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

NCT01554826 Phase 3 COMPLETED

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.

Details

Lead sponsor	Hualan Biological Engineering, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	810
Start date	2009-03
Completion	2010-02

Conditions

• Influenza

Interventions

• Influenza Split Vaccine
• Inactivated Influenza Vaccine

Primary outcomes

• Number of subjects with adverse reactions as a measure of safety study — 28 days after the vaccination
  Local reactions, systemic reactions, severity degree and AEFI correlation

Countries

China