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: January 23, 2014
Last verified: January 2014
  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:


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
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: 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

Publications:
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: January 23, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Novartis:
influenza
vaccine
adjuvants
flu

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

ClinicalTrials.gov processed this record on October 23, 2014