NCT01554813

Clinical Trial of Inactivated Influenza Vaccine (0.5ml Formulation)

A Single - Blind, Randomized, - Controlled Clinical Trial With Inactivated Influenza Vaccine (Split Virion) (0.5ml Formulation)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Hualan Biological Engineering, Inc. · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

The clinical trial was conducted in Jintan City of Jiangsu Province, China in May, 2006. The purpose of the clinical trial was to evaluate the safety and immunogenicity against Hualan's Influenza Vaccine (Split Virion), Inactivated (0.5ml) administered on age 6 months and old population.

Detailed description

The clinical trial was designed randomized and blind. Participants included up to 900 persons. The clinical trial had two stages: the first stage selected 60 subjects to be administered test vaccine for preliminary safety study; 840 subjects were selected at the second stage for the observation of the safety and immunogenicity against the test vaccine administered on large population on the basis of the first stage. There were 560 subjects and 280 subjects in the test group and control group respectively. Venous blood from subjects was collected before immunization and 4 weeks after the whole immunization for the analysis of the immunogenicity. The information about adverse reactions/time was reported to the SFDA every month during the trial under the status of blinding. Unblinding was conducted after the subject follow-up and observation.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza split vaccine of 15 μg HA	60 subjects were assigned (20 infants, 20 children and 20 adults) to receive influenza vaccine (split virion), inactivated, 0.5ml, one dose regime
BIOLOGICAL	Influenza split vaccine of 15 μg HA	558 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime
BIOLOGICAL	Influenza split vaccine	280 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-07-01
• Completion: 2006-10-01
• First posted: 2012-03-15
• Last updated: 2012-09-06

Locations

1 site across 1 country: China