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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00848887
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : January 24, 2014
Novartis Vaccines
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Influenza Biological: Adjuvanted and un-adjuvanted influenza vaccines Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
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
Study Start Date : October 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: 1 Biological: Adjuvanted and un-adjuvanted influenza vaccines
16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.

Primary Outcome Measures :
  1. Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment. [ Time Frame: 50 days ]

Secondary Outcome Measures :
  1. Strain-specific influenza antibody titers will be used to assess Immunogenicity [ Time Frame: 50 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00848887

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

Publications of Results:
Responsible Party: Novartis Identifier: NCT00848887     History of Changes
Other Study ID Numbers: V104P2
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014

Keywords provided by Novartis:

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs