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An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dennis Clements, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01960725
First received: October 7, 2013
Last updated: March 10, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Diarrhea
Gastroenteritis
Biological: RV5 (Pentavalent Rotavirus Vaccine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Masking Description:
Open Label
Primary Purpose: Prevention
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)

Further study details as provided by Duke University:

Primary Outcome Measures:
  • G1 Serum-neutralizing Antibody [ Time Frame: 1 month following vaccine series completion ]
    Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)


Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • 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


Enrollment: 66
Study Start Date: February 2014
Study Completion Date: May 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Dosing Group
Group will receive RV5 vaccine at 2, 4, and 6 months of age
Biological: RV5 (Pentavalent Rotavirus Vaccine)
Other Name: RotaTeq
Experimental: Alternate Dosing Group
Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age
Biological: RV5 (Pentavalent Rotavirus Vaccine)
Other Name: RotaTeq

  Eligibility

Ages Eligible for Study:   up to 83 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960725

Locations
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Dennis Clements
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Dennis A Clements, MD, PhD Duke University
  More Information

Responsible Party: Dennis Clements, Professor of Pediatrics, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01960725     History of Changes
Other Study ID Numbers: Pro00049081
MISP-50891 ( Other Grant/Funding Number: Merck Investigator Studies Program )
Study First Received: October 7, 2013
Results First Received: November 8, 2016
Last Updated: March 10, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Duke University:
Gastroenteritis
Diarrhea
Rotavirus
Vaccine
Dehydration

Additional relevant MeSH terms:
Diarrhea
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 28, 2017