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of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)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
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™.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Geometric Mean Titer (GMT) for Pertussis Toxoid
Secondary Outcome
Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A
Condition
Rotavirus Gastroenteritis
Intervention
Rotavirus Vaccine, Live, Oral, Pentavalent
Study Arms / Comparison Groups
1
Description: RotaTeq™ + DTwP
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
0
Start Date
December 2009
Completion Date
September 2010
Primary Completion Date
August 2010
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
Gender
All
Ages
6 Weeks - 12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Monitor, ,
Administrative Informations
NCT ID
NCT01003431
Organization ID
V260-036
Secondary IDs
V260-036
Responsible Party
Sponsor
Study Sponsor
Merck Sharp & Dohme LLC
Study Sponsor
Medical Monitor, Study Director, Merck Sharp & Dohme LLC
Verification Date
October 2015