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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

522 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-22

Study Completion Date

2009-08-26

Brief Summary

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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 (second dose).

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Detailed Description

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Conditions

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Infections, Rotavirus

Study Groups

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Rotarix Group

Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.

Rotarix™

Intervention Type BIOLOGICAL

Two oral doses, with at least 4 weeks interval in-between

Interventions

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Rotarix™

Two oral doses, with at least 4 weeks interval in-between

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

19 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes