CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
IVACFLU +1 morebiological
Likely dose
IVACFLU 15 mcgfrom 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/NCT01507779
NCT01507779Phase 1Completed
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Evaluation of The Safety and Immunogenicity of an Influenza A/H1N1 Vaccine (IVACFLU), Produced by IVAC, in Healthy Adults in Vietnam

PATH·interventional·Posted Jan 11, 2012·Updated Feb 27, 2019

In Brief

A Phase 1 clinical trial evaluating IVACFLU and Placebo for Influenza. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The study hypothesis is that two 0.5 ml doses of non-adjuvanted whole virion monovalent A/H1N1 influenza vaccine (IVACFLU)--each dose with an HA content of 15 mcg from A/California/07/2009 (H1N1)-like virus--will be safe and immunogenic in healthy adults.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesVietnam
CollaboratorsInstitute of Vaccines and Medical Biologicals, Vietnam, Pasteur Institute, Ho Chi Minh City

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 11, 2012
Enrollment StartApr 1, 2012
Primary CompletionNov 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.5 years ago

Interventions

IVACFLUbiological

IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.

Placeboother

Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.