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

Status:	Completed
Conditions:	Influenza
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	4/6/2019
Start Date:	July 11, 2016
End Date:	October 4, 2017

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

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.

Inclusion Criteria:

- Subjects ≥ 18 years of age, mentally competent, in good health as determined by
medical history, physical examination and clinical judgment by the Investigator; able
to comply with all study procedures, to be contacted, and to be available for study
visits according to the protocol.

Exclusion Criteria:

- Individuals who are pregnant or breastfeeding. Female subjects of childbearing
potential must have a negative pregnancy test prior to study vaccines being
administered.

- Females of childbearing potential who refuse to use an acceptable method of birth
control from Day 1 (1st vaccination) to 3 weeks after the second study vaccination,
and, if sexually active, who have not used a reliable birth control method for at
least two months prior to study entry.

- Individuals with a body temperature ≥38.0 °C (≥100.4 °F) or any acute illness within 3
days of intended study vaccination.

- Individuals who received any type of influenza vaccine (e.g., "seasonal") within 7
days prior to enrolment in this study or who are planning to receive any type of
influenza vaccine within 7 days (before or after) from the study vaccines.

- Individuals who received any other licensed vaccines within 14 days (for inactivated
vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are
planning to receive any (non-influenza) vaccine within 28 days (before or after) from
the study vaccines.

- Individuals with known or suspected impairment of the immune system.

We found this trial at

sites

Rochester Clinical Research Inc.

Rochester, New York 14609

from

Rochester, NY