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

This study has been completed.

Study NCT00329745 Information provided by GlaxoSmithKline

First Received: May 24, 2006 Last Updated: September 11, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Condition:	Rotavirus Gastroenteritis
Interventions:	Biological: Rotarix™ Biological: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Rotarix Group	During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
Placebo Group	During the primary study (NCT00197210) subjects received two oral doses of placebo.

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Rotarix Group	During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
Placebo Group	During the primary study (NCT00197210) subjects received two oral doses of placebo.

Baseline Measures

	Rotarix Group	Placebo Group	Total
Number of Participants [units: participants]	4359	4328	8687
Age [units: months] Mean ± Standard Deviation	35.4 ± 1.18	35.4 ± 1.26	35.4 ± 1.22
Gender [units: subjects]
Female	2108	2097	4205
Male	2251	2231	4482

Outcome Measures

1. Primary:

Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains [ From Year 2 up to Year 3 ]

Show Outcome Measure 1

2. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs) [ From the end of the primary study up to Year 3 ]

Show Outcome Measure 2