NCT02228980

Study of a Single Dose or Two Doses of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China

Immunogenicity and Safety of a Single Dose (Subjects From 3 Years of Age) or Two Doses Given 28 Days Apart (Children From 6 to 35 Months of Age) of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 602 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

The main purpose of this trial is to describe the product profile in terms of immunogenicity and safety following administration of trivalent influenza vaccine (split-virion, inactivated) produced at Shenzhen (SP Shz TIV). Primary objective: * To describe in each group the immune response induced by a single dose (subjects aged ≥ 3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV. Secondary objective: * To describe in each group the safety profile of the vaccine after a single dose (subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35 months).

Detailed description

Healthy subjects will be included to receive one or two doses of SP Shz TIV The study will assess the immunogenicity and safety of a single dose (in subjects from 3 years) or two doses of SP Shz TIV vaccine given 28 days apart (pediatric population from 6 to 35 months).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation	0.25 mL Intramuscular (2 doses given 28 days apart)
BIOLOGICAL	Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation	0.5 mL Intramuscular
BIOLOGICAL	Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation	0.5 mL Intramuscular
BIOLOGICAL	Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation	0.5 mL Intramuscular

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-12-01
• Completion: 2015-10-01
• First posted: 2014-08-29
• Last updated: 2016-01-29
• Results posted: 2016-01-29

Locations

1 site across 1 country: China