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ISRCTN
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ISRCTN11877362
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ClinicalTrials.gov identifier
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NCT00263666
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Public title
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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
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Scientific title
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Acronym
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Rota022
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Serial number at source
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444563-022
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Study hypothesis
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The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' HRV vaccine given concomitantly with routine vaccines including Oral Poliomyelitis Vaccine (OPV) in HIV positive infants.
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Lay summary
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Ethics approval
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Ethics approval received in 2004.
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Study design
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A phase II, double-blind, randomised, placebo-controlled study
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Countries of recruitment
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South Africa
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Disease/condition/study domain
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Vaccine/immunisation
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2004
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Anticipated end date
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01/01/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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100
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Interventions
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Intervention: three doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (RIX4414) at 106.5 CCID50 viral concentration
Control: placebo
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Primary outcome measure(s)
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Percentage of subjects who report grade "2" or grade "3" fever, vomiting or diarrhoea during the 15-day f/u period after each dose.
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Secondary outcome measure(s)
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1. Reactogenicity
2. Serious adverse events (SAEs)
3. CD4 count and human immunodeficiency virus (HIV) viral load at screening and visit 4
4. Immunogenicity
5. Rotavirus shedding until ceases
6. Enteric pathogens
7. Immunogenicity of antigens contained in concomitantly administered routine vaccine DTPw-HBV/Hib + OPV
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Sources of funding
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1. RAPID trials (USA)
2. World Health Organization (WHO) (Switzerland)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/16394298
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Contact name
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Dr
Duncan
Steele
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Address
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20, Avenue Appia
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City/town
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Geneva-27
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Zip/Postcode
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CH 1211
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Country
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Switzerland
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Tel
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+41 (0)227913752
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Email
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steeled@who.int
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Sponsor
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World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
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Address
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20, Avenue Appia
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City/town
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Geneva-27
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Zip/Postcode
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CH 1211
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Country
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Switzerland
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Sponsor website:
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http://www.who.int
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Date applied
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25/11/2005
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Last edited
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26/03/2008
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Date ISRCTN assigned
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25/11/2005
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