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)
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
2 other identifiers
interventional
192
0 countries
N/A
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™.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2013
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2013
CompletedFirst Posted
Study publicly available on registry
August 20, 2013
CompletedStudy Start
First participant enrolled
September 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2014
CompletedResults Posted
Study results publicly available
April 9, 2015
CompletedNovember 14, 2018
October 1, 2018
9 months
August 16, 2013
March 27, 2015
October 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
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.
4 to 6 weeks after the third dose of DTP-IPV
Secondary Outcomes (12)
Percentage of Participants Reporting an Adverse Event With Incidence >=1%
Up to 14 days after any of the 6 study visits
Percentage of Participants Reporting an Adverse Event of Special Interest: Fever
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)
Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea
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)
Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting
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)
Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events
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)
- +7 more secondary outcomes
Study Arms (2)
Concomitant RotaTeq™ and DTP-IPV
EXPERIMENTALRotaTeq™ (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).
Staggered RotaTeq™ and DTP-IPV
ACTIVE COMPARATORRotaTeq™ (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
Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains
Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule
Eligibility Criteria
You may qualify if:
- Japanese participant
- Age 6 weeks through \<11 weeks (42 to 76 days from date of birth) at Visit 1
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 28140752RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2013
First Posted
August 20, 2013
Study Start
September 19, 2013
Primary Completion
June 6, 2014
Study Completion
June 6, 2014
Last Updated
November 14, 2018
Results First Posted
April 9, 2015
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will share
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf