Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: Influenza vaccine

• Registration Number: NCT00408395
• Lead Sponsor: Novartis Vaccines

Brief Summary

This is a study of the safety and immunogenicity of three commercially available influenza vaccines in children.

Detailed Description

A Phase II, Observer-Blind, Randomized, Parallel Groups, Multicenter, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine versus Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine in Healthy Children

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-12-05
• Study First Submitted QC: 2006-12-05
• Study First Posted: 2006-12-06
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2011-12
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

Inclusion Criteria

• 6 months to < 36 months of age

Exclusion Criteria

• Any severe acute respiratory disease and infections requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
• Other serious diseases such as: cancer, autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic or renal disease, or surgery planned during the study period.
• Known or suspected impairment/alteration of immune function
• History of hypersensitivity to any component of the study vaccine, egg products or other vaccine component, or impairment/alteration of immune function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: Trivalent Seasonal Influenza Vaccine	Influenza vaccine	-
2: Adjuvanted Trivalent Seasonal Influenza Vaccine	Influenza vaccine	-

Primary Outcome Measures

Name	Time	Method
To evaluate the immunogenicity of the 2 vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by the hemagglutination inhibition (HI) test

Secondary Outcome Measures

Name	Time	Method
To evaluate the immunogenicity of the 2 vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test
To evaluate the safety and tolerability of the 2 vaccines administered 4 weeks apart

Trial Locations

Locations (1)

University of Tampere Medical School; 🇫🇮 Tampere, Finland