NCT01554826

Clinical Trial of the Inactivated Influenza Vaccine (0.25ml Formulation for Pediatric Use)

A Double - Blind, Randomized, - Controlled Clinical Trial With Inactivated Influenza Vaccine (Split Virion)(0.25ml Formulation for Pediatric Use)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 810 (actual)
• Sponsor: Hualan Biological Engineering, Inc. · Industry
• Sex: All
• Age: 6 Months – 36 Months
• Healthy volunteers: Accepted

Summary

The clinical trial was designed to evaluate the immunogenicity and safety against pediatric Inactivated influenza vaccine (Split Virion) (0.25ml formulation) of Hualan administered on infants age 6 months to 36 months.

Detailed description

The clinical trial was designed randomized and double-blind. Participants included up to 810 persons (540 persons in test group and 270 persons in control group). Healthy 6-36 months infants were selected, whose guardians were volunteers and had signed the informed consent. Subjects were selected according to the inclusion and exclusion criteria. Every subject accepted 30min's observation in the hospital after vaccination and received periodic follow-up till the fourth week after the boost vaccination. Blood of subjects was collected at the third week after the boost vaccination for the analysis of the immunogenicity. During the test, the adverse reactions and detailed information were reported to the SFDA under the status of blinding every month. Unblinding was conducted after the completion of the follow-up of subjects.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Split Vaccine	0.25ml, two doses (540 subjects were randomly assigned to receive the first dose, among them, 515 subjects received a boost dose); two doses were assigned to be vaccinated 4 weeks apart
BIOLOGICAL	Inactivated Influenza Vaccine	0.25ml, two doses (270 subjects were randomly assigned to receive the first dose; among them, 263 subjects received a boost dose); two doses was administrated at 4 weeks apart

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-05-01
• Completion: 2010-02-01
• First posted: 2012-03-15
• Last updated: 2012-09-06

Locations

1 site across 1 country: China