CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 889 enrolled
Drug / intervention
IVACFLU-S +1 morebiological
Likely dose
0.5 mL per dose of IVACFLU-S (inactivated trivalent influenza vaccine)AI-extracted
Key inclusion· 4
  • ✓Aged 18 through 60 years
  • ✓Healthy or medically stable with stable conditions for ≥3 months and stable medication dosing for ≥1 month
  • ✓Willing to provide written informed consent and comply with study procedures
  • ✓For women: not pregnant/breastfeeding and willing to use reliable contraception through Day 22
Key exclusion· 12
  • ✕Acute severe illness within 2 weeks of enrollment
  • ✕Received seasonal influenza vaccine in last 6 months
  • ✕Any non-study vaccine within 4 weeks prior to enrollment
  • ✕Known or suspected congenital or acquired immunodeficiency

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

Search/NCT03095599
NCT03095599Phase 3Completed
CompareCT.gov

A Phase 2/3 Double Blinded, Randomized, Placebo-Controlled Study in Healthy Adult Volunteers in Vietnam to Examine the Safety and Immunogenicity of a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVACFLU-S) Produced by IVAC

Institute of Vaccines and Medical Biologicals, Vietnam·interventional·Posted Mar 29, 2017·Updated Jul 22, 2019

In Brief

A Phase 3 clinical trial evaluating IVACFLU-S and Placebo for Influenza, Human. Completed, enrolled 889 participants across 1 site.

Detailed Summary

This Phase 2/3 study assessed whether a single dose of seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) is safe and well-tolerated in adults 18 to 60 years of age; and whether it will induce immune responses to each of the 3 vaccine antigens to meet 1 or both age group-specific Vietnam Ministry of Health (MOH) licensure requirements.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesVietnam
CollaboratorsPasteur Institute, Ho Chi Minh City, PATH, Quintiles, Inc., World Health Organization

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 29, 2017
Enrollment StartMar 20, 2017
Primary CompletionOct 5, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.3 years ago

Interventions

IVACFLU-Sbiological

IVACFLU-S is seasonal inactivated, split virion, trivalent influenza vaccine (A/H3N2, A/H1N1, and B), produced in GCP facility by IVAC uses embryonated chicken eggs. This vaccine is purified by sucrose gradient ultracentrifugation (Alfa Wassermann, West Caldwell, NJ), and inactivated with formaldehyde. Each 0.5 mL dose of vaccine contains * NYMC X-179A (A/California/7/2009) (H1N1) - 15μg hemagglutinin (HA) * NYMC X-263B (A/HongKong/4801/2014) (H3N2) - 15μg HA * NYMC BX-35 (B/Brisbane/60/2008) (B) - 15μg HA

Placeboother

Phosphate buffered saline with pH 7.2; 0.5 ml/per dose