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

NCT00383903 | Completed Phase 2

• 1 other identifier: 444563/013
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 6

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.

Conditions

Infections, Rotavirus

Outcome Measures

Primary Outcomes (1)

• Seroconversion after HRV vaccination

Secondary Outcomes (1)

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

Interventions

HRV vaccine BIOLOGICAL

Two or three oral doses

Eligibility Criteria

• Age: 5 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Brits, 0250, South Africa

Location

GSK Investigational Site

Ga-Rankuwa, 0208, South Africa

Location

GSK Investigational Site

Pretoria, 2, South Africa

Location

GSK Investigational Site

Pretoria North, 2, South Africa

Location

GSK Investigational Site

Rooihuiskraal, 0145, South Africa

Location

GSK Investigational Site

Sunnyside, Pretoria, 2, South Africa

Location

Related Publications (3)

• 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.

  BACKGROUND

• 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 ASCOOD. Bangkok, Thailand, 8-10 March 2006.

  BACKGROUND

• 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.

  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Rotavirus Infections

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2006
• First Posted: October 4, 2006
• Study Start: September 1, 2003
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

ZA (6)