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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848887
• Other study ID #: V104P2
• Secondary ID: 2008-002602-20
• Status: Completed
• Phase: Phase 1
• First received: February 19, 2009
• Last updated: January 23, 2014
• Start date: October 2008
• Est. completion date: May 2009

Study information

• Verified date: January 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 35 Months

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Adjuvanted and un-adjuvanted influenza vaccines
16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.

Locations

Country	Name	City	State
Belgium	UCL St. Luc - Pharmacy	Brussel

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Della Cioppa G, Vesikari T, Sokal E, Lindert K, Nicolay U. Trivalent and quadrivalent MF59(®)-adjuvanted influenza vaccine in young children: a dose- and schedule-finding study. Vaccine. 2011 Nov 3;29(47):8696-704. doi: 10.1016/j.vaccine.2011.08.111. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.		50 days	Yes
Secondary	Strain-specific influenza antibody titers will be used to assess Immunogenicity		50 days	No