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

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ClinicalTrials.gov Identifier: NCT00139334
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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).

Condition or disease Intervention/treatment Phase
Infections, Rotavirus Biological: Rotavirus Phase 2

Detailed Description:
"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."

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official 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
Study Start Date : June 2005
Study Completion Date : January 2006



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Weeks to 7 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139334


Locations
Bangladesh
GSK Investigational Site
Dhaka, Bangladesh, 1000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Publications:
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.
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.

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 103992
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 103992
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 103992
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 103992
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 103992
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 103992
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00139334     History of Changes
Obsolete Identifiers: NCT00209976
Other Study ID Numbers: 103992
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases