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An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01960725
Recruitment Status : Completed
First Posted : October 11, 2013
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dennis Clements, Duke University

Tracking Information
First Submitted Date  ICMJE October 7, 2013
First Posted Date  ICMJE October 11, 2013
Results First Submitted Date  ICMJE November 8, 2016
Results First Posted Date  ICMJE April 21, 2017
Last Update Posted Date April 21, 2017
Study Start Date  ICMJE February 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
G1 Serum-neutralizing Antibody [ Time Frame: 1 month following vaccine series completion ]
Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2017)
  • G2 Serum-neutralizing Antibody [ Time Frame: 1 month following vaccine series completion ]
    Post dose 3 G2 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
  • G3 Serum-neutralizing Antibody [ Time Frame: 1 month following vaccine series completion ]
    Post dose 3 G3 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
  • G4 Serum-neutralizing Antibody [ Time Frame: 1 month following vaccine series completion ]
    Post dose 3 G4 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
  • P1 Serum-neutralizing Antibody [ Time Frame: 1 month following vaccine series completion ]
    Post dose 3 P1 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2013)
  • G2 Serum-neutralizing Antibody [ Time Frame: 1 month following vaccine series completion ]
    Post dose 3 G2 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
  • G3 Serum-neutralizing Antibody [ Time Frame: 1 month following vaccine series completion ]
    Post dose 3 G3 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
  • G4 Serum-neutralizing Antibody [ Time Frame: 1 month following vaccine series completion ]
    Post dose 3 G4 serum-neutralizing antibody(SNA) geometric mean titer (GMT)
  • P[8] serum-neutralizing antibody [ Time Frame: 1 month following vaccine series completion ]
    Post dose 3 P[8] serum-neutralizing antibody(SNA) geometric mean titer (GMT)
Current Other Pre-specified Outcome Measures
 (submitted: March 10, 2017)
  • Serum Rotavirus Immunoglobulin A [ Time Frame: 1 month following vaccine series completion ]
    Post dose 3 serum rotavirus Immunoglobulin A geometric mean titer (GMT)
  • Reactogenicity Assessment [ Time Frame: 7 days after each dose, up to 10 months post-vaccination ]
    Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined
  • Adverse Event Assessment [ Time Frame: 28 days after each dose, up to 10 months post-vaccination ]
    Proportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined
  • Serious Adverse Event Assessment [ Time Frame: After each dose and up to 10 months post-vaccination ]
    Proportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined
Original Other Pre-specified Outcome Measures
 (submitted: October 9, 2013)
  • Serum Rotavirus Immunoglobulin A [ Time Frame: 1 month following vaccine series completion ]
    Post dose 3 serum rotavirus Immunoglobulin A geometric mean titer (GMT)
  • Reactogenicity Assessment [ Time Frame: 7 days ]
    Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined
  • Adverse Event Assessment [ Time Frame: 28 days ]
    Proportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined
  • Serious Adverse Event Assessment [ Time Frame: 10 months ]
    Proportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined
 
Descriptive Information
Brief Title  ICMJE An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
Official Title  ICMJE 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)
Brief 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). 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Prevention
Condition  ICMJE
  • Diarrhea
  • Gastroenteritis
Intervention  ICMJE Biological: RV5 (Pentavalent Rotavirus Vaccine)
Other Name: RotaTeq
Study Arms  ICMJE
  • Active Comparator: Standard Dosing Group
    Group will receive RV5 vaccine at 2, 4, and 6 months of age
    Intervention: Biological: RV5 (Pentavalent Rotavirus Vaccine)
  • Experimental: Alternate Dosing Group
    Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
    Intervention: Biological: RV5 (Pentavalent Rotavirus Vaccine)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 10, 2017)
66
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2013)
60
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female infants who are 14 through 41 or 56 through 83 days of age at Visit 1 (Day of initial vaccination)
  2. Parent / legal guardian has read and signed the informed consent document
  3. Child and parent / legal guardian is available for the entire study period and can be reached by telephone
  4. Healthy infant as determined by medical history and by a baseline physical examination
  5. Infant weight at time of enrollment must exceed birth weight

Exclusion Criteria:

  1. History of hypersensitivity to the vaccine or any component of the vaccine
  2. History of Severe Combined Immunodeficiency Disease (SCID)
  3. History of immunocompromise ( infant is known to be HIV positive, to have hypogammaglobulinemia or to have an underlying malignancy)
  4. History of intussusception
  5. 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
  6. Prior receipt of a rotavirus vaccine
  7. Less than 37 weeks gestation
  8. 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
  9. Receipt of blood products within 4 weeks of study vaccination
  10. 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.
  11. 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).
  12. Insufficient weight gain requiring future weight checks in addition to routine scheduled well child visits
  13. 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.
  14. Household contact who is immunodeficient (any malignancies or otherwise immunocompromised, primary immunodeficiency, receiving immunosuppressive therapy)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 83 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01960725
Other Study ID Numbers  ICMJE Pro00049081
MISP-50891 ( Other Grant/Funding Number: Merck Investigator Studies Program )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dennis Clements, Duke University
Study Sponsor  ICMJE Dennis Clements
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Dennis A Clements, MD, PhD Duke University
PRS Account Duke University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP