At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation for Influenza. Completed, enrolled 602 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
0.25 mL Intramuscular (2 doses given 28 days apart)
0.5 mL Intramuscular
0.5 mL Intramuscular
0.5 mL Intramuscular