MedTrace Logo

Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Adults and Elders

NCT01003145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2012-01-20

No results posted yet for this study

Summary

This was a randomized, laboratory-blinded study in healthy male and non-pregnant female designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 vaccine (AdimFlu-S). In the adult cohort, all volunteers were randomized in a 1:1:1 ratio to receive 2 injections of AdimFlu-S (A/H1N1) 15 mcg HA at 3 weeks apart, 2 injections of AdimFlu-S (A/H1N1) 30 mcg HA at 3 weeks apart or 1 injection of AdimFlu-S (A/H1N1) 15 mcg HA. In the elders cohort, all volunteers were randomized in a 1:1 ratio to receive 2 injections of AdimFlu-S (A/H1N1) 15 mcg HA at 3 weeks apart or 2 injections of AdimFlu-S (A/H1N1) 30 mcg HA at 3 weeks apart.

Following immunization, safety was measured by assessment of adverse events for 6 weeks following the first vaccination, serious adverse events and new-onset chronic medical conditions through 7 months post first vaccination; and reactogenicity to the vaccines for 7 days following each vaccination. Immunogenicity testing included hemagglutinin inhibition (HAI) testing on serum obtained before first vaccination, and three and six weeks after first vaccination.

Conditions

Interventions

BIOLOGICAL

Influenza A (H1N1) 2009 monovalent vaccine, inactivated

Sponsors & Collaborators

  • Adimmune Corporation

    lead INDUSTRY

Principal Investigators

  • Feng Yee Chang · Tri-Service General Hospital

  • Yung Ching Liu · Taipei Medical University Wang Fang Hospital

  • Szu Min Hsieh · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Taiwan

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 NCT01003145 on ClinicalTrials.gov