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Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00420316
First Posted: January 11, 2007
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: January 5, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Infections, Rotavirus
Interventions: Biological: Rotarix (primary vaccination study)
Biological: Placebo (primary vaccination study)

  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
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Reporting Groups
  Description
Rotarix Group Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Placebo Group Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.

Participant Flow:   Overall Study
    Rotarix Group   Placebo Group
STARTED   1082   531 
COMPLETED   1070   522 
NOT COMPLETED   12   9 
Withdrawal by Subject                0                1 
Lost to Follow-up                12                8 



  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 Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Placebo Group Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Total Total of all reporting groups

Baseline Measures
   Rotarix Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 1082   531   1613 
Age 
[Units: Months]
Mean (Standard Deviation)
 31.2  (1.12)   31.3  (1.19)   31.23  (1.14) 
Gender 
[Units: Participants]
Count of Participants
     
Female      510  47.1%      266  50.1%      776  48.1% 
Male      572  52.9%      265  49.9%      837  51.9% 


  Outcome Measures
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1.  Primary:   Number of Subjects With Any Rotavirus Gastroenteritis (RVGE)   [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]

2.  Secondary:   Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE)   [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]

3.  Secondary:   Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype   [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]

4.  Secondary:   Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype   [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]

5.  Secondary:   Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype   [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]

6.  Secondary:   Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype   [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]

7.  Secondary:   Number of Subjects With Severe Gastroenteritis (GE)   [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]

8.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: During the study period for the long-term follow-up (i.e. 6 months) ]

9.  Secondary:   Number of Subjects Reporting Intussusception (IS)   [ Time Frame: During the period starting from the end of the second follow-up up to the start of the study (end of July 2006 to beginning of January 2007) ]


  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
None reported.


  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: NCT00420316     History of Changes
Other Study ID Numbers: 109810
First Submitted: January 10, 2007
First Posted: January 11, 2007
Results First Submitted: January 5, 2017
Results First Posted: February 23, 2017
Last Update Posted: February 23, 2017