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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00586339
First received: December 21, 2007
Last updated: July 19, 2012
Last verified: July 2012
Results First Received: February 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: HPV-16/18 Infections
Cervical Neoplasia
Interventions: Biological: Cervarix TM
Biological: Placebo Control

  Participant Flow
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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
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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  
Number of Participants  
[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  
Gender  
[units: Subjects]
       
Female     61     59     30     150  
Male     0     0     0     0  



  Outcome Measures
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1.  Primary:   Number of Subjects Reporting Any Solicited Local Symptoms.   [ Time Frame: Within 7 days (Days 0-6) after vaccination. ]

Measure Type Primary
Measure Title Number of Subjects Reporting Any Solicited Local Symptoms.
Measure Description

Solicited local symptoms assessed were pain and swelling. Any = incidence of a particular symptom regardless of intensity grade. Solicited adverse events (AEs) = symptom to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events was actively solicited from the subject or an observer during a specified post-vaccination follow-up period.

Solicited local symptoms were assessed as related to the study vaccination.

Time Frame Within 7 days (Days 0-6) after vaccination.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  61     59     30  
Number of Subjects Reporting Any Solicited Local Symptoms.  
[units: Subjects]
     
Pain     52     27     28  
Swelling     19     2     12  

No statistical analysis provided for Number of Subjects Reporting Any Solicited Local Symptoms.



2.  Primary:   Number of Subjects Reporting Severe (Grade 3) Solicited Local Symptoms.   [ Time Frame: Within 7 days (Days 0-6) after vaccination. ]

Measure Type Primary
Measure Title Number of Subjects Reporting Severe (Grade 3) Solicited Local Symptoms.
Measure Description Grade 3 swelling was greater than 50 millimeter (mm) i.e. >50 mm and grade 3 pain was pain that prevented normal everyday activities.
Time Frame Within 7 days (Days 0-6) after vaccination.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  61     59     30  
Number of Subjects Reporting Severe (Grade 3) Solicited Local Symptoms.  
[units: subjects]
     
Pain     3     0     1  
Swelling     1     0     4  

No statistical analysis provided for Number of Subjects Reporting Severe (Grade 3) Solicited Local Symptoms.



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

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, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C).

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 vaccination.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  61     59     30  
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.  
[units: Subjects]
     
Any arthralgia     4     4     2  
Grade 3 arthralgia     0     0     0  
Related arthralgia     2     1     2  
Any fatigue     18     16     8  
Grade 3 fatigue     0     1     0  
Related fatigue     15     12     7  
Fever >= 37.5°C     2     3     2  
Fever > 39.0°C     0     1     0  
Related fever     1     0     0  
Any gastrointestinal     15     11     13  
Grade 3 gastrointestinal     1     0     0  
Related gastrointestinal     5     3     4  
Any headache     23     26     16  
Grade 3 headache     0     0     0  
Related headache     10     9     3  
Any myalgia     3     3     7  
Grade 3 myalgia     0     0     0  
Related myalgia     2     3     7  
Any rash     1     2     1  
Grade 3 rash     0     0     0  
Related rash     0     1     0  
Any urticaria     0     0     0  
Grade 3 urticaria     0     0     0  
Related urticaria     0     0     0  

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



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

Measure Type Primary
Measure Title Number of Subjects Reporting Any and Related Unsolicited Symptoms.
Measure Description

Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

Related = event assessed by the investigator as causally related to the study vaccination.

Time Frame Within 30 days (Days 0-29) after vaccination.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  61     59     30  
Number of Subjects Reporting Any and Related Unsolicited Symptoms.  
[units: Subjects]
     
Any unsolicited AE     53     46     26  
Related unsolicited AE     16     3     7  

No statistical analysis provided for Number of Subjects Reporting Any and Related Unsolicited Symptoms.



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

Measure Type Primary
Measure Title Number of Subjects Reporting Severe (Grade 3) Unsolicited Symptoms.
Measure Description

Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

Grade 3= event that prevented normal activity.

Time Frame Within 30 days (Days 0-29) after vaccination.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  61     59     30  
Number of Subjects Reporting Severe (Grade 3) Unsolicited Symptoms.  
[units: subjects]
  1     1     0  

No statistical analysis provided for Number of Subjects Reporting Severe (Grade 3) Unsolicited Symptoms.



6.  Primary:   Number of Subjects With Medically Significant Conditions.   [ Time Frame: Up to Month 7. ]

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

Medically significant conditions 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.

Time Frame Up to Month 7.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  61     59     30  
Number of Subjects With Medically Significant Conditions.  
[units: Subjects]
  18     21     5  

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



7.  Primary:   Number of Subjects Reporting Serious Adverse Events (SAEs).   [ Time Frame: 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 results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame Up to Month 7.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  61     59     30  
Number of Subjects Reporting Serious Adverse Events (SAEs).  
[units: Subjects]
  3     2     1  

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



8.  Primary:   Number of Subjects With Medically Significant Conditions.   [ Time Frame: Up to Month 12. ]

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

Medically significant conditions 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.

Time Frame Up to Month 12.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  61     59     30  
Number of Subjects With Medically Significant Conditions.  
[units: subjects]
  19     21     5  

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



9.  Primary:   Number of Subjects Reporting Serious Adverse Events (SAEs).   [ Time Frame: Up to Month 12. ]

Measure Type Primary
Measure Title Number of Subjects Reporting Serious Adverse Events (SAEs).
Measure Description SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame Up to Month 12.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  61     59     30  
Number of Subjects Reporting Serious Adverse Events (SAEs).  
[units: subjects]
  3     2     1  

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



10.  Primary:   Number of Subjects With Pregnancies and Their Outcome.   [ Time Frame: 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 Up to Month 12.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  0     1     0  
Number of Subjects With Pregnancies and Their Outcome.  
[units: subjects]
      1      

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



11.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7, 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, at Months 1, 2, 4, 6 and 7  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  60     57     29  
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.  
[units: Subjects]
     
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.



12.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At month 10 and month12. ]

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 ALAT, BAS, CREA, EOS, Hct, Hgb, LYM and MON.
Time Frame At month 10 and month12.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  60     57     29  
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.  
[units: subjects]
     
ALAT [pre-vacc Normal; post-vacc Normal] Month 10     44     40     20  
ALAT [pre-vacc Normal; post-vacc Below] Month 10     0     0     0  
ALAT [pre-vacc Normal; post-vacc Above] Month 10     1     4     1  
ALAT [pre-vacc Normal; post-vacc Missing] Month 10     0     0     0  
ALAT [pre-vacc Normal; post-vacc Normal] Month 12     38     39     20  
ALAT [pre-vacc Normal; post-vacc Below] Month 12     0     0     0  
ALAT [pre-vacc Normal; post-vacc Above] Month 12     6     6     1  
ALAT [pre-vacc Normal; post-vacc Missing] Month 12     0     0     0  
ALAT [pre-vacc Low; post-vacc Normal] Month 10     0     0     0  
ALAT [pre-vacc Low; post-vacc Below] Month 10     1     0     0  
ALAT [pre-vacc Low; post-vacc Above] Month 10     0     0     0  
ALAT [pre-vacc Low; post-vacc Missing] Month 10     0     0     0  
ALAT [pre-vacc Low; post-vacc Normal] Month 12     0     0     0  
ALAT [pre-vacc Low; post-vacc Below] Month 12     1     0     0  
ALAT [pre-vacc Low; post-vacc Above] Month 12     0     0     0  
ALAT [pre-vacc Low; post-vacc Missing] Month 12     0     0     0  
ALAT [pre-vacc High; post-vacc Normal] Month 10     8     4     1  
ALAT [pre-vacc High; post-vacc Below] Month 10     0     0     0  
ALAT [pre-vacc High; post-vacc Above] Month 10     1     2     2  
ALAT [pre-vacc High; post-vacc Missing] Month 10     0     0     0  
ALAT [pre-vacc High; post-vacc Normal] Month 12     8     5     2  
ALAT [pre-vacc High; post-vacc Below] Month 12     0     0     0  
ALAT [pre-vacc High; post-vacc Above] Month 12     1     2     1  
ALAT [pre-vacc High; post-vacc Missing] Month 12     0     0     0  
BAS [pre-vacc Normal; post-vacc Normal] Month 10     55     50     24  
BAS [pre-vacc Normal; post-vacc Below] Month 10     0     0     0  
BAS [pre-vacc Normal; post-vacc Above] Month 10     0     0     0  
BAS [pre-vacc Normal; post-vacc Missing] Month 10     0     0     0  
BAS [pre-vacc Normal; post-vacc Normal] Month 12     54     52     24  
BAS [pre-vacc Normal; post-vacc Below] Month 12     0     0     0  
BAS [pre-vacc Normal; post-vacc Above] Month 12     0     0     0  
BAS [pre-vacc Normal; post-vacc Missing] Month 12     0     0     0  
CREA [pre-vacc Normal; post-vacc Normal] Month 10     20     22     15  
CREA [pre-vacc Normal; post-vacc Below] Month 10     4     11     4  
CREA [pre-vacc Normal; post-vacc Above] Month 10     0     0     0  
CREA [pre-vacc Normal; post-vacc Missing] Month 10     0     0     0  
CREA [pre-vacc Normal; post-vacc Normal] Month 12     18     24     13  
CREA [pre-vacc Normal; post-vacc Below] Month 12     6     10     6  
CREA [pre-vacc Normal; post-vacc Above] Month 12     0     0     0  
CREA [pre-vacc Normal; post-vacc Missing] Month 12     0     0     0  
CREA [pre-vacc Low; post-vacc Normal] Month 10     11     4     2  
CREA [pre-vacc Low; post-vacc Below] Month 10     20     13     3  
CREA [pre-vacc Low ; post-vacc Above] Month 10     0     0     0  
CREA [pre-vacc Low; post-vacc Missing] Month 10     0     0     0  
CREA [pre-vacc Low; post-vacc Normal] Month 12     4     4     3  
CREA [pre-vacc Low; post-vacc Below] Month 12     26     14     2  
CREA [pre-vacc Low; post-vacc Above] Month 12     0     0     0  
CREA [pre-vacc Low; post-vacc Missing] Month 12     0     0     0  
EOS [pre-vacc Normal; post-vacc Normal] Month 10     46     46     22  
EOS [pre-vacc Normal; post-vacc Below] Month 10     0     0     0  
EOS [pre-vacc Normal ; post-vacc Above] Month 10     3     2     2  
EOS [pre-vacc Normal; post-vacc Missing] Month 10     0     0     0  
EOS [pre-vacc Normal; post-vacc Normal] Month 12     46     49     24  
EOS [pre-vacc Normal; post-vacc Below] Month 12     0     0     0  
EOS [pre-vacc Normal; post-vacc Above] Month 12     2     1     0  
EOS [pre-vacc Normal; post-vacc Missing] Month 12     0     0     0  
EOS [pre-vacc High; post-vacc Normal] Month 10     3     2     0  
EOS [pre-vacc High; post-vacc Below] Month 10     0     0     0  
EOS [pre-vacc High; post-vacc Above] Month 10     3     0     0  
EOS [pre-vacc High; post-vacc Missing] Month 10     0     0     0  
EOS [pre-vacc High; post-vacc Normal] Month 12     4     2     0  
EOS [pre-vacc High; post-vacc Below] Month 12     0     0     0  
EOS [pre-vacc High; post-vacc Above] Month 12     2     0     0  
EOS [pre-vacc High; post-vacc Missing] Month 12     0     0     0  
Hct [pre-vacc Normal; post-vacc Normal] Month 10     35     31     20  
Hct [pre-vacc Normal; post-vacc Below] Month 10     6     7     2  
Hct [pre-vacc Normal ; post-vacc Above] Month 10     0     0     0  
Hct [pre-vacc Normal; post-vacc Missing] Month 10     0     0     0  
Hct [pre-vacc Normal; post-vacc Normal] Month 12     32     32     22  
Hct [pre-vacc Normal; post-vacc Below] Month 12     9     8     0  
Hct [pre-vacc Normal; post-vacc Above] Month 12     0     0     0  
Hct [pre-vacc Normal; post-vacc Missing] Month 12     0     0     0  
Hct [pre-vacc Low; post-vacc Normal] Month 10     6     4     1  
Hct [pre-vacc Low; post-vacc Below] Month 10     8     7     1  
Hct [pre-vacc Low ; post-vacc Above] Month 10     0     0     0  
Hct [pre-vacc Low; post-vacc Missing] Month 10     0     0     0  
Hct [pre-vacc Low; post-vacc Normal] Month 12     4     4     1  
Hct [pre-vacc Low; post-vacc Below] Month 12     9     7     1  
Hct [pre-vacc Low; post-vacc Above] Month 12     0     0     0  
Hct [pre-vacc Low; post-vacc Missing] Month 12     0     0     0  
Hct [pre-vacc High; post-vacc Normal] Month 10     0     0     0  
Hct [pre-vacc High; post-vacc Below] Month 10     0     1     0  
Hct [pre-vacc High; post-vacc Above] Month 10     0     0     0  
Hct [pre-vacc High; post-vacc Missing] Month 10     0     0     0  
Hct [pre-vacc High; post-vacc Normal] Month 12     0     1     0  
Hct [pre-vacc High; post-vacc Below] Month 12     0     0     0  
Hct [pre-vacc High; post-vacc Above] Month 12     0     0     0  
Hct [pre-vacc High; post-vacc Missing] Month 12     0     0     0  
Hgb [pre-vacc Normal; post-vacc Normal] Month 10     44     38     21  
Hgb [pre-vacc Normal; post-vacc Below] Month 10     2     5     0  
Hgb [pre-vacc Normal ; post-vacc Above] Month 10     0     0     0  
Hgb [pre-vacc Normal; post-vacc Missing] Month 10     0     0     0  
Hgb [pre-vacc Normal; post-vacc Normal] Month 12     43     42     21  
Hgb [pre-vacc Normal; post-vacc Below] Month 12     2     3     0  
Hgb [pre-vacc Normal; post-vacc Above] Month 12     0     0     0  
Hgb [pre-vacc Normal; post-vacc Missing] Month 12     0     0     0  
Hgb [pre-vacc Low; post-vacc Normal] Month 10     2     5     1  
Hgb [pre-vacc Low; post-vacc Below] Month 10     7     2     2  
Hgb [pre-vacc Low ; post-vacc Above] Month 10     0     0     0  
Hgb [pre-vacc Low; post-vacc Missing] Month 10     0     0     0  
Hgb [pre-vacc Low; post-vacc Normal] Month 12     4     4     3  
Hgb [pre-vacc Low; post-vacc Below] Month 12     5     3     0  
Hgb [pre-vacc Low; post-vacc Above] Month 12     0     0     0  
Hgb [pre-vacc Low; post-vacc Missing] Month 12     0     0     0  
LYM [pre-vacc Normal; post-vacc Normal] Month 10     46     48     21  
LYM [pre-vacc Normal; post-vacc Below] Month 10     3     1     0  
LYM [pre-vacc Normal; post-vacc Above] Month 10     0     0     1  
LYM [pre-vacc Normal; post-vacc Missing] Month 10     0     0     0  
LYM [pre-vacc Normal; post-vacc Normal] Month 12     45     48     21  
LYM [pre-vacc Normal; post-vacc Below] Month 12     3     2     1  
LYM [pre-vacc Normal; post-vacc Above] Month 12     0     1     0  
LYM [pre-vacc Normal; post-vacc Missing] Month 12     0     0     0  
LYM [pre-vacc Low; post-vacc Normal] Month 10     4     1     1  
LYM [pre-vacc Low; post-vacc Below] Month 10     1     0     0  
LYM [pre-vacc Low; post-vacc Above] Month 10     0     0     0  
LYM [pre-vacc Low; post-vacc Missing] Month 10     0     0     0  
LYM [pre-vacc Low; post-vacc Normal] Month 12     3     1     1  
LYM [pre-vacc Low; post-vacc Below] Month 12     2     0     0  
LYM [pre-vacc Low; post-vacc Above] Month 12     0     0     0  
LYM [pre-vacc Low; post-vacc Missing] Month 12     0     0     0  
LYM [pre-vacc High; post-vacc Normal] Month 10     1     0     1  
LYM [pre-vacc High; post-vacc Below] Month 10     0     0     0  
LYM [pre-vacc High; post-vacc Above] Month 10     0     0     0  
LYM [pre-vacc High; post-vacc Missing] Month 10     0     0     0  
LYM [pre-vacc High; post-vacc Normal] Month 12     1     0     1  
LYM [pre-vacc High; post-vacc Below] Month 12     0     0     0  
LYM [pre-vacc High; post-vacc Above] Month 12     0     0     0  
LYM [pre-vacc High; post-vacc Missing] Month 12     0     0     0  
MON [pre-vacc Normal; post-vacc Normal] Month 10     50     48     24  
MON [pre-vacc Normal; post-vacc Below] Month 10     2     1     0  
MON [pre-vacc Normal; post-vacc Above] Month 10     0     0     0  
MON [pre-vacc Normal; post-vacc Missing] Month 10     0     0     0  
MON [pre-vacc Normal; post-vacc Normal] Month 12     50     45     24  
MON [pre-vacc Normal; post-vacc Below] Month 12     1     5     0  
MON [pre-vacc Normal; post-vacc Above] Month 12     0     1     0  
MON [pre-vacc Normal; post-vacc Missing] Month 12     0     0     0  
MON [pre-vacc Low; post-vacc Normal] Month 10     2     1     0  
MON [pre-vacc Low; post-vacc Below] Month 10     1     0     0  
MON [pre-vacc Low; post-vacc Above] Month 10     0     0     0  
MON [pre-vacc Low; post-vacc Missing] Month 10     0     0     0  
MON [pre-vacc Low; post-vacc Normal] Month 12     2     1     0  
MON [pre-vacc Low; post-vacc Below] Month 12     1     0     0  
MON [pre-vacc Low; post-vacc Above] Month 12     0     0     0  
MON [pre-vacc Low; post-vacc Missing] Month 12     0     0     0  

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



13.  Primary:   Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.   [ Time Frame: At Months 1, 2, 4, 6 and 7. ]

Measure Type Primary
Measure Title Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.
Measure Description

CD4+ cell count categories, at baseline, assessed were (i) below 200 CD4+ cells per cubic millimetre (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above 500 CD4+ cells/mm^3.

WHO classification of HIV-associated clinical disease:

  1. = Asymptomatic HIV-associated symptoms = WHO clinical stage 1
  2. = Mild HIV-associated symptoms = WHO clinical stage 2
  3. = Advanced HIV-associated symptoms = WHO clinical stage 3
  4. = Severe HIV-associated symptoms = WHO clinical stage 4
Time Frame At Months 1, 2, 4, 6 and 7.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  60     57     0  
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.  
[units: Subjects]
     
<200 CD4+cells/mm^3 [stage 1] Mth 1(N=2;1)     2     1      
<200 CD4+cells/mm^3 [stage 2] Mth 1(N=2;1)     0     0      
<200 CD4+cells/mm^3 [stage 3] Mth 1(N=2;1)     0     0      
<200 CD4+cells/mm^3 [stage 4] Mth 1(N=2;1)     0     0      
200-500 CD4+cells/mm^3 [stage 1] Mth 1(N=35;36)     31     33      
200-500 CD4+cells/mm^3 [stage 2] Mth 1(N=35;36)     2     2      
200-500 CD4+cells/mm^3 [stage 3] Mth 1(N=35;36)     2     1      
200-500 CD4+cells/mm^3 [stage 4] Mth 1(N=35;36)     0     0      
>500 CD4+cells/mm^3 [stage 1] Mth 1(N=23;20)     23     20      
>500 CD4+cells/mm^3 [stage 2] Mth 1(N=23;20)     0     0      
>500 CD4+cells/mm^3 [stage 3] Mth 1(N=23;20)     0     0      
>500 CD4+cells/mm^3 [stage 4] Mth 1(N=23;20)     0     0      
<200 CD4+cells/mm^3 [stage 1] Mth 2 (N=2;1)     2     1      
<200 CD4+cells/mm^3 [stage 2] Mth 2 (N=2;1)     0     0      
<200 CD4+cells/mm^3 [stage 3] Mth 2 (N=2;1)     0     0      
<200 CD4+cells/mm^3 [stage 4] Mth 2 (N=2;1)     0     0      
200-500 CD4+cells/mm^3 [stage 1] Mth 2(N=35;36)     30     33      
200-500 CD4+cells/mm^3 [stage 2] Mth 2(N=35;36)     2     3      
200-500 CD4+cells/mm^3 [stage 3] Mth 2(N=35;36)     2     1      
200-500 CD4+cells/mm^3 [stage 4] Mth 2(N=35;36)     0     0      
>500 CD4+cells/mm^3 [stage 1] Mth 2 (N=23;20)     22     19      
>500 CD4+cells/mm^3 [stage 2] Mth 2 (N=23;20)     0     0      
>500 CD4+cells/mm^3 [stage 3] Mth 2 (N=23;20)     0     0      
>500 CD4+cells/mm^3 [stage 4] Mth 2 (N=23;20)     0     0      
<200 CD4+cells/mm^3 [stage 1] Mth 4 (N=2;1)     2     1      
<200 CD4+cells/mm^3 [stage 2] Mth 4 (N=2;1)     0     0      
<200 CD4+cells/mm^3 [stage 3] Mth 4 (N=2;1)     0     0      
<200 CD4+cells/mm^3 [stage 4] Mth 4 (N=2;1)     0     0      
200-500 CD4+cells/mm^3 [stage 1] Mth 4(N=35;36)     28     27      
200-500 CD4+cells/mm^3 [stage 2] Mth 4(N=35;36)     2     1      
200-500 CD4+cells/mm^3 [stage 3] Mth 4(N=35;36)     2     5      
200-500 CD4+cells/mm^3 [stage 4] Mth 4(N=35;36)     0     0      
>500 CD4+cells/mm^3 [stage 1] Mth 4 (N=23;20)     23     20      
>500 CD4+cells/mm^3 [stage 2] Mth 4 (N=23;20)     0     0      
>500 CD4+cells/mm^3 [stage 3] Mth 4 (N=23;20)     0     0      
>500 CD4+cells/mm^3 [stage 4] Mth 4 (N=23;20)     0     0      
<200 CD4+cells/mm^3 [stage 1] Mth 6 (N=2;1)     2     1      
<200 CD4+cells/mm^3 [stage 2] Mth 6 (N=2;1)     0     0      
<200 CD4+cells/mm^3 [stage 3] Mth 6 (N=2;1)     0     0      
<200 CD4+cells/mm^3 [stage 4] Mth 6 (N=2;1)     0     0      
200-500 CD4+cells/mm^3 [stage 1] Mth 6 (N=35;36)     28     28      
200-500 CD4+cells/mm^3 [stage 2] Mth 6 (N=35;36)     2     1      
200-500 CD4+cells/mm^3 [stage 3] Mth 6 (N=35;36)     2     5      
200-500 CD4+cells/mm^3 [stage 4] Mth 6 (N=35;36)     0     0      
>500 CD4+cells/mm^3 [stage 1] Mth 6 (N=23;20)     23     19      
>500 CD4+cells/mm^3 [stage 2] Mth 6 (N=23;20)     0     0      
>500 CD4+cells/mm^3 [stage 3] Mth 6 (N=23;20)     0     0      
>500 CD4+cells/mm^3 [stage 4] Mth 6 (N=23;20)     0     0      
<200 CD4+cells/mm^3 [stage 1] Mth 7 (N=2;1)     2     1      
<200 CD4+cells/mm^3 [stage 2] Mth 7 (N=2;1)     0     0      
<200 CD4+cells/mm^3 [stage 3] Mth 7 (N=2;1)     0     0      
<200 CD4+cells/mm^3 [stage 4] Mth 7 (N=2;1)     0     0      
200-500 CD4+cells/mm^3 [stage 1] Mth 7 (N=35;36)     28     28      
200-500 CD4+cells/mm^3 [stage 2] Mth 7 (N=35;36)     2     0      
200-500 CD4+cells/mm^3 [stage 3] Mth 7 (N=35;36)     2     4      
200-500 CD4+cells/mm^3 [stage 4] Mth 7 (N=35;36)     0     0      
>500 CD4+cells/mm^3 [stage 1] Mth 7 (N=23;20)     21     19      
>500 CD4+cells/mm^3 [stage 2] Mth 7 (N=23;20)     1     1      
>500 CD4+cells/mm^3 [stage 3] Mth 7 (N=23;20)     0     0      
>500 CD4+cells/mm^3 [stage 4] Mth 7 (N=23;20)     0     0      

No statistical analysis provided for Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.



14.  Primary:   Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.   [ Time Frame: At Month 10 and Month 12. ]

Measure Type Primary
Measure Title Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.
Measure Description CD4+ cell count categories, at baseline, assessed were (i) below 200 CD4+ cells per cubic millimetre (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above 500 CD4+ cells/mm^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1 2 = Mild HIV-associated symptoms = WHO clinical stage 2 3 = Advanced HIV-associated symptoms = WHO clinical stage 3 4 = Severe HIV-associated symptoms = WHO clinical stage 4
Time Frame At Month 10 and Month 12.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  60     57     0  
Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.  
[units: subjects]
     
<200 CD4+cells/mm^3 [stage 1] Mth 10 (N=2;1)     1     1      
<200 CD4+cells/mm^3 [stage 2] Mth 10 (N=2;1)     1     0      
<200 CD4+cells/mm^3 [stage 3] Mth 10 (N=2;1)     0     0      
<200 CD4+cells/mm^3 [stage 4] Mth 10 (N=2;1)     0     0      
200-500 CD4+cells/mm^3 [stage 1] Mth 10 (N=31;30)     26     25      
200-500 CD4+cells/mm^3 [stage 2] Mth 10 (N=31;30)     1     0      
200-500 CD4+cells/mm^3 [stage 3] Mth 10 (N=31;30)     4     4      
200-500 CD4+cells/mm^3 [stage 4] Mth 10 (N=31;30)     0     1      
>500 CD4+cells/mm^3 [stage 1] Mth 10 (N=22;19)     21     18      
>500 CD4+cells/mm^3 [stage 2] Mth 10 (N=22;19)     1     1      
>500 CD4+cells/mm^3 [stage 3] Mth 10 (N=22;19)     0     0      
>500 CD4+cells/mm^3 [stage 4] Mth 10 (N=22;19)     0     0      
<200 CD4+cells/mm^3 [stage 1] Mth 12 (N=2;1)     0     1      
<200 CD4+cells/mm^3 [stage 2] Mth 12 (N=2;1)     2     0      
<200 CD4+cells/mm^3 [stage 3] Mth 12 (N=2;1)     0     0      
<200 CD4+cells/mm^3 [stage 4] Mth 12 (N=2;1)     0     0      
200-500 CD4+cells/mm^3 [stage 1] Mth 12 (N=31;32)     24     23      
200-500 CD4+cells/mm^3 [stage 2] Mth 12 (N=31;32)     3     2      
200-500 CD4+cells/mm^3 [stage 3] Mth 12 (N=31;32)     4     6      
200-500 CD4+cells/mm^3 [stage 4] Mth 12 (N=31;32)     0     1      
>500 CD4+cells/mm^3 [stage 1] Mth 12 (N=21;19)     20     17      
>500 CD4+cells/mm^3 [stage 2] Mth 12 (N=21;19)     1     2      
>500 CD4+cells/mm^3 [stage 3] Mth 12 (N=21;19)     0     0      
>500 CD4+cells/mm^3 [stage 4] Mth 12 (N=21;19)     0     0      

No statistical analysis provided for Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage at Each Time Point by Cluster of Differentiation 4 (CD4+) Cell Count Category at Baseline in All HIV+ Subjects.



15.  Primary:   Number of CD4+ Cells Per Cubic Millimeter at Each Time Point in All HIV+ Subjects.   [ Time Frame: At pre-vaccination and at Months 1, 2, 4, 6 and 7. ]

Measure Type Primary
Measure Title Number of CD4+ Cells Per Cubic Millimeter at Each Time Point in All HIV+ Subjects.
Measure Description No text entered.
Time Frame At pre-vaccination and at Months 1, 2, 4, 6 and 7.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  61     59     0  
Number of CD4+ Cells Per Cubic Millimeter at Each Time Point in All HIV+ Subjects.  
[units: cells/mm^3]
Median ( Inter-Quartile Range )
     
CD4+/mm^3 [at pre-vaccination] (N=61;59)     451.0  
  ( 310.0 to 596.0 )  
  458.0  
  ( 363.0 to 611.0 )  
   
   
CD4+/mm^3 [at Month 1] (N=60;57)     464.0  
  ( 346.0 to 578.5 )  
  426.0  
  ( 352.0 to 584.0 )  
   
   
CD4+/mm^3 [at Month 2] (N=58;57)     436.0  
  ( 322.0 to 591.0 )  
  438.0  
  ( 320.0 to 580.0 )  
   
   
CD4+/mm^3 [at Month 4] (N=57;54)     469.0  
  ( 346.0 to 596.0 )  
  423.0  
  ( 308.0 to 563.0 )  
   
   
CD4+/mm^3 [at Month 6] (N=57;54)     452.0  
  ( 339.0 to 625.0 )  
  426.0  
  ( 334.0 to 550.0 )  
   
   
CD4+/mm^3 [at Month 7] (N=56;53)     419.0  
  ( 327.0 to 593.0 )  
  464.0  
  ( 359.0 to 602.0 )  
   
   

No statistical analysis provided for Number of CD4+ Cells Per Cubic Millimeter at Each Time Point in All HIV+ Subjects.



16.  Primary:   Number of CD4+ Cells Per Cubic Millimetre at Each Time Point in All HIV+ Subjects.   [ Time Frame: At Month 10 and Month 12 ]

Measure Type Primary
Measure Title Number of CD4+ Cells Per Cubic Millimetre at Each Time Point in All HIV+ Subjects.
Measure Description No text entered.
Time Frame At Month 10 and Month 12  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  61     59     0  
Number of CD4+ Cells Per Cubic Millimetre at Each Time Point in All HIV+ Subjects.  
[units: cells/mm^3]
Median ( Inter-Quartile Range )
     
CD4+/mm^3 [at Month 10] (N=55;50)     427.0  
  ( 347.0 to 621.0 )  
  442.0  
  ( 318.0 to 549.0 )  
   
   
CD4+/mm^3 [at Month 12] (N=54;52)     450.5  
  ( 328.0 to 534.0 )  
  453.0  
  ( 332.0 to 636.0 )  
   
   

No statistical analysis provided for Number of CD4+ Cells Per Cubic Millimetre at Each Time Point in All HIV+ Subjects.



17.  Primary:   HIV Viral Load at Each Time Point in All HIV+ Subjects.   [ Time Frame: At pre-vaccination and at Months 1, 2, 4, 6 and 7. ]

Measure Type Primary
Measure Title HIV Viral Load at Each Time Point in All HIV+ Subjects.
Measure Description The viral load was calculated by estimating the amount of virus in blood samples and was given in number of Ribonucleic acid (RNA) copies per millilitre.
Time Frame At pre-vaccination and at Months 1, 2, 4, 6 and 7.  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  61     59     0  
HIV Viral Load at Each Time Point in All HIV+ Subjects.  
[units: RNA copies/mL (in log10)]
Median ( Inter-Quartile Range )
     
HIV viral load [at pre-vaccination] (N=61;59)     4.4  
  ( 3.7 to 4.8 )  
  4.4  
  ( 3.7 to 4.7 )  
   
   
HIV viral load [at Month 1] (N=60;57)     4.4  
  ( 3.7 to 4.9 )  
  4.2  
  ( 3.6 to 4.9 )  
   
   
HIV viral load [at Month 2] (N=57;57)     4.4  
  ( 3.6 to 5.1 )  
  4.6  
  ( 4.1 to 4.8 )  
   
   
HIV viral load [at Month 4] (N=57;54)     4.5  
  ( 3.8 to 4.8 )  
  4.5  
  ( 4.0 to 4.9 )  
   
   
HIV viral load [at Month 6] (N=57;54)     4.6  
  ( 3.7 to 5.0 )  
  4.5  
  ( 3.8 to 4.9 )  
   
   
HIV viral load [at Month 7] (N=55;53)     4.5  
  ( 3.8 to 5.0 )  
  4.5  
  ( 3.9 to 4.9 )  
   
   

No statistical analysis provided for HIV Viral Load at Each Time Point in All HIV+ Subjects.



18.  Primary:   HIV Viral Load at Each Time Point in All HIV+ Subjects.   [ Time Frame: At Month 10 and Month 12 ]

Measure Type Primary
Measure Title HIV Viral Load at Each Time Point in All HIV+ Subjects.
Measure Description The viral load was calculated by estimating the amount of virus in blood samples and was given in number of Ribonucleic acid (RNA) copies per millilitre.
Time Frame At Month 10 and Month 12  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  61     59     0  
HIV Viral Load at Each Time Point in All HIV+ Subjects.  
[units: RNA copies/mL (in log10)]
Median ( Inter-Quartile Range )
     
HIV viral load [at Month 10] (N=54;50)     4.5  
  ( 4.0 to 4.9 )  
  4.5  
  ( 3.8 to 5.0 )  
   
   
HIV viral load [at Month 12] (N=53;52)     4.5  
  ( 3.8 to 4.9 )  
  4.5  
  ( 3.6 to 4.8 )  
   
   

No statistical analysis provided for HIV Viral Load at Each Time Point in All HIV+ Subjects.



19.  Primary:   Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.   [ Time Frame: At Months 2 and 7 ]

Measure Type Primary
Measure Title Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.
Measure Description

Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per millilitre (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.

A seronegative subject was a subject whose antibody titres are below the cut-off value.

Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus.

Time Frame At Months 2 and 7  
Safety Issue No  

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 According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

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  
Number of Participants Analyzed  
[units: participants]
  43     40     24  
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.  
[units: Subjects]
     
anti-HPV-16 [at Month 2] (N=41;40;24)     41     31     24  
anti-HPV-16 [at Month 7] (N=42;40;24)     42     31     24  
anti-HPV-18 [at Month 2] (N=42;40;24)     42     26     24  
anti-HPV-18 [at Month 7] (N=43;40;24)     43     25     24  

No statistical analysis provided for Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.



20.  Primary:   Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.   [ Time Frame: At Month 12 ]

Measure Type Primary
Measure Title Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.
Measure Description

Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per millilitre (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.

A seronegative subject was a subject whose antibody titres are below the cut-off value.

Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus.

Time Frame At Month 12  
Safety Issue No  

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 According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

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  
Number of Participants Analyzed  
[units: participants]
  42     37     22  
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.  
[units: subjects]
     
anti-HPV-16 [at Month 12] (N=41;37;22)     41     28     22  
anti-HPV-18 [at Month 12] (N=42;37;22)     42     24     22  

No statistical analysis provided for Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies.



21.  Primary:   Concentrations for HPV-16 and HPV-18 Antibodies.   [ Time Frame: At Months 0, 2 and 7. ]

Measure Type Primary
Measure Title Concentrations for HPV-16 and HPV-18 Antibodies.
Measure Description

Concentrations were expressed as geometric mean antibody concentrations (GMCs) and were given in EL.U/mL.

The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay were 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.

Time Frame At Months 0, 2 and 7.  
Safety Issue No  

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 According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

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  
Number of Participants Analyzed  
[units: participants]
  43     40     24  
Concentrations for HPV-16 and HPV-18 Antibodies.  
[units: EL.U/mL]
Geometric Mean ( 95% Confidence Interval )
     
anti-HPV-16 [at pre-vaccination] (N=42;40,24)     29.7  
  ( 20.1 to 43.7 )  
  25.7  
  ( 16.6 to 39.9 )  
  21.8  
  ( 10.9 to 43.3 )  
anti-HPV-16 [at Month 2] (N=41;40,24)     2245.2  
  ( 1634.2 to 3084.5 )  
  32.9  
  ( 19.3 to 56.0 )  
  6166.8  
  ( 4079.5 to 9322.2 )  
anti-HPV-16 [at Month 7] (N=42;40,24)     3583.1  
  ( 2759.9 to 4651.9 )  
  27.2  
  ( 17.6 to 42.0 )  
  7871.9  
  ( 6185.3 to 10018.4 )  
anti-HPV-18 [at pre-vaccination] (N=43;40,24)     13.2  
  ( 9.0 to 19.3 )  
  12.5  
  ( 8.2 to 19.1 )  
  11.1  
  ( 5.8 to 21.2 )  
anti-HPV-18 [at Month 2] (N=42;40,24)     1339.3  
  ( 901.6 to 1989.5 )  
  16.9  
  ( 10.1 to 28.3 )  
  2380.2  
  ( 1718.7 to 3296.2 )  
anti-HPV-18 [at Month 7] (N=43;40,24)     1952.1  
  ( 1466.3 to 2598.7 )  
  14.5  
  ( 9.2 to 22.9 )  
  3755.3  
  ( 2608.4 to 5406.5 )  

No statistical analysis provided for Concentrations for HPV-16 and HPV-18 Antibodies.



22.  Primary:   Concentrations for HPV-16 and HPV-18 Antibodies.   [ Time Frame: At Month 12. ]

Measure Type Primary
Measure Title Concentrations for HPV-16 and HPV-18 Antibodies.
Measure Description

Concentrations were expressed as geometric mean antibody concentrations (GMCs) and were given in EL.U/mL.

The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay were 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18

Time Frame At Month 12.  
Safety Issue No  

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 According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

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  
Number of Participants Analyzed  
[units: participants]
  42     37     22  
Concentrations for HPV-16 and HPV-18 Antibodies.  
[units: EL.U/mL]
Geometric Mean ( 95% Confidence Interval )
     
anti-HPV-16 [at Month 12] (N=41;37,22)     748.1  
  ( 520.0 to 1076.3 )  
  20.7  
  ( 13.9 to 30.9 )  
  2793.6  
  ( 2087.8 to 3738.0 )  
anti-HPV-18 [at Month 12] (N=42;37,22)     343.1  
  ( 236.2 to 498.2 )  
  13.0  
  ( 8.5 to 19.7 )  
  1021.3  
  ( 627.4 to 1662.6 )  

No statistical analysis provided for Concentrations for HPV-16 and HPV-18 Antibodies.



23.  Primary:   Cell Mediated Immune Response (CMI) (B-cell and T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellullar Cytokine Staining (ICS).   [ Time Frame: At Months 0, 2, 7 and 12. ]

Measure Type Primary
Measure Title Cell Mediated Immune Response (CMI) (B-cell and T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellullar Cytokine Staining (ICS).
Measure Description The CMI response is the measure of the cytokines production (i.e. Cluster of Differentiation 40 Ligand (CD40L), Interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α)) by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining assay. The results were expressed as a frequency of positive CD4 or CD8 T cell producing at least 1 cytokine within the CD4 or CD8 T cell sub-population. All doubles= T cell expressing at least 2 cytokines. The CMI analyses for B-cell response were not performed due to a technical issue.
Time Frame At Months 0, 2, 7 and 12.  
Safety Issue No  

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 According-To-Protocol cohort for immunogenicity included evaluable subjects (i.e. those HPV DNA- subjects during the vaccination phase) for whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

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  
Number of Participants Analyzed  
[units: participants]
  36     32     18  
Cell Mediated Immune Response (CMI) (B-cell and T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellullar Cytokine Staining (ICS).  
[units: cells]
Geometric Mean ( Inter-Quartile Range )
     
CD4-ALL DOUBLES [HPV-16] at Month 0 (N=33;29;15)     256.0  
  ( 119.0 to 390.0 )  
  154.0  
  ( 96.0 to 235.0 )  
  259.0  
  ( 160.0 to 377.0 )  
CD4-ALL DOUBLES [HPV-16] at Month 2 (N=29;26;17)     4082.0  
  ( 2997.0 to 6209.0 )  
  154.5  
  ( 94.0 to 293.0 )  
  1691.0  
  ( 1247.0 to 2809.0 )  
CD4-ALL DOUBLES [HPV-16] at Month 7 (N=32;32;18)     4717.5  
  ( 2050.5 to 9242.5 )  
  177.5  
  ( 106.0 to 302.0 )  
  3121.5  
  ( 1726.0 to 4538.0 )  
CD4-ALL DOUBLES [HPV-16] at Month 12 (N=36;28;13)     3063.5  
  ( 1294.0 to 5294.5 )  
  184.5  
  ( 136.0 to 326.5 )  
  2490.0  
  ( 1247.0 to 4499.0 )  
CD4-ALL DOUBLES [HPV-18] at Month 0 (N=33;29;15)     218.0  
  ( 131.0 to 281.0 )  
  114.0  
  ( 82.0 to 188.0 )  
  273.0  
  ( 135.0 to 387.0 )  
CD4-ALL DOUBLES [HPV-18] at Month 2 (N=29;26;17)     2658.0  
  ( 1157.0 to 4197.0 )  
  156.5  
  ( 98.0 to 231.0 )  
  1065.0  
  ( 624.0 to 1681.0 )  
CD4-ALL DOUBLES [HPV-18] at Month 7 (N=32;32;18)     2917.5  
  ( 1365.0 to 5976.0 )  
  143.5  
  ( 88.5 to 227.5 )  
  1834.0  
  ( 973.0 to 2827.0 )  
CD4-ALL DOUBLES [HPV-18] at Month 12 (N=36;28;13)     1694.5  
  ( 783.0 to 3401.0 )  
  220.0  
  ( 121.0 to 285.5 )  
  1783.0  
  ( 939.0 to 2891.0 )  
CD4-CD40L [HPV-16] at Month 0 (N=33;29;15)     200.0  
  ( 97.0 to 277.0 )  
  101.0  
  ( 50.0 to 170.0 )  
  208.0  
  ( 119.0 to 239.0 )  
CD4-CD40L [HPV-16] at Month 2 (N=29;26;17)     3940.0  
  ( 2653.0 to 5999.0 )  
  125.5  
  ( 82.0 to 229.0 )  
  1437.0  
  ( 1165.0 to 2649.0 )  
CD4-CD40L [HPV-16] at Month 7 (N=32;32;18)     3400.5  
  ( 1743.0 to 6893.0 )  
  143.5  
  ( 50.0 to 182.0 )  
  2303.0  
  ( 1483.0 to 3871.0 )  
CD4-CD40L [HPV-16] at Month 12 (N=36;28;13)     2569.0  
  ( 1209.5 to 4946.5 )  
  162.5  
  ( 81.5 to 320.0 )  
  2201.0  
  ( 930.0 to 4090.0 )  
CD4-CD40L [HPV-18] at Month 0 (N=33;29;15)     150.0  
  ( 110.0 to 225.0 )  
  98.0  
  ( 45.0 to 147.0 )  
  222.0  
  ( 82.0 to 306.0 )  
CD4-CD40L [HPV-18] at Month 2 (N=29;26;17)     2467.0  
  ( 911.0 to 3549.0 )  
  142.5  
  ( 75.0 to 195.0 )  
  974.0  
  ( 509.0 to 1598.0 )  
CD4-CD40L [HPV-18] at Month 7 (N=32;32;18)     2247.5  
  ( 1154.0 to 4510.0 )  
  108.5  
  ( 50.5 to 185.0 )  
  1524.5  
  ( 706.0 to 2327.0 )  
CD4-CD40L [HPV-18] at Month 12 (N=36;28;13)     1484.0  
  ( 739.5 to 3045.0 )  
  178.0  
  ( 90.0 to 250.0 )  
  1587.0  
  ( 782.0 to 2596.0 )  
CD4-IFN-γ [HPV-16] at Month 0 (N=33;29;15)     57.0  
  ( 31.0 to 161.0 )  
  57.0  
  ( 7.0 to 85.0 )  
  66.0  
  ( 50.0 to 102.0 )  
CD4-IFN-γ [HPV-16] at Month 2 (N=29;26;17)     1748.0  
  ( 890.0 to 2632.0 )  
  50.0  
  ( 7.0 to 85.0 )  
  760.0  
  ( 535.0 to 956.0 )  
CD4- IFN-γ [HPV-16] at Month 7 (N=32;32;18)     1807.0  
  ( 741.5 to 3483.0 )  
  51.0  
  ( 7.0 to 111.0 )  
  900.5  
  ( 763.0 to 1718.0 )  
CD4- IFN-γ [HPV-16] at Month 12 (N=36;28;13)     735.0  
  ( 365.0 to 1290.5 )  
  49.5  
  ( 19.0 to 97.5 )  
  592.0  
  ( 320.0 to 895.0 )  
CD4-IFN-γ [HPV-18] at Month 0 (N=33;29;15)     25.0  
  ( 7.0 to 99.0 )  
  40.0  
  ( 7.0 to 58.0 )  
  54.0  
  ( 34.0 to 72.0 )  
CD4-IFN-γ [HPV-18] at Month 2 (N=29;26;17)     1045.0  
  ( 422.0 to 1619.0 )  
  43.5  
  ( 7.0 to 77.0 )  
  407.0  
  ( 285.0 to 532.0 )  
CD4- IFN-γ [HPV-18] at Month 7 (N=32;32;18)     915.0  
  ( 453.0 to 2156.5 )  
  31.5  
  ( 7.0 to 68.5 )  
  626.5  
  ( 415.0 to 917.0 )  
CD4- IFN-γ [HPV-18] at Month 12 (N=36;28;13)     341.5  
  ( 226.5 to 1052.0 )  
  39.0  
  ( 7.0 to 91.5 )  
  436.0  
  ( 291.0 to 587.0 )  
CD4-IL-2 [HPV-16] at Month 0 (N=33;29;15)     187.0  
  ( 97.0 to 285.0 )  
  104.0  
  ( 42.0 to 150.0 )  
  176.0  
  ( 105.0 to 313.0 )  
CD4-IL-2 [HPV-16] at Month 2 (N=29;26;17)     3716.0  
  ( 2951.0 to 5879.0 )  
  79.0  
  ( 44.0 to 148.0 )  
  1601.0  
  ( 1030.0 to 2493.0 )  
CD4- IL-2 [HPV-16] at Month 7 (N=32;32;18)     4329.0  
  ( 1939.0 to 8847.0 )  
  113.5  
  ( 52.5 to 175.0 )  
  2830.5  
  ( 1509.0 to 4251.0 )  
CD4- IL-2 [HPV-16] at Month 12 (N=36;28;13)     2946.0  
  ( 983.5 to 4840.5 )  
  135.5  
  ( 62.0 to 235.5 )  
  2366.0  
  ( 1075.0 to 4397.0 )  
CD4-IL-2 [HPV-18] at Month 0 (N=33;29;15)     132.0  
  ( 50.0 to 225.0 )  
  76.0  
  ( 43.0 to 106.0 )  
  206.0  
  ( 109.0 to 301.0 )  
CD4-IL-2 [HPV-18] at Month 2 (N=29;26;17)     2527.0  
  ( 1153.0 to 3850.0 )  
  103.5  
  ( 55.0 to 158.0 )  
  921.0  
  ( 587.0 to 1428.0 )  
CD4- IL-2 [HPV-18] at Month 7 (N=32;32;18)     2664.0  
  ( 1258.0 to 5289.0 )  
  87.5  
  ( 57.0 to 153.5 )  
  1572.5  
  ( 900.0 to 2678.0 )  
CD4- IL-2 [HPV-18] at Month 12 (N=36;28;13)     1533.5  
  ( 713.5 to 3229.0 )  
  134.0  
  ( 57.0 to 206.5 )  
  1633.0  
  ( 741.0 to 2787.0 )  
CD4-TNF-α [HPV-16] at Month 0 (N=33;29;15)     148.0  
  ( 61.0 to 226.0 )  
  132.0  
  ( 50.0 to 221.0 )  
  185.0  
  ( 127.0 to 261.0 )  
CD4-TNF-α [HPV-16] at Month 2 (N=29;26;17)     3131.0  
  ( 1811.0 to 4864.0 )  
  105.0  
  ( 55.0 to 215.0 )  
  1332.0  
  ( 980.0 to 1894.0 )  
CD4-TNF-α [HPV-16] at Month 7 (N=32;32;18)     4315.0  
  ( 1815.5 to 8347.5 )  
  154.0  
  ( 58.0 to 247.5 )  
  2479.0  
  ( 1426.0 to 3988.0 )  
CD4-TNF-α [HPV-16] at Month 12 (N=36;28;13)     2662.5  
  ( 1088.0 to 4675.0 )  
  135.5  
  ( 81.5 to 257.0 )  
  2133.0  
  ( 1125.0 to 4064.0 )  
CD4-TNF-α [HPV-18] at Month 0 (N=33;29;15)     150.0  
  ( 92.0 to 211.0 )  
  84.0  
  ( 72.0 to 148.0 )  
  229.0  
  ( 65.0 to 295.0 )  
CD4-TNF-α [HPV-18] at Month 2 (N=29;26;17)     2319.0  
  ( 1065.0 to 3666.0 )  
  94.5  
  ( 56.0 to 173.0 )  
  982.0  
  ( 505.0 to 1198.0 )  
CD4-TNF-α [HPV-18] at Month 7 (N=32;32;18)     2689.0  
  ( 1236.5 to 5303.5 )  
  109.0  
  ( 58.5 to 168.5 )  
  1526.5  
  ( 869.0 to 2682.0 )  
CD4-TNF-α [HPV-18] at Month 12 (N=36;28;13)     1542.5  
  ( 627.5 to 3175.5 )  
  138.0  
  ( 59.5 to 198.5 )  
  1650.0  
  ( 860.0 to 2541.0 )  
CD8-ALL DOUBLES [HPV-16] at Month 0 (N=32;29;15)     43.0  
  ( 16.0 to 79.0 )  
  40.0  
  ( 11.0 to 58.0 )  
  26.0  
  ( 11.0 to 73.0 )  
CD8-ALL DOUBLES [HPV-16] at Month 2 (N=29;26;17)     65.0  
  ( 34.0 to 107.0 )  
  40.5  
  ( 11.0 to 90.0 )  
  48.0  
  ( 34.0 to 118.0 )  
CD8-ALL DOUBLES [HPV-16] at Month 7 (N=32;30;18)     38.0  
  ( 24.5 to 94.0 )  
  32.5  
  ( 11.0 to 76.0 )  
  48.0  
  ( 26.0 to 71.0 )  
CD8-ALL DOUBLES [HPV-16] at Month 12 (N=36;26;13)     53.5  
  ( 11.0 to 118.5 )  
  37.0  
  ( 11.0 to 72.0 )  
  45.0  
  ( 11.0 to 58.0 )  
CD8-ALL DOUBLES [HPV-18] at Month 0 (N=32;29;15)     51.0  
  ( 29.5 to 89.0 )  
  11.0  
  ( 11.0 to 58.0 )  
  31.0  
  ( 11.0 to 63.0 )  
CD8-ALL DOUBLES [HPV-18] at Month 2 (N=29;26;17)     65.0  
  ( 11.0 to 85.0 )  
  39.5  
  ( 11.0 to 91.0 )  
  62.0  
  ( 32.0 to 85.0 )  
CD8-ALL DOUBLES [HPV-18] at Month 7 (N=32;30;18)     40.0  
  ( 15.5 to 100.0 )  
  35.5  
  ( 11.0 to 63.0 )  
  44.0  
  ( 11.0 to 74.0 )  
CD8-ALL DOUBLES [HPV-18] at Month 12 (N=36;26;13)     39.5  
  ( 11.0 to 128.5 )  
  35.0  
  ( 11.0 to 75.0 )  
  21.0  
  ( 11.0 to 47.0 )  
CD8-CD40L [HPV-16] at Month 0 (N=32;29;15)     7.0  
  ( 7.0 to 31.0 )  
  7.0  
  ( 7.0 to 7.0 )  
  7.0  
  ( 7.0 to 34.0 )  
CD8-CD40L [HPV-16] at Month 2 (N=29;26;17)     28.0  
  ( 7.0 to 55.0 )  
  7.0  
  ( 7.0 to 27.0 )  
  7.0  
  ( 7.0 to 44.0 )  
CD8-CD40L [HPV-16] at Month 7 (N=32;30;18)     26.5  
  ( 7.0 to 38.5 )  
  7.0  
  ( 7.0 to 20.0 )  
  24.0  
  ( 7.0 to 49.0 )  
CD8-CD40L [HPV-16] at Month 12 (N=36;26;13)     7.0  
  ( 7.0 to 15.5 )  
  7.0  
  ( 7.0 to 32.0 )  
  7.0  
  ( 7.0 to 7.0 )  
CD8-CD40L [HPV-18] at Month 0 (N=32;29;15)     18.5  
  ( 7.0 to 36.5 )  
  7.0  
  ( 7.0 to 7.0 )  
  7.0  
  ( 7.0 to 27.0 )  
CD8- CD40L [HPV-18] at Month 2 (N=29;26;17)     7.0  
  ( 7.0 to 42.0 )  
  7.0  
  ( 7.0 to 43.0 )  
  38.0  
  ( 7.0 to 60.0 )  
CD8-CD40L [HPV-18] at Month 7 (N=32;30;18)     7.0  
  ( 7.0 to 29.0 )  
  7.0  
  ( 7.0 to 7.0 )  
  7.0  
  ( 7.0 to 57.0 )  
CD8-CD40L [HPV-18] at Month 12 (N=36;26;13)     7.0  
  ( 7.0 to 23.0 )  
  7.0  
  ( 7.0 to 7.0 )  
  7.0  
  ( 7.0 to 7.0 )  
CD8-IFN-γ [HPV-16] at Month 0 (N=32;29;15)     35.5  
  ( 7.0 to 73.5 )  
  25.0  
  ( 7.0 to 54.0 )  
  7.0  
  ( 7.0 to 42.0 )  
CD8-IFN-γ [HPV-16] at Month 2 (N=29;26;17)     39.0  
  ( 24.0 to 103.0 )  
  7.0  
  ( 7.0 to 80.0 )  
  39.0  
  ( 22.0 to 62.0 )  
CD8-IFN-γ [HPV-16] at Month 7 (N=32;30;18)     25.0  
  ( 7.0 to 76.0 )  
  23.5  
  ( 7.0 to 66.0 )  
  28.5  
  ( 7.0 to 55.0 )  
CD8-IFN-γ [HPV-16] at Month 12 (N=36;26;13)     47.5  
  ( 7.0 to 106.0 )  
  28.5  
  ( 7.0 to 43.0 )  
  26.0  
  ( 7.0 to 50.0 )  
CD8-IFN-γ [HPV-18] at Month 0 (N=32;29;15)     39.0  
  ( 7.0 to 85.0 )  
  7.0  
  ( 7.0 to 47.0 )  
  9.0  
  ( 7.0 to 41.0 )  
CD8-IFN-γ [HPV-18] at Month 2 (N=29;26;17)     37.0  
  ( 7.0 to 78.0 )  
  27.5  
  ( 7.0 to 84.0 )  
  53.0  
  ( 23.0 to 68.0 )  
CD8-IFN-γ [HPV-18] at Month 7 (N=32;30;18)     33.0  
  ( 8.5 to 82.0 )  
  22.0  
  ( 7.0 to 59.0 )  
  38.0  
  ( 7.0 to 59.0 )  
CD8-IFN-γ [HPV-18] at Month 12 (N=36;26;13)     29.0  
  ( 7.0 to 96.5 )  
  31.0  
  ( 7.0 to 54.0 )  
  7.0  
  ( 7.0 to 23.0 )  
CD8-IL-2 [HPV-16] at Month 0 (N=32;29;15)     7.0  
  ( 7.0 to 29.0 )  
  7.0  
  ( 7.0 to 25.0 )  
  7.0  
  ( 7.0 to 34.0 )  
CD8-IL-2 [HPV-16] at Month 2 (N=29;26;17)     24.0  
  ( 7.0 to 35.0 )  
  20.0  
  ( 7.0 to 34.0 )  
  32.0  
  ( 7.0 to 62.0 )  
CD8-IL-2 [HPV-16] at Month 7 (N=32;30;18)     20.5  
  ( 7.0 to 33.0 )  
  7.0  
  ( 7.0 to 7.0 )  
  28.5  
  ( 7.0 to 55.0 )  
CD8-IL-2 [HPV-16] at Month 12 (N=36;26;13)     7.0  
  ( 7.0 to 38.5 )  
  7.5  
  ( 7.0 to 33.0 )  
  7.0  
  ( 7.0 to 27.0 )  
CD8-IL-2 [HPV-18] at Month 0 (N=32;29;15)     7.0  
  ( 7.0 to 30.5 )  
  7.0  
  ( 7.0 to 7.0 )  
  7.0  
  ( 7.0 to 32.0 )  
CD8-IL-2 [HPV-18] at Month 2 (N=29;26;17)     7.0  
  ( 7.0 to 37.0 )  
  7.0  
  ( 7.0 to 24.0 )  
  11.0  
  ( 7.0 to 44.0 )  
CD8-IL-2 [HPV-18] at Month 7 (N=32;30;18)     7.0  
  ( 7.0 to 7.0 )  
  7.0  
  ( 7.0 to 7.0 )  
  17.5  
  ( 7.0 to 41.0 )  
CD8-IL-2 [HPV-18] at Month 12 (N=36;26;13)     7.0  
  ( 7.0 to 7.0 )  
  7.0  
  ( 7.0 to 17.0 )  
  7.0  
  ( 7.0 to 38.0 )  
CD8-TNF-α [HPV-16] at Month 0 (N=32;29;15)     26.0  
  ( 7.0 to 71.0 )  
  34.0  
  ( 7.0 to 54.0 )  
  7.0  
  ( 7.0 to 36.0 )  
CD8-TNF-α [HPV-16] at Month 2 (N=29;26;17)     34.0  
  ( 7.0 to 52.0 )  
  28.5  
  ( 7.0 to 65.0 )  
  30.0  
  ( 7.0 to 55.0 )  
CD8-TNF-α [HPV-16] at Month 7 (N=32;30;18)     25.5  
  ( 7.0 to 53.5 )  
  15.5  
  ( 7.0 to 66.0 )  
  28.5  
  ( 7.0 to 50.0 )  
CD8-TNF-α [HPV-16] at Month 12 (N=36;26;13)     35.5  
  ( 7.0 to 97.0 )  
  9.0  
  ( 7.0 to 38.0 )  
  26.0  
  ( 7.0 to 50.0 )  
CD8-TNF-α [HPV-18] at Month 0 (N=32;29;15)     21.5  
  ( 7.0 to 55.0 )  
  7.0  
  ( 7.0 to 46.0 )  
  7.0  
  ( 7.0 to 41.0 )  
CD8-TNF-α [HPV-18] at Month 2 (N=29;26;17)     38.0  
  ( 7.0 to 66.0 )  
  7.0  
  ( 7.0 to 54.0 )  
  28.0  
  ( 7.0 to 50.0 )  
CD8-TNF-α [HPV-18] at Month 7 (N=32;30;18)     28.5  
  ( 7.0 to 73.5 )  
  25.5  
  ( 7.0 to 57.0 )  
  22.0  
  ( 7.0 to 59.0 )  
CD8-TNF-α [HPV-18] at Month 12 (N=36;26;13)     28.0  
  ( 7.0 to 101.0 )  
  18.0  
  ( 7.0 to 68.0 )  
  7.0  
  ( 7.0 to 7.0 )  

No statistical analysis provided for Cell Mediated Immune Response (CMI) (B-cell and T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellullar Cytokine Staining (ICS).



24.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7, 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, at Months 1, 2, 4, 6 and 7  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  60     57     29  
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.  
[units: Subjects]
     
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.



25.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7, 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, at Months 1, 2, 4, 6 and 7  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  60     57     29  
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.  
[units: Subjects]
     
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.



26.  Primary:   Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.   [ Time Frame: At Day 7, 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, at Months 1, 2, 4, 6 and 7  
Safety Issue No  

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 Total Vaccinated cohort 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  
Number of Participants Analyzed  
[units: participants]
  60     57     29  
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.  
[units: Subjects]
     
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  
MON [pre-vacc Low; post-vacc Normal] Month 4     2     1     0  
MON [pre-vacc Low; post-vacc Below] Month 4     1     0     0  
MON [pre-vacc Low; post-vacc Above] Month 4     0     0     0  
MON [pre-vacc Low; post-vacc Missing] Month 4     0     0     0  
MON [pre-vacc Low; post-vacc Normal] Month 6     1     1     0  
MON [pre-vacc Low; post-vacc Below] Month 6     2     0     0  
MON [pre-vacc Low; post-vacc Above] Month 6     0     0     0  
MON [pre-vacc Low; post-vacc Missing] Month 6