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

GlaxoSmithKline375 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

375

Conditions

Infections, Rotavirus Rotavirus Vaccines

Interventions

Rotarix™BIOLOGICAL

oral doses

PlaceboBIOLOGICAL

oral dose

Eligibility

Sex: ALLMin age: 5 WeeksMax age: 10 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

City of Muntinlupa, Philippines

Outcomes

Primary Outcomes

Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody

Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group.

Time frame: At Month 3

Secondary Outcomes

Number of Seroconverted Subjects for Anti-RV IgA Antibody

Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the first and third routine EPI immunization. This outcome measure only concerns subjects in the Rotarix-Placebo-Rotarix Group.

Time frame: At Month 3

Serum IgA Antibody Concentrations Against Rotavirus

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). This outcome measure only concerns subjects in Placebo-Rotarix-Rotarix and Rotarix-Placebo-Rotarix Groups.

Time frame: At Month 3

Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea

Any symptom = occurrence of the symptom (i.e. fever or vomiting or diarrhea) regardless of intensity grade or relationship to vaccination. Grade 2 fever = rectal temperature greater than (\>) 38.5 - less than or equal to (≤) 39.5degrees Celsius (°C) or axillary temperature \> 38.0 - ≤ 39.0°C. Grade 3 fever = rectal temperature \> 39.5°C or axillary temperature \> 39.0°C. Grade 2 vomiting = 2 episodes of vomiting/ day. Grade 3 vomiting = 3 or more episodes of vomiting/ day. Grade 2 diarrhea = 4-5 looser than normal stools/ day. Grade 3 diarrhea = 6 or more looser than normal stools/ day.

Data from ClinicalTrials.gov

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