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COMPLETEDPHASE3

Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)

A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-country and Multi-center Study to Assess the Efficacy and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants.

NCT00329745•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in infants previously vaccinated with human rotavirus (HRV) vaccine or placebo in the following schedules: at 3 and 4 months of age in study rota-028; at 2 and 4 months of age in study rota-029 or rota-030. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

Note that no new subjects will be recruited in this extension phase studies. The expected total enrolment for the primary studies was as follows: rota-028: 5700 rota-029: 3018 rota-030: 1102

Eligibility

Age

2 - 3 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.
•A male or female between, and including, 6 and 12 weeks of age in Hong Kong and Taiwan or 11 to 17 weeks of age in Singapore at the time of the first vaccination according to the country recommendations for the routine vaccination schedules.
•Written informed consent obtained from the parent or guardian of the subject, prior any study procedure.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
•Child is unlikely to remain in the study area for the duration of the study
•Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
•History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
•Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Oral intake of immunoglobulins is allowed.
•Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
•First or second degree of consanguinity of parents.

Locations (4)

GSK Investigational Site

Singapore, Singapore

GSK Investigational Site

Singapore, Singapore

GSK Investigational Site

Singapore, Singapore

GSK Investigational Site

Singapore, Singapore

Key Dates

Start Date

January 1, 2007

Primary Completion Date

July 1, 2008

Completion Date

July 1, 2008

Last Updated

December 9, 2016

Enrollment

8,687

ACTUAL participants

Conditions

Infections, Rotavirus

Interventions

Rotarix™

BIOLOGICAL

Placebo

BIOLOGICAL

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

NCT00480324

Infections, RotavirusRotavirus Vaccines

View study

COMPLETEDPHASE3

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age

NCT00533507

Infections, Rotavirus

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)

Inclusion Criteria

Exclusion Criteria

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

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age

Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011

Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines

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

Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis