MedTrace Logo

Safety Trial of Monovalent Whole Virus Influenza (H1N1) Vaccine

NCT01507779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-02-27

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

BIOLOGICAL

IVACFLU

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.

OTHER

Placebo

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

Sponsors & Collaborators

  • Institute of Vaccines and Medical Biologicals, Vietnam

    collaborator INDUSTRY

  • Pasteur Institute, Ho Chi Minh City

    collaborator OTHER_GOV

  • PATH

    lead OTHER

Principal Investigators

  • Kathleen M Neuzil, MD, MPH · PATH

  • Le V Be, MD, PhD · Institute of Vaccines and Medical Biologicals, Vietnam

  • Ho V Thang, MD, MSc · Pasteur Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

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 NCT01507779 on ClinicalTrials.gov