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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 6, 2014

Interventions

  • Biological: RotaTeq™ (V260)
    • Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains
  • Biological: DTP-IPV
    • Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule

Arms, Groups and Cohorts

  • Experimental: Concomitant RotaTeq™ and DTP-IPV
    • RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4).
  • Active Comparator: Staggered RotaTeq™ and DTP-IPV
    • RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 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 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4).

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
    • Time Frame: 4 to 6 weeks after the third dose of DTP-IPV
    • Participant serum was collected for determination of antibody responses. Threshold levels for seroresponse were the following: Diphtheria Toxin, >=0.1 International Units (IU)/mL; Tetanus Toxin, >=0.01 IU/mL; Pertussis Toxin and Pertussis FHA, >=10 Enzyme Units (EU)/mL; Poliovirus Types 1, 2, and 3, neutralizing antibody (NA) titer >=8.

Secondary Measures

  • Percentage of Participants Reporting an Adverse Event With Incidence >=1%
    • Time Frame: Up to 14 days after any of the 6 study visits
    • An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events with an incidence >=1% in either treatment group were recorded.
  • Percentage of Participants Reporting an Adverse Event of Special Interest: Fever
    • Time Frame: Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)
    • An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.
  • Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea
    • Time Frame: Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)
    • An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.
  • Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting
    • Time Frame: Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)
    • An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.
  • Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events
    • Time Frame: Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)
    • An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.
  • Geometric Mean Titers for Diphtheria Toxin Antibody
    • Time Frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    • Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
  • Geometric Mean Titers for Tetanus Toxin Antibody
    • Time Frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    • Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
  • Geometric Mean Titers for Pertussis Toxin Antibody
    • Time Frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    • Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
  • Geometric Mean Titers for Pertussis FHA Antibody
    • Time Frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    • Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
  • Geometric Mean Titers for Poliovirus Type 1 Antibody
    • Time Frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    • Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.
  • Geometric Mean Titers for Poliovirus Type 2 Antibody
    • Time Frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    • Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.
  • Geometric Mean Titers for Poliovirus Type 3 Antibody
    • Time Frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
    • Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.

Participating in This Clinical Trial

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 with 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

Gender Eligibility: All

Minimum Age: 6 Weeks

Maximum Age: 11 Weeks

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Merck Sharp & Dohme LLC

Citations Reporting on Results

Tanaka Y, Yokokawa R, Rong HS, Kishino H, Stek JE, Nelson M, Lawrence J. Concomitant administration of diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine derived from Sabin strains (DTaP-sIPV) with pentavalent rotavirus vaccine in Japanese infants. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-7. doi: 10.1080/21645515.2017.1279769. Epub 2017 Jan 31.

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