NCT03344029

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,600 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	SP Shz TIV	0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0
BIOLOGICAL	Hualan TIV	0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0

Timeline

• Start date: 2017-11-03
• Primary completion: 2018-05-22
• Completion: 2018-05-22
• First posted: 2017-11-17
• Last updated: 2022-04-25

Locations

1 site across 1 country: China