Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00130832
First received: August 12, 2005
Last updated: May 5, 2014
Last verified: May 2014
Results First Received: August 7, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Rotavirus Infections
Gastroenteritis
Interventions: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Biological: Comparator: Oral Poliovirus Vaccine (OPV)
Biological: Comparator: Oral Poliovirus Vaccine (OPV) (staggered)

  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
Enrollment occurred at 9 study sites in Mexico, Costa Rica, Guatemala, and Brazil from 19-Oct-2005 (first subject in) to 06-Jan-2006 (last subject randomized).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Excluded from randomization were subjects with history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea, or failure to thrive, clinical evidence of active gastrointestinal illness and those with fever, a rectal temperature ≥38.1°C (≥100.5°F) at time of immunization.

Reporting Groups
  Description
RotaTeq and Oral Poliovirus (OPV) Concomitantly Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
RotaTeq and Oral Poliovirus (OPV) Staggered Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later

Participant Flow:   Overall Study
    RotaTeq and Oral Poliovirus (OPV) Concomitantly     RotaTeq and Oral Poliovirus (OPV) Staggered  
STARTED     372     363  
COMPLETED     356 [1]   346 [2]
NOT COMPLETED     16     17  
Adverse Event                 1                 1  
Lost to Follow-up                 1                 2  
Protocol Violation                 6                 8  
Withdrawal by Subject                 6                 1  
Moved                 2                 2  
Unspecified                 0                 3  
[1] Those who received all 3 doses of concomitant RotaTeq™/ OPV with blood draw ~42 days postdose 3
[2] Those who received all 3 doses; last 2 blood draws ~42 days postdose 3 of RotaTeq™ and postdose OPV



  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.
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Reporting Groups
  Description
RotaTeq and Oral Poliovirus (OPV) Concomitantly Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
RotaTeq and Oral Poliovirus (OPV) Staggered Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
Total Total of all reporting groups

Baseline Measures
    RotaTeq and Oral Poliovirus (OPV) Concomitantly     RotaTeq and Oral Poliovirus (OPV) Staggered     Total  
Number of Participants  
[units: participants]
  372     363     735  
Age, Customized  
[units: participants]
     
5 Weeks of Age and Under     8     1     9  
6 to 12 Weeks of Age     364     362     726  
Over 12 Weeks of Age     0     0     0  
Gender  
[units: participants]
     
Female     189     194     383  
Male     183     169     352  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     2     1     3  
Black     10     7     17  
Hispanic American     263     257     520  
Multi-Racial     56     61     117  
White     41     37     78  



  Outcome Measures
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1.  Primary:   Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3   [ Time Frame: Approximately 42 days Postdose 3 ]

2.  Primary:   GMT of Serum Anti-rotavirus Immunoglobulin A (IgA)   [ Time Frame: Approximately 42 days Postdose 3 ]

3.  Primary:   Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered   [ Time Frame: Approximately 42 days Postdose 3 ]


  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: Vice President, Late Stage Development Group Leader
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: NCT00130832     History of Changes
Other Study ID Numbers: V260-014, 2005_030
Study First Received: August 12, 2005
Results First Received: August 7, 2009
Last Updated: May 5, 2014
Health Authority: Brazil: Ministry of Health