Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01198769
First received: September 9, 2010
Last updated: June 7, 2012
Last verified: March 2012
Results First Received: March 22, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Rotavirus Gastroenteritis
Intervention: Biological: Rotarix TM

  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 subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.

Participant Flow:   Overall Study
    Rotarix Group  
STARTED     15  
COMPLETED     15  
NOT COMPLETED     0  



  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 subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.

Baseline Measures
    Rotarix Group  
Number of Participants  
[units: participants]
  15  
Age  
[units: Weeks]
Mean ± Standard Deviation
 
Weeks     8.9  ± 0.80  
Gender  
[units: Subjects]
 
Female     8  
Male     7  



  Outcome Measures
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1.  Primary:   Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody.   [ Time Frame: 2 months post-Dose 2 (at study Month 4) ]

2.  Secondary:   Serum Anti-rotavirus IgA Antibody Concentrations.   [ Time Frame: 2 months post-Dose 2 (at study Month 4) ]

3.  Secondary:   Number of Subjects Reporting Solicited General Symptoms.   [ Time Frame: During the 8-day (Days 0-7) post-vaccination period ]

4.  Secondary:   Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample.   [ Time Frame: From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2) ]

5.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs).   [ Time Frame: Within the 31-day (Days 0-30) follow-up period after vaccination ]

6.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs).   [ Time Frame: During the entire study period (from Dose 1 at Day 0 up to Month 4) ]


  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


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01198769     History of Changes
Other Study ID Numbers: 114351
Study First Received: September 9, 2010
Results First Received: March 22, 2012
Last Updated: June 7, 2012
Health Authority: Taiwan: Food and Drug Administration, Department of Health, Executive Yuan