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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)

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ClinicalTrials.gov Identifier: NCT01926015
Recruitment Status : Completed
First Posted : August 20, 2013
Results First Posted : April 9, 2015
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE August 16, 2013
First Posted Date  ICMJE August 20, 2013
Results First Submitted Date  ICMJE March 27, 2015
Results First Posted Date  ICMJE April 9, 2015
Last Update Posted Date November 14, 2018
Actual Study Start Date  ICMJE September 19, 2013
Actual Primary Completion Date June 6, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 16, 2013)
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 ]
Change History Complete list of historical versions of study NCT01926015 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2013)
  • Percentage of Participants Reporting Adverse Events with an Incidence ≥1% [ Time Frame: Up to 14 days after each visit (Visits 1-6) ]
  • Percentage of Participants Reporting Adverse Events of Special Interest [ Time Frame: Up to 14 days after each visit (Visits 1-6) ]
  • Percentage of Participants Reporting Adverse Events of Special Interest [ Time Frame: Up to 14 days after the last visit (Visit 6) ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
Brief Summary 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™.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Rotavirus Disease
Intervention  ICMJE
  • Biological: RotaTeq™ (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
Study Arms  ICMJE
  • 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).
    Interventions:
    • Biological: RotaTeq™ (V260)
    • Biological: DTP-IPV
  • 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).
    Interventions:
    • Biological: RotaTeq™ (V260)
    • Biological: DTP-IPV
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2015)
192
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2013)
190
Actual Study Completion Date  ICMJE June 6, 2014
Actual Primary Completion Date June 6, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Weeks to 11 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Japan
 
Administrative Information
NCT Number  ICMJE NCT01926015
Other Study ID Numbers  ICMJE V260-060
132252 ( Registry Identifier: JAPIC-CTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP