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
  Purpose

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


Condition Intervention Phase
Influenza
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:
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:
Influenza
Flu
Vaccine
Adjuvant

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 July 22, 2014