Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S)

NCT02598089 | Completed Phase 1 Results DMC

• 1 other identifier: IVACFLU-S-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1; A/H3N2 and B strains) or placebo (phosphate buffered saline). A total of 60 healthy male and female adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo (30).

Conditions

Influenza, Human

Keywords

Seasonal Influenza; Trivalent Vaccine; Inactivated Vaccine

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Immediate Adverse Events

  Any adverse event occurring within the 30 minute post vaccination period.

  30-minute post-vaccination period.

• Number and Percentage of Participants Reporting Solicited Local Reactogenicity

  Number of subjects reporting solicited local reactions (redness, swelling, pain, hardness, and tenderness) at the injection site post-vaccination with study vaccine or placebo.

  7-day period (Days 1-7) post-vaccination.

• Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity

  Number of subjects reporting solicted systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or placebo

  7-day period (Days 1-7) post-vaccination

• Number and Percentage of Participants With Unsolicited Adverse Events

  Unsolicited AEs were any AEs that occurred any time after the vaccine/placebo was administered (temporally related to investigational product), whether or not deemed "related" to the product, and are not solicited (specifically asked of the subject). Unsolicited AEs were to be observed by the study center personnel while the subject was at the study center for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a "solicited AE" (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination were to be recorded as an "unsolicited AE. In this study, laboratory results were considered AEs when (1) the result was judged to be clinically significant by the Principal Investigator, regardless of grade; or (2) the result is Grade 2 or higher. Note: all unsolicited AEs were mild in intensity. Please see Adverse Events section of this report for detailed information of AEs.

  Within 21 days post-vaccination

• Number and Percentage of Participants With Serious Adverse Events (SAEs)

  Over the entire study period (Day 91)

Secondary Outcomes (6)

• Number and Percentage of Subjects With Seroconversion Against Each of the 3 Antigens

  Day 22

• Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine

  Day 1 and Day 22 post vaccination

• Geometric Mean Titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) Antibodies for Each Antigen

  Pre- (Day 1) and post-vaccination (Day 22)

• Geometric Mean Fold Rises (GMFRs) of Serum Hemaggluntination Inhibition (HAI) Antibodies

  Day 22/Day1

• Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 1) and Post-Vaccination (Day 22) for Each of the 3 Antigens

  Pre- (Day 1) and Post-vaccination (Day 22)

Study Arms (2)

Trivalent Seasonal Influenza Vaccine

EXPERIMENTAL

0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: * NYMC BX-51B reassortant of B/Massachusetts/2/2012 * NYMC X-179A reassortant of A/California/7/2009 (H1N1) * NYMC X-223A reassortant of H3/A/Texas/50/2012 (H3N2)

Biological: Trivalent Seasonal Influenza Vaccine

Placebo

PLACEBO COMPARATOR

This is the placebo comparator: 0.5 mL of Phosphate Buffered Saline

Other: Placebo

Interventions

Trivalent Seasonal Influenza Vaccine BIOLOGICAL

Also known as: IVACFLU-S

Trivalent Seasonal Influenza Vaccine

Placebo OTHER

0.5 mL of phosphate buffered saline

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female adult 18 through 45 years of age at the enrollment visit.
• Literate (by self-report) and willing to provide written informed consent.
• Healthy, as established by the medical history, physical examination, and screening laboratory evaluations.
• Capable and willing to complete Diary Cards and willing to return for all follow-up visits.
• For females, willing to utilize reliable birth control measures (e.g., intrauterine device, hormonal contraception, condoms) through the Day 22 visit.

You may not qualify if:

• Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
• Receipt of any non-study vaccine within 4 weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 22 visit.
• Current or recent (within 2 weeks of enrollment) acute illness with or without fever.
• Receipt of immune globulin or other blood products within 3 months prior to study enrollment or planned receipt of such products prior to the Day 22 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 means prednisone or equivalent, 0.5 mg per kg per day; topical steroids are 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, which in the opinion of the investigator, might interfere 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 immunodeficient condition of any kind.
• Confirmed hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• Known human immunodeficiency virus (HIV) infection (self-report).

Sponsors & Collaborators

• Institute of Vaccines and Medical Biologicals, Vietnam: lead
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator
• World Health Organization: collaborator
• Department of Health and Human Services: collaborator
• PATH: collaborator
• Quintiles, Inc.: collaborator

Study Sites (1)

Hung Ha District Health Center

Thái Bình, Thai Binh Province, Vietnam

Location

Related Publications (1)

• Anh DD, Thiem VD, Anh NTH, Huong VM, Nga NT, Thang TC, Thai DH, Chien VC, Holt R, Wahid R, Flores J, Berlanda Scorza F, Taylor DN. Randomized safety and immunogenicity trial of a seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) in healthy young Vietnamese adults. Vaccine. 2016 Oct 26;34(45):5457-5462. doi: 10.1016/j.vaccine.2016.08.052. Epub 2016 Aug 24.

  PMID: 27567493 RESULT

Related Links

• Article published in the journal Vaccine

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Le Van Be
• Organization: IVAC

ivaclevanbe@gmail.com

Study Officials

• Dang D. Anh, Ph. D

  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 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, 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 5, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 15, 2019
• Results First Posted: January 28, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)