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)

NCT ID: NCT01926015

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-19
• Study Completion Date: 2014-06-06

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™.

Conditions

Rotavirus Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

RotaTeq™ (V260)

Intervention Type: BIOLOGICAL

Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains

DTP-IPV

Intervention Type: BIOLOGICAL

Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule

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).

Group Type: ACTIVE_COMPARATOR

RotaTeq™ (V260)

Intervention Type: BIOLOGICAL

Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains

DTP-IPV

Intervention Type: BIOLOGICAL

Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule

Interventions

RotaTeq™ (V260)

Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains

Intervention Type: BIOLOGICAL

DTP-IPV

Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule

Intervention Type: BIOLOGICAL

Other Intervention Names

RotaTeq™; Tetrabik™; BIKEN

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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 11 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 28140752 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

132252

Identifier Type: REGISTRY

Identifier Source: secondary_id

V260-060

Identifier Type: -

Identifier Source: org_study_id