Overview

This trial is active, not recruiting.

Condition avian influenza
Treatments ah5n1c, placebo
Phase phase 3
Sponsor Seqirus
Collaborator Biomedical Advanced Research and Development Authority
Start date July 2016
End date November 2017
Trial size 3192 participants
Trial identifier NCT02839330, V89_18

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 798 healthy adults receiving placebo. Subjects will be randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment will be stratified by age: 18 to <65 years of age and ≥65 years of age, to allow adequate safety assessment of the entire age spectrum.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)
ah5n1c
Intramuscular (IM) administration, containing 7.5 mcg H5N1 hemagglutinin antigen (HA) + 0.25 mL MF59 (approximately 0.5 mL total volume).
(Experimental)
aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)
ah5n1c
Intramuscular (IM) administration, containing 7.5 mcg H5N1 hemagglutinin antigen (HA) + 0.25 mL MF59 (approximately 0.5 mL total volume).
(Experimental)
aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)
ah5n1c
Intramuscular (IM) administration, containing 7.5 mcg H5N1 hemagglutinin antigen (HA) + 0.25 mL MF59 (approximately 0.5 mL total volume).
(Placebo Comparator)
Placebo; receive 2 doses (on Day 1 and Day 22)
placebo
Placebo

Primary Outcomes

Measure
Geometric mean titer (GMT) at Day 43 by lot on Day 43
time frame: Day 43
Percentage of subjects with Haemagglutination Inhibition titer (HI) ≥ 1:40 Day 43 by age cohort
time frame: Day 43

Secondary Outcomes

Measure
Geometric mean titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by vaccine group
time frame: Day 1, Day 22, Day 43, and Day 183
Percentage of subjects with Haemagglutination Inhibition (HI) titer ≥ 1:40 on Day 1, Day 22, and Day 183 by vaccine group (aH5N1c or placebo) and by age cohort
time frame: Day 1, Day 22, and Day 183
Percentage of subjects achieving seroconversion on Day 22, and Day 43 by vaccine group (aH5N1c or placebo) and by age cohort (18 to <65 years of age and ≥65 years of age).
time frame: Day 22, and Day 43
Geometric mean Haemagglutination Inhibition (HI) titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by vaccine group (aH5N1c or placebo) and by age cohort
time frame: Day 1, Day 22, Day 43 and Day 183
Percentage of subjects with Haemagglutination Inhibition (HI) titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by vaccine group (aH5N1c or placebo) and by age cohort
time frame: Day 1, Day 22, Day 43, and Day 183
Percentage of subjects achieving seroconversion on Day 22, and Day 43 by vaccine group (aH5N1c or placebo) and by age cohort (18 to <60 years of age and ≥60 years of age)
time frame: Day 22, and Day 43
Geometric mean ratio (GMR) of Haemagglutination Inhibition (HI) titer: Day 22/Day 1, Day 43/Day 1 by vaccine group (aH5N1c or placebo) and by age cohort
time frame: Day 22/Day 1, Day 43/Day 1

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Seqirus.