DiarrheaPhase 4NCT01960725
An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
A Phase 4 study testing RV5 (Pentavalent Rotavirus Vaccine) in people with Diarrhea and Gastroenteritis, run by Dennis Clements at 1 site in United States.
Trial summary
This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2 months and 4 months). Read more about this study
- Who is it for?
- Ages 14 to 83 daysHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Gastroenteritis
- What is being tested?
- RV5 (Pentavalent Rotavirus Vaccine)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to May 2016
- 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 14 to 83 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female infants who are 14 through 41 or 56 through 83 days of age at Visit 1 (Day of initial vaccination)
- Parent / legal guardian has read and signed the informed consent document
- Child and parent / legal guardian is available for the entire study period and can be reached by telephone
- Healthy infant as determined by medical history and by a baseline physical examination
- Infant weight at time of enrollment must exceed birth weight
Who cannot join
- History of hypersensitivity to the vaccine or any component of the vaccine
- History of Severe Combined Immunodeficiency Disease (SCID)
- History of immunocompromise ( infant is known to be HIV positive, to have hypogammaglobulinemia or to have an underlying malignancy)
- History of intussusception
- Any clinically significant history of gastrointestinal disease including active acute gastrointestinal illness, chronic diarrhea, failure to thrive, congenital abdominal disorders, abdominal surgery or liver disease
- Prior receipt of a rotavirus vaccine
Show all 14Show fewer
- Less than 37 weeks gestation
- The subject has participated in a study with an experimental agent within one month of enrollment in the study or anticipated receipt of an experimental agent during participation in the study
- Receipt of blood products within 4 weeks of study vaccination
- Receipt of a live virus vaccine within 4 weeks of study vaccination or an inactivated vaccine within 2 weeks. Concomitant administration of routinely recommended vaccines is allowed. A dose of hepatitis B vaccine administered in the birthing hospital is permitted. Planned routine use of inactivated influenza vaccine for children over 6 months of age is permitted.
- Acute illness within 48 hours of vaccination (axillary temperature of 100.4°F or higher, 3 or more grossly watery stools, vomiting). (Infants with stable unchanged gastroesophageal reflux may be enrolled).
- Insufficient weight gain requiring future weight checks in addition to routine scheduled well child visits
- The subject has any condition that the investigator believes would put the subject at an increased risk of injury or would render the subject unable to complete the trial or fulfill the requirements of the study protocol.
- Household contact who is immunodeficient (any malignancies or otherwise immunocompromised, primary immunodeficiency, receiving immunosuppressive therapy)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: An Open-label, Pilot Study to Compare the Safety and Immunogenicity of an Alternate Dosing Schedule (2-5 Weeks, 2 Months, and 4 Months) for Pentavalent Rotavirus Vaccine (RotaTeq) to the Standard Recommended Schedule (2, 4, and 6 Months)
This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2 months and 4 months). In this interventional, open-label study, infants 2 through 5 weeks of age (14 to 41 days) will be enrolled and vaccinated with RV5 according to a 2-5 week, 2 and 4 month schedule and infants 2 months of age (56 to 83 days) will be vaccinated according to the standard recommended schedule (2, 4, and 6 months of age). Sera will be obtained from subjects one month following the final dose of vaccine and will be assayed for anti-rotavirus IgA and rotavirus neutralizing antibody responses against the G1, G2, G3, G4 and P[8] serotypes. Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titers (GMTs) will be compared between children receiving pentavalent rotavirus vaccine (RV5) according to the alternate dosing schedule versus the standard recommended schedule. Likewise, post dose 3 G2, G3, G4 and P[8] SNA and serum rotavirus IgA GMTs will be compared between children receiving RV5 according to the alternate dosing schedule and the standard recommended schedule. The safety and tolerability of RV5 in children receiving vaccine according to the alternate dosing schedule will be described.
- Conditions
- Diarrhea, Gastroenteritis
- Being tested
- RV5 (Pentavalent Rotavirus Vaccine)
- Keywords
- Gastroenteritis, Diarrhea, Rotavirus, Vaccine, Dehydration
- Medical subject headings
- Diarrhea, Gastroenteritis, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV5 (Pentavalent Rotavirus Vaccine)Biological
Also called RotaTeq
| Study group | Role | What they receive |
|---|---|---|
| Standard Dosing Group | Active comparator | Group will receive RV5 vaccine at 2, 4, and 6 months of age Receives: Biological: RV5 (Pentavalent Rotavirus Vaccine) |
| Alternate Dosing Group | Experimental | Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age Receives: Biological: RV5 (Pentavalent Rotavirus Vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
G1 Serum-neutralizing Antibody
Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)
Measured: 1 month following vaccine series completion
Secondary outcomes (4)
G2 Serum-neutralizing Antibody
Post dose 3 G2 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Measured: 1 month following vaccine series completion
G3 Serum-neutralizing Antibody
Post dose 3 G3 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Measured: 1 month following vaccine series completion
G4 Serum-neutralizing Antibody
Post dose 3 G4 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Measured: 1 month following vaccine series completion
P1 Serum-neutralizing Antibody
Post dose 3 P1 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Measured: 1 month following vaccine series completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2015
- Study completionMay 2016
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.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dennis Clements
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Dennis Clements, Duke University
- Investigators
- Dennis A Clements, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960725
- Sponsor's protocol ID
- Pro00049081
- Other IDs
- MISP-50891
- Status last verified
- Mar 2017
- First submitted
- 7 Oct 2013
- Last updated
- 21 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Pilot Study to Compare the Safety and Immunogenicity of an Alternate Dosing Schedule (2-5 Weeks, 2 Months, and 4 Months) for Pentavalent Rotavirus Vaccine (RotaTeq) to the Standard Recommended Schedule (2, 4, and 6 Months)
- ClinicalTrials.gov ID
- NCT01960725
- Acronym / sponsor ID
- Pro00049081
- Conditions
- Diarrhea, Gastroenteritis
- Keywords
- Gastroenteritis, Diarrhea, Rotavirus, Vaccine, Dehydration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Dennis ClementsUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Posted 21 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to assess the safety and immunogenicity of pentavalent rotavirus vaccine (RV5) when administered according to an alternate dosing schedule (2-5 weeks, 2 months and 4 months). In this interventional, open-label study, infants 2 through 5 weeks of age (14 to 41 days) will be enrolled and vaccinated with RV5 according to a 2-5 week, 2 and 4 month schedule and infants 2 months of age (56 to 83 days) will be vaccinated according to the standard recommended schedule (2, 4, and 6 months of age). Sera will be obtained from subjects one month following the final dose of vaccine and will be assayed for anti-rotavirus IgA and rotavirus neutralizing antibody responses against the G1, G2, G3, G4 and P[8] serotypes. Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titers (GMTs) will be compared between children receiving pentavalent rotavirus vaccine (RV5) according to the alternate dosing schedule versus the standard recommended schedule. Likewise, post dose 3 G2, G3, G4 and P[8] SNA and serum rotavirus IgA GMTs will be compared between children receiving RV5 according to the alternate dosing schedule and the standard recommended schedule. The safety and tolerability of RV5 in children receiving vaccine according to the alternate dosing schedule will be described.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dosing Group | Active comparator | Biological: RV5 (Pentavalent Rotavirus Vaccine)Group will receive RV5 vaccine at 2, 4, and 6 months of age |
| Alternate Dosing Group | Experimental | Biological: RV5 (Pentavalent Rotavirus Vaccine)Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age |
Who may qualify
- Ages
- 14 to 83 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female infants who are 14 through 41 or 56 through 83 days of age at Visit 1 (Day of initial vaccination)
- Parent / legal guardian has read and signed the informed consent document
- Child and parent / legal guardian is available for the entire study period and can be reached by telephone
- Healthy infant as determined by medical history and by a baseline physical examination
- Infant weight at time of enrollment must exceed birth weight
Key exclusion criteria (14 listed)
- History of hypersensitivity to the vaccine or any component of the vaccine
- History of Severe Combined Immunodeficiency Disease (SCID)
- History of immunocompromise ( infant is known to be HIV positive, to have hypogammaglobulinemia or to have an underlying malignancy)
- History of intussusception
- Any clinically significant history of gastrointestinal disease including active acute gastrointestinal illness, chronic diarrhea, failure to thrive, congenital abdominal disorders, abdominal surgery or liver disease
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 |
|---|---|---|
| RV5 (Pentavalent Rotavirus Vaccine)Also: RotaTeq | Biological | Alternate Dosing Group, Standard Dosing Group |
Primary outcome
G1 Serum-neutralizing Antibody
Time frame: 1 month following vaccine series completion
Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)
4 secondary outcomes
G2 Serum-neutralizing Antibody
Time frame: 1 month following vaccine series completion
G3 Serum-neutralizing Antibody
Time frame: 1 month following vaccine series completion
G4 Serum-neutralizing Antibody
Time frame: 1 month following vaccine series completion
P1 Serum-neutralizing Antibody
Time frame: 1 month following vaccine series completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Dennis A Clements, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RV5 (Pentavalent Rotavirus Vaccine) in people with Diarrhea and Gastroenteritis, run by Dennis Clements at 1 site in United States.
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 5 inclusion and 14 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 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 21 Apr 2017). 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?
G1 Serum-neutralizing Antibody (time frame: 1 month following vaccine series completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2017.