At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Randomized, Controlled, Single Centre, Phase IIb Study to Assess the Immunogenicity, Reactogenicity and Safety of Three Live Oral Rotavirus Vaccines, ROTAVAC® , ROTAVAC 5CM and Rotarix® in Healthy Zambian Infants
In Brief
A Phase 3 clinical trial evaluating ROTAVAC®, ROTAVAC 5D, and 1 other intervention for Diarrhea and Diarrhea Rotavirus. Completed, enrolled 450 participants across 1 site.
Detailed Summary
The study is being conducted to evaluate and compare the immunogenicity of ROTAVAC® and ROTAVAC 5D 28 days after the last dose of the vaccine, when administered to infants in a three-dose schedule at 6, 10 and 14 weeks of age. The study will also assess the reactogenicity of the vaccine 7 days after each vaccination and safety from first vaccination up to 4 weeks after the last vaccination with ROTAVAC® and ROTAVAC 5D, and of Rotarix® when administered to infants in a two-dose schedule at 6 and 10 weeks of age.
Study Details
Timeline
Interventions
0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.
0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.
1.5 ml of the liquid vaccine will be administered orally twice at 6 and 10 weeks of age.