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

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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

	Rotarix Group	Placebo Group
STARTED	4359	4328
COMPLETED	4272	4226
NOT COMPLETED	87	102
Protocol Violation	1	0
Withdrawal by Subject	0	1
Lost to Follow-up	86	101

Baseline Characteristics

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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.

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

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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 ]

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Measure Type	Primary
Measure Title	Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains
Measure Description	Severe RV GE is an episode of severe GE in which rotavirus other than vaccine strain was identified in a GE stool sample. Note that this outcome measure is secondary in the study protocol. We have reported it here as primary outcome measure, since none of the primary outcome measures in the study protocol pertain to the time point (Year 3 follow-up) presented in this summary.
Time Frame	From Year 2 up to Year 3
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy.

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.

Measured Values

	Rotarix Group	Placebo Group
Number of Participants Analyzed [units: participants]	4222	4185
Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains [units: subjects]	0	13

No statistical analysis provided for Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains

2. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	107070, 107072, 107076
Study First Received:	May 24, 2006
Results First Received:	July 2, 2009
Last Updated:	September 11, 2009
ClinicalTrials.gov Identifier:	NCT00329745 History of Changes
Health Authority:	Singapore: Health Sciences Authority