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.
Novartis Vaccines
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: February 19, 2009
Last updated: January 23, 2014
Last verified: January 2014

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

Condition Intervention Phase
Biological: Adjuvanted and un-adjuvanted influenza vaccines
Phase 1

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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 410
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Adjuvanted and un-adjuvanted influenza vaccines
16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.


Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848887

UCL St. Luc - Pharmacy
Brussel, Belgium, 1200
Sponsors and Collaborators
Novartis Vaccines
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00848887     History of Changes
Other Study ID Numbers: V104P2, 2008-002602-20
Study First Received: February 19, 2009
Last Updated: January 23, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Novartis:

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014