NCT02612909

Brief Summary

The study hypothesis was that two 0.5 mL doses of whole virion monovalent A/H5N1 influenza vaccine (IVACFLU-A/H5N1) adjuvanted with alum would be safe and well tolerated in healthy adults, and that at least one of the two doses tested would be immunogenic in 60% or more of the subjects tested.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
930

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 7, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 16, 2019

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

October 15, 2015

Results QC Date

January 17, 2019

Last Update Submit

May 12, 2019

Conditions

Avian Influenza

Keywords

Avian InfluenzaA/H5N1 vaccineIVAC

Outcome Measures

Primary Outcomes (1)

  • Number and Percentage of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer of ≥1:40

    Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.

    Day 1, Day 43

Secondary Outcomes (17)

  • Phase 2: Number and Percentage of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer of ≥1:40

    Day 1, Day 22

  • Phase 2: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Hemagglutination Inhibition (HAI) Titer

    Day 22, Day 43

  • Phase 3: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Hemagglutination Inhibition (HAI) Titer

    Day 43

  • Phase 2: Geometric Mean Hemagglutination Inhibition (HAI) Titer

    Day 1, Day 22, Day 43

  • Phase 3: Geometric Mean Hemagglutination Inhibition (HAI) Titer

    Day 1, Day 43

  • +12 more secondary outcomes

Study Arms (5)

Phase 2: Placebo

PLACEBO COMPARATOR

Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.

Biological: Placebo

Phase 2: Vaccine (15 mcg)

ACTIVE COMPARATOR

Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.

Biological: IVACFLU-A/H5N1 vaccine

Phase 2: Vaccine (30 mcg)

ACTIVE COMPARATOR

Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.

Biological: IVACFLU-A/H5N1 vaccine

Phase 3: Placebo

PLACEBO COMPARATOR

Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days.

Biological: Placebo

Phase 3: Vaccine

EXPERIMENTAL

Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.

Biological: IVACFLU-A/H5N1 vaccine

Interventions

IVACFLU-A/H5N1 vaccineBIOLOGICAL

Monovalent A/H5N1 influenza vaccine (MIV), whole virion inactivated, purified by sucrose gradient on ultracentrifuge. The vaccine was produced in eggs, inactivated with formaldehyde, and formulated with aluminum hydroxide 0.6 mg/0.5 mL with no preservative.

Phase 2: Vaccine (15 mcg)Phase 2: Vaccine (30 mcg)Phase 3: Vaccine
PlaceboBIOLOGICAL

Includes 4.500mg sodium chloride, 0.685 mg sodium phosphate dibasic dihydrate, and 0.186 mg sodium phosphate monobasic dihydrate.

Also known as: Sterile Phosphate Buffered Saline (PBS)
Phase 2: PlaceboPhase 3: Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female adult 18 through 60 years of age at the enrollment visit.
  • Literate (by self-report) and willing to provide written informed consent.
  • Healthy adults, as established by the medical history and screening evaluations, including physical examination, capable and willing to complete Diary Cards, and willing to return for all follow-up visits.
  • For females able to become pregnant, willing to utilize reliable birth control measures (intrauterine device, hormonal contraception, condoms) through the Day 43 visit.

You may not qualify if:

  • Participation in another clinical trial involving any vaccine or therapy within the previous three months, or planned enrollment in such a trial during the period of this study.
  • Received any non-study vaccine within 4 weeks prior to enrollment or refused to postpone receipt of such vaccines until after the Day 43 visit.
  • Current or recent (within 2 weeks of enrollment) acute illness with or without fever.
  • Received immune globulin or other blood products within 3 months prior to study enrollment or planned receipt of such products prior to the Day 43 visit.
  • Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this meant prednisone or equivalent, 0.5 mg per kg per day; topical or intranasal steroids were allowed.)
  • History of asthma.
  • Hypersensitivity after previous administration of any vaccine.
  • Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein, antibiotics, and rubber (from the vaccine vial stoppers).
  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatobiliary, metabolic, neurologic, psychiatric, or renal functional abnormality, as determined by medical history, physical examination, or clinical laboratory screening tests (Phase 2 only), which in the opinion of the investigator, might have interfered with the study objectives.
  • History of any blood or solid organ cancer.
  • History of thrombocytopenic purpura or known bleeding disorder.
  • History of seizures.
  • Known or suspected immunosuppressed or immune deficient condition of any kind.
  • Known Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection by self-report (Phase 3) or a positive test for either HBV surface antigen (HBsAg) or HCV antibody using anti-HCV test (Phase 2).
  • Known HIV infection (self-report)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Phase 3: Hai Phong Provincial Preventive Medicine Center

Haiphong, Hai Phong, Vietnam

Location

Phase 2 & 3: Khanh Hoa Provincial Health Department

Nha Trang, Khanh Hoa, Vietnam

Location

Related Publications (1)

  • Duong TN, Thiem VD, Anh DD, Cuong NP, Thang TC, Huong VM, Chien VC, Phuong NTL, Montomoli E, Holt R, Scorza FB, Flores J, Tewari T. A Phase 2/3 double blinded, randomized, placebo-controlled study in healthy adult participants in Vietnam to examine the safety and immunogenicity of an inactivated whole virion, alum adjuvanted, A(H5N1) influenza vaccine (IVACFLU-A/H5N1). Vaccine. 2020 Feb 5;38(6):1541-1550. doi: 10.1016/j.vaccine.2019.11.059. Epub 2019 Dec 4.

    PMID: 31812464DERIVED

MeSH Terms

Conditions

Influenza in Birds

Condition Hierarchy (Ancestors)

Orthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsBird DiseasesAnimal Diseases

Results Point of Contact

Title
Le Van Be
Organization
IVAC
ivaclevabe@dng.vnn.vn
(+84 90) 3501529

Study Officials

  • Tran N Duong, MD, PhD

    National Institute of Hygiene and Epidemiology, Vietnam

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2015

First Posted

November 24, 2015

Study Start

March 7, 2017

Primary Completion

August 29, 2017

Study Completion

August 30, 2017

Last Updated

May 21, 2019

Results First Posted

April 16, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

VN(2)