OTHER NCT02542462.
Trial name or title | "Potential Mechanisms for Intussusception After Rotavirus Vaccine‐Pilot Study" |
Methods | Prospective randomized clinical trial , phase 4 |
Participants |
Number: 101 Description: Healthy infants aged 6 ‐ 13 weeks |
Interventions | 1. RV1, single oral dose of licensed rotavirus vaccine, given alone 2. RV1, with other routine vaccines 3. RV5, single oral dose of licensed rotavirus vaccine given alone 4. RV5, with other routine vaccines |
Outcomes | 1. The effects of RV1 and RV5 with or without other routine immunizations on gastrointestinal anatomy 2. The feasibility of conducting a larger‐scale study as determined by study recruitment rates and percentage of completed study visits |
Starting date | November 2015 Completion: May 2017 (actual primary completion date), May 2018 (estimated study completion date) |
Contact information | Mary A. Staat, MD, MPH Children's Hospital Medical Center, Cincinnati Ohio, United States, 45219 |
Notes |
Location: USA Registration number: NCT02542462 Source of funding: Children's Hospital Medical Center, Cincinnati, USA |