Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants

GlaxoSmithKline765 enrolled

Overview

This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus \[HRV\] vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Combined diphtheria and tetanus toxoids and acellular pertussis (DTPa) and Hepatitis B (HBV) vaccines are allowed to be co-administered along with Rotarix vaccine/Placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

765

Conditions

Infections, Rotavirus Rotavirus Vaccines

Interventions

RotarixBIOLOGICAL

Two-dose oral vaccination.

PlaceboBIOLOGICAL

Two-dose oral administration.

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 14 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male or female infant between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination. * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study * Healthy subjects as established by medical history and clinical examination before entering into the study. * Written informed consent obtained from the parent or guardian of the subject. * Born between a gestation period of 36 and 42 weeks inclusive. Exclusion Criteria: * Use of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period. * History of use of experimental rotavirus vaccine. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. * 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). * Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception. * Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition determined by the investigator. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Previous confirmed occurrence of RV GE. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required). * A family history of congenital or hereditary immunodeficiency. * Acute disease at the time of enrolment. * Gastroenteritis within 7 days preceding the study vaccine administration. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Locations (20)

GSK Investigational Site

Aichi, Japan

GSK Investigational Site

Chiba, Japan

Outcomes

Primary Outcomes

Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains

Time frame: From 2 weeks after Dose 2 up to 2 years of age

Secondary Outcomes

Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains

A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system).

Time frame: From 2 weeks after Dose 2 up to 2 years of age

Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type

Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe RV GE was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).

Time frame: From 2 weeks after Dose 2 up to 2 years of age

Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types

Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).

Data from ClinicalTrials.gov

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