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

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

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
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

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. ]

2.  Secondary:

Number of Subjects Reporting Any Unsolicited Symptoms.   [ Time Frame: Within 30 days after each dose ]

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). ]

4.  Secondary:

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

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). ]

6.  Secondary:

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

7.  Secondary:

Number of Subjects Who Seroconverted Against Rotavirus   [ Time Frame: Two months after dose 3 ]

8.  Secondary:

Number of Subjects With Vaccine Take.   [ Time Frame: Two months after the dose 3 ]

9.  Secondary:

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

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 ]

11.  Secondary:

Geometric Mean Concentration for Anti-PRP Antibodies.   [ Time Frame: Two months after dose 3 ]

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 ]

13.  Secondary:

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

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 ]

15.  Secondary:

Geometric Mean Concentration for Anti-HBs Antibodies.   [ Time Frame: Two months after dose 3 ]

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 ]

17.  Secondary:

Geometric Mean Concentration for Anti-BPT Antibodies.   [ Time Frame: Two months after dose 3 ]

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 ]

19.  Secondary:

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

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 ]

21.  Secondary:

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

22.  Secondary:

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

23.  Secondary:

Number of Subjects With the RV in Stool Samples   [ Time Frame: From Dose 1 until post Dose 3 ]

24.  Secondary:

Rotavirus Vaccine Strain Identification if Applicable.   [ Time Frame: From dose 1 until 2 months after dose 3 or until end of RV shedding ]