CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 38 enrolled
Drug / intervention
LAIV H2N2 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01982331
NCT01982331Phase 1Completed
CompareCT.gov

Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/California/66/395 (H2N2)Influenza Vaccine

PATH·interventional·Posted Nov 13, 2013·Updated Feb 26, 2019

In Brief

A Phase 1 clinical trial evaluating LAIV H2N2 and Placebo for Influenza. Completed, enrolled 38 participants across 1 site.

Detailed Summary

This is a phase I study to evaluate the safety of a vaccine to protect against influenza viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of vaccine or placebo one month apart.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesRussia
CollaboratorsMinistry of Health, Russian Federation, Institute of Experimental Medicine, Russia

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 13, 2013
Enrollment StartOct 1, 2013
Primary CompletionJan 1, 2014
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.6 years ago

Interventions

LAIV H2N2biological

vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28

Placeboother

placebo delivered intranasally. .25cc to each nostril at day 0 and day 28