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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 : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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™.

Condition or disease Intervention/treatment Phase
Rotavirus Disease Biological: RotaTeq™ (V260) Biological: DTP-IPV Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : September 19, 2013
Actual Primary Completion Date : June 6, 2014
Actual Study Completion Date : June 6, 2014


Arm Intervention/treatment
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).
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

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).
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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.



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Ages Eligible for Study:   6 Weeks to 11 Weeks   (Child)
Sexes Eligible for Study:   All
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926015


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01926015     History of Changes
Other Study ID Numbers: V260-060
132252 ( Registry Identifier: JAPIC-CTI )
First Posted: August 20, 2013    Key Record Dates
Results First Posted: April 9, 2015
Last Update Posted: June 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Diphtheria
Rotavirus Infections
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs