A phase II, double-blind, randomised, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of three doses of GlaxoSmithKline (GSK) Biologicals? oral live attenuated human rotavirus (HRV) vaccine (RIX4414 at 106.5 CCID50) administered to human immunodeficiency virus (HIV) infected infants at 6, 10 and 14 weeks of age in South Africa

Phase 2

Completed

• Conditions: Vaccination; Vaccine/immunisation; Infections and Infestations

• Registration Number: ISRCTN11877362
• Lead Sponsor: World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)

Brief Summary

2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16394298

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-25
• Study Completion: 2006-01-01
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Parents/guardians of subjects who could comply with the protocol requirements (e.g. completion of diary cards, return for follow-up visits)
2. Male or female 6 - 10 weeks of age at the time of first vaccination
3. Written informed consent from parents/guardians
4. Documented HIV status of the subject as confirmed by Polymerase Chain Reaction (PCR)
5. HIV asymptomatic and HIV mildly symptomatic
6. Categories N and A according to CDC HIV clinical classification
7. Born after a gestation period of 36 - 42 weeks

Exclusion Criteria

1. Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period
2. Previous routine vaccination except Bacillus Calmette-Guerin (BCG) and hepatits B virus (HBV)
3. Clinically significant history of chronic gastrointestinal tract (GIT) disease including any incorrected congenital malformation of GIT
4. History of allergic disease or reaction likely to be exacerbated by any component of the vaccine
5. Acute illness at the time of enrolement
6. Diarrhea with in 7 days preceding the study vaccination
7. Administration of immunoglobulins and/or blood products since birth or planned during study period
8. Use of any investigational or non-registered drug or vaccine other than study vaccines during the study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of subjects who report grade 2 or grade 3 fever, vomiting or diarrhoea during the 15-day f/u period after each dose.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Reactogenicity<br> 2. Serious adverse events (SAEs)<br> 3. CD4 count and human immunodeficiency virus (HIV) viral load at screening and visit 4<br> 4. Immunogenicity<br> 5. Rotavirus shedding until ceases<br> 6. Enteric pathogens<br> 7. Immunogenicity of antigens contained in concomitantly administered routine vaccine DTPw-HBV/Hib + OPV<br>