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COMPLETEDNCT00779779

Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants

This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (se...

Lead sponsor: GlaxoSmithKline•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

GlaxoSmithKline

Age

0 - 0 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 .
•A male or female at least 6 weeks of age at the time of the first vaccination.
•Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria

•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Acute disease at the time of enrolment.
•Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
•Any contraindication as stated in the updated and approved Prescribing Information

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 28, 2018Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment522

Start dateNov 2008

Last updatedAug 28, 2018

Condition

Infections, Rotavirus

Locations shown

GSK Investigational Site

Colombo

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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: August 28, 2018Data synced to Clareo: May 10, 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.

View ClinicalTrials.gov Terms and Conditions