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)

Study Overview
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Brief Summary
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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™.

Official Title
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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

Conditions
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Rotavirus Disease

Intervention / Treatment
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* Biological: RotaTeq™ (V260)
* Biological: DTP-IPV


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 11 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concomitant RotaTeq™ and DTP-IPV<br>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). | Biological: RotaTeq™ (V260)<br>* Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains<br>* Other names: RotaTeq™;Biological: DTP-IPV<br>* Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule<br>* Other names: BIKEN;|
| Active Comparator: Staggered RotaTeq™ and DTP-IPV<br>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). | Biological: RotaTeq™ (V260)<br>* Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains<br>* Other names: RotaTeq™;Biological: DTP-IPV<br>* Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule<br>* Other names: BIKEN;|

What is the study measuring?
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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 | 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% | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |