Safety and Immunogenicity of Three Commercially Available Influenza Vaccines in Children Aged 6 to <36 Months

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00311428
• Collaborator: Novartis Vaccines (Industry)
• Enrollment: 270
• Location: 1

Study Details

Study Description

Brief Summary

This phase IV protocol is designed to evaluate the safety, clinical tolerability and immunogenicity of the 2005-2006 formulation of three widely used conventional influenza vaccines in children aged 6 to 35 months

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Influenza	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Prevention
• Official Title: A Phase IV, Observer-Blind, Randomized, Parallel Groups, Single-Center, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of Two 0.25 mL Intramuscular Doses of Three Commercially Available Influenza Vaccines in Healthy Subjects Aged 6 to <36 Months.
• Study Start Date: Oct 1, 2005

Outcome Measures

Primary Outcome Measures

1. Seroprotection, GMR's and Seroconversion rate at day 0 and day 50 following vaccination. []

Secondary Outcome Measures

1. Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 35 Months
• Sexes Eligible for Study: All

Inclusion Criteria:

• children of 6 months to <36 months of age, whose parents or legal guardians have given written informed consent prior to study entry

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, 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Tampere Medical School	Tampere		Finland

Sponsors and Collaborators

• Novartis
• Novartis Vaccines

Investigators

• Study Chair: Novartis Vaccines Information Services, Novartis Vaccines & Diagnostics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00311428
• Other Study ID Numbers: M71P1; EUDRACT: 2004-001952-35
• First Posted: Apr 6, 2006
• Last Update Posted: Sep 14, 2006
• Last Verified: Sep 1, 2006

• Keywords provided by , ,: Influenza; Children; Vaccine
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Sep 14, 2006