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
• Interventions: Biological: RotaTeq™ (V260); Biological: DTP-IPV

• 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

Study Timeline

• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-16
• Study First Posted: 2013-08-20
• Study Start: 2013-09-19
• Primary Completion: 2014-06-06
• Study Completion: 2014-06-06
• Results First Submitted: 2015-03-27
• Results First Submitted QC: 2015-03-27
• Results First Posted: 2015-04-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-14

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

Arm && Interventions

Group	Intervention	Description
Concomitant RotaTeq™ and DTP-IPV	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).
Concomitant RotaTeq™ and DTP-IPV	RotaTeq™ (V260)	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).
Staggered RotaTeq™ and DTP-IPV	RotaTeq™ (V260)	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).
Staggered RotaTeq™ and DTP-IPV	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).

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.