A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose TIV

NCT02263040 | Completed Phase 1 Results

• 1 other identifier: 14-0909
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pilot study is to assess the immunogenicity and reactogenicity of Fluzone High Dose with Fluzone (standard adult dose) influenza vaccines in healthcare workers.

Conditions

Influenza

Keywords

influenza vaccine; adult; immunogenicity; reactogenicity

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Seroconversion to A/California/07/2009 (H1N1)

  Seroconversion to influenza strains contained in the vaccine, as measured by hemagglutination inhibition (HAI) assay. 4-fold or greater increase.

  21 days (18-28)

• Number of Participants With Seroconversion to A/Texas/50/2012 (H3N2)

  Four-fold or higher rise in titres to A/Texas/50/2012 (H3N2) as measured by hemagglutination inhibition assay

  21 days post vaccination (18-28)

• Number of Participants With Seroconversion to Influenza B/Phuket/3073/2013

  Four fold or higher increase in titres to B/Phuket/3073/2013 as measured by hemagglutination inhibition assay

  21 days post-vaccination (18-28)

• Number of Participants With Seroconversion to A/Switzerland/9715293/2013 (H3N2)

  Four-fold or higher rise in titres against A/Switzerland/9715293/2013 (H3N2) as measured by hemagglutination inhibition assay

  21 days post vaccination (18-28)

• Number of Participants With Seroconversion to B/Massachusetts/02/2012

  Four fold or higher increase in titres to B/Massachusetts/02/2012 as measured by hemagglutination inhibition assay

  21 days post-vaccination (18-28)

Secondary Outcomes (7)

• Geometric Mean Fold Ratio (GMFR) Against A/California/07/2009 (H1N1)

  21 days (18-28)

• Geometric Mean Fold Ratio (GMFR): A/Switzerland/9715293/2013

  21 days (18-28)

• Geometric Mean Fold Ratio (GMFR): A/Texas/50/2012

  21 days (18-28)

• Geometric Mean Fold Ratio (GMFR): B/Phuket/3073/2013 Ether-treated

  21 days (18-28)

• Geometric Mean Fold Ratio (GMFR): B/Massachusetts/02/2012 Ether-treated

  21 days (18-28)

Study Arms (2)

High Dose Fluzone

EXPERIMENTAL

Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5 mL containing 60μg hemagglutinin per virus strain

Biological: Fluzone High-Dose

Fluzone (standard dose)

ACTIVE COMPARATOR

Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5 mL containing 15μg hemagglutinin per virus strain for adults

Biological: Fluzone (standard dose)

Interventions

Fluzone High-Dose BIOLOGICAL

Influenza vaccine

High Dose Fluzone

Fluzone (standard dose) BIOLOGICAL

Influenza vaccine

Fluzone (standard dose)

Eligibility Criteria

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

You may qualify if:

• years old, inclusive, as of October 1st of year of enrolment;
• Healthcare worker, broadly defined as a person either providing health care, or working in an acute care hospital or long term healthcare facility;
• Has access to email and the internet for adverse event reporting, or is willing to complete forms on paper and deliver to the site study office;
• Understand the study, agree to its requirements, and give written consent;

You may not qualify if:

• Receipt of influenza vaccine for the current northern hemisphere season prior to randomization;
• Serious adverse event to a previous dose of influenza vaccine;
• Immunoglobulin E mediated allergic reaction to a previous dose of influenza vaccine or to any excipients in the study vaccines
• Previous episode of Guillain-Barré syndrome with 6 weeks of receiving an influenza vaccine;
• Receipt of immunoglobulins, blood or blood-derived products in the past 3 months;
• Receipt of another vaccine, or initiation of new medication, or hospital admission for any reason within the 30 days prior to the study dose of vaccine
• Plans to receive any vaccine, initiate any medication, or be admitted to hospital before day 21 after vaccination (visit 2);
• Known or suspected congenital or acquired immunodeficiency (including HIV infection); or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Any condition, including but not limited to drug and alcohol addiction, which, in the opinion of the investigator might interfere with the ability to comply with trial conduct or completion;
• Moderate or severe acute illness or active infection or fever (temperature ≥37.8oC) on the day the vaccine dose is due (participant may receive dose of vaccine 48 hours after symptoms have resolved and body temperature has returned to normal without the use of antipyretics.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Fluzone High-Dose; Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Allison McGeer
• Organization: Mount Sinai Hospital, Toronto

allison.mcgeer@sinaihealthsystem.ca

416-586-3118

Study Officials

• Allison J McGeer, MD

  MOUNT SINAI HOSPITAL

  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: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 13, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 31, 2016
• Last Updated: January 28, 2019
• Results First Posted: January 28, 2019

Record last verified: 2018-08

Locations

CA (1)