An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)

Diarrhea Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01960725
• Other study ID #: Pro00049081
• Secondary ID: MISP-50891
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 7, 2013
• Last updated: January 7, 2016
• Start date: February 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 83 Days

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• Gastroenteritis

Intervention

Biological:
• RV5 (Pentavalent Rotavirus Vaccine)

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Dennis Clements	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum rotavirus Immunoglobulin A	Post dose 3 serum rotavirus Immunoglobulin A geometric mean titer (GMT)	1 month following vaccine series completion	No
Other	Reactogenicity Assessment	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	7 days	Yes
Other	Adverse Event Assessment	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	28 days	Yes
Other	Serious Adverse Event Assessment	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	10 months	Yes
Primary	G1 serum-neutralizing antibody	Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)	1 month following vaccine series completion	No
Secondary	G2 serum-neutralizing antibody	Post dose 3 G2 serum-neutralizing antibody(SNA) geometric mean titer (GMT)	1 month following vaccine series completion	No
Secondary	G3 serum-neutralizing antibody	Post dose 3 G3 serum-neutralizing antibody(SNA) geometric mean titer (GMT)	1 month following vaccine series completion	No
Secondary	G4 serum-neutralizing antibody	Post dose 3 G4 serum-neutralizing antibody(SNA) geometric mean titer (GMT)	1 month following vaccine series completion	No
Secondary	P[8] serum-neutralizing antibody	Post dose 3 P[8] serum-neutralizing antibody(SNA) geometric mean titer (GMT)	1 month following vaccine series completion	No