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Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S) - PHASE 2/3

NCT03095599 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 889

Last updated 2019-07-22

Study results available
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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.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

IVACFLU-S

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Pasteur Institute, Ho Chi Minh City

    collaborator OTHER_GOV

  • PATH

    collaborator OTHER

  • Quintiles, Inc.

    collaborator INDUSTRY

  • World Health Organization

    collaborator OTHER

  • Institute of Vaccines and Medical Biologicals, Vietnam

    lead INDUSTRY

Principal Investigators

  • Phan Cong Hung, MD · Pasteur Institute, Ho Chi Minh City

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2017-10-05
Completion
2017-10-05

Countries

  • Vietnam

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03095599 on ClinicalTrials.gov