A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-09

Study Completion Date

2007-09-04

Brief Summary

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This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.

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Detailed Description

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Conditions

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Infections, Rotavirus Rotavirus Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PLACEBO-ROTARIX-ROTARIX GROUP

Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

Group Type EXPERIMENTAL

Rotarix™

Intervention Type BIOLOGICAL

oral doses

Placebo

Intervention Type BIOLOGICAL

oral dose

ROTARIX-PLACEBO-ROTARIX GROUP

Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

Group Type EXPERIMENTAL

Rotarix™

Intervention Type BIOLOGICAL

oral doses

Placebo

Intervention Type BIOLOGICAL

oral dose

PLACEBO GROUP

Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

oral dose

Interventions

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Rotarix™

oral doses

Intervention Type BIOLOGICAL

Placebo

oral dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy infants between, and including, 5-10 weeks of age at the time of the first dose of HRV liquid vaccine or placebo.
* Birth weight of the subject should be \> 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 study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine 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. BCG is administered at birth according to the local EPI.
* Concurrently participating in another clinical study, at any time during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Minimum Eligible Age

5 Weeks

Maximum Eligible Age

10 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

City of Muntinlupa, , Philippines

Site Status

Countries

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Philippines

References

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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.

Reference Type BACKGROUND

PMID: 21256876 (View on PubMed)

Study Documents

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