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

• ClinicalTrials.gov Identifier: NCT03344029
• Recruitment Status: Completed
• First Posted: November 17, 2017
• Last Update Posted: June 25, 2019
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Influenza; Flu	Biological: SP Shz TIV; Biological: Hualan TIV	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Blind-observer, monocenter, randomized, comparative, Phase IV study
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: November 3, 2017
• Actual Primary Completion Date: May 22, 2018
• Actual Study Completion Date: May 22, 2018

Arms and Interventions

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 Name: 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 Name: Hualan Trivalent Influenza Vaccine

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: Day 28 post-vaccination ]
   GMTs were assessed using the hemagglutination inhibition (HAI) assay.
2. Percentage of Participants with TIV Seroconversion Following a Single Dose of SP Shz TIV or Hualan TIV [ Time Frame: Day 28 post-vaccination ]
   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.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 59 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

China

Sanofi Pasteur Investigational Site 001

Huai'an, China, 223300

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Medical Director; Sanofi Pasteur, a Sanofi Company

More Information

Publications of Results:

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.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT03344029
• Other Study ID Numbers: FST00002; U1111-1183-5912 ( Other Identifier: WHO Universal Trial Number (UTN) )
• First Posted: November 17, 2017
• Last Update Posted: June 25, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available, Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com.

• 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

Keywords provided by Sanofi:

Influenza; Flu

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs