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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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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Time Frame	No text entered.
Additional Description	Adverse events were not systematically followed up in this study. Only the adverse events (and serious adverse events) leading to subject withdrawal or drop-out were collected.

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.

Serious Adverse Events

	Rotarix Group	Placebo Group
Total, serious adverse events
# participants affected / at risk	10/4359 (0.23%)	11/4328 (0.25%)
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura * # participants affected / at risk	0/4359 (0.00%)	2/4328 (0.05%)
Lymphadenitis * # participants affected / at risk	1/4359 (0.02%)	1/4328 (0.02%)
Gastrointestinal disorders
Intussusception * # participants affected / at risk	2/4359 (0.05%)	1/4328 (0.02%)
Gastritis * # participants affected / at risk	1/4359 (0.02%)	1/4328 (0.02%)
Infections and infestations
Gastroenteritis * # participants affected / at risk	3/4359 (0.07%)	2/4328 (0.05%)
Upper respiratory tract * # participants affected / at risk	0/4359 (0.00%)	3/4328 (0.07%)
Epyema * # participants affected / at risk	0/4359 (0.00%)	1/4328 (0.02%)
Kawasaki's disease * # participants affected / at risk	1/4359 (0.02%)	0/4328 (0.00%)
Injury, poisoning and procedural complications
Burns third degree * # participants affected / at risk	1/4359 (0.02%)	0/4328 (0.00%)
Croup infectious * # participants affected / at risk	0/4359 (0.00%)	1/4328 (0.02%)
Overdose * # participants affected / at risk	0/4359 (0.00%)	1/4328 (0.02%)
Metabolism and nutrition disorders
Dehydratation * # participants affected / at risk	0/4359 (0.00%)	1/4328 (0.02%)
Hypoglycaemia * # participants affected / at risk	0/4359 (0.00%)	1/4328 (0.02%)
Nervous system disorders
Febrile convulsion * # participants affected / at risk	1/4359 (0.02%)	0/4328 (0.00%)
Skin and subcutaneous tissue disorders
Dermatitis atopic * # participants affected / at risk	1/4359 (0.02%)	0/4328 (0.00%)

*	Indicates events were collected by non-systematic assessment.

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