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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01926015
First received: August 16, 2013
Last updated: July 10, 2014
Last verified: July 2014
  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
Study Completion Date: June 2014
Primary Completion Date: June 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
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.

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: July 10, 2014
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 July 22, 2014