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: April 13, 2015
Last verified: April 2015
Results First Received: March 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Caregiver, 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  
Number of Participants  
[units: participants]
  513     507     1020  
Age  
[units: Weeks]
Mean (Standard Deviation)
  8.4  (1.4)     8.3  (1.4)     8.3  (1.4)  
Gender  
[units: Participants]
     
Female     232     240     472  
Male     281     267     548  



  Outcome Measures
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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
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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
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


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: April 13, 2015
Health Authority: United States: Food and Drug Administration