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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Rotavirus Vaccines; Infections, Rotavirus

Treatments: Biological: Rotarix™; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432380

109216

2015-001544-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 375 patients

Sex: All

Ages: 5 to 10 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

375 participants in 3 patient groups, including a placebo group

PLACEBO-ROTARIX-ROTARIX GROUP

Experimental group

Description:

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.

Treatment:

Biological: Rotarix™

Biological: Placebo

ROTARIX-PLACEBO-ROTARIX GROUP

Experimental group

Description:

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.

Treatment:

Biological: Rotarix™

Biological: Placebo

PLACEBO GROUP

Placebo Comparator group

Description:

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.

Treatment:

Biological: Placebo