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)

Phase 4

Completed

Conditions: Rotavirus Disease

Registration Number: NCT01926015

Lead Sponsor: Merck Sharp & Dohme LLC

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 192

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3	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

Name	Time	Method
Percentage of Participants Reporting an Adverse Event With Incidence >=1%	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: 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)	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	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	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	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
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)	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	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 Pertussis Toxin Antibody	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	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	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	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	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.