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)
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ClinicalTrials.gov Identifier: NCT01926015 |
Recruitment Status
:
Completed
First Posted
: August 20, 2013
Results First Posted
: April 9, 2015
Last Update Posted
: June 2, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rotavirus Disease | Biological: RotaTeq™ (V260) Biological: DTP-IPV | Phase 4 |
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 |

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).
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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:
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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:
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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.
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926015
Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
Study Data/Documents: CSR Synopsis

Publications of Results:
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 Key Record Dates |
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 |