Clinical trial NCT00889889: Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination
Official title: Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Cell-Derived Trivalent Subunit Influenza Vaccine in Subjects Aged >= 18 Years and <= 64 Years During Two Consecutive Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Phase II
Placebo-controlled
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2009-04-29
Enrollment: 1270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Immunogenicity and safety of a cell-derived influenza vaccine in adults aged \>= 18 and \<= 64 years, plus revaccination


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 \<= 64 years.
3. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria

1. Known to be allergic to constituents of the vaccine.
2. A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
3. Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.

Primary outcomes:
measure: To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines.
timeFrame: 3 weeks
measure: To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.
timeFrame: 6 months
Secondary outcomes:
measure: To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.
timeFrame: 6 months
measure: To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination.
timeFrame: 3 weeks
measure: To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine.
timeFrame: 6 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 45690
state: Florida
city: Pembroke Pines
country: United States
facility: Site Reference ID/Investigator# 45687
state: Florida
city: South Miami
country: United States
facility: Site Reference ID/Investigator# 45697
state: Florida
city: Lenexa
country: United States
facility: Site Reference ID/Investigator# 45691
state: Kansas
city: Overland Park
country: United States
facility: Site Reference ID/Investigator# 45689
state: Kansas
city: Wichita
country: United States
facility: Site Reference ID/Investigator# 45694
state: Kansas
city: Lexington
country: United States
facility: Site Reference ID/Investigator# 45682
state: Kentucky
city: Kansas City
country: United States
facility: Site Reference ID/Investigator# 45684
state: Missouri
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 45685
state: Nebraska
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 45686
state: Nevada
city: Raleigh
country: United States
facility: Site Reference ID/Investigator# 45688
state: North Carolina
city: Nashville
country: United States
facility: Site Reference ID/Investigator# 45696
state: Tennessee
city: Austin
country: United States
facility: Site Reference ID/Investigator# 45683
state: Texas
city: Fort Worth
country: United States
facility: Site Reference ID/Investigator# 45695
state: Texas
city: Salt Lake City
country: United States
facility: Site Reference ID/Investigator# 45692
state: Utah
Study officials:
affiliation: Abbott
name: Hanka de Voogd, MD
role: STUDY_DIRECTOR
References: