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Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa

Primary Purpose

Infections, Rotavirus

Status

Completed

Phase

Phase 2

Locations

South Africa

Study Type

Interventional

Intervention

HRV vaccine

About this trial

This is an interventional prevention trial for Infections, Rotavirus

Eligibility Criteria

5 Weeks - 10 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy infants born after a normal gestation period (>=36 weeks), between 5 and 10 weeks of age at Dose 1 with confirmed negative HIV status of the subject's mother.
Written informed consent was obtained from the parent/guardian of the subject before study entry.

Exclusion Criteria:

History of allergic disease/polio disease,
Confirmed or suspected immunosuppressive or immunodeficient condition,
Clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator,
Received treatment prohibited by the protocol.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

Sites / Locations

GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site

Outcomes

Primary Outcome Measures

Seroconversion after HRV vaccination

Secondary Outcome Measures

shedding, serum anti-rota IgA antibody concentrations, anti-polio 1, 2 and 3 seroprotection rates, reactogenicity, safety

Full Information

NCT ID

NCT00383903

First Posted

October 3, 2006

Last Updated

September 14, 2016

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00383903

Brief Title

Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa

Official Title

A Phase II, Randomized, Double-blind, Placebo-controlled Study of Safety, Reactogenicity and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine at 10E6.5 CCID50 Viral Concentration in Healthy Infants (Approximately 5-10 Weeks Old) in the Republic of South Africa

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

September 2004 (Actual)

Study Completion Date

September 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections, Rotavirus

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

472 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

HRV vaccine

Intervention Description

Two or three oral doses

Primary Outcome Measure Information:

Title

Seroconversion after HRV vaccination

Secondary Outcome Measure Information:

Title

shedding, serum anti-rota IgA antibody concentrations, anti-polio 1, 2 and 3 seroprotection rates, reactogenicity, safety

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Weeks

Maximum Age & Unit of Time

10 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy infants born after a normal gestation period (>=36 weeks), between 5 and 10 weeks of age at Dose 1 with confirmed negative HIV status of the subject's mother. Written informed consent was obtained from the parent/guardian of the subject before study entry. Exclusion Criteria: History of allergic disease/polio disease, Confirmed or suspected immunosuppressive or immunodeficient condition, Clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator, Received treatment prohibited by the protocol. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Brits

ZIP/Postal Code

0250

Country

South Africa

Facility Name

GSK Investigational Site

City

Ga-Rankuwa

ZIP/Postal Code

0208

Country

South Africa

Facility Name

GSK Investigational Site

City

Pretoria North

ZIP/Postal Code

Country

South Africa

Facility Name

GSK Investigational Site

City

Pretoria

ZIP/Postal Code

Country

South Africa

Facility Name

GSK Investigational Site

City

Rooihuiskraal

ZIP/Postal Code

0145

Country

South Africa

Facility Name

GSK Investigational Site

City

Sunnyside, Pretoria

ZIP/Postal Code

Country

South Africa

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

Citation

Steele AD et al. Comparison of 2 different regimens (two doses versus three doses) in terms of reactogenicity and immunogenicity of the live attenuated human rotavirus vaccine Rotarix™ (RIX4414) in South African infants. Abstract presented at the 9th dsRNA Virus Meeting. Cape Town, South Africa, 21-26 Oct 2006.

Results Reference

background

Citation

Results Reference

background

Citation

Steele AD et al. Difference in immune responses between 2 different regimens of RIX4414 ( 106.5 CCID50 viral concentration) in South Africa. Abstract presented at the 4th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Warsaw, Poland, 01-04 Sept 2005.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

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

Available IPD and Supporting Information:

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

444563/013

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

444563/013

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

444563/013

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

444563/013

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

444563/013

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

444563/013

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa

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