A Study to Test 2 Doses of the HRV Vaccine Given With or Without OPV in Healthy Infants in Bangladesh

NCT00139334 | Completed Phase 2

• 1 other identifier: 103992
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to provide immunogenicity data for GSK Biologicals' HRV vaccine when co-administered with OPV or when given alone (HRV vaccine dose given 15 days after the OPV dose).

Conditions

Infections, Rotavirus

Outcome Measures

Primary Outcomes (1)

• Endpoints : Safety/immunogenicity.Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Visit 6 in the group receiving of HRV vaccine concomitantly with OPV versus placebo group.

Secondary Outcomes (1)

• Immunogenicity of GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion, vaccine take, and rotavirus shedding at Visit 6 in each group; Immunogenicity of OPV at Visit 6 in each group; Reactogenicity and safety in each group.

Interventions

Rotavirus BIOLOGICAL

Eligibility Criteria

• Age: 5 Weeks - 7 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants aged 6 weeks±1 at first study vaccination.

You may not qualify if:

• Malnutrition, no history of rotavirus gastroenteritis, allergic disease or chronic gastrointestinal disease, not received protocol-prohibited treatment.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Dhaka, 1000, Bangladesh

Location

Related Publications (3)

• Bhattacharya SK et al. Immune response in infants sero-positive at pre-vaccination: Human rotavirus vaccine Rotarix™. Abstract presented at 5th World Congress WSPID, Bangkok, Thailand, 15-18 November 2007.

  BACKGROUND

• Zaman et al. Immunogenicity of an Oral Polio Vaccine is Unaffected when Co-Administered with a Human Rotavirus Vaccine in Bangladeshi Children. Absract presented at 5th World Congress WSPID, Bangkok, Thailand, 15-18 November 2007.

  BACKGROUND

• Zaman K, Sack DA, Yunus M, Arifeen SE, Podder G, Azim T, Luby S, Breiman RF, Neuzil K, Datta SK, Delem A, Suryakiran PV, Bock HL; Bangladeshi Rotavirus Vaccine study group. Successful co-administration of a human rotavirus and oral poliovirus vaccines in Bangladeshi infants in a 2-dose schedule at 12 and 16 weeks of age. Vaccine. 2009 Feb 25;27(9):1333-9. doi: 10.1016/j.vaccine.2008.12.059. Epub 2009 Jan 20.

  PMID: 19162114 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: August 30, 2005
• First Posted: August 31, 2005
• Study Start: June 1, 2005
• Study Completion: January 1, 2006
• Last Updated: September 21, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

BA (1)