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

NCT ID: NCT03344029

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-03
• Study Completion Date: 2018-05-22

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.

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.

Conditions

Influenza; Flu

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

SP Shz TIV

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

Group Type: EXPERIMENTAL

SP Shz TIV

Intervention Type: BIOLOGICAL

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

Hualan TIV

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

Group Type: ACTIVE_COMPARATOR

Hualan TIV

Intervention Type: BIOLOGICAL

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

Interventions

SP Shz TIV

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

Intervention Type: BIOLOGICAL

Hualan TIV

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine; Hualan Trivalent Influenza Vaccine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur, a Sanofi Company

Locations

Sanofi Pasteur Investigational Site 001

Huai'an, , China

Countries

China

References

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.

Reference Type: RESULT

PMID: 30779689 (View on PubMed)

Other Identifiers

U1111-1183-5912

Identifier Type: OTHER

Identifier Source: secondary_id

FST00002

Identifier Type: -

Identifier Source: org_study_id