0 up to Month 12 ]

Measure Type Primary
Measure Title Number of Subjects Reporting Serious Adverse Events
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Reporting Groups
  Description
HIV+/Cervarix Group 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.
HIV+/Aluminium Hydroxide Group 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.
HIV-/Cervarix Group 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.

Measured Values
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group 
Participants Analyzed 
[Units: Participants]
 61   59   30 
Number of Subjects Reporting Serious Adverse Events 
[Units: Participants]
Count of Participants
 3   2   1 

No statistical analysis provided for Number of Subjects Reporting Serious Adverse Events



8.  Primary:   Number of Subjects With Pregnancies and Their Outcome   [ Time Frame: From Day 0 up to Month 12 ]

Measure Type Primary
Measure Title Number of Subjects With Pregnancies and Their Outcome
Measure Description Pregnancy outcome with live infant having no apparent congenital anomaly.
Time Frame From Day 0 up to Month 12  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Reporting Groups
  Description
HIV+/Cervarix Group 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.
HIV+/Aluminium Hydroxide Group 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.
HIV-/Cervarix Group 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.

Measured Values
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group 
Participants Analyzed 
[Units: Participants]
 0   1   0 
Number of Subjects With Pregnancies and Their Outcome 
[Units: Participants]
Count of Participants
    1    

No statistical analysis provided for Number of Subjects With Pregnancies and Their Outcome



9.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed   [ Time Frame: At Day 7 and at Months 1, 2, 4, 6 and 7 ]

Measure Type Primary
Measure Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Reporting Groups
  Description
HIV+/Cervarix Group 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.
HIV+/Aluminium Hydroxide Group 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.
HIV-/Cervarix Group 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.

Measured Values
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group 
Participants Analyzed 
[Units: Participants]
 60   57   29 
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed 
[Units: Participants]
Count of Participants
     
Hgb [pre-vacc Normal; post-vacc Normal] Day 7   13   11   13 
Hgb [pre-vacc Normal; post-vacc Below] Day 7   1   3   0 
Hgb [pre-vacc Normal; post-vacc Above] Day 7   0   0   0 
Hgb [pre-vacc Normal; post-vacc Missing] Day 7   0   0   0 
Hgb [pre-vacc Normal; post-vacc Normal] Month 1   46   43   23 
Hgb [pre-vacc Normal; post-vacc Below] Month 1   3   5   2 
Hgb [pre-vacc Normal; post-vacc Above] Month 1   0   0   0 
Hgb [pre-vacc Normal; post-vacc Missing] Month 1   0   0   0 
Hgb [pre-vacc Normal; post-vacc Normal] Month 2   46   43   24 
Hgb [pre-vacc Normal; post-vacc Below] Month 2   1   4   0 
Hgb [pre-vacc Normal; post-vacc Above] Month 2   0   1   0 
Hgb [pre-vacc Normal; post-vacc Missing] Month 2   0   0   0 
Hgb [pre-vacc Normal; post-vacc Normal] Month 4   46   43   23 
Hgb [pre-vacc Normal; post-vacc Below] Month 4   1   3   0 
Hgb [pre-vacc Normal; post-vacc Above] Month 4   0   0   0 
Hgb [pre-vacc Normal; post-vacc Missing] Month 4   0   0   0 
Hgb [pre-vacc Normal; post-vacc Normal] Month 6   42   39   23 
Hgb [pre-vacc Normal; post-vacc Below] Month 6   5   6   0 
Hgb [pre-vacc Normal; post-vacc Above] Month 6   0   0   0 
Hgb [pre-vacc Normal; post-vacc Missing] Month 6   0   0   0 
Hgb [pre-vacc Normal; post-vacc Normal] Month 7   43   38   22 
Hgb [pre-vacc Normal; post-vacc Below] Month 7   3   7   0 
Hgb [pre-vacc Normal; post-vacc Above] Month 7   0   0   0 
Hgb [pre-vacc Normal; post-vacc Missing] Month 7   0   0   0 
Hgb [pre-vacc Low; post-vacc Normal] Day 7   0   0   1 
Hgb [pre-vacc Low; post-vacc Below] Day 7   1   1   1 
Hgb [pre-vacc Low; post-vacc Above] Day 7   0   0   0 
Hgb [pre-vacc Low; post-vacc Missing] Day 7   0   0   0 
Hgb [pre-vacc Low; post-vacc Normal] Month 1   1   6   3 
Hgb [pre-vacc Low; post-vacc Below] Month 1   10   3   1 
Hgb [pre-vacc Low; post-vacc Above] Month 1   0   0   0 
Hgb [pre-vacc Low; post-vacc Missing] Month 1   0   0   0 
Hgb [pre-vacc Low; post-vacc Normal] Month 2   3   2   3 
Hgb [pre-vacc Low; post-vacc Below] Month 2   8   7   1 
Hgb [pre-vacc Low; post-vacc Above] Month 2   0   0   0 
Hgb [pre-vacc Low; post-vacc Missing] Month 2   0   0   0 
Hgb [pre-vacc Low; post-vacc Normal] Month 4   5   4   2 
Hgb [pre-vacc Low; post-vacc Below] Month 4   5   4   1 
Hgb [pre-vacc Low; post-vacc Above] Month 4   0   0   0 
Hgb [pre-vacc Low; post-vacc Missing] Month 4   0   0   0 
Hgb [pre-vacc Low; post-vacc Normal] Month 6   6   3   2 
Hgb [pre-vacc Low; post-vacc Below] Month 6   4   6   1 
Hgb [pre-vacc Low; post-vacc Above] Month 6   0   0   0 
Hgb [pre-vacc Low; post-vacc Missing] Month 6   0   0   0 
Hgb [pre-vacc Low; post-vacc Normal] Month 7   4   2   2 
Hgb [pre-vacc Low; post-vacc Below] Month 7   6   6   1 
Hgb [pre-vacc Low; post-vacc Above] Month 7   0   0   0 
Hgb [pre-vacc Low; post-vacc Missing] Month 7   0   0   0 
Hct [pre-vacc Normal; post-vacc Normal] Day 7   11   11   13 
Hct [pre-vacc Normal; post-vacc Below] Day 7   3   3   1 
Hct [pre-vacc Normal; post-vacc Above] Day 7   0   0   0 
Hct [pre-vacc Normal; post-vacc Missing] Day 7   0   0   0 
Hct [pre-vacc Normal; post-vacc Normal] Month 1   42   37   22 
Hct [pre-vacc Normal; post-vacc Below] Month 1   2   6   4 
Hct [pre-vacc Normal; post-vacc Above] Month 1   0   0   0 
Hct [pre-vacc Normal; post-vacc Missing] Month 1   0   0   0 
Hct [pre-vacc Normal; post-vacc Normal] Month 2   37   36   24 
Hct [pre-vacc Normal; post-vacc Below] Month 2   5   6   1 
Hct [pre-vacc Normal; post-vacc Above] Month 2   0   1   0 
Hct [pre-vacc Normal; post-vacc Missing] Month 2   0   0   0 
Hct [pre-vacc Normal; post-vacc Normal] Month 4   38   36   24 
Hct [pre-vacc Normal; post-vacc Below] Month 4   4   5   0 
Hct [pre-vacc Normal; post-vacc Above] Month 4   0   0   0 
Hct [pre-vacc Normal; post-vacc Missing] Month 4   0   0   0 
Hct [pre-vacc Normal; post-vacc Normal] Month 6   36   33   22 
Hct [pre-vacc Normal; post-vacc Below] Month 6   6   7   1 
Hct [pre-vacc Normal; post-vacc Above] Month 6   0   0   1 
Hct [pre-vacc Normal; post-vacc Missing] Month 6   0   0   0 
Hct [pre-vacc Normal; post-vacc Normal] Month 7   34   30   20 
Hct [pre-vacc Normal; post-vacc Below] Month 7   7   10   2 
Hct [pre-vacc Normal; post-vacc Above] Month 7   0   0   1 
Hct [pre-vacc Normal; post-vacc Missing] Month 7   0   0   0 
Hct [pre-vacc Low; post-vacc Normal] Day 7   0   0   1 
Hct [pre-vacc Low; post-vacc Below] Day 7   1   1   0 
Hct [pre-vacc Low; post-vacc Above] Day 7   0   0   0 
Hct [pre-vacc Low; post-vacc Missing] Day 7   0   0   0 
Hct [pre-vacc Low; post-vacc Normal] Month 1   4   2   1 
Hct [pre-vacc Low; post-vacc Below] Month 1   12   11   2 
Hct [pre-vacc Low; post-vacc Above] Month 1   0   0   0 
Hct [pre-vacc Low; post-vacc Missing] Month 1   0   0   0 
Hct [pre-vacc Low; post-vacc Normal] Month 2   4   3   2 
Hct [pre-vacc Low; post-vacc Below] Month 2   12   10   1 
Hct [pre-vacc Low; post-vacc Above] Month 2   0   0   0 
Hct [pre-vacc Low; post-vacc Missing] Month 2   0   0   0 
Hct [pre-vacc Low; post-vacc Normal] Month 4   6   3   1 
Hct [pre-vacc Low; post-vacc Below] Month 4   9   9   1 
Hct [pre-vacc Low; post-vacc Above] Month 4   0   0   0 
Hct [pre-vacc Low; post-vacc Missing] Month 4   0   0   0 
Hct [pre-vacc Low; post-vacc Normal] Month 6   8   4   2 
Hct [pre-vacc Low; post-vacc Below] Month 6   7   9   0 
Hct [pre-vacc Low; post-vacc Above] Month 6   0   0   0 
Hct [pre-vacc Low; post-vacc Missing] Month 6   0   0   0 
Hct [pre-vacc Low; post-vacc Normal] Month 7   8   3   2 
Hct [pre-vacc Low; post-vacc Below] Month 7   7   9   0 
Hct [pre-vacc Low; post-vacc Above] Month 7   0   0   0 
Hct [pre-vacc Low; post-vacc Missing] Month 7   0   0   0 
Hct [pre-vacc High; post-vacc Normal] Month 1   0   0   0 
Hct [pre-vacc High; post-vacc Below] Month 1   0   1   0 
Hct [pre-vacc High; post-vacc Above] Month 1   0   0   0 
Hct [pre-vacc High; post-vacc Missing] Month 1   0   0   0 
Hct [pre-vacc High; post-vacc Normal] Month 2   0   0   0 
Hct [pre-vacc High; post-vacc Below] Month 2   0   1   0 
Hct [pre-vacc High; post-vacc Above] Month 2   0   0   0 
Hct [pre-vacc High; post-vacc Missing] Month 2   0   0   0 
Hct [pre-vacc High; post-vacc Normal] Month 4   0   1   0 
Hct [pre-vacc High; post-vacc Below] Month 4   0   0   0 
Hct [pre-vacc High; post-vacc Above] Month 4   0   0   0 
Hct [pre-vacc High; post-vacc Missing] Month 4   0   0   0 
Hct [pre-vacc High; post-vacc Normal] Month 6   0   1   0 
Hct [pre-vacc High; post-vacc Below] Month 6   0   0   0 
Hct [pre-vacc High; post-vacc Above] Month 6   0   0   0 
Hct [pre-vacc High; post-vacc Missing] Month 6   0   0   0 
Hct [pre-vacc High; post-vacc Normal] Month 7   0   0   0 
Hct [pre-vacc High; post-vacc Below] Month 7   0   1   0 
Hct [pre-vacc High; post-vacc Above] Month 7   0   0   0 
Hct [pre-vacc High; post-vacc Missing] Month 7   0   0   0 

No statistical analysis provided for Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed



10.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed   [ Time Frame: At Day 7 and at Months 1, 2, 4, 6 and 7 ]

Measure Type Primary
Measure Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Reporting Groups
  Description
HIV+/Cervarix Group 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.
HIV+/Aluminium Hydroxide Group 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.
HIV-/Cervarix Group 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.

Measured Values
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group 
Participants Analyzed 
[Units: Participants]
 60   57   29 
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed 
[Units: Participants]
Count of Participants
     
RBC [pre-vacc Normal; post-vacc Normal] Day 7   14   12   15 
RBC [pre-vacc Normal; post-vacc Below] Day 7   1   2   0 
RBC [pre-vacc Normal; post-vacc Above] Day 7   0   0   0 
RBC [pre-vacc Normal; post-vacc Missing] Day 7   0   0   0 
RBC [pre-vacc Normal; post-vacc Normal] Month 1   46   44   25 
RBC [pre-vacc Normal; post-vacc Below] Month 1   5   4   4 
RBC [pre-vacc Normal; post-vacc Above] Month 1   0   0   0 
RBC [pre-vacc Normal; post-vacc Missing] Month 1   0   0   0 
RBC [pre-vacc Normal; post-vacc Normal] Month 2   44   45   28 
RBC [pre-vacc Normal; post-vacc Below] Month 2   5   3   0 
RBC [pre-vacc Normal; post-vacc Above] Month 2   0   0   0 
RBC [pre-vacc Normal; post-vacc Missing] Month 2   0   0   0 
RBC [pre-vacc Normal; post-vacc Normal] Month 4   43   40   25 
RBC [pre-vacc Normal; post-vacc Below] Month 4   6   6   1 
RBC [pre-vacc Normal; post-vacc Above] Month 4   0   0   0 
RBC [pre-vacc Normal; post-vacc Missing] Month 4   0   0   0 
RBC [pre-vacc Normal; post-vacc Normal] Month 6   40   40   25 
RBC [pre-vacc Normal; post-vacc Below] Month 6   9   5   1 
RBC [pre-vacc Normal; post-vacc Above] Month 6   0   0   0 
RBC [pre-vacc Normal; post-vacc Missing] Month 6   0   0   0 
RBC [pre-vacc Normal; post-vacc Normal] Month 7   43   37   24 
RBC [pre-vacc Normal; post-vacc Below] Month 7   5   8   1 
RBC [pre-vacc Normal; post-vacc Above] Month 7   0   0   0 
RBC [pre-vacc Normal; post-vacc Missing] Month 7   0   0   0 
RBC [pre-vacc Low; post-vacc Normal] Day 7   0   0   0 
RBC [pre-vacc Low; post-vacc Below] Day 7   0   1   0 
RBC [pre-vacc Low; post-vacc Above] Day 7   0   0   0 
RBC [pre-vacc Low; post-vacc Missing] Day 7   0   0   0 
RBC [pre-vacc Low; post-vacc Normal] Month 1   4   4   0 
RBC [pre-vacc Low; post-vacc Below] Month 1   5   5   0 
RBC [pre-vacc Low; post-vacc Above] Month 1   0   0   0 
RBC [pre-vacc Low; post-vacc Missing] Month 1   0   0   0 
RBC [pre-vacc Low; post-vacc Normal] Month 2   3   1   0 
RBC [pre-vacc Low; post-vacc Below] Month 2   6   8   0 
RBC [pre-vacc Low; post-vacc Above] Month 2   0   0   0 
RBC [pre-vacc Low; post-vacc Missing] Month 2   0   0   0 
RBC [pre-vacc Low; post-vacc Normal] Month 4   4   4   0 
RBC [pre-vacc Low; post-vacc Below] Month 4   4   4   0 
RBC [pre-vacc Low; post-vacc Above] Month 4   0   0   0 
RBC [pre-vacc Low; post-vacc Missing] Month 4   0   0   0 
RBC [pre-vacc Low; post-vacc Normal] Month 6   3   4   0 
RBC [pre-vacc Low; post-vacc Below] Month 6   5   5   0 
RBC [pre-vacc Low; post-vacc Above] Month 6   0   0   0 
RBC [pre-vacc Low; post-vacc Missing] Month 6   0   0   0 
RBC [pre-vacc Low; post-vacc Normal] Month 7   2   4   0 
RBC [pre-vacc Low; post-vacc Below] Month 7   6   4   0 
RBC [pre-vacc Low; post-vacc Above] Month 7   0   0   0 
RBC [pre-vacc Low; post-vacc Missing] Month 7   0   0   0 
PLA [pre-vacc Normal; post-vacc Normal] Day 7   13   14   15 
PLA [pre-vacc Normal; post-vacc Below] Day 7   0   0   0 
PLA [pre-vacc Normal; post-vacc Above] Day 7   0   0   0 
PLA [pre-vacc Normal; post-vacc Missing] Day 7   0   0   0 
PLA [pre-vacc Normal; post-vacc Normal] Month 1   56   54   29 
PLA [pre-vacc Normal; post-vacc Below] Month 1   0   0   0 
PLA [pre-vacc Normal; post-vacc Above] Month 1   0   0   0 
PLA [pre-vacc Normal; post-vacc Missing] Month 1   0   1   0 
PLA [pre-vacc Normal; post-vacc Normal] Month 2   51   54   28 
PLA [pre-vacc Normal; post-vacc Below] Month 2   0   0   0 
PLA [pre-vacc Normal; post-vacc Above] Month 2   2   1   0 
PLA [pre-vacc Normal; post-vacc Missing] Month 2   1   0   0 
PLA [pre-vacc Normal; post-vacc Normal] Month 4   52   51   26 
PLA [pre-vacc Normal; post-vacc Below] Month 4   0   0   0 
PLA [pre-vacc Normal; post-vacc Above] Month 4   0   1   0 
PLA [pre-vacc Normal; post-vacc Missing] Month 4   1   0   0 
PLA [pre-vacc Normal; post-vacc Normal] Month 6   53   52   26 
PLA [pre-vacc Normal; post-vacc Below] Month 6   0   0   0 
PLA [pre-vacc Normal; post-vacc Above] Month 6   0   0   0 
PLA [pre-vacc Normal; post-vacc Missing] Month 6   0   0   0 
PLA [pre-vacc Normal; post-vacc Normal] Month 7   51   50   25 
PLA [pre-vacc Normal; post-vacc Below] Month 7   0   0   0 
PLA [pre-vacc Normal; post-vacc Above] Month 7   1   1   0 
PLA [pre-vacc Normal; post-vacc Missing] Month 7   0   0   0 
PLA [pre-vacc Low; post-vacc Normal] Month 1   0   0   0 
PLA [pre-vacc Low; post-vacc Below] Month 1   1   0   0 
PLA [pre-vacc Low; post-vacc Above] Month 1   0   0   0 
PLA [pre-vacc Low; post-vacc Missing] Month 1   0   0   0 
PLA [pre-vacc Low; post-vacc Normal] Month 2   0   0   0 
PLA [pre-vacc Low; post-vacc Below] Month 2   1   0   0 
PLA [pre-vacc Low; post-vacc Above] Month 2   0   0   0 
PLA [pre-vacc Low; post-vacc Missing] Month 2   0   0   0 
PLA [pre-vacc Low; post-vacc Normal] Month 4   0   0   0 
PLA [pre-vacc Low; post-vacc Below] Month 4   1   0   0 
PLA [pre-vacc Low; post-vacc Above] Month 4   0   0   0 
PLA [pre-vacc Low; post-vacc Missing] Month 4   0   0   0 
PLA [pre-vacc Low; post-vacc Normal] Month 6   0   0   0 
PLA [pre-vacc Low; post-vacc Below] Month 6   1   0   0 
PLA [pre-vacc Low; post-vacc Above] Month 6   0   0   0 
PLA [pre-vacc Low; post-vacc Missing] Month 6   0   0   0 
PLA [pre-vacc Low; post-vacc Normal] Month 7   1   0   0 
PLA [pre-vacc Low; post-vacc Below] Month 7   0   0   0 
PLA [pre-vacc Low; post-vacc Above] Month 7   0   0   0 
PLA [pre-vacc Low; post-vacc Missing] Month 7   0   0   0 
PLA [pre-vacc High; post-vacc Normal] Day 7   0   1   0 
PLA [pre-vacc High; post-vacc Below] Day 7   0   0   0 
PLA [pre-vacc High; post-vacc Above] Day 7   2   0   0 
PLA [pre-vacc High; post-vacc Missing] Day 7   0   0   0 
PLA [pre-vacc High; post-vacc Normal] Month 1   1   0   0 
PLA [pre-vacc High; post-vacc Below] Month 1   0   0   0 
PLA [pre-vacc High; post-vacc Above] Month 1   2   2   0 
PLA [pre-vacc High; post-vacc Missing] Month 1   0   0   0 
PLA [pre-vacc High; post-vacc Normal] Month 2   3   2   0 
PLA [pre-vacc High; post-vacc Below] Month 2   0   0   0 
PLA [pre-vacc High; post-vacc Above] Month 2   0   0   0 
PLA [pre-vacc High; post-vacc Missing] Month 2   0   0   0 
PLA [pre-vacc High; post-vacc Normal] Month 4   2   1   0 
PLA [pre-vacc High; post-vacc Below] Month 4   0   0   0 
PLA [pre-vacc High; post-vacc Above] Month 4   1   1   0 
PLA [pre-vacc High; post-vacc Missing] Month 4   0   0   0 
PLA [pre-vacc High; post-vacc Normal] Month 6   3   1   0 
PLA [pre-vacc High; post-vacc Below] Month 6   0   0   0 
PLA [pre-vacc High; post-vacc Above] Month 6   0   1   0 
PLA [pre-vacc High; post-vacc Missing] Month 6   0   0   0 
PLA [pre-vacc High; post-vacc Normal] Month 7   2   1   0 
PLA [pre-vacc High; post-vacc Below] Month 7   0   0   0 
PLA [pre-vacc High; post-vacc Above] Month 7   1   1   0 
PLA [pre-vacc High; post-vacc Missing] Month 7   0   0   0 

No statistical analysis provided for Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed



11.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7 and at Months 1, 2, 4, 6 and 7 ]

Measure Type Primary
Measure Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Reporting Groups
  Description
HIV+/Cervarix Group 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.
HIV+/Aluminium Hydroxide Group 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.
HIV-/Cervarix Group 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.

Measured Values
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group 
Participants Analyzed 
[Units: Participants]
 60   57   29 
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. 
[Units: Participants]
Count of Participants
     
WBC [pre-vacc Normal; post-vacc Normal] Day 7   9   12   12 
WBC [pre-vacc Normal; post-vacc Below] Day 7   4   2   1 
WBC [pre-vacc Normal; post-vacc Above] Day 7   0   0   0 
WBC [pre-vacc Normal; post-vacc Missing] Day 7   0   0   0 
WBC [pre-vacc Normal; post-vacc Normal] Month 1   39   43   23 
WBC [pre-vacc Normal; post-vacc Below] Month 1   7   6   3 
WBC [pre-vacc Normal; post-vacc Above] Month 1   0   0   0 
WBC [pre-vacc Normal; post-vacc Missing] Month 1   0   0   0 
WBC [pre-vacc Normal; post-vacc Normal] Month 2   38   41   24 
WBC [pre-vacc Normal; post-vacc Below] Month 2   6   9   2 
WBC [pre-vacc Normal; post-vacc Above] Month 2   0   0   0 
WBC [pre-vacc Normal; post-vacc Missing] Month 2   0   0   0 
WBC [pre-vacc Normal; post-vacc Normal] Month 4   37   41   22 
WBC [pre-vacc Normal; post-vacc Below] Month 4   6   7   2 
WBC [pre-vacc Normal; post-vacc Above] Month 4   0   0   0 
WBC [pre-vacc Normal; post-vacc Missing] Month 4   0   0   0 
WBC [pre-vacc Normal; post-vacc Normal] Month 6   35   38   21 
WBC [pre-vacc Normal; post-vacc Below] Month 6   8   8   2 
WBC [pre-vacc Normal; post-vacc Above] Month 6   0   0   1 
WBC [pre-vacc Normal; post-vacc Missing] Month 6   0   0   0 
WBC [pre-vacc Normal; post-vacc Normal] Month 7   34   38   21 
WBC [pre-vacc Normal; post-vacc Below] Month 7   8   8   2 
WBC [pre-vacc Normal; post-vacc Above] Month 7   0   0   0 
WBC [pre-vacc Normal; post-vacc Missing] Month 7   0   0   0 
WBC [pre-vacc Low; post-vacc Normal] Day 7   1   1   1 
WBC [pre-vacc Low; post-vacc Below] Day 7   1   0   1 
WBC [pre-vacc Low; post-vacc Above] Day 7   0   0   0 
WBC [pre-vacc Low; post-vacc Missing] Day 7   0   0   0 
WBC [pre-vacc Low; post-vacc Normal] Month 1   9   5   2 
WBC [pre-vacc Low; post-vacc Below] Month 1   5   3   1 
WBC [pre-vacc Low; post-vacc Above] Month 1   0   0   0 
WBC [pre-vacc Low; post-vacc Missing] Month 1   0   0   0 
WBC [pre-vacc Low; post-vacc Normal] Month 2   10   5   0 
WBC [pre-vacc Low; post-vacc Below] Month 2   4   2   2 
WBC [pre-vacc Low; post-vacc Above] Month 2   0   0   0 
WBC [pre-vacc Low; post-vacc Missing] Month 2   0   0   0 
WBC [pre-vacc Low; post-vacc Normal] Month 4   8   2   1 
WBC [pre-vacc Low; post-vacc Below] Month 4   6   4   1 
WBC [pre-vacc Low; post-vacc Above] Month 4   0   0   0 
WBC [pre-vacc Low; post-vacc Missing] Month 4   0   0   0 
WBC [pre-vacc Low; post-vacc Normal] Month 6   6   5   0 
WBC [pre-vacc Low; post-vacc Below] Month 6   8   3   2 
WBC [pre-vacc Low; post-vacc Above] Month 6   0   0   0 
WBC [pre-vacc Low; post-vacc Missing] Month 6   0   0   0 
WBC [pre-vacc Low; post-vacc Normal] Month 7   6   3   1 
WBC [pre-vacc Low; post-vacc Below] Month 7   8   4   1 
WBC [pre-vacc Low; post-vacc Above] Month 7   0   0   0 
WBC [pre-vacc Low; post-vacc Missing] Month 7   0   0   0 
NEU [pre-vacc Normal; post-vacc Normal] Day 7   9   11   12 
NEU [pre-vacc Normal; post-vacc Below] Day 7   4   3   1 
NEU [pre-vacc Normal; post-vacc Above] Day 7   0   0   0 
NEU [pre-vacc Normal; post-vacc Missing] Day 7   0   0   0 
NEU [pre-vacc Normal; post-vacc Normal] Month 1   36   36   21 
NEU [pre-vacc Normal; post-vacc Below] Month 1   11   5   4 
NEU [pre-vacc Normal; post-vacc Above] Month 1   1   0   0 
NEU [pre-vacc Normal; post-vacc Missing] Month 1   0   0   0 
NEU [pre-vacc Normal; post-vacc Normal] Month 2   38   35   22 
NEU [pre-vacc Normal; post-vacc Below] Month 2   8   6   3 
NEU [pre-vacc Normal; post-vacc Above] Month 2   0   1   0 
NEU [pre-vacc Normal; post-vacc Missing] Month 2   0   0   0 
NEU [pre-vacc Normal; post-vacc Normal] Month 4   36   30   19 
NEU [pre-vacc Normal; post-vacc Below] Month 4   9   10   4 
NEU [pre-vacc Normal; post-vacc Above] Month 4   0   0   0 
NEU [pre-vacc Normal; post-vacc Missing] Month 4   0   0   0 
NEU [pre-vacc Normal; post-vacc Normal] Month 6   33   33   19 
NEU [pre-vacc Normal; post-vacc Below] Month 6   12   5   4 
NEU [pre-vacc Normal; post-vacc Above] Month 6   0   0   0 
NEU [pre-vacc Normal; post-vacc Missing] Month 6   0   0   0 
NEU [pre-vacc Normal; post-vacc Normal] Month 7   35   32   18 
NEU [pre-vacc Normal; post-vacc Below] Month 7   9   6   4 
NEU [pre-vacc Normal; post-vacc Above] Month 7   0   0   0 
NEU [pre-vacc Normal; post-vacc Missing] Month 7   0   0   0 
NEU [pre-vacc Low; post-vacc Normal] Day 7   0   1   0 
NEU [pre-vacc Low; post-vacc Below] Day 7   2   0   2 
NEU [pre-vacc Low; post-vacc Above] Day 7   0   0   0 
NEU [pre-vacc Low; post-vacc Missing] Day 7   0   0   0 
NEU [pre-vacc Low; post-vacc Normal] Month 1   7   6   1 
NEU [pre-vacc Low; post-vacc Below] Month 1   5   10   3 
NEU [pre-vacc Low; post-vacc Above] Month 1   0   0   0 
NEU [pre-vacc Low; post-vacc Missing] Month 1   0   0   0 
NEU [pre-vacc Low; post-vacc Normal] Month 2   6   7   0 
NEU [pre-vacc Low; post-vacc Below] Month 2   6   8   3 
NEU [pre-vacc Low; post-vacc Above] Month 2   0   0   0 
NEU [pre-vacc Low; post-vacc Missing] Month 2   0   0   0 
NEU [pre-vacc Low; post-vacc Normal] Month 4   6   7   1 
NEU [pre-vacc Low; post-vacc Below] Month 4   6   7   2 
NEU [pre-vacc Low; post-vacc Above] Month 4   0   0   0 
NEU [pre-vacc Low; post-vacc Missing] Month 4   0   0   0 
NEU [pre-vacc Low; post-vacc Normal] Month 6   5   6   0 
NEU [pre-vacc Low; post-vacc Below] Month 6   7   10   3 
NEU [pre-vacc Low; post-vacc Above] Month 6   0   0   0 
NEU [pre-vacc Low; post-vacc Missing] Month 6   0   0   0 
NEU [pre-vacc Low; post-vacc Normal] Month 7   5   6   0 
NEU [pre-vacc Low; post-vacc Below] Month 7   7   9   3 
NEU [pre-vacc Low; post-vacc Above] Month 7   0   0   0 
NEU [pre-vacc Low; post-vacc Missing] Month 7   0   0   0 

No statistical analysis provided for Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.



12.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7 and at Months 1, 2, 4, 6 and 7 ]

Measure Type Primary
Measure Title Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

Reporting Groups
  Description
HIV+/Cervarix Group 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.
HIV+/Aluminium Hydroxide Group 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.
HIV-/Cervarix Group 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.

Measured Values
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group 
Participants Analyzed 
[Units: Participants]
 60   57   29 
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. 
[Units: Participants]
Count of Participants
     
LYM [pre-vacc Normal; post-vacc Normal] Day 7   12   14   14 
LYM [pre-vacc Normal; post-vacc Below] Day 7   0   0   0 
LYM [pre-vacc Normal; post-vacc Above] Day 7   0   0   0 
LYM [pre-vacc Normal; post-vacc Missing] Day 7   0   0   0 
LYM [pre-vacc Normal; post-vacc Normal] Month 1   52   55   27 
LYM [pre-vacc Normal; post-vacc Below] Month 1   2   0   0 
LYM [pre-vacc Normal; post-vacc Above] Month 1   0   1   0 
LYM [pre-vacc Normal; post-vacc Missing] Month 1   0   0   0 
LYM [pre-vacc Normal; post-vacc Normal] Month 2   50   54   26 
LYM [pre-vacc Normal; post-vacc Below] Month 2   1   2   0 
LYM [pre-vacc Normal; post-vacc Above] Month 2   1   0   0 
LYM [pre-vacc Normal; post-vacc Missing] Month 2   0   0   0 
LYM [pre-vacc Normal; post-vacc Normal] Month 4   49   50   23 
LYM [pre-vacc Normal; post-vacc Below] Month 4   2   3   0 
LYM [pre-vacc Normal; post-vacc Above] Month 4   0   0   1 
LYM [pre-vacc Normal; post-vacc Missing] Month 4   0   0   0 
LYM [pre-vacc Normal; post-vacc Normal] Month 6   48   52   22 
LYM [pre-vacc Normal; post-vacc Below] Month 6   3   1   0 
LYM [pre-vacc Normal; post-vacc Above] Month 6   0   0   2 
LYM [pre-vacc Normal; post-vacc Missing] Month 6   0   0   0 
LYM [pre-vacc Normal; post-vacc Normal] Month 7   48   49   22 
LYM [pre-vacc Normal; post-vacc Below] Month 7   2   3   0 
LYM [pre-vacc Normal; post-vacc Above] Month 7   0   0   1 
LYM [pre-vacc Normal; post-vacc Missing] Month 7   0   0   0 
LYM [pre-vacc Low; post-vacc Normal] Day 7   2   1   1 
LYM [pre-vacc Low; post-vacc Below] Day 7   0   0   0 
LYM [pre-vacc Low; post-vacc Above] Day 7   0   0   0 
LYM [pre-vacc Low; post-vacc Missing] Day 7   0   0   0 
LYM [pre-vacc Low; post-vacc Normal] Month 1   3   1   1 
LYM [pre-vacc Low; post-vacc Below] Month 1   2   0   0 
LYM [pre-vacc Low; post-vacc Above] Month 1   0   0   0 
LYM [pre-vacc Low; post-vacc Missing] Month 1   0   0   0 
LYM [pre-vacc Low; post-vacc Normal] Month 2   4   1   1 
LYM [pre-vacc Low; post-vacc Below] Month 2   1   0   0 
LYM [pre-vacc Low; post-vacc Above] Month 2   0   0   0 
LYM [pre-vacc Low; post-vacc Missing] Month 2   0   0   0 
LYM [pre-vacc Low; post-vacc Normal] Month 4   3   1   1 
LYM [pre-vacc Low; post-vacc Below] Month 4   2   0   0 
LYM [pre-vacc Low; post-vacc Above] Month 4   0   0   0 
LYM [pre-vacc Low; post-vacc Missing] Month 4   0   0   0 
LYM [pre-vacc Low; post-vacc Normal] Month 6   3   1   1 
LYM [pre-vacc Low; post-vacc Below] Month 6   2   0   0 
LYM [pre-vacc Low; post-vacc Above] Month 6   0   0   0 
LYM [pre-vacc Low; post-vacc Missing] Month 6   0   0   0 
LYM [pre-vacc Low; post-vacc Normal] Month 7   3   1   1 
LYM [pre-vacc Low; post-vacc Below] Month 7   2   0   0 
LYM [pre-vacc Low; post-vacc Above] Month 7   0   0   0 
LYM [pre-vacc Low; post-vacc Missing] Month 7   0   0   0 
LYM [pre-vacc High; post-vacc Normal] Day 7   1   0   0 
LYM [pre-vacc High; post-vacc Below] Day 7   0   0   0 
LYM [pre-vacc High; post-vacc Above] Day 7   0   0   0 
LYM [pre-vacc High; post-vacc Missing] Day 7   0   0   0 
LYM [pre-vacc High; post-vacc Normal] Month 1   1   0   1 
LYM [pre-vacc High; post-vacc Below] Month 1   0   0   0 
LYM [pre-vacc High; post-vacc Above] Month 1   0   0   0 
LYM [pre-vacc High; post-vacc Missing] Month 1   0   0   0 
LYM [pre-vacc High; post-vacc Normal] Month 2   1   0   1 
LYM [pre-vacc High; post-vacc Below] Month 2   0   0   0 
LYM [pre-vacc High; post-vacc Above] Month 2   0   0   0 
LYM [pre-vacc High; post-vacc Missing] Month 2   0   0   0 
LYM [pre-vacc High; post-vacc Normal] Month 4   1   0   1 
LYM [pre-vacc High; post-vacc Below] Month 4   0   0   0 
LYM [pre-vacc High; post-vacc Above] Month 4   0   0   0 
LYM [pre-vacc High; post-vacc Missing] Month 4   0   0   0 
LYM [pre-vacc High; post-vacc Normal] Month 6   1   0   1 
LYM [pre-vacc High; post-vacc Below] Month 6   0   0   0 
LYM [pre-vacc High; post-vacc Above] Month 6   0   0   0 
LYM [pre-vacc High; post-vacc Missing] Month 6   0   0   0 
LYM [pre-vacc High; post-vacc Normal] Month 7   1   0   1 
LYM [pre-vacc High; post-vacc Below] Month 7   0   0   0 
LYM [pre-vacc High; post-vacc Above] Month 7   0   0   0 
LYM [pre-vacc High; post-vacc Missing] Month 7   0   0   0 
MON [pre-vacc Normal; post-vacc Normal] Day 7   13   14   15 
MON [pre-vacc Normal; post-vacc Below] Day 7   0   0   0 
MON [pre-vacc Normal; post-vacc Above] Day 7   0   0   0 
MON [pre-vacc Normal; post-vacc Missing] Day 7   0   0   0 
MON [pre-vacc Normal; post-vacc Normal] Month 1   56   54   28 
MON [pre-vacc Normal; post-vacc Below] Month 1   1   1   1 
MON [pre-vacc Normal; post-vacc Above] Month 1   0   1   0 
MON [pre-vacc Normal; post-vacc Missing] Month 1   0   0   0 
MON [pre-vacc Normal; post-vacc Normal] Month 2   52   55   28 
MON [pre-vacc Normal; post-vacc Below] Month 2   2   1   0 
MON [pre-vacc Normal; post-vacc Above] Month 2   1   0   0 
MON [pre-vacc Normal; post-vacc Missing] Month 2   0   0   0 
MON [pre-vacc Normal; post-vacc Normal] Month 4   51   52   26 
MON [pre-vacc Normal; post-vacc Below] Month 4   3   1   0 
MON [pre-vacc Normal; post-vacc Above] Month 4   0   0   0 
MON [pre-vacc Normal; post-vacc Missing] Month 4   0   0   0 
MON [pre-vacc Normal; post-vacc Normal] Month 6   53   52   26 
MON [pre-vacc Normal; post-vacc Below] Month 6   1   1   0 
MON [pre-vacc Normal; post-vacc Above] Month 6   0   0   0 
MON [pre-vacc Normal; post-vacc Missing] Month 6   0   0   0 
MON [pre-vacc Normal; post-vacc Normal] Month 7   50   50   24 
MON [pre-vacc Normal; post-vacc Below] Month 7   3   2   1 
MON [pre-vacc Normal; post-vacc Above] Month 7   0   0   0 
MON [pre-vacc Normal; post-vacc Missing] Month 7   0   0   0 
MON [pre-vacc Low; post-vacc Normal] Day 7   2   1   0 
MON [pre-vacc Low; post-vacc Below] Day 7   0   0   0 
MON [pre-vacc Low; post-vacc Above] Day 7   0   0   0 
MON [pre-vacc Low; post-vacc Missing] Day 7   0   0   0 
MON [pre-vacc Low; post-vacc Normal] Month 1   2   1   0 
MON [pre-vacc Low; post-vacc Below] Month 1   1   0   0 
MON [pre-vacc Low; post-vacc Above] Month 1   0   0   0 
MON [pre-vacc Low; post-vacc Missing] Month 1   0   0   0 
MON [pre-vacc Low; post-vacc Normal] Month 2   3   1   0 
MON [pre-vacc Low; post-vacc Below] Month 2   0   0   0 
MON [pre-vacc Low; post-vacc Above] Month 2   0   0   0 
MON [pre-vacc Low; post-vacc Missing] Month 2   0   0   0