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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00498303
First received: July 9, 2007
Last updated: April 21, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Seasonal Influenza
Vaccine
Biological: trivalent split influenza vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Estimated Enrollment: 120
Study Start Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • n/a
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498303

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

No publications provided

ClinicalTrials.gov Identifier: NCT00498303     History of Changes
Other Study ID Numbers: V44P11S, 2007-001403-38
Study First Received: July 9, 2007
Last Updated: April 21, 2008
Health Authority: Germany: Paul-Ehrlich-Institute

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

ClinicalTrials.gov processed this record on April 23, 2014