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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00329745
First received: May 24, 2006
Last updated: November 21, 2012
Last verified: November 2012
Results First Received: July 2, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
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
No text entered.

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.
No text entered.

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

2.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: From the end of the primary study up to Year 3 ]


  Serious Adverse Events


  Other Adverse Events


  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:
unchecked 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.
unchecked 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.


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 )
Study First Received: May 24, 2006
Results First Received: July 2, 2009
Last Updated: November 21, 2012
Health Authority: Singapore: Health Sciences Authority