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A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01600092
First received: May 14, 2012
Last updated: February 17, 2017
Last verified: February 2017
Results First Received: March 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Rotavirus Gastroenteritis
Interventions: Biological: RotaTeq™ experimental formulation
Biological: RotaTeq™ existing formulation

  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
A total of 1039 participants were screened

Reporting Groups
  Description
RotaTeq™ Experimental Formulation Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
RotaTeq™ Existing Formulation Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).

Participant Flow:   Overall Study
    RotaTeq™ Experimental Formulation   RotaTeq™ Existing Formulation
STARTED   513   507 
Received at Least 1 Vaccination   510 [1]   504 
Received All 3 Vaccinations   500   494 
COMPLETED   495   491 
NOT COMPLETED   18   16 
Adverse Event                2                0 
Lost to Follow-up                4                6 
Withdrawal by parent/guardian                8                6 
Physician Decision                1                1 
Randomized but not vaccinated                3                3 
[1] 1 participant received RotaTeq™ existing formulation as their first vaccination



  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™ Experimental Formulation Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
RotaTeq™ Existing Formulation Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
Total Total of all reporting groups

Baseline Measures
   RotaTeq™ Experimental Formulation   RotaTeq™ Existing Formulation   Total 
Overall Participants Analyzed 
[Units: Participants]
 513   507   1020 
Age 
[Units: Weeks]
Mean (Standard Deviation)
 8.4  (1.4)   8.3  (1.4)   8.3  (1.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      232  45.2%      240  47.3%      472  46.3% 
Male      281  54.8%      267  52.7%      548  53.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]   [ Time Frame: 42 days after vaccination 3 (up to 185 days) ]

2.  Secondary:   Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability   [ Time Frame: Up to 7 days after any vaccination (up to 147 days) ]

3.  Secondary:   Number of Participants With Tier-1 Adverse Events: Intussusception   [ Time Frame: Up to Day 185 ]

4.  Secondary:   Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A   [ Time Frame: 42 days after vaccination 3 (up to 185 days) ]

5.  Secondary:   Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]   [ Time Frame: Baseline and 42 days after vaccination 3 (up to 185 days) ]


  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
No text entered.


  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
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01600092     History of Changes
Other Study ID Numbers: V260-035
Study First Received: May 14, 2012
Results First Received: March 9, 2015
Last Updated: February 17, 2017