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Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00496054
First received: July 3, 2007
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
Results First Received: November 12, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Gastroenteritis
Rotavirus
Intervention: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

  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

Phase III

First Patient In (FPI): 09-May-2008

Last Patient Out (LPO): 20-Nov-2008

Multi-center study

  1. Department of Paediatrics, Kashyap Nursing Home, Mumbai.
  2. Department of Paediatrics, KEM Hospital, Pune
  3. Department of Paediatrics, J.K.Lon, SMS Hospital, Jaipur
  4. Panchsheel Hospital, Delhi

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Open‐label, single‐arm study. Healthy infants between the ages of 6 weeks through exactly 12 weeks (≥42 to ≤84 days) at entry who did not have clinical evidence of active gastrointestinal illness; who did not have fever, with a rectal temperature of greater than and equal to 38 degrees Celsius at first vaccination were enrolled in the study.

Reporting Groups
  Description
RotaTeq™ Vaccine (V260) Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.

Participant Flow:   Overall Study
    RotaTeq™ Vaccine (V260)  
STARTED     110  
COMPLETED     102  
NOT COMPLETED     8  
Adverse Event                 1  
Lost to Follow-up                 7  



  Baseline Characteristics
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Reporting Groups
  Description
RotaTeq™ Vaccine (V260) Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.

Baseline Measures
    RotaTeq™ Vaccine (V260)  
Number of Participants  
[units: participants]
 		  110  
Age  
[units: Days]
Mean ± Standard Deviation 		  59.01  ± 13.52  
Gender  
[units: participants]
 		 
Female     47  
Male     63  
Height  
[units: Centimeters]
Mean ± Standard Deviation 		  57.61  ± 5.04  
Temperature  
[units: Fahrenheit]
Mean ± Standard Deviation 		  98.58  ± 0.70  
Weight  
[units: Kilograms]
Mean ± Standard Deviation 		  4.73  ± 0.71  



  Outcome Measures
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1.  Primary:   The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 1

2.  Primary:   The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 2

3.  Primary:   The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 3

4.  Primary:   The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 4

5.  Primary:   The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 5

6.  Primary:   The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 6

7.  Primary:   The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 7

8.  Primary:   The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 8

9.  Primary:   The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 9

10.  Primary:   The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 10

11.  Primary:   The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 11

12.  Primary:   The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 12

13.  Primary:   The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 13

14.  Primary:   The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 14

15.  Primary:   The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 15

16.  Primary:   The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 16

17.  Primary:   The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 17

18.  Primary:   The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 18

19.  Primary:   The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 19

20.  Primary:   The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 20

21.  Primary:   The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 21

22.  Primary:   The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 22

23.  Primary:   The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 23

24.  Primary:   The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1   [ Time Frame: Baseline and Approximately 6 Months ]
  Show Outcome Measure 24


  Serious Adverse Events
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  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:
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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided by Merck

Publications automatically indexed to this study:


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00496054     History of Changes
Other Study ID Numbers: 2007_020, V260-021
Study First Received: July 3, 2007
Results First Received: November 12, 2009
Last Updated: April 20, 2010
Health Authority: India: Ministry of Health