Clinical trial NCT01926015: 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: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rotavirus Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-08-20
Enrollment: 192
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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™.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
timeFrame: 4 to 6 weeks after the third dose of DTP-IPV
Secondary outcomes:
measure: Percentage of Participants Reporting an Adverse Event With Incidence >=1%
timeFrame: Up to 14 days after any of the 6 study visits
measure: Percentage of Participants Reporting an Adverse Event of Special Interest: Fever
timeFrame: 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)
measure: Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea
timeFrame: 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)
measure: Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting
timeFrame: 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)
measure: Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events
timeFrame: 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)
measure: Geometric Mean Titers for Diphtheria Toxin Antibody
timeFrame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
measure: Geometric Mean Titers for Tetanus Toxin Antibody
timeFrame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
measure: Geometric Mean Titers for Pertussis Toxin Antibody
timeFrame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
measure: Geometric Mean Titers for Pertussis FHA Antibody
timeFrame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
measure: Geometric Mean Titers for Poliovirus Type 1 Antibody
timeFrame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
measure: Geometric Mean Titers for Poliovirus Type 2 Antibody
timeFrame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
measure: Geometric Mean Titers for Poliovirus Type 3 Antibody
timeFrame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.