Condition category
Infections and Infestations
Date applied
25/11/2005
Date assigned
25/11/2005
Last edited
21/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Duncan Steele

ORCID ID

Contact details

20
Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)227913752
steeled@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00263666

Protocol/serial number

444563-022

Study information

Scientific title

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

Acronym

Rota022

Study hypothesis

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.

Ethics approval

Ethics approval received in 2004.

Study design

Phase II double-blind randomised placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Vaccine/immunisation

Intervention

Intervention: three doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (RIX4414) at 106.5 CCID50 viral concentration
Control: placebo

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

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

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

Overall trial start date

01/01/2004

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

01/01/2004

Recruitment end date

01/01/2006

Locations

Countries of recruitment

South Africa

Trial participating centre

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Sponsor information

Organisation

World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)

Sponsor details

20
Avenue Appia
Geneva-27
CH 1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

RAPID trials (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

World Health Organization (WHO) (Switzerland)

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00263666

Publication summary

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

Publication citations

  1. Results

    Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, Cervantes Y, Linhares AC, López P, Macías-Parra M, Ortega-Barría E, Richardson V, Rivera-Medina DM, Rivera L, Salinas B, Pavía-Ruz N, Salmerón J, Rüttimann R, Tinoco JC, Rubio P, Nuñez E, Guerrero ML, Yarzábal JP, Damaso S, Tornieporth N, Sáez-Llorens X, Vergara RF, Vesikari T, Bouckenooghe A, Clemens R, De Vos B, O'Ryan M, , Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis., N. Engl. J. Med., 2006, 354, 1, 11-22, doi: 10.1056/NEJMoa052434.

Additional files

Editorial Notes

21/03/2016: added link to results - basic reporting.