Back to resultsA Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)
Primary Purpose
Rotavirus Gastroenteritis, Diphtheria, Tetanus
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rotavirus Vaccine, Live, Oral, Pentavalent
Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)
Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)
Sponsored by
About this trial
This is an interventional prevention trial for Rotavirus Gastroenteritis
Eligibility Criteria
Inclusion Criteria:
- Healthy infants
Exclusion Criteria:
- History of abdominal disorders, intestinal folding, or abdominal surgery
- Impaired immune system
- Prior administration of any rotavirus vaccine or DTwP/DTaP
- Fever of >= 38.1C (100.5F) at the time of vaccination
- History of prior rotavirus infection, chronic diarrhea, or failure to thrive
- Evidence of active gastrointestinal illness
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
RotaTeq™ + DTwP
Rotarix™ + DTwP
RotaTeq™ + DTaP
Outcomes
Primary Outcome Measures
Geometric Mean Titer (GMT) for Pertussis Toxoid
Secondary Outcome Measures
Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A
Full Information
NCT ID
NCT01003431
First Posted
October 27, 2009
Last Updated
October 8, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01003431
Brief Title
A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)
Official Title
A Randomized, Open-Label Clinical Study to Assess the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine When Administered Concomitantly With RotaTeq™ or Rotarix™ in Healthy Infants in South Africa
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Study Start Date
December 2009 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotatrix™.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotavirus Gastroenteritis, Diphtheria, Tetanus, Pertussis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
RotaTeq™ + DTwP
Arm Title
2
Arm Type
Active Comparator
Arm Description
Rotarix™ + DTwP
Arm Title
3
Arm Type
Active Comparator
Arm Description
RotaTeq™ + DTaP
Intervention Type
Biological
Intervention Name(s)
Rotavirus Vaccine, Live, Oral, Pentavalent
Intervention Description
[Intervention name: RotaTeq™ administered concomitantly with Tritanrix™ HepB (DTwP)] Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration.
Intervention Type
Biological
Intervention Name(s)
Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)
Intervention Description
Two 1.0 mL oral doses of Rotarix™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration (the second administration will be Tritanrix™ HepB only).
Intervention Type
Biological
Intervention Name(s)
Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)
Intervention Description
Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of INFANRIX™ will be given at the same time with about 1 month between each administration.
Primary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) for Pertussis Toxoid
Time Frame
1 month post dose 3
Secondary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A
Time Frame
1 month post dose 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy infants
Exclusion Criteria:
History of abdominal disorders, intestinal folding, or abdominal surgery
Impaired immune system
Prior administration of any rotavirus vaccine or DTwP/DTaP
Fever of >= 38.1C (100.5F) at the time of vaccination
History of prior rotavirus infection, chronic diarrhea, or failure to thrive
Evidence of active gastrointestinal illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)
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