Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent Influenza Vaccine Comparator in Chinese Subjects 18 to 59 Years

Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent Influenza Vaccine Comparator in Healthy Chinese Subjects Aged 18 to 59 Years

This was a blind-observer, monocenter, randomized, comparative, Phase IV study designed to evaluate the immunogenicity and safety of the Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine (SP Shz TIV) versus the Trivalent Influenza Vaccine manufactured by Hualan Biological Engineering Inc (Hualan TIV) comparator in healthy Chinese participants aged 18 to 59 years.

Study Overview

• Status: Completed
• Conditions: Influenza; Flu
• Intervention / Treatment: Biological: SP Shz TIV; Biological: Hualan TIV

Detailed Description

This study is designed to demonstrate the non-inferiority of the immune response in terms of geometric mean titers (GMTs) and seroconversion rates for the 3 strains (A/H1N1, A-H3N2, and B) after a single dose of either the SP Shz TIV or Hualan TIV. Vaccine immune responses will be assessed on Day 0 (pre-vaccination) and Day 28 post-vaccination. Solicited reactions will be collected from Day 0 up to Day 7 after vaccination, unsolicited non-serious adverse events (AEs) will be collected from Day 0 up to Day 28 post-vaccination, and serious AEs will be collected from Day 0 up to 6 months post-vaccination.

• Study Type: Interventional
• Enrollment (Actual): 1600
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Huai'an, China, 223300
    • Sanofi Pasteur Investigational Site 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 57 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged ≥ 18 to 59 years on the day of inclusion
• Informed consent form has been signed and dated
• Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

• Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non- childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile
• Participation at the time of study 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 or planned receipt of any vaccine within the period from 2 weeks before trial vaccination to 2 weeks following trial vaccination
• Previous vaccination against influenza (in the previous 6 months) with either the trial vaccines or another vaccine
• Receipt of immune globulins, blood or blood-derived product 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 vaccines 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
• Self-reported thrombocytopenia contraindicating intramuscular vaccination
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Current alcohol abuse or drug addiction
• Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥ 37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
• Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, 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 study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SP Shz TIV; Participants aged 18 to 59 years will receive a single injection of SP Shz TIV.	Biological: SP Shz TIV; 0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0; Other Names: Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine
Active Comparator: Hualan TIV; Participants aged 18 to 59 years will receive a single injection of Hualan TIV.	Biological: Hualan TIV; 0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0; Other Names: Hualan Trivalent Influenza Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary of Geometric Mean Titers (GMTs) of Each of the Three Strains of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV	GMTs were assessed using the hemagglutination inhibition (HAI) assay.	Day 28 post-vaccination
Percentage of Participants with TIV Seroconversion Following a Single Dose of SP Shz TIV or Hualan TIV	Seroconversion rates were assessed using a HAI assay. Seroconversion was defined as titers <10 (1/dil) at Day 0 and post-injection titer ≥40 (1/dil) at Day 28, or titer ≥10 (1/dil) at Day 0 and a ≥4-fold increase in titer (1/dil) at Day 28.	Day 28 post-vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMTs of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV	GMTs were assessed using the HAI assay.	Day 28 post-vaccination
GMT Ratios of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV	GMTs were assessed using the HAI assay.	Day 28 post-vaccination
Percentage of Participants with TIV Antibody Titers ≥10 (1/dil) Following a Single Dose of SP Shz TIV or Hualan TIV	TIV antibody levels were assessed using the HAI assay.	Day 28 post-vaccination
Percentage of Participants with TIV Antibody Titers ≥40 (1/dil) Following a Single Dose of SP Shz TIV or Hualan TIV	TIV antibody levels were assessed using the HAI assay.	Day 28 post-vaccination
Percentage of Participants Reporting Solicited Injection site or Systemic Reactions Following a Single Dose of SP Shz TIV or Hualan TIV	Solicited injection site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering	Day 0 up to Day 7 post-vaccination

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General Publications

• Hu Y, Chu K, Lavis N, Li X, Liang B, Liu S, Shao M, Shu JD, Tabar C, Samson S. Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China versus a comparator influenza vaccine: a phase IV randomized study. Hum Vaccin Immunother. 2019;15(5):1066-1069. doi: 10.1080/21645515.2019.1581541. Epub 2019 Apr 2.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2017
• Primary Completion (Actual): May 22, 2018
• Study Completion (Actual): May 22, 2018

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Influenza; Flu
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: FST00002; U1111-1183-5912 (Other Identifier: WHO Universal Trial Number (UTN))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No