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

NCT03344029 | Completed Phase 4

• 2 other identifiers: FST00002U1111-1183-5912
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza; Flu

Keywords

Influenza; Flu

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• GMTs of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV

  Day 28 post-vaccination

• GMT Ratios of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV

  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

  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

  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

  Day 0 up to Day 7 post-vaccination

Study Arms (2)

SP Shz TIV

EXPERIMENTAL

Participants aged 18 to 59 years will receive a single injection of SP Shz TIV.

Biological: SP Shz TIV

Hualan TIV

ACTIVE COMPARATOR

Participants aged 18 to 59 years will receive a single injection of Hualan TIV.

Biological: Hualan TIV

Interventions

SP Shz TIV BIOLOGICAL

0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0

Also known as: Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine

SP Shz TIV

Hualan TIV BIOLOGICAL

0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0

Also known as: Hualan Trivalent Influenza Vaccine

Hualan TIV

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi Pasteur Investigational Site 001

Huai'an, 223300, China

Location

Related Publications (1)

• 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.

  PMID: 30779689 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Director

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An observer-blind procedure will be followed in the study such that neither the Investigator, subject, nor the Sponsor will know which vaccine has been administered.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Blind-observer, monocenter, randomized, comparative, Phase IV study

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: November 3, 2017
• Primary Completion: May 22, 2018
• Study Completion: May 22, 2018
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)