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 Description

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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™.

Condition or disease	Intervention/treatment	Phase
Rotavirus Disease	Biological: RotaTeq™ (V260); Biological: DTP-IPV	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	192 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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
Actual Study Start Date :	September 19, 2013
Actual Primary Completion Date :	June 6, 2014
Actual Study Completion Date :	June 6, 2014

Arms and Interventions

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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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
7. 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
8. 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
9. 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
10. 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.
11. 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.
12. 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.

Eligibility Criteria

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Ages Eligible for Study:	6 Weeks to 11 Weeks (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director:	Medical Director	Merck Sharp & Dohme Corp.

More Information

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Study Data/Documents: CSR Synopsis 

Publications of Results:

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 Japanese infants. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-7. doi: 10.1080/21645515.2017.1279769. Epub 2017 Jan 31.

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01926015 History of Changes
Other Study ID Numbers:	V260-060; 132252 ( Registry Identifier: JAPIC-CTI )
First Posted:	August 20, 2013
Results First Posted:	April 9, 2015
Last Update Posted:	June 2, 2017
Last Verified:	May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Additional relevant MeSH terms:

Diphtheria; Rotavirus Infections; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections	Reoviridae Infections; RNA Virus Infections; Virus Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs