Clinical trial NCT00999206: Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine
Official title: Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Vaccine
CHMP criteria
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2009-10-21
Enrollment: 3138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity


Eligibility criteria: Inclusion Criteria

1. Female or male subjects \>= 18 years of age (adults \>= 18 to \< =60 years of age or elderly \>= 61 years of age).
2. Willing and able to give informed consent before any protocol procedures are performed.
3. Able to adhere to visit schedules and all protocol required study procedures.
4. Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).

Exclusion Criteria

1. Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).
2. Presence of any significant condition that may prohibit inclusion as determined by the Investigator.
3. A serious adverse reaction after a previous (influenza) vaccination.
4. A history of Guillain-Barré syndrome.
5. Known to be allergic to constituents of the study vaccines.

Primary outcomes:
measure: Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Site Reference ID/Investigator# 44652
city: Auchenflower
country: Australia
facility: Site Reference ID/Investigator# 44662
city: Blacktown
country: Australia
facility: Site Reference ID/Investigator# 44651
city: Blacktown
country: Australia
facility: Site Reference ID/Investigator# 44659
city: Broadmeadow
country: Australia
facility: Site Reference ID/Investigator# 44647
city: Caboolture
country: Australia
facility: Site Reference ID/Investigator# 44649
city: Carina Heights
country: Australia
facility: Site Reference ID/Investigator# 44646
city: Herston
country: Australia
facility: Site Reference ID/Investigator# 44650
city: Hornsby
country: Australia
facility: Site Reference ID/Investigator# 44663
city: Kippa-Ring
country: Australia
facility: Site Reference ID/Investigator# 44645
city: Malvern East
country: Australia
facility: Site Reference ID/Investigator# 44644
city: Maroubra Junction
country: Australia
facility: Site Reference ID/Investigator# 44648
city: Sherwood
country: Australia
facility: Site Reference ID/Investigator# 44643
city: Christchurch
country: New Zealand
facility: Site Reference ID/Investigator# 44653
city: Dunedin
country: New Zealand
facility: Site Reference ID/Investigator# 44658
city: Grafton
country: New Zealand
facility: Site Reference ID/Investigator# 44656
city: Rotorua
country: New Zealand
facility: Site Reference ID/Investigator# 44655
city: Tauranga
country: New Zealand
facility: Site Reference ID/Investigator# 44654
city: Wellington
country: New Zealand
facility: Site Reference ID/Investigator# 44657
Study officials:
affiliation: Abbott Healthcare Products B.V.
name: Hanka de Voogd, MD
role: STUDY_DIRECTOR
References: