Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Vaccines )

ClinicalTrials.gov Identifier:

NCT00408395

First received: December 5, 2006

Last updated: December 1, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 5, 2006

Last Updated Date

December 1, 2011

Start Date ^ICMJE

November 2006

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00408395 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Condition ^ICMJE

Influenza

Intervention ^ICMJE

Biological: Influenza vaccine

Seasonal Influenza Vaccine

Study Arm (s)

Experimental: 1: Trivalent Seasonal Influenza Vaccine
Intervention: Biological: Influenza vaccine
Experimental: 2: Adjuvanted Trivalent Seasonal Influenza Vaccine
Intervention: Biological: Influenza vaccine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

281

Completion Date

August 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Months to 35 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT00408395

Other Study ID Numbers ^ICMJE

V70P2, 2006-003181-34

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Vaccines )

Study Sponsor ^ICMJE

Novartis Vaccines

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Novartis Vaccines (formerly Chiron Vaccines)

Novartis

Information Provided By

Novartis

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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