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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention
Condition:	Infections, Rotavirus
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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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.
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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.
Total	Total of all reporting groups

Baseline Measures

	Rotarix Group	Placebo Group	Total
Overall Participants Analyzed; [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: Participants]; Count of Participants
Female	2108 48.4%	2097 48.5%	4205 48.4%
Male	2251 51.6%	2231 51.5%	4482 51.6%

  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 [ Time Frame: From Year 2 up to Year 3 ]

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2. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: 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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  Limitations and Caveats

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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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  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.

Results Point of Contact:  

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

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00329745 History of Changes
Obsolete Identifiers:	NCT00329953, NCT00331734
Other Study ID Numbers:	107070; 107072 ( Other Identifier: GSK ); 107076 ( Other Identifier: GSK )
First Submitted:	May 24, 2006
First Posted:	May 25, 2006
Results First Submitted:	July 2, 2009
Results First Posted:	October 14, 2009
Last Update Posted:	December 9, 2016