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Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00735020
First received: August 13, 2008
Last updated: November 16, 2011
Last verified: November 2011
History of Changes
  Purpose

This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.


Condition Intervention Phase
Influenza
 Biological: Adjuvanted Influenza Vaccine
Biological: Influenza Vaccine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase I, Observer-Blind, Randomized, Single-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines in Healthy Adults Aged 18 to 39 Years.

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers. [ Time Frame: 36 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine [ Time Frame: 36 Days ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: June 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Adjuvanted Influenza Vaccine
1 dose of Adjuvanted Influenza Vaccine
Active Comparator: 2 Biological: Influenza Vaccine
1 dose of Influenza Vaccine

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment

Exclusion Criteria:

  • serious medical conditions
  • allergies to vaccine components, including but not limited to egg/chicken products
  • reduced immune function
  • recent use of immunosuppressive therapy
  • recent use of influenza vaccine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735020

Locations
Switzerland
I.P.A.S.
Ligornetto, Switzerland, 36 6853
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00735020     History of Changes
Other Study ID Numbers: V104P1
Study First Received: August 13, 2008
Last Updated: November 16, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by Novartis:
influenza
vaccine
adjuvants
flu

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 May 21, 2013