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

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.
ClinicalTrials.gov Identifier: NCT00735020
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : January 24, 2014
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Influenza Biological: Adjuvanted Influenza Vaccine Biological: Influenza Vaccine Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Study Start Date : June 2008
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Biological: Adjuvanted Influenza Vaccine
1 dose of Adjuvanted Influenza Vaccine
Active Comparator: 2 Biological: Influenza Vaccine
1 dose of Influenza Vaccine


Outcome Measures

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

Secondary Outcome Measures :
  1. To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine [ Time Frame: 36 Days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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 Vaccines
ClinicalTrials.gov Identifier: NCT00735020     History of Changes
Other Study ID Numbers: V104P1
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014

Keywords provided by Novartis ( Novartis Vaccines ):
influenza
vaccine
adjuvants
flu

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