Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00750893
First received: September 10, 2008
Last updated: March 6, 2014
Last verified: March 2014
Results First Received: January 28, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Infections, Rotavirus
Intervention: Biological: Rotarix™ or Rotarix™ liquid formulation (oral suspension or prefilled syringe)

  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

This post marketing study (PMS) will cover a period of 6 consecutive years. Data is presented up to Year 5 time point and will be updated when data from later time points are available.

Year 1 & Year 2 data were combined and presented at the Year 2 time point and Year 3 & Year 4 data were combined and presented at the Year 4 time point.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant flow and baseline measure are given for the Year 4 time point in order to account for all the subjects participating in this study.

Reporting Groups
  Description
Rotarix Group Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.

Participant Flow:   Overall Study
    Rotarix Group  
STARTED     1052  
COMPLETED     892  
NOT COMPLETED     160  
Adverse Event                 2  
Withdrawal by Subject                 3  
Lost to Follow-up                 149  
Unspecified                 6  



  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 Subjects who received 2 oral doses of Rotarix™. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.

Baseline Measures
    Rotarix Group  
Number of Participants  
[units: participants]
  1052  
Age  
[units: weeks]
Mean ± Standard Deviation
  9.6  ± 2.30  
Gender  
[units: subjects]
 
Female     539  
Male     513  



  Outcome Measures
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1.  Primary:   Number of Subjects Reporting Solicited General Symptoms   [ Time Frame: During the 8 day follow-up period after each vaccine dose for Year 1 & Year 2 study period ]

2.  Primary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs)   [ Time Frame: During the 31 day follow-up period after each vaccine dose for Year 1 & Year 2 study period ]

3.  Primary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs)   [ Time Frame: During the 31 day follow-up period after each vaccine dose for Year 3 & Year 4 study period ]

4.  Primary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs)   [ Time Frame: During the 31 day follow-up period after each vaccine dose for Year 5 study period ]

5.  Primary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: During the post marketing study period for Year 1 & Year 2 study period ]

6.  Primary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: During the post marketing study period for Year 3 & Year 4 study period ]

7.  Primary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: During the post marketing study period for Year 5 study period ]

8.  Primary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs)   [ Time Frame: During the 31 day follow-up period after each vaccine dose for Year 6 study period ]
Results not yet posted.   Anticipated Posting Date:   12/2014   Safety Issue:   No

9.  Primary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: During the post marketing study period for Year 6 study period ]
Results not yet posted.   Anticipated Posting Date:   12/2014   Safety Issue:   No


  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


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00750893     History of Changes
Other Study ID Numbers: 111700
Study First Received: September 10, 2008
Results First Received: January 28, 2011
Last Updated: March 6, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)