A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age

This study has been completed.

Sponsor:

Collaborator:

Novartis Vaccines

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00848887

First received: February 19, 2009

Last updated: December 7, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 19, 2009

Last Updated Date

December 7, 2011

Start Date ^ICMJE

October 2008

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment. [ Time Frame: 50 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00848887 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Strain-specific influenza antibody titers will be used to assess Immunogenicity [ Time Frame: 50 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age

Official Title ^ICMJE

A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine With or Without a Second Influenza B Strain in Combination With or Without One of Three Different Doses of Adjuvant in Healthy Children, Aged 6 to <36 Months

Brief Summary

This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Influenza

Intervention ^ICMJE

Biological: Adjuvanted and un-adjuvanted influenza vaccines

16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.

Study Arm (s)

Experimental: 1

Intervention: Biological: Adjuvanted and un-adjuvanted influenza vaccines

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

410

Completion Date

May 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Children of 6 month to <36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator.

Exclusion Criteria:

History of serious disease. History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. Known or suspected 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

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00848887

Other Study ID Numbers ^ICMJE

V104P2, 2008-002602-20

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Novartis Vaccines

Investigators ^ICMJE

Study Chair:

Novartis Vaccines

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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