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Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008

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: NCT00498303
Recruitment Status : Completed
First Posted : July 10, 2007
Last Update Posted : April 22, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Annual trial for registration of trivalent split influenza vaccine with the strain composition of the season 2007/2008 in healthy adult and elderly subjects

Condition or disease Intervention/treatment Phase
Seasonal Influenza Vaccine Biological: trivalent split influenza vaccine Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase III, Multicenter, Uncontrolled, Open-Label Study to Evaluate Safety and Immunogenicity of Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2007/2008 When Administered to Adult and Elderly Subjects
Study Start Date : June 2007

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
  2. evaluate safety of trivalent split influenza vaccine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
  • available for all the visits scheduled in the study and able to comply with all study requirements
  • in good health as determined by: medical history, physical examination, clinical judgment of the investigator

Exclusion Criteria:

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): NCT00498303


Locations
Germany
Werksarztzentrum Herborn
Herborn, Germany, 35745
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
More Information

ClinicalTrials.gov Identifier: NCT00498303     History of Changes
Other Study ID Numbers: V44P11S
2007-001403-38
First Posted: July 10, 2007    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008

Keywords provided by Novartis:
influenza vaccine

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