MedDataX Logo

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

NCT ID: NCT00263666

Last Updated: 2020-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-16

Study Completion Date

2008-02-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

HIV infected infants as determined prior to study entry (screening) and asymptomatic or mildly symptomatic (WHO stages I and II) of disease will be enrolled. The study will have two groups: Group HRV and Group Placebo. Three-dose immunisation will be administered at approximately 6, 10, and 14 weeks of age. Routine EPI (Expanded Program on Immunisation) vaccinations will be administered concomitantly with the study vaccines. At the time of first dose, subjects will be aged 6 to 10 weeks. This study will evaluate safety, reactogenicity and immunogenicity of the HRV vaccine relative to the placebo.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infections, Rotavirus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The study was conducted in a double-blind manner. The parents/guardians of the subjects and the study personnel were unaware of the administered treatment (HRV vaccine or placebo).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rotarix Group

Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.

Group Type EXPERIMENTAL

Rotarix

Intervention Type BIOLOGICAL

Oral vaccination

Tritanrix-HB+Hib

Intervention Type BIOLOGICAL

Concomitant routine vaccination, IM administration

Polio Sabin

Intervention Type BIOLOGICAL

Oral administration, concomitant routine vaccination

Placebo Group

Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Oral administration

Tritanrix-HB+Hib

Intervention Type BIOLOGICAL

Concomitant routine vaccination, IM administration

Polio Sabin

Intervention Type BIOLOGICAL

Oral administration, concomitant routine vaccination

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rotarix

Oral vaccination

Intervention Type BIOLOGICAL

Placebo

Oral administration

Intervention Type BIOLOGICAL

Tritanrix-HB+Hib

Concomitant routine vaccination, IM administration

Intervention Type BIOLOGICAL

Polio Sabin

Oral administration, concomitant routine vaccination

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female between, and including 6 and 10 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parents or guardians of the subject
* Documented HIV status of the subject as confirmed by PCR.
* HIV asymptomatic and HIV mildly symptomatic; Stages I and II disease according to WHO's most recent classification for HIV stages in infants and children.
* Born after a gestation period of 36 to 42 weeks.

Exclusion Criteria

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Previous routine vaccination except OPV, BCG and HBV vaccination at birth
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
* Acute disease at time of enrolment.
* Gastroenteritis within 7 days preceding the study vaccine administration.
* Previous confirmed occurrence of RV gastroenteritis.
* Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
* HIV moderately and severely symptomatic: stages III and IV according to WHO's recent classification.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
Minimum Eligible Age

6 Weeks

Maximum Eligible Age

10 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Attridgerville, Gauteng, South Africa

Site Status

GSK Investigational Site

Coronationville, Gauteng, South Africa

Site Status

GSK Investigational Site

Garankuwa, North West, South Africa

Site Status

GSK Investigational Site

Brits, , South Africa

Site Status

GSK Investigational Site

Capital Park, , South Africa

Site Status

GSK Investigational Site

Ga-Rankuwa, , South Africa

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Africa

References

Explore related publications, articles, or registry entries linked to this study.

Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8.

Reference Type BACKGROUND
PMID: 24047799 (View on PubMed)

Steele AD, Madhi SA, Louw CE, Bos P, Tumbo JM, Werner CM, Bicer C, De Vos B, Delem A, Han HH. Safety, Reactogenicity, and Immunogenicity of Human Rotavirus Vaccine RIX4414 in Human Immunodeficiency Virus-positive Infants in South Africa. Pediatr Infect Dis J. 2011 Feb;30(2):125-30. doi: 10.1097/INF.0b013e3181f42db9.

Reference Type BACKGROUND
PMID: 20842070 (View on PubMed)

Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, Cervantes Y, Linhares AC, Lopez P, Macias-Parra M, Ortega-Barria E, Richardson V, Rivera-Medina DM, Rivera L, Salinas B, Pavia-Ruz N, Salmeron J, Ruttimann R, Tinoco JC, Rubio P, Nunez E, Guerrero ML, Yarzabal JP, Damaso S, Tornieporth N, Saez-Llorens X, Vergara RF, Vesikari T, Bouckenooghe A, Clemens R, De Vos B, O'Ryan M; Human Rotavirus Vaccine Study Group. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006 Jan 5;354(1):11-22. doi: 10.1056/NEJMoa052434.

Reference Type DERIVED
PMID: 16394298 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Dataset Specification

View Document

Document Type: Study Protocol

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-001484-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

444563/022

Identifier Type: -

Identifier Source: org_study_id