Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00518453
First received: August 17, 2007
Last updated: November 4, 2011
Last verified: November 2011
  Purpose

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).


Condition Intervention Phase
Influenza
Biological: Surface antigen inactivated influenza vaccine
Phase 2

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 II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly 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 [ Time Frame: 21 days post-immunization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of the study vaccine in the study population [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 129
Study Start Date: July 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Fluvirin Biological: Surface antigen inactivated influenza vaccine
1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition

  Eligibility

Ages Eligible for Study:   18 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Subjects eligible for enrollment into this study are male and female adult volunteers

Exclusion Criteria:

  • Any serious disease
  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: NCT00518453

Locations
United Kingdom
The Health Centre
Suffolk, United Kingdom
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00518453     History of Changes
Other Study ID Numbers: V78P5S, 2007-002063-27
Study First Received: August 17, 2007
Last Updated: November 4, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 August 25, 2014