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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines ) Identifier:
First received: August 13, 2008
Last updated: January 23, 2014
Last verified: January 2014

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

Condition Intervention Phase
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:

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


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

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 identifier: NCT00735020

Ligornetto, Switzerland, 36 6853
Sponsors and Collaborators
Novartis Vaccines
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

Responsible Party: Novartis ( Novartis Vaccines ) Identifier: NCT00735020     History of Changes
Other Study ID Numbers: V104P1
Study First Received: August 13, 2008
Last Updated: January 23, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Novartis:

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases processed this record on April 23, 2014