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

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ClinicalTrials.gov Identifier: NCT00263666
Recruitment Status : Completed
First Posted : December 9, 2005
Results First Posted : March 13, 2009
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Infections, Rotavirus
Interventions: Biological: Rotarix
Biological: Placebo
Biological: TritanrixTM-HB+Hib
Biological: SabinPolioTM vaccine

  Participant Flow

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

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
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 
Overall Participants Analyzed 
[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]
Count of Participants 		     
Female      28  56.0%      25  50.0%      53  53.0% 
Male      22  44.0%      25  50.0%      47  47.0% 


  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 ]
  Show Outcome Measure 7

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:   Rotavirus Vaccine Strain Identification.   [ Time Frame: From dose 1 until 2 months after dose 3 or until end of RV shedding ]
  Show Outcome Measure 22

23.  Secondary:   Enteric Pathogens Identification.   [ Time Frame: From Dose 1 until 2 months after dose 3 or until end of RV shedding ]
  Show Outcome Measure 23

24.  Secondary:   Number of Subjects With the RV in Stool Samples   [ Time Frame: From Dose 1 until post Dose 3 ]
  Show Outcome Measure 24


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information