An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)

NCT01960725 | Completed Phase 4 Results

• 2 other identifiers: Pro00049081MISP-50891
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea; Gastroenteritis

Keywords

Gastroenteritis; Diarrhea; Rotavirus; Vaccine; Dehydration

Outcome Measures

Primary Outcomes (1)

• G1 Serum-neutralizing Antibody

  Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)

  1 month following vaccine series completion

Secondary Outcomes (4)

• G2 Serum-neutralizing Antibody

  1 month following vaccine series completion

• G3 Serum-neutralizing Antibody

  1 month following vaccine series completion

• G4 Serum-neutralizing Antibody

  1 month following vaccine series completion

• P1 Serum-neutralizing Antibody

  1 month following vaccine series completion

Other Outcomes (4)

• Serum Rotavirus Immunoglobulin A

  1 month following vaccine series completion

• Reactogenicity Assessment

  7 days after each dose, up to 10 months post-vaccination

• Adverse Event Assessment

  28 days after each dose, up to 10 months post-vaccination

Study Arms (2)

Standard Dosing Group

ACTIVE COMPARATOR

Group will receive RV5 vaccine at 2, 4, and 6 months of age

Biological: RV5 (Pentavalent Rotavirus Vaccine)

Alternate Dosing Group

EXPERIMENTAL

Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age

Biological: RV5 (Pentavalent Rotavirus Vaccine)

Interventions

RV5 (Pentavalent Rotavirus Vaccine) BIOLOGICAL

Also known as: RotaTeq

Alternate Dosing Group; Standard Dosing Group

Eligibility Criteria

• Age: 14 Days - 83 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Dennis Clements: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Diarrhea; Gastroenteritis; Dehydration

Interventions

RotaTeq

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes

Results Point of Contact

• Title: Dr. Dennis Clements
• Organization: Duke University School of Medicine

dennis.clements@duke.edu

919-684-7790

Study Officials

• Dennis A Clements, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 11, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: April 21, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)