Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US

NCT03282240 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: QHD00013U1111-1183-5556
• Study Type: interventional
• Target: 2,670
• Locations: 1 country
• Sites: 36

Brief Summary

This randomized, modified double-blind, active-controlled, multi-center trial assessed the safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in adults.

Conditions

Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine

  GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.

  Day 28 post-vaccination

• Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine

  Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (\<) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (\>=) 40 (1/dilution) at Day 28, or HAI titer \>=10 (1/dilution) at Day 0 and a \>=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.

  Day 28 post-vaccination

Secondary Outcomes (13)

• GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine

  Day 28 post-vaccination

• GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine

  Day 28 post-vaccination

• Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine

  Day 0 (pre-vaccination) and Day 28 post-vaccination

Study Arms (3)

QIV-HD

EXPERIMENTAL

Participants randomized to receive a single injection of 0.7 mL QIV-HD by intramuscular (IM) route at Day 0.

Biological: QIV-HD

TIV-HD1 (Licensed TIV-HD1)

ACTIVE COMPARATOR

Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.

Biological: Licensed TIV-HD1

TIV-HD2 (Investigational TIV-HD2)

ACTIVE COMPARATOR

Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.

Biological: Investigational TIV-HD2

Interventions

QIV-HD BIOLOGICAL

0.7 mL-dose was administered intramuscularly (IM) into the upper arm area.

Also known as: High-dose quadrivalent influenza vaccine

QIV-HD

Licensed TIV-HD1 BIOLOGICAL

0.5 mL-dose was administered IM into the upper arm area.

Also known as: High-dose trivalent influenza vaccine

TIV-HD1 (Licensed TIV-HD1)

Investigational TIV-HD2 BIOLOGICAL

0.5 mL-dose was administered IM into the upper arm area.

Also known as: High-dose trivalent influenza vaccine (alternate B strain)

TIV-HD2 (Investigational TIV-HD2)

Eligibility Criteria

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

You may qualify if:

• Informed consent form had been signed and dated.
• Able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if:

• Participation at the time of trial enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2.
• Previous vaccination against influenza (in the preceding 6 months) with either the trial vaccine or another vaccine.
• Receipt of immune globulins, blood or blood-derived products in the past 3 months.
• Known or suspected congenital or acquired immunodeficiency; 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).
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
• Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on investigator's judgment.
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
• Alcohol or substance abuse that, in the opinion of the investigator, might interfere with the trial conduct or completion.
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
• Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed trial.
• Personal or family history of Guillain-Barré syndrome.
• Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and participants who have a history of neoplastic disease and have been disease free for \>= 5 years).
• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature \>= 38.0°C \[\>= 100.4°F\]). A prospective participant should not be included in the trial until the condition has resolved or the febrile event had subsided.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (36)

Sanofi Pasteur Investigational Site 037

Anaheim, California, 92801, United States

Location

Sanofi Pasteur Investigational Site 029

Redding, California, 96001, United States

Location

Sanofi Pasteur Investigational Site 003

San Diego, California, 92117, United States

Location

Sanofi Pasteur Investigational Site 016

Colorado Springs, Colorado, 80920, United States

Location

Sanofi Pasteur Investigational Site 035

Milford, Connecticut, 06460, United States

Location

Sanofi Pasteur Investigational Site 031

Hollywood, Florida, 33024, United States

Location

Sanofi Pasteur Investigational Site 009

Jacksonville, Florida, 32205, United States

Location

Sanofi Pasteur Investigational Site 017

Jacksonville, Florida, 32216, United States

Location

Sanofi Pasteur Investigational Site 030

Stockbridge, Georgia, 30281, United States

Location

Sanofi Pasteur Investigational Site 010

Boise, Idaho, 83712, United States

Location

Sanofi Pasteur Investigational Site 034

Meridian, Idaho, 83642, United States

Location

Sanofi Pasteur Investigational Site 021

Council Bluffs, Iowa, 51501, United States

Location

Sanofi Pasteur Investigational Site 023

Wichita, Kansas, 67205, United States

Location

Sanofi Pasteur Investigational Site 028

Wichita, Kansas, 67207, United States

Location

Sanofi Pasteur Investigational Site 012

Bardstown, Kentucky, 40004, United States

Location

Sanofi Pasteur Investigational Site 018

Metairie, Louisiana, 70427, United States

Location

Sanofi Pasteur Investigational Site 026

Biloxi, Mississippi, 39531, United States

Location

Sanofi Pasteur Investigational Site 014

St Louis, Missouri, 63104, United States

Location

Sanofi Pasteur Investigational Site 011

Omaha, Nebraska, 68134, United States

Location

Sanofi Pasteur Investigational Site 024

Las Vegas, Nevada, 89104, United States

Location

Sanofi Pasteur Investigational Site 008

Rochester, New York, 14609, United States

Location

Sanofi Pasteur Investigational Site 005

Wilmington, North Carolina, 28401, United States

Location

Sanofi Pasteur Investigational Site 036

Winston-Salem, North Carolina, 27045, United States

Location

Sanofi Pasteur Investigational Site 004

Cleveland, Ohio, 44122, United States

Location

Sanofi Pasteur Investigational Site 015

Oklahoma City, Oklahoma, 73112, United States

Location

Sanofi Pasteur Investigational Site 013

Warwick, Rhode Island, 02886, United States

Location

Sanofi Pasteur Investigational Site 033

Mt. Pleasant, South Carolina, 29464, United States

Location

Sanofi Pasteur Investigational Site 001

Nashville, Tennessee, 37212, United States

Location

Sanofi Pasteur Investigational Site 002

Dallas, Texas, 75234, United States

Location

Sanofi Pasteur Investigational Site 025

Tomball, Texas, 77375, United States

Location

Sanofi Pasteur Investigational Site 027

Salt Lake City, Utah, 84109, United States

Location

Sanofi Pasteur Investigational Site 006

Salt Lake City, Utah, 84121, United States

Location

Sanofi Pasteur Investigational Site 019

Salt Lake City, Utah, 84123, United States

Location

Sanofi Pasteur Investigational Site 020

South Jordan, Utah, 84095, United States

Location

Sanofi Pasteur Investigational Site 022

West Jordan, Utah, 83642, United States

Location

Sanofi Pasteur Investigational Site 038

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• Chang LJ, Meng Y, Janosczyk H, Landolfi V, Talbot HK; QHD00013 Study Group. Safety and immunogenicity of high-dose quadrivalent influenza vaccine in adults >/=65 years of age: A phase 3 randomized clinical trial. Vaccine. 2019 Sep 16;37(39):5825-5834. doi: 10.1016/j.vaccine.2019.08.016. Epub 2019 Aug 17.

  PMID: 31431411 DERIVED

Related Links

• Related info

MeSH Terms

Conditions

Influenza, Human

Interventions

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: Trial Transparency Team
• Organization: Sanofi Pasteur Inc.

Contact-US@sanofi.com

800-633-1610

Study Officials

• Medical Director

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: QHD00013 was a modified double-blind trial with an unblinded administrator used at each trial site. The administrator was not involved in any of the blinded study assessments (e.g., safety).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: QHD00013 was a phase III, randomized, modified double-blind, active-controlled, multi-center trial.

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 13, 2017
• Study Start: September 8, 2017
• Primary Completion: November 2, 2017
• Study Completion: April 19, 2018
• Last Updated: April 7, 2022
• Results First Posted: December 17, 2019

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (36)