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Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00496054
First Posted: July 4, 2007
Last Update Posted: April 13, 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):
Merck Sharp & Dohme Corp.
Results First Submitted: November 12, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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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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
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) 
Overall Participants Analyzed 
[Units: Participants]
 110 
Age 
[Units: Days]
Mean (Standard Deviation)
 59.01  (13.52) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      47  42.7% 
Male      63  57.3% 
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
  Show All Outcome Measures

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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

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

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

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

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

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

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

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

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

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

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

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


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00496054     History of Changes
Other Study ID Numbers: V260-021
2007_020
First Submitted: July 3, 2007
First Posted: July 4, 2007
Results First Submitted: November 12, 2009
Results First Posted: March 11, 2010
Last Update Posted: April 13, 2017