NCT01960725

An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Dennis Clements · Academic / Other
• Sex: All
• Age: 14 Days – 83 Days
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	RV5 (Pentavalent Rotavirus Vaccine)

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-12-01
• Completion: 2016-05-01
• First posted: 2013-10-11
• Last updated: 2017-04-21
• Results posted: 2017-04-21

Locations

1 site across 1 country: United States