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) - Full Text View

Purpose

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	Intervention	Phase
Rotavirus Disease	Biological: RotaTeq™ (V260) Biological: DTP-IPV	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

Genetic and Rare Diseases Information Center resources: Whooping Cough Tetanus Diphtheria

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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:

Percentage of Participants Reporting an Adverse Event With Incidence >=1% [ Time Frame: Up to 14 days after any of the 6 study visits ] [ Designated as safety issue: Yes ]
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: 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) ] [ Designated as safety issue: Yes ]
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: 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) ] [ Designated as safety issue: Yes ]
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 [ 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) ] [ Designated as safety issue: Yes ]
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 [ 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) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV ] [ Designated as safety issue: No ]
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 [ Time Frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV ] [ Designated as safety issue: No ]
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 Toxin Antibody [ Time Frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV ] [ Designated as safety issue: No ]
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 [ Time Frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV ] [ Designated as safety issue: No ]
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 [ Time Frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV ] [ Designated as safety issue: No ]
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 [ Time Frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV ] [ Designated as safety issue: No ]
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 [ Time Frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV ] [ Designated as safety issue: No ]
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.


Enrollment:	192
Study Start Date:	September 2013
Study Completion Date:	June 2014
Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	6 Weeks to 11 Weeks (Child)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926015

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Director	Merck Sharp & Dohme Corp.

More Information


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01926015 History of Changes
Other Study ID Numbers:	V260-060 132252
Study First Received:	August 16, 2013
Results First Received:	March 27, 2015
Last Updated:	March 27, 2015
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:


Whooping Cough Diphtheria Rotavirus Infections Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Respiratory Tract Infections Infection Respiratory Tract Diseases	Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Reoviridae Infections RNA Virus Infections Virus Diseases Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016