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: January 23, 2014
Last verified: January 2014

February 19, 2009
January 23, 2014
October 2008
May 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00848887 on ClinicalTrials.gov Archive Site
Strain-specific influenza antibody titers will be used to assess Immunogenicity [ Time Frame: 50 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Influenza
Biological: Adjuvanted and un-adjuvanted influenza vaccines
16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.
Experimental: 1
Intervention: Biological: Adjuvanted and un-adjuvanted influenza vaccines
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 2011 Sep 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
410
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
6 Months to 35 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00848887
V104P2, 2008-002602-20
Not Provided
Novartis
Novartis
Novartis Vaccines
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
January 2014

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