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A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00263666
First received: December 8, 2005
Last updated: October 27, 2011
Last verified: October 2011
History of Changes
Results First Received: February 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Rotavirus Gastroenteritis
Interventions: Biological: Rotarix
Biological: Placebo
Biological: TritanrixTM-HB+Hib
Biological: SabinPolioTM vaccine

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In case of discrepancy between the HIV results (DNA PCR positive, viral load negative), performed at the Screening Visit (one week prior to first vaccination) the infants were not enrolled in the study.

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Participant Flow:   Overall Study
    Rotarix Group     Placebo Group  
STARTED     50     50  
COMPLETED     43     39  
NOT COMPLETED     7     11  
Adverse Event                 6                 8  
Lost to Follow-up                 1                 2  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Total Total of all reporting groups

Baseline Measures
    Rotarix Group     Placebo Group     Total  
Number of Participants  
[units: participants]
 		  50     50     100  
Age  
[units: weeks]
Mean ± Standard Deviation 		  7.1  ± 1.10     6.9  ± 1.02     7.0  ± 1.06  
Gender  
[units: participants]
 		     
Female     28     25     53  
Male     22     25     47  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Reporting Grade “2” or Grade “3” Fever, Vomiting or Diarrhea.   [ Time Frame: Within the 15-day solicited follow-up period after any dose. ]
  Show Outcome Measure 1

2.  Secondary:   Number of Subjects Reporting Any Unsolicited Symptoms.   [ Time Frame: Within 30 days after each dose ]
  Show Outcome Measure 2

3.  Secondary:   Number of Subjects Reporting Any Serious Adverse Events.   [ Time Frame: Until 2 months after dose 3 (for subjects RV negative at Day 42 post-dose 3) or until end of RV shedding (for subjects who shed RV at Day 42 post-dose 3). ]
  Show Outcome Measure 3

4.  Secondary:   Number of Subjects Reporting Each Type of Solicited Symptom.   [ Time Frame: Within the 15-day solicited follow-up period after each dose ]
  Show Outcome Measure 4

5.  Secondary:   The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent.   [ Time Frame: At the screening visit and 2 months after dose 3 (Visit 4). ]
  Show Outcome Measure 5

6.  Secondary:   Human Immunodeficiency Virus (HIV) Viral Load   [ Time Frame: At the screening visit and 2 months after dose 3. ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects Who Seroconverted Against Rotavirus   [ Time Frame: Two months after dose 3 ]
  Hide Outcome Measure 7

Measure Type Secondary
Measure Title Number of Subjects Who Seroconverted Against Rotavirus
Measure Description A subject with anti-rotavirus Immunoglobulin (IgA) antibody concentration < 20 units/milliliter (U/mL) before vaccination and ≥ 20 U/mL after vaccination is considered as seroconverted.
Time Frame Two months after dose 3  
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.
Analysis was performed on subjects from the According to Protocol Cohort for immunogenicity for whom results were available

Reporting Groups
  Description
Rotarix Group Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
Placebo Group Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.

Measured Values
    Rotarix Group     Placebo Group  
Number of Participants Analyzed  
[units: participants]
 		  21     22  
Number of Subjects Who Seroconverted Against Rotavirus  
[units: subjects]
 		  12     4  

No statistical analysis provided for Number of Subjects Who Seroconverted Against Rotavirus



8.  Secondary:   Number of Subjects With Vaccine Take.   [ Time Frame: Two months after the dose 3 ]
  Show Outcome Measure 8

9.  Secondary:   Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations.   [ Time Frame: Two months after dose 3 ]
  Show Outcome Measure 9

10.  Secondary:   Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value.   [ Time Frame: Two months after dose 3 ]
  Show Outcome Measure 10

11.  Secondary:   Geometric Mean Concentration for Anti-PRP Antibodies.   [ Time Frame: Two months after dose 3 ]
  Show Outcome Measure 11

12.  Secondary:   Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value   [ Time Frame: Two months after dose 3 ]
  Show Outcome Measure 12

13.  Secondary:   Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies.   [ Time Frame: Two months after dose 3 ]
  Show Outcome Measure 13

14.  Secondary:   Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value   [ Time Frame: Two months after dose 3 ]
  Show Outcome Measure 14

15.  Secondary:   Geometric Mean Concentration for Anti-HBs Antibodies.   [ Time Frame: Two months after dose 3 ]
  Show Outcome Measure 15

16.  Secondary:   Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value   [ Time Frame: Two months after dose 3 ]
  Show Outcome Measure 16

17.  Secondary:   Geometric Mean Concentration for Anti-BPT Antibodies.   [ Time Frame: Two months after dose 3 ]
  Show Outcome Measure 17

18.  Secondary:   Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value   [ Time Frame: Two months after dose 3 ]
  Show Outcome Measure 18

19.  Secondary:   Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies.   [ Time Frame: Two months after dose 3 ]
  Show Outcome Measure 19

20.  Secondary:   Rotavirus Antigen Excretion in Stool Samples   [ Time Frame: At day of each vaccination and at planned days following each vaccine dose until 2 months after dose 3 or until end of RV shedding ]
  Show Outcome Measure 20

21.  Secondary:   Rotavirus in Diarrheal Stool Samples   [ Time Frame: From Dose 1 until 2 months after dose 3 or until end of RV shedding ]
  Show Outcome Measure 21

22.  Secondary:   Enteric Pathogens Identification.   [ Time Frame: From Dose 1 until 2 months after dose 3 or until end of RV shedding ]
  Show Outcome Measure 22

23.  Secondary:   Rotavirus Vaccine Strain Identification if Applicable.   [ Time Frame: From dose 1 until 2 months after dose 3 or until end of RV shedding ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


Limitations and Caveats
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
No text entered.  


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


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00263666     History of Changes
Other Study ID Numbers: 444563/022
Study First Received: December 8, 2005
Results First Received: February 13, 2009
Last Updated: October 27, 2011
Health Authority: South Africa: Medicines Control Council