Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2012/2013 Season
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
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 2, 2012
CompletedFirst Posted
Study publicly available on registry
July 4, 2012
CompletedAugust 6, 2012
August 1, 2012
Same day
July 2, 2012
August 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Solicited local and systemic reactions, overall inconvenience
Reactogenicity and inconvenience
3 days
Unsolicited adverse events
Other adverse events
3 weeks
Study Arms (1)
Trivalent influenza subunit vaccine Influvac
EXPERIMENTAL3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1
Interventions
3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1
Eligibility Criteria
You may qualify if:
- Willing and able to give informed consent and able to adhere to all protocol required study procedures.
- Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
- Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the Investigator.
You may not qualify if:
- Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
- A serious adverse reaction after a previous (influenza) vaccination.
- 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.
- Having any condition which suppresses the immune system and autoimmune disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Site Reference ID/Investigator# 74593
Hamburg, 22769, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Serge van de Witte, PhD
Abbott Healthcare Products BV
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2012
First Posted
July 4, 2012
Study Start
July 1, 2012
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
August 6, 2012
Record last verified: 2012-08