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

NCT02839330 | Completed Phase 3 Results FDA Drug

• 1 other identifier: V89_18
• Study Type: interventional
• Target: 3,196
• Locations: 1 country
• Sites: 26

Brief 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.

Conditions

Avian Influenza

Keywords

Influenza; Vaccine; Flu; Avian; Pandemic; H5N1; MF59

Outcome Measures

Primary Outcomes (5)

• Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot

  Hemagglutination Inhibition (HI) GMT was assessed at Day 1 and Day 43 for 3 consecutively produced lots.

  Day 1, Day 43

• Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort

  Percentage of subjects with HI titer ≥ 1:40 at Day 43 was assessed by age cohort (18 to \<65 years of age and ≥65 years of age) for the pooled lots. Center for Biologics Evaluation and Research (CBER) criterion for subjects aged 18 to \<65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%. CBER criterion for subjects aged ≥65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 60%.

  Day 1, Day 43

• Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination

  Percentages of subjects with solicited local, solicited systemic, and other AEs as measured for 7 days (inclusive) following each vaccination (first and second) and any (first or second) vaccination, by treatment group and calculated for several time intervals after vaccination : 30 minutes, 1 to 3 days (without 30 minutes), 4 to 7 days, and 1 to 7 days (without 30 minutes), and 1 to 3 days (including 30 minutes) and 1 to 7 days (including 30 minutes). Analysis for intervals of the first 30 minutes, days 1 to 3, and days 4 to 7 was not performed.

  Day 1 to Day 7

• Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination

  Percentages of subjects with any unsolicited AEs reported through 21 days after each (first and second) and any (first or second) vaccination by treatment group.

  Day 1 to Day 43

• Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group.

  Percentages of subjects with any adverse events (AE), adverse events of special interest (AESI), new onset of chronic disease (NOCD), and serious adverse event (SAE) through study termination by treatment group.

  Day 1 to Day 387

Secondary Outcomes (7)

• Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).

  Day 1, Day 22, Day 43, and Day 183

• Secondary Immunogenicity Endpoint: 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 (18 to <65 Years of Age and ≥65 Years of Age).

  Day 1, Day 22, Day 43 and Day 183

• Secondary Immunogenicity Endpoint: 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).

  Day 22, and Day 43

• Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)

  Day 1, Day 22, Day 43 and Day 183

• Secondary Immunogenicity Endpoint: 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 (18 to <60 Years of Age and ≥60 Years of Age)

  Day 1, Day 22, Day 43, and Day 183

Study Arms (4)

Group A

EXPERIMENTAL

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

Biological: aH5N1c

Group B

EXPERIMENTAL

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

Biological: aH5N1c

Group C

EXPERIMENTAL

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

Biological: aH5N1c

Group D

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

aH5N1c BIOLOGICAL

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

Group A; Group B; Group C

Placebo BIOLOGICAL

Placebo: Saline injection

Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seqirus: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (26)

Optimal Research, LLC

Huntsville, Alabama, 35802, United States

Location

Radiant Research

Chandler, Arizona, 85224, United States

Location

Clinical Research Consortium Arizona

Tempe, Arizona, 85283, United States

Location

Optimal Research Site

San Diego, California, 92108, United States

Location

California Research Foundation

San Diego, California, 92123, United States

Location

Clinical Research Consulting, LLC

Milford, Connecticut, 06460, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Optimal Research, LLC

Melbourne, Florida, 32934, United States

Location

Great Lakes Clinical Trials LLC

Chicago, Illinois, 60640, United States

Location

Optimal Research

Peoria, Illinois, 61614, United States

Location

Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

Optimal Research, LLC

Rockville, Maryland, 20850, United States

Location

The Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

RCR/United Medical Associates, PC

Binghamton, New York, 13901, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

PMG Research of Raleigh

Raleigh, North Carolina, 60640, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27609, United States

Location

Aventiv Research

Columbus, Ohio, 43213, United States

Location

Medical Research South

Charleston, South Carolina, 29407, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Biogenics Research Institute

San Antonio, Texas, 78229, United States

Location

J. Lewis Research Inc.-Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. / FirstMed East

Salt Lake City, Utah, 84121, United States

Location

J. Lewis Research, Inc/Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

J. Lewis Research, Inc/Jordan River Family Medicine

South Jordan, Utah, 84095, United States

Location

Related Publications (1)

• 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.

  PMID: 35455245 DERIVED

MeSH Terms

Conditions

Influenza in Birds; Influenza, Human

Condition Hierarchy (Ancestors)

Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Bird Diseases; Animal Diseases; Respiratory Tract Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Seqirus Clinical Trial Disclosure Manager
• Organization: Seqirus

Seqirus.ClinicalTrials@Seqirus.com

1-855-358-8966

Study Officials

• Clinical Program Director

  Seqirus

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 20, 2016
• Study Start: July 11, 2016
• Primary Completion: October 4, 2017
• Study Completion: October 4, 2017
• Last Updated: December 6, 2024
• Results First Posted: April 4, 2019

Record last verified: 2019-04

Locations

US (26)