Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)
Status: | Completed |
---|---|
Conditions: | Influenza |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | January 2013 |
End Date: | April 2013 |
Randomized, Age-stratified, Double Blind, Controlled Phase 3 Study Comparing a Vero Cell-derived Trivalent Seasonal Influenza Vaccine Made by the Modified Manufacturing Process With Vaccine Made by the Current Manufacturing Process and a Licensed Trivalent Influenza Vaccine in Healthy Adults Aged 18 Years and Older
The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza
vaccine produced by the modified manufacturing process:
1. induces immune responses comparable to that produced by the current manufacturing
process
2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza
vaccine
3. demonstrates consistency of immune response among three different lots.
vaccine produced by the modified manufacturing process:
1. induces immune responses comparable to that produced by the current manufacturing
process
2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza
vaccine
3. demonstrates consistency of immune response among three different lots.
Inclusion Criteria:
- Participant is 18 to 49 years of age, inclusive, at the time of screening (for Cohort
18 to 49 years of age);
- Participant is 50 years of age, inclusive, or older at the time of screening (for
Cohort 50 years of age or older);
- Participant gave written informed consent prior to study entry
- Participant is generally healthy without any significant medical risk conditions, as
determined by the Investigator's clinical judgment through collection of medical
history and performance of a physical examination;
- Participant is willing and able to comply with the requirements of the protocol;
- Participant agrees to keep a record of symptoms for the duration of the study;
- If female and capable of bearing children - participant has a negative urine pregnancy
test at the study site, within 36 hours prior to vaccination, and agrees to employ
adequate birth control measures for the duration of the study. For the purposes of
this study adequate birth control measures incorporate one of the following FDA
approved birth control measures for the duration of the study:
- Hormonal types of birth control (such as implants, birth control pills, patches
or other methods) or an intrauterine device, OR
- A barrier type of birth control measure (i.e., condoms, diaphragms, cervical
caps, etc.).
Exclusion Criteria:
- Participant has been vaccinated with seasonal trivalent influenza vaccine in the
current season;
- Participant has an oral temperature of ≥100.4°F (≥38.0°C) on the day of vaccination in
this study;
- Participant has received a live vaccine within 4 weeks, or an inactivated or subunit
vaccine within 2 weeks of study entry;
- Participant with a known history of infection with Human Immunodeficiency Virus (HIV),
Hepatitis B Virus (HBsAgs) or Hepatitis C Virus (HCV);
- Participant has any medically diagnosed or suspected immune deficient condition based
on medical history and physical examination as determined by the Investigator;
- Participant has an immune compromising condition or disease, or is currently
undergoing a form of treatment or was undergoing a form of treatment within 30 days
prior to study entry that can be expected to influence immune response. Such treatment
includes, but is not limited to, systemic or high dose inhaled corticosteroids (> 800
μg/day of beclomethasone dipropionate or equivalent), radiation treatment or other
immunosuppressive or cytotoxic drugs (use of inhaled and nasal steroids will be
permitted);
- Participant has a known history of Guillain Barré Syndrome, demyelinating disorders
(including acute demyelinating encephalomyelitis (ADEM), Multiple Sclerosis) or
convulsions;
- Participant has a history of severe allergic reactions or anaphylaxis as determined by
the Investigator;
- Participant has a rash, dermatologic condition or tattoos which may interfere with
injection site reaction rating as determined by the Investigator;
- Participant has received any blood products (e.g. blood transfusion or
immunoglobulins) within 90 days prior to study entry;
- Participant has donated one or more units of blood (approximately 450 mL) or plasma
within 30 days prior to study entry;
- Participant has a functional or surgical asplenia;
- Participant has a known or suspected problem with alcohol or drug abuse as determined
by the Investigator;
- Participant is a member of the team conducting this study or is in a dependent
relationship with one of the study team members. Dependent relationships include close
relatives (ie., children, partner/spouse, siblings, parents) as well as employees of
the Investigator or study site personnel conducting the study;
- If female, participant is pregnant or lactating at the time of study enrollment;
- Participant is currently enrolled or has participated in another clinical study
involving an investigational product (IP) or investigational device within 30 days
prior to study enrolment or is scheduled to participate in another clinical study
involving an IP or investigational device during the course of this study;
- Participant has any condition that in the opinion of the Investigator would interfere
with evaluation of the vaccine or interpretation of study results.
We found this trial at
20
sites
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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