A Phase III, Multicenter, Uncontrolled, Open Label Study to Evaluate Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011, When Administered to Adult and Elderly Subjects
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Seasonal Influenza
- Sponsor
- Novartis Vaccines
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Antibody response to each influenza vaccine antigen as measured by hemagglutination inhibition at 21 days post immunization
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at risks and elderly. Due to antigenic changes of influenza viruses, the virus strains used in interpandemic influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Following a change in the vaccine antigen composition recommendation from the previous season, immunogenicity and tolerability of the newly composed vaccines are subject of evaluation in an annual clinical trial in non-elderly adult and elderly subjects according to the guidelines set by EMEA (CPMP/BWP/214/96).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female volunteers of 18 years of age and older, mentally competent, willing and able to give written informed consent prior to study entry;
- •Individuals able to comply with all the study requirements;
- •Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator.
Exclusion Criteria
- •Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study;
- •Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to:
- •Cancer, except for localized skin cancer;
- •Advanced congestive heart failure;
- •Chronic obstructive pulmonary disease (COPD);
- •Autoimmune disease (including rheumatoid arthritis);
- •Acute or progressive hepatic disease;
- •Acute or progressive renal disease;
- •Severe neurological or psychiatric disorder;
- •Severe asthma;
Outcomes
Primary Outcomes
Antibody response to each influenza vaccine antigen as measured by hemagglutination inhibition at 21 days post immunization
Time Frame: 22 days