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

Seqirus

Status and phase: Completed; Phase 3

Conditions: Avian Influenza

Treatments: Biological: aH5N1c; Biological: Placebo

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT02839330

V89_18

Details and patient eligibility

About

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.

Enrollment: 3,196 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,196 participants in 4 patient groups, including a placebo group

Group A

Experimental group

Description:

aH5N1c lot #1; receive 2 doses (on Day 1 and Day 22)

Treatment:

Biological: aH5N1c

Group B

Experimental group

Description:

aH5N1c lot #2; receive 2 doses (on Day 1 and Day 22)

Treatment:

Biological: aH5N1c

Group C

Experimental group

Description:

aH5N1c lot #3; receive 2 doses (on Day 1 and Day 22)

Treatment:

Biological: aH5N1c

Group D

Placebo Comparator group

Description:

Placebo; receive 2 doses (on Day 1 and Day 22)

Treatment:

Biological: Placebo