Rotavirus GastroenteritisPhase 3NCT01600092
A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)
A Phase 3 study testing RotaTeq™ experimental formulation and RotaTeq™ existing formulation in people with Rotavirus Gastroenteritis, run by Merck Sharp & Dohme LLC.
Trial summary
A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Gastroenteritis
- What is being tested?
- RotaTeq™ experimental formulation and RotaTeq™ existing formulation
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- No sites listed yet
- Study dates
- 29 Apr 2013to 25 Mar 2014
- Phase
- Phase 3
- 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 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent or legal guardian agrees to have infant participate by giving written informed consent
Who cannot join
- History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
- History of intussusception
- Known or suspected impairment of immunological function, including Severe
- Combined Immunodeficiency (SCID)
- Prior administration of any rotavirus vaccine
- Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD)
Show all 11Show fewer
- Receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. Participant using non-systemic corticosteroids will be eligible for vaccination.
- Residing in a household with an immunocompromised person
- Prior receipt of a blood transfusion or blood products, including immunoglobulins
- Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study
- Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study
About this study
Official title: A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™
A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.
- Conditions
- Rotavirus Gastroenteritis
- Being tested
- RotaTeq™ experimental formulation, RotaTeq™ existing formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotaTeq™ experimental formulationBiological
Also called V260
RotaTeq™ existing formulationBiological
Also called V260
| Study group | Role | What they receive |
|---|---|---|
| RotaTeq™ Experimental Formulation | Experimental | Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days) Receives: Biological: RotaTeq™ experimental formulation |
| RotaTeq™ Existing Formulation | Active comparator | Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days). Receives: Biological: RotaTeq™ existing formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Measured: 42 days after vaccination 3 (up to 185 days)
Secondary outcomes (4)
Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal >=38.1° C, >=100.5° F), and irritability.
Measured: Up to 7 days after any vaccination (up to 147 days)
Number of Participants With Tier-1 Adverse Events: Intussusception
The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception
Measured: Up to Day 185
Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A
Measured: 42 days after vaccination 3 (up to 185 days)
Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Measured: Baseline and 42 days after vaccination 3 (up to 185 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study start29 Apr 2013
- Primary completion25 Mar 2014
- Study completion25 Mar 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 GastroenteritisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,020 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
- NCT01600092
- Sponsor's protocol ID
- V260-035
- Status last verified
- Oct 2018
- First submitted
- 14 May 2012
- 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
Martinon-Torres F, Greenberg D, Varman M, Killar JA, Hille D, Strable EL, Stek JE, Kaplan SS. Safety, Tolerability and Immunogenicity of Pentavalent Rotavirus Vaccine Manufactured by a Modified Process. Pediatr Infect Dis J. 2017 Apr;36(4):417-422. doi: 10.1097/INF.0000000000001511.
PubMed 28141698
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
- A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™
- ClinicalTrials.gov ID
- NCT01600092
- Acronym / sponsor ID
- V260-035
- Conditions
- Rotavirus Gastroenteritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,020 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2013 (actual)
- Primary completion
- 25 Mar 2014 (actual)
- Study completion
- 25 Mar 2014 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Posted 19 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RotaTeq™ Experimental Formulation | Experimental | Biological: RotaTeq™ experimental formulationThree 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days) |
| RotaTeq™ Existing Formulation | Active comparator | Biological: RotaTeq™ existing formulationThree 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days). |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parent or legal guardian agrees to have infant participate by giving written informed consent
Key exclusion criteria (11 listed)
- History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery
- History of intussusception
- Known or suspected impairment of immunological function, including Severe
- Combined Immunodeficiency (SCID)
- Prior administration of any rotavirus vaccine
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™ experimental formulationAlso: V260 | Biological | RotaTeq™ Experimental Formulation |
| RotaTeq™ existing formulationAlso: V260 | Biological | RotaTeq™ Existing Formulation |
Primary outcome
Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Time frame: 42 days after vaccination 3 (up to 185 days)
4 secondary outcomes
Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability
Time frame: Up to 7 days after any vaccination (up to 147 days)
Number of Participants With Tier-1 Adverse Events: Intussusception
Time frame: Up to Day 185
Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A
Time frame: 42 days after vaccination 3 (up to 185 days)
Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Time frame: Baseline and 42 days after vaccination 3 (up to 185 days)
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 28141698Martinon-Torres F, Greenberg D, Varman M, Killar JA, Hille D, Strable EL, Stek JE, Kaplan SS. Safety, Tolerability and Immunogenicity of Pentavalent Rotavirus Vaccine Manufactured by a Modified Process. Pediatr Infect Dis J. 2017 Apr;36(4):417-422. doi: 10.1097/INF.0000000000001511.
- 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 3 study testing RotaTeq™ experimental formulation and RotaTeq™ existing formulation in people with Rotavirus Gastroenteritis, 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 1 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 Mar 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?
Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] (time frame: 42 days after vaccination 3 (up to 185 days)). 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 NCT01600092, 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.