To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)

Infections, Rotavirus Clinical Trial

Official title:

A Placebo-controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine, When Given to Healthy Infants, in Vietnam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345956
• Other study ID #: 105722
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2006
• Last updated: October 27, 2016
• Start date: September 2006
• Est. completion date: March 2007

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To provide specific data on immunogenicity of GSK Biologicals' HRV liquid vaccine, when co-administered with the routine Expanded Program of Immunization (EPI) in Vietnam. The study will also assess reactogenicity and safety of the HRV liquid vaccine relative to the placebo

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 10 Weeks

Eligibility

Inclusion Criteria:

• Healthy male or female infant between, and including, 6 and 10 weeks of age with a birth weight of > 2000 grams.

• Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the HRV liquid vaccine or placebo within 30 days preceding the first dose of HRV liquid vaccine or placebo, or planned use during the study period.

• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.

• Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after.

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

• History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.

Study Design

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

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

Biological:
• Human rotavirus liquid vaccine

Locations

Country	Name	City	State
Vietnam	GSK Investigational Site	Hanoi
Vietnam	GSK Investigational Site	Nhatrang

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Vietnam, 

References & Publications (2)

Anh DD et al. Immunogenicity, Reactogenicity and Safety of the Oral Live Attenuated Human Rotavirus Vaccine RIX4414(Rotarix™) Oral Suspension (Liquid Formulation) in Vietnamese Infants. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.

Anh DD, Carlos CC, Thiem DV, Hutagalung Y, Gatchalian S, Bock HL, Smolenov I, Suryakiran PV, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 (Rotarix™) oral suspension (liquid formulation) when co-administered with expanded program on immunization (EPI) vaccines in Vietnam and the Philippines in 2006-2007. Vaccine. 2011 Mar 3;29(11):2029-36. doi: 10.1016/j.vaccine.2011.01.018. Epub 2011 Jan 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-RV IgA antibody SC at Month 2 • Safety: solicited & unsolicited adverse events and SAEs

External 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.