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)

Rotavirus Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926015
• Other study ID #: V260-060
• Secondary ID: 132252
• Status: Completed
• Phase: Phase 4
• Start date: September 19, 2013
• Est. completion date: June 6, 2014

Study information

• Verified date: October 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: June 6, 2014
• Est. primary completion date: June 6, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 11 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Rotavirus Disease
• Rotavirus Infections

Intervention

Biological:
• RotaTeq™ (V260)
Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains
• DTP-IPV
Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Reporting an Adverse Event With Incidence >=1%	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.	Up to 14 days after any of the 6 study visits
Secondary	Percentage of Participants Reporting an Adverse Event of Special Interest: Fever	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.	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)
Secondary	Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea	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.	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)
Secondary	Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting	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.	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)
Secondary	Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events	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.	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)
Secondary	Geometric Mean Titers for Diphtheria Toxin Antibody	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	Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Secondary	Geometric Mean Titers for Tetanus Toxin Antibody	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	Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Secondary	Geometric Mean Titers for Pertussis Toxin Antibody	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	Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Secondary	Geometric Mean Titers for Pertussis FHA Antibody	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	Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Secondary	Geometric Mean Titers for Poliovirus Type 1 Antibody	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.	Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Secondary	Geometric Mean Titers for Poliovirus Type 2 Antibody	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.	Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Secondary	Geometric Mean Titers for Poliovirus Type 3 Antibody	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.	Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV