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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00586339
First Posted: January 4, 2008
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: February 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Infections, Papillomavirus
Interventions: Biological: Cervarix TM
Biological: Placebo Control

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
HIV+ subjects were randomised to receive either Cervarix or Aluminium Hydroxide vaccines; HIV- subjects were not randomised and all received Cervarix vaccine.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrolment was staggered as follows: 1) Enrolment of Human immunodeficiency virus positive (HIV+) subjects with cluster of differentiation 4 (CD4+) cell count >200 cells per cubic millimeter (cells/mm^3) and HIV negative (HIV-) subjects (up to 30 subjects) for blinded safety evaluation; 2) Enrolment of remaining HIV+/HIV- subjects.

Reporting Groups
  Description
HIV+/Cervarix Group Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
HIV+/Aluminium Hydroxide Group Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
HIV-/Cervarix Group Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.

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



  Baseline Characteristics
  Hide Baseline Characteristics

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

Reporting Groups
  Description
HIV+/Cervarix Group Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
HIV+/Aluminium Hydroxide Group Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
HIV-/Cervarix Group Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
Total Total of all reporting groups

Baseline Measures
   HIV+/Cervarix Group   HIV+/Aluminium Hydroxide Group   HIV-/Cervarix Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   59   30   150 
Age 
[Units: Years]
Mean (Standard Deviation)
 21.6  (2.21)   22.7  (1.70)   21.3  (1.65)   21.9  (1.85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      61 100.0%      59 100.0%      30 100.0%      150 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
African heritage/African American   61   59   30   150 


  Outcome Measures
  Show All Outcome Measures

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

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

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

Solicited general symptoms assessed were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal, headache, myalgia, rash and urticaria.

Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship.

Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Urticaria = Urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as causally related to the vaccination.

Time Frame Within 7 days (Days 0-6) after each dose and across doses  

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

Reporting Groups
  Description
HIV+/Cervarix Group Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
HIV+/Aluminium Hydroxide Group Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
HIV-/Cervarix Group Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.

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

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



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

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

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

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

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

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

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

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

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

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

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

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

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

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

17.  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 ]

18.  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 ]

19.  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 ]

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

21.  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 ]

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

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

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

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

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

27.  Primary:   Cell Mediated Immune Response (CMI) (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 ]

28.  Primary:   Cell Mediated Immune Response (CMI) (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry   [ Time Frame: At Month 0 ]

29.  Primary:   CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry   [ Time Frame: At Month 2 ]

30.  Primary:   CMI (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry   [ Time Frame: At Month 7 ]

31.  Primary:   CMI (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry   [ Time Frame: At Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00586339     History of Changes
Other Study ID Numbers: 107863
First Submitted: December 21, 2007
First Posted: January 4, 2008
Results First Submitted: February 16, 2012
Results First Posted: March 22, 2012
Last Update Posted: October 26, 2017