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of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)

This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014