Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Recombinant Influenza Vaccine,Seasonal Formulation)
Evaluation of the Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Quadrivalent Recombinant Influenza Vaccine,Seasonal Formulation) Administered Intramuscularly to Healthy Children and Adolescents Age 6-17 Years
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Maine
-
Auburn, Maine, United States, 04210
- Maine Research Associates, LLC
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female age 6-17 years (Cohort A: 6-8 years of age; Cohort B: 9-17 years of age)
- Female subjects of child-bearing potential (as defined by the onset of menses) must agree to avoid becoming pregnant and to use effective method of contraception or practice abstinence for at least 28 day prior to the first study vaccine administration, until the completion of the study. Female subjects of child-bearing potential must have a negative pregnancy test within 24 hours prior to vaccine administration.
- In good general health, as determined by medical history and targeted physical examination, if indicated
The parent(s) or legal representative(s) of each potential subject must:
- Comprehend the study requirements and agree to comply with planned study procedures and visits
- Provide written consent prior to enrollment and initiation of any study procedures Pediatric assent will be obtained in accordance with the Institutional Review Board/Independent Ethics Committee determination.
Exclusion Criteria:
- Known allergy to eggs, severe allergy (e.g. anaphylaxis) to other components of either vaccine or contraindications to receipt of the comparator IIV4
- Immunosuppression as a result of an underlying illness or treatment. Note: Subjects on nasal or topical steroids will be allowed
- Active neoplastic disease or a history of any malignancy.
- History of receiving influenza vaccine within the past 6 months or plans during the study to receive influenza vaccine outside of this study.
- History of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
- Receipt of any non-study licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study, or plans during the study to receive a licensed vaccine within 4 weeks of a study dose [See above for influenza vaccines].
- Acute or chronic medical condition that, in the opinion of the investigator, would render immunization unsafe or would interfere with the evaluation of immune responses
- History of severe reactions following immunization.
- An acute illness, including a body temperature greater than 100*F, within 3 days prior to immunization.
- Receipt of an experimental vaccine or medication within 1 month prior to enrollment in this study, or expectation of receiving an experimental vaccine, medication, or blood product during the study Stage in which the subject will participate.
- Developmental delay, neurologic disorder, or seizure disorder requiring ongoing medical management (note: history of seizure is not an exclusion criterion).
- Any other condition or situation that would, in the opinion of the investigator, place the potential subject an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- History of Guillain-Barré syndrome.
- Known pregnancy, positive urine or serum pregnancy test within 24 hours prior to planned study vaccination, or breast-feeding.
- Concurrent participation in another clinical trial (in active or follow-up phase).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Study Group 1, Flublok
Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
|
Intramuscular (Relevant year formulation)
Other Names:
|
|
Active Comparator: Study Group 2, Fluarix
Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
|
Intramuscular (Relevant year formulation)
|
|
Experimental: Study Group 3, Flublok
Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
|
Intramuscular (Relevant year formulation)
Other Names:
|
|
Active Comparator: Study Group 4, Fluarix
Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
|
Intramuscular (Relevant year formulation)
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site and Systemic Events and Unsolicited Adverse Events Following Vaccination With Quadrivalent Vaccine.
Time Frame: Day 0 up to Day 28 post vaccination
|
Solicited injection site reactions: Pain, Bruising, Redness, and Swelling; Solicited systemic reactions: Headache, Chills, Fever, Fatigue, Muscle Pain, Joint Pain and Nausea.
|
Day 0 up to Day 28 post vaccination
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Time Frame: Day 28 after final vaccination
|
Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.
|
Day 28 after final vaccination
|
|
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Time Frame: Day 0 and Day 28 after final vaccination (Cohort B includes 1-Dose subjects at Day 28 and 2-Dose subjects at Day 56)
|
Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique.
For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) and seroprotection and seroconversion will be calculated.
|
Day 0 and Day 28 after final vaccination (Cohort B includes 1-Dose subjects at Day 28 and 2-Dose subjects at Day 56)
|
|
Seroprotection to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Time Frame: Day 28 after final vaccination
|
Seroprotection is defined as: A titer ≥ 40 (l/dil) at pre vaccination and at Day 28 after the final vaccination.
|
Day 28 after final vaccination
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Chair: Lisa Dunkle, MD, Protein Sciences Corporation
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- PSC08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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