Rotavirus DiseasePhase 4NCT01926015
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)
A Phase 4 study testing RotaTeq™ (V260) and DTP-IPV in people with Rotavirus Disease, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Disease
- What is being tested?
- RotaTeq™ (V260) and DTP-IPV
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- 19 Sep 2013to 6 Jun 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Japanese participant
- Age 6 weeks through <11 weeks (42 to 76 days from date of birth) at Visit 1
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
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
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™.
- Conditions
- Rotavirus Disease
- Being tested
- RotaTeq™ (V260), DTP-IPV
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotaTeq™ (V260)Biological
Also called RotaTeq™
Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains
DTP-IPVBiological
Also called Tetrabik™, BIKEN
Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule
| Study group | Role | What they receive |
|---|---|---|
| Concomitant RotaTeq™ and DTP-IPV | Experimental | 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). Receives: Biological: RotaTeq™ (V260); Biological: DTP-IPV |
| Staggered RotaTeq™ and DTP-IPV | Active comparator | 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). Receives: Biological: RotaTeq™ (V260); Biological: DTP-IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 to 6 weeks after the third dose of DTP-IPV
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study start19 Sep 2013
- Primary completion6 Jun 2014
- Study completion6 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotavirus DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926015
- Sponsor's protocol ID
- V260-060
- Other IDs
- 132252
- Status last verified
- Oct 2018
- First submitted
- 16 Aug 2013
- Last updated
- 14 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 28140752
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01926015
- Acronym / sponsor ID
- V260-060
- Conditions
- Rotavirus Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2013 (actual)
- Primary completion
- 6 Jun 2014 (actual)
- Study completion
- 6 Jun 2014 (actual)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Posted 9 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concomitant RotaTeq™ and DTP-IPV | Experimental | Biological: RotaTeq™ (V260), Biological: DTP-IPVRotaTeq™ (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). |
| Staggered RotaTeq™ and DTP-IPV | Active comparator | Biological: RotaTeq™ (V260), Biological: DTP-IPVRotaTeq™ (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). |
Who may qualify
- Ages
- 6 to 11 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Japanese participant
- Age 6 weeks through <11 weeks (42 to 76 days from date of birth) at Visit 1
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RotaTeq™ (V260)Also: RotaTeq™Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains | Biological | Concomitant RotaTeq™ and DTP-IPV, Staggered RotaTeq™ and DTP-IPV |
| DTP-IPVAlso: Tetrabik™, BIKENDiphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule | Biological | Concomitant RotaTeq™ and DTP-IPV, Staggered RotaTeq™ and DTP-IPV |
Primary outcome
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.
12 secondary outcomes
Percentage of Participants Reporting an Adverse Event With Incidence >=1%
Time frame: 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)
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)
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)
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)
Geometric Mean Titers for Diphtheria Toxin Antibody
Time frame: 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
Geometric Mean Titers for Pertussis Toxin Antibody
Time frame: 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
Geometric Mean Titers for Poliovirus Type 1 Antibody
Time frame: 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
Geometric Mean Titers for Poliovirus Type 3 Antibody
Time frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28140752Tanaka 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.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RotaTeq™ (V260) and DTP-IPV in people with Rotavirus Disease, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01926015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.