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OpenTrials
Completed

NCT Number: NCT00139334

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

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).

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Key information

Conditions

Infections, Rotavirus Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

5 week–7 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site

Dhaka, 1000, Bangladesh

About this study

"The study will have four groups: Group HRV + OPV, Group HRV alone, Group Placebo + OPV and Group Placebo alone. Two-dose immunisation will be administered in healthy infants at approximately 12 and 16 weeks of age. Immunogenicity, reactogenicity and safety relative to the placebo will also be evaluated. Treatment allocation: randomized (2:2:1:1). Routine EPI vaccines should be administered during the study following the EPI recommendation in Bangladesh."

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Rotavirus

Biological

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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine (RIX4414 at 106.5 CCID50) When Given Concomitantly With OPV Versus Given Alone (HRV Vaccine Dose Given 15 Days After the OPV Dose) in Healthy Infants in Bangladesh

Important dates

Study start
2005
Study completion
2006
First posted
Aug 31, 2005
Registry last updated
Sep 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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