Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
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: 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
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014