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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

NCT ID: NCT02839330

Last Updated: 2024-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-11

Study Completion Date

2017-10-04

Brief Summary

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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.

Detailed Description

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Conditions

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Avian Influenza

Keywords

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Influenza Vaccine Flu Avian Pandemic H5N1 MF59

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

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

Group Type EXPERIMENTAL

aH5N1c

Intervention Type BIOLOGICAL

Intramuscular (IM) administration, containing 7.5 mcg H5N1 hemagglutinin antigen (HA) + 0.25 mL MF59 (approximately 0.5 mL total volume).

Group B

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

Group Type EXPERIMENTAL

aH5N1c

Intervention Type BIOLOGICAL

Intramuscular (IM) administration, containing 7.5 mcg H5N1 hemagglutinin antigen (HA) + 0.25 mL MF59 (approximately 0.5 mL total volume).

Group C

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

Group Type EXPERIMENTAL

aH5N1c

Intervention Type BIOLOGICAL

Intramuscular (IM) administration, containing 7.5 mcg H5N1 hemagglutinin antigen (HA) + 0.25 mL MF59 (approximately 0.5 mL total volume).

Group D

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo: Saline injection

Interventions

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aH5N1c

Intramuscular (IM) administration, containing 7.5 mcg H5N1 hemagglutinin antigen (HA) + 0.25 mL MF59 (approximately 0.5 mL total volume).

Intervention Type BIOLOGICAL

Placebo

Placebo: Saline injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biomedical Advanced Research and Development Authority

FED

Sponsor Role collaborator

Seqirus

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Program Director

Role: STUDY_DIRECTOR

Seqirus

Locations

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Optimal Research, LLC

Huntsville, Alabama, United States

Site Status

Radiant Research

Chandler, Arizona, United States

Site Status

Clinical Research Consortium Arizona

Tempe, Arizona, United States

Site Status

Optimal Research Site

San Diego, California, United States

Site Status

California Research Foundation

San Diego, California, United States

Site Status

Clinical Research Consulting, LLC

Milford, Connecticut, United States

Site Status

Innovative Research of West Florida, Inc.

Clearwater, Florida, United States

Site Status

Optimal Research, LLC

Melbourne, Florida, United States

Site Status

Great Lakes Clinical Trials LLC

Chicago, Illinois, United States

Site Status

Optimal Research

Peoria, Illinois, United States

Site Status

Heartland Research Associates

Wichita, Kansas, United States

Site Status

Optimal Research, LLC

Rockville, Maryland, United States

Site Status

The Center for Pharmaceutical Research

Kansas City, Missouri, United States

Site Status

Sundance Clinical Research, LLC

St Louis, Missouri, United States

Site Status

RCR/United Medical Associates, PC

Binghamton, New York, United States

Site Status

Rochester Clinical Research, Inc

Rochester, New York, United States

Site Status

PMG Research of Raleigh

Raleigh, North Carolina, United States

Site Status

PMG Research of Winston-Salem

Winston-Salem, North Carolina, United States

Site Status

Aventiv Research

Columbus, Ohio, United States

Site Status

Medical Research South

Charleston, South Carolina, United States

Site Status

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Site Status

Biogenics Research Institute

San Antonio, Texas, United States

Site Status

J. Lewis Research Inc.-Foothill Family Clinic

Salt Lake City, Utah, United States

Site Status

J. Lewis Research, Inc. / FirstMed East

Salt Lake City, Utah, United States

Site Status

J. Lewis Research, Inc/Foothill Family Clinic South

Salt Lake City, Utah, United States

Site Status

J. Lewis Research, Inc/Jordan River Family Medicine

South Jordan, Utah, United States

Site Status

Countries

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United States

References

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Peterson J, Van Twuijver E, Versage E, Hohenboken M. Phase 3 Randomized, Multicenter, Placebo-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. Vaccines (Basel). 2022 Mar 23;10(4):497. doi: 10.3390/vaccines10040497.

Reference Type DERIVED
PMID: 35455245 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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V89_18

Identifier Type: -

Identifier Source: org_study_id