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

Infections, Rotavirus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00139334
• Other study ID #: 103992
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2005
• Last updated: September 20, 2016
• Start date: June 2005
• Est. completion date: January 2006

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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).

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."

Other known NCT identifiers

• NCT00209976

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Weeks to 7 Weeks

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

Biological:
• Rotavirus

Locations

Country	Name	City	State
Bangladesh	GSK Investigational Site	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Bangladesh, 

References & 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.

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

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