- ICH GCP
- US Clinical Trials Registry
- 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)
October 19, 2018 updated by: Merck Sharp & Dohme LLC
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
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™.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
192
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains
Other Names:
Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule
Other Names:
|
Active Comparator: 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).
|
Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains
Other Names:
Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3
Time Frame: 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.
|
4 to 6 weeks after the third dose of DTP-IPV
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Reporting an Adverse Event With Incidence >=1%
Time Frame: 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.
|
Up to 14 days after any of the 6 study visits
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Fever
Time Frame: 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.
|
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)
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea
Time Frame: 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.
|
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)
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting
Time Frame: 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.
|
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)
|
Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events
Time Frame: 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.
|
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)
|
Geometric Mean Titers for Diphtheria Toxin Antibody
Time Frame: 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
|
Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
|
Geometric Mean Titers for Tetanus Toxin Antibody
Time Frame: 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
|
Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
|
Geometric Mean Titers for Pertussis Toxin Antibody
Time Frame: 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
|
Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
|
Geometric Mean Titers for Pertussis FHA Antibody
Time Frame: 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
|
Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
|
Geometric Mean Titers for Poliovirus Type 1 Antibody
Time Frame: 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.
|
Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
|
Geometric Mean Titers for Poliovirus Type 2 Antibody
Time Frame: 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.
|
Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
|
Geometric Mean Titers for Poliovirus Type 3 Antibody
Time Frame: 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.
|
Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 19, 2013
Primary Completion (Actual)
June 6, 2014
Study Completion (Actual)
June 6, 2014
Study Registration Dates
First Submitted
August 16, 2013
First Submitted That Met QC Criteria
August 16, 2013
First Posted (Estimate)
August 20, 2013
Study Record Updates
Last Update Posted (Actual)
November 14, 2018
Last Update Submitted That Met QC Criteria
October 19, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V260-060
- 132252 (Registry Identifier: JAPIC-CTI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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