Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2012/2013 Season

Abbott Biologicals120 enrolled

Overview

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.

An open, baseline-controlled study in two age groups: adults and elderly. The subjects will be screened within 14 days prior to or at Visit 1 (Day 1). At Visit 1 (Day 1) subjects will be vaccinated after blood sampling for baseline serum antihemagglutinin antibody titration. Subjects will be asked to record local and systemic reactions daily on a diary at home for 72 hours after vaccination. One week later (Visit 2, Day 8) the subjects will return to the study site to hand in the diary and for the assessment of safety and tolerability (reactogenicity and overall inconvenience). Three weeks after vaccination (Visit 3, Day 22) the subjects will return to the study site for blood sampling to assess immunogenicity and for the assessment of safety and tolerability.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

120

Conditions

Prophylaxis of Influenza

Interventions

Trivalent influenza subunit vaccine InfluvacBIOLOGICAL

3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Site Reference ID/Investigator# 74593

Hamburg, Germany

Outcomes

Primary Outcomes

Antihemagglutinin antibody titers and the derived parameters seroprotection, seroconversion and mean fold increase

Standard parameters to quantify antibody levels. Recommended in the CHMP guideline.

Time frame: 3 weeks

Solicited local and systemic reactions, overall inconvenience

Reactogenicity and inconvenience

Time frame: 3 days

Unsolicited adverse events

Other adverse events

Time frame: 3 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.