A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01003431
First received: October 27, 2009
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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™.


Condition Intervention Phase
Rotavirus Gastroenteritis
Diphtheria
Tetanus
Pertussis
Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Biological: Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)
Biological: Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Geometric Mean Titer (GMT) for Pertussis Toxoid [ Time Frame: 1 month post dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A [ Time Frame: 1 month post dose 3 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
RotaTeq™ + DTwP
Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
[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.
Active Comparator: 2
Rotarix™ + DTwP
Biological: Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)
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).
Active Comparator: 3
RotaTeq™ + DTaP
Biological: Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)
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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003431

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01003431     History of Changes
Other Study ID Numbers: V260-036, V260-036
Study First Received: October 27, 2009
Last Updated: November 4, 2013
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Diphtheria
Gastroenteritis
Whooping Cough
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Gastrointestinal Diseases
Digestive System Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections

ClinicalTrials.gov processed this record on April 16, 2014