Clinical Trials Logo
  1. Home
  2. Avian Influenza
  3. NCT02839330

A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age

Avian Influenza Clinical Trial

Official title:
A Phase 3 Randomized, Observer-Blind, Multi-center, Controlled Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of an Adjuvanted Cell Culture-Derived, H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age

Clinical Trial Summary

This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18 years of age receiving the vaccine and 797 healthy adults receiving placebo. Subjects were randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment was stratified by age: 18 to <65 years of age and ≥65 years of age, to allow adequate safety assessment of the entire age spectrum.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02839330
Study type Interventional
Source Seqirus
Contact
Status Completed
Phase Phase 3
Start date July 11, 2016
Completion date October 4, 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT01698060 - Immunogenicity of ND1.1 by Delivery Directly to the Ileum Phase 1
Completed NCT02213354 - H7N9 Mix and Match With MF59 in Healthy Elderly Persons Phase 2
Completed NCT02295813 - Safety and Pharmacokinetics Study of FBF001 Phase 1
Completed NCT00561184 - Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine Phase 2
Completed NCT02921997 - H7N9 Vaccination With and Without AS03 and Unadjuvanted H3N2v Vaccination: Standard and Systems Biology Analyses Phase 2
Completed NCT03682120 - Safety/Efficacy Study of Seqirus A/H7N9 IIV With or Without MF59(R) Adjuvant to Prevent Avian Influenza Phase 2
Completed NCT00895544 - Immunogenicity and Safety Study of a Single Prime-Boost Vaccination Schedule With a H5N1 Influenza Vaccine in Adults Phase 1/Phase 2
Completed NCT02251288 - A Phase I Study Priming With an Inactivated A/H7N9 Influenza Virus Vaccine With or Without MF59 Adjuvant Followed by Live Attenuated A/H7N9 Influenza Virus Vaccine Phase 1
Completed NCT02612909 - A Safety and Immunogenicity Study of IVACFLU-A/H5N1 Phase 2/Phase 3
Completed NCT02229357 - Evaluation of Priming Effects by PLAI Vaccine on the Subsequent Response to Inactivated H5N1 Vaccine Phase 2
Completed NCT01150552 - Studies of Avian Influenza Transmission to Humans in Egypt N/A
Completed NCT03472976 - H5N1 With or Without Topical Aldara in Healthy Adults Phase 1
Completed NCT01897701 - A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1 Phase 1
Completed NCT01107262 - Avian Influenza Studies In Lebanon N/A
Completed NCT03014310 - H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults: Immunology Phase 1
Completed NCT00298233 - High-Dose Versus Standard-Dose Oseltamivir to Treat Severe Influenza and Avian Influenza Phase 2
Completed NCT03318315 - Co-Administration of AS03 Adjuvanted A/H7N9 IIV With IIV4 Phase 2
Completed NCT03312231 - Sanofi 2017 H7N9 With/Without AS03 in Adults/Elderly Phase 2
Completed NCT03738241 - 2017 A/H7N9 IIV Revaccination Phase 2
Completed NCT03589807 - 2013/2017 H7N9 Prime-Boost Interval Phase 2