Clinical trial NCT01633749: Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2012/2013 Season
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prophylaxis of Influenza
Keywords: Influenza
Vaccine
CHMP criteria
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2012-07-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Antihemagglutinin antibody titers and the derived parameters seroprotection, seroconversion and mean fold increase
timeFrame: 3 weeks
measure: Solicited local and systemic reactions, overall inconvenience
timeFrame: 3 days
measure: Unsolicited adverse events
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 74593
Study officials:
affiliation: Abbott Healthcare Products BV
name: Serge van de Witte, PhD
role: STUDY_DIRECTOR
References: