Immunogenicity and Safety of Concomitant Administration of V260 (RotaTeq™) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01926015
First received: August 16, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of V260 (RotaTeq™) in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates to DTP-IPV with concomitant administration of V260 are non-inferior to those with staggered administration of V260.


Condition Intervention Phase
Rotavirus Disease
Biological: V260
Biological: DTP-IPV
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Post-marketing, Randomized, Open-label Study to Assess the Immunogenicity and Safety of Concomitant Administration of V260 and Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Japanese Healthy Infants

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Antibody Response Rates to Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Polio Virus Type 1/2/3 [ Time Frame: From 4 to 6 weeks after the third DTP-IPV vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants Reporting Adverse Events with an Incidence ≥1% [ Time Frame: Up to 14 days after each visit (Visits 1-6) ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Reporting Adverse Events of Special Interest [ Time Frame: Up to 14 days after each visit (Visits 1-6) ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Reporting Adverse Events of Special Interest [ Time Frame: Up to 14 days after the last visit (Visit 6) ] [ Designated as safety issue: Yes ]
  • Geometric Mean Titer (GMT) of Diphtheria Toxin, Tetanus Toxin, Pertussis Toxin, Pertussis FHA, and Polio Virus Type 1/2/3 [ Time Frame: From 4 to 6 weeks after the third DTP-IPV vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: September 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concomitant V260 and DTP-IPV
V260 (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2, Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4).
Biological: V260
Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains
Other Name: RotaTeq™
Biological: DTP-IPV
Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule
Other Names:
  • Tetrabik™
  • BIKEN
Experimental: Staggered V260 and DTP-IPV
V260 (2 mL oral dose) administered at Visit 1, Visit 3 (6 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2, Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4).
Biological: V260
Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains
Other Name: RotaTeq™
Biological: DTP-IPV
Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule
Other Names:
  • Tetrabik™
  • BIKEN

  Eligibility

Ages Eligible for Study:   42 Days to 76 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Japanese participant
  • Age 6 weeks through <11 weeks (42 to 76 days from date of birth) at Visit 1

Exclusion Criteria:

  • History of hypersensitivity and/or anaphylaxis to any of the product ingredients in V260 or DTP-IPV
  • Gastrointestinal disorder, growth retardation, or failure to thrive
  • History of intussusception
  • Untreated congenital gastrointestinal disorder (such as Meckel diverticulum)
  • Known or suspected impairment of immunological function, including severe immunodeficiency (SCID)
  • Cardiovascular, renal, liver, or blood disease
  • History of convulsion
  • Undergoing immunosuppressive therapy or living with a close relative with congenital immune deficiency
  • Prior vaccination of rotavirus vaccine and/or DTP-IPV vaccine
  • Live vaccine received within 28 days or inactivated vaccine received within 7 days
  • At high risk for tuberculosis exposure
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01926015     History of Changes
Other Study ID Numbers: V260-060, 132252
Study First Received: August 16, 2013
Last Updated: December 16, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Rotavirus Infections
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 16, 2014