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A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine

Rotavirus Infection Clinical Trial

Official title:
A Phase 1 Double Blinded, Randomized, Placebo-controlled Dose Escalation Study to Examine the Safety, Reactogenicity, Tolerability and Immunogenicity of the P2-VP8 Subunit Rotavirus Vaccine in Healthy Adult Volunteers

Clinical Trial Summary

This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult volunteers to determine if it is safe and if the immune systems of healthy adults respond to this vaccine.

Clinical Trial Description

The trial will be a double-blinded, randomized, placebo-controlled dose-escalation study in which three dose-levels of vaccine will be tested in adults. Cohorts of 16 individuals (12 vaccine recipients and 4 placebo recipients) per dose level will receive three intramuscular injections four weeks apart. The three dose levels of vaccine to test will be 10 microgram (μg), 30 μg and 60 μg. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01764256
Study type Interventional
Source PATH
Contact
Status Completed
Phase Phase 1
Start date December 2012
Completion date September 2013
View Details
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