Prophylaxis of Influenza Clinical Trial
Official title:
Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Northern Hemisphere Season 2012/2013. An Open-label, Baseline-controlled Study in Two Age Groups: Adult Subjects ≥ 18 and ≤ 60 Years and Elderly Subjects ≥ 61 Years of Age
Annual study to investigate influenza vaccine (flu vaccine) developed for the 2012/2013 season for the prevention of influenza infection. The immunizing effect is being investigated, as well as its tolerability and safety.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria 1. Willing and able to give informed consent and able to adhere to all protocol required study procedures. 2. Men and women aged = 18 and = 60 years or = 61 years of age at the day of study vaccination. 3. Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator. Exclusion Criteria 1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. 2. A serious adverse reaction after a previous (influenza) vaccination. 3. Presence of any significant condition that may prohibit inclusion as determined by the investigator. 4. Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period. 5. Having any condition which suppresses the immune system and autoimmune disorders. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Germany | Site Reference ID/Investigator# 74593 | Hamburg |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Biologicals |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Antihemagglutinin antibody titers and the derived parameters seroprotection, seroconversion and mean fold increase | Standard parameters to quantify antibody levels. Recommended in the CHMP guideline. | 3 weeks | No |
| Primary | Solicited local and systemic reactions, overall inconvenience | Reactogenicity and inconvenience | 3 days | Yes |
| Primary | Unsolicited adverse events | Other adverse events | 3 weeks | Yes |