Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults
A Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults Greater Than or Equal to 18 to Less Than 65 Years of Age
2 other identifiers
interventional
1,359
1 country
10
Brief Summary
The purpose of this study is to investigate the effectiveness, safety, and tolerability of an influenza vaccine. Influenza is a highly infectious disease that occurs throughout the world in the winter months. Infection with an influenza virus is a major public health threat as it has the ability to spread rapidly and affect large numbers of people. Up to 1359 healthy adults ages 18 to less than 65 years old will participate in this study for up to 24 days. Volunteers will receive an injection of either influenza vaccine with thimerosal, vaccine without thimerosal, or placebo with thimerosal. Volunteers will be asked to document information about any health changes for 21 days following vaccination. Volunteers will return to the clinic on days 5 and 21 after vaccination to share this information with study staff. On day 21, volunteers will have a physical examination. Blood samples will be taken prior to vaccination and at Day 21 post-vaccination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2006
Shorter than P25 for phase_3
10 active sites
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
First Submitted
Initial submission to the registry
June 1, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedFirst Posted
Study publicly available on registry
June 5, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedAugust 27, 2010
June 1, 2008
2 months
June 1, 2006
August 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immunogenicity endpoints of seroprotection rate and seroconversion rate will be assessed.
Day 0 prior to vaccination and day 21 after vaccination.
Secondary Outcomes (2)
Comparison of the geometric mean titers to influenza hemagglutinin antigens after vaccination of the active treatment arms.
Day 0 prior to vaccination and day 21 after vaccination.
The number and rate of the type, frequency and intensity of adverse events in the active treatment arms.
Solicited adverse events through day 4 (days 0, 1, 2, 3, 4) following vaccination; unsolicited adverse events to day 21 after vaccination.
Study Arms (5)
1
EXPERIMENTAL250 subjects-Lot #1 multiple-dose vial (thimerosal-containing).
2
EXPERIMENTAL250 subjects-Lot #2 multiple-dose vial (thimerosal-containing).
3
EXPERIMENTAL250 subjects-Lot #3 multiple-dose vial (thimerosal-containing).
4
PLACEBO COMPARATOR250 subjects-multiple-dose vial placebo (thimerosal-containing).
5
EXPERIMENTAL250 subjects-Prefilled Lot #1, #2, or #3 (TBD) (thimerosal-free).
Interventions
CSL influenza vaccine-prefilled syringe presentation (thimerosal-free) 15 mcg per dose of each of the hemagglutinins of H1N1, H3N2, and B strains (total of 45 mcg of hemagglutinins). Single dose of 0.5 mL administered on study day 0.
CSL influenza vaccine-multiple dose vial presentation (thimerosal-containing) containing 15 mcg per dose of each of the hemagglutinins of H1N1, H3N2, and B strains (total of 45 mcg of hemagglutinins). Single dose of 0.5 mL administered on study day 0.
Phosphate buffered isotonic saline solution containing thimerosal. Single dose of 0.5 mL administered on study day 0.
Eligibility Criteria
You may qualify if:
- Is a healthy male or nonpregnant female (as indicated by a negative urine or serum pregnancy test immediately prior to vaccine administration) aged greater than or equal to 18 years to less than 65 years at the time of informed consent.
- Provides written informed consent to participate in the study and adherence to all protocol requirements.
- Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history, and a targeted physical examination based on medical history.
- Is able to understand and comply with planned study procedures.
- Is female of nonchildbearing potential, ie, either surgically sterilized or 1 year postmenopausal. If female is of child bearing potential, she must be abstinent or using adequate contraceptive precautions, eg, intrauterine device, oral contraceptive, or equivalent hormonal contraception (eg, progestogen-only implant, cutaneous hormonal patch, injectable contraceptives, or diaphragm) and agree to continue such precautions for 2 months after vaccination.
You may not qualify if:
- Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken feathers, neomycin, polymyxin, thimerosal, or any components of the study vaccines.
- Has been vaccinated against influenza in the previous 6 months.
- Has underlying medical condition for which influenza vaccination is recommended; chronic heart or lung condition including asthma; metabolic disease; kidney disease; blood disorder (such as sickle cell anemia); or weakened immune system including HIV/AIDS.
- Has acute clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality.
- Has known history of Guillain-Barré Syndrome.
- Has clinical signs of active infection and/or an oral temperature of greater than or equal to 38°C (100.4°F). Study entry may be deferred for such individuals at the discretion of the Principal Investigator (PI).
- Has history of neurological disorders or seizures, with exception of a single febrile seizure during childhood.
- Has confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed immunodeficiency disorder (congenital or acquired).
- Currently receiving (within the 90 days before receiving the study vaccines) immunosuppressive or immunomodulative therapy, systemic corticosteroids, and including the following medications:
- Chronic or long-term corticosteroids: greater than 15mg/day of oral prednisolone or equivalent daily;
- Sporadic corticosteroids: greater than 40mg/day of oral prednisolone or equivalent for more than 2 courses of greater than 14 days in the 3 months preceding vaccination;
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- Note: Use of topical or inhalant corticosteroids prior to administration of the study vaccines or throughout the study is acceptable.
- Participated in a clinical trial or use of an investigational compound within 30 days before receiving the study vaccine or plans to enter a study during the study period.
- Was vaccinated with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the study vaccine.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Stanford University
Stanford, California, 94305-5208, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Maryland Baltimore
Baltimore, Maryland, 21201, United States
Saint Louis University
St Louis, Missouri, 63131, United States
University of Rochester
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27704, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Vanderbilt University
Nashville, Tennessee, 37232-2573, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Clinical Alliance for Research & Education - Infectious Diseases
Annandale, Virginia, 22003, United States
Related Publications (1)
Talbot HK, Keitel W, Cate TR, Treanor J, Campbell J, Brady RC, Graham I, Dekker CL, Ho D, Winokur P, Walter E, Bennet J, Formica N, Hartel G, Skeljo M, Edwards KM. Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine. Vaccine. 2008 Jul 29;26(32):4057-61. doi: 10.1016/j.vaccine.2008.05.024. Epub 2008 Jun 2.
PMID: 18602726BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
June 1, 2006
First Posted
June 5, 2006
Study Start
June 1, 2006
Primary Completion
August 1, 2006
Study Completion
August 1, 2006
Last Updated
August 27, 2010
Record last verified: 2008-06