Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Recombinant Influenza Vaccine,Seasonal Formulation)

NCT01959945 | Completed Phase 3 Results DMC

• 1 other identifier: PSC08
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

Flublok was studied previously in children 6 -59 months of age and demonstrated less than satisfactory immunogenicity results, especially in the 6-36 month age group. Thus, the initial introduction of Flublok Quadrivalent Formulation (RIV4) into the pediatric population will evaluate immunogenicity and safety older children and adolescents, aged 6-17. This clinical trial is designed to demonstrate safety and non-inferior immunogenicity of Flublok-Q in pediatric subjects 6-17 years of age as compared to IIV4. Positive results in this study may support further studies in younger children.

Conditions

Influenza

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting Solicited Injection Site and Systemic Events and Unsolicited Adverse Events Following Vaccination With Quadrivalent Vaccine.

  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 Outcomes (3)

• Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine

  Day 0 and Day 28 after final vaccination (Cohort B includes 1-Dose subjects at Day 28 and 2-Dose subjects at Day 56)

• Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine

  Day 28 after final vaccination

• Seroprotection to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine

  Day 28 after final vaccination

Study Arms (4)

Study Group 1, Flublok

EXPERIMENTAL

Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine

Biological: Flublok® Quadrivalent Influenza Virus Vaccine

Study Group 2, Fluarix

ACTIVE COMPARATOR

Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine

Biological: Fluarix Quadrivalent® Influenza Virus Vaccine

Study Group 3, Flublok

EXPERIMENTAL

Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine

Biological: Flublok® Quadrivalent Influenza Virus Vaccine

Study Group 4, Fluarix

ACTIVE COMPARATOR

Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine

Biological: Fluarix Quadrivalent® Influenza Virus Vaccine

Interventions

Flublok® Quadrivalent Influenza Virus Vaccine BIOLOGICAL

Intramuscular (Relevant year formulation)

Also known as: Recombinant Influenza Vaccine (RIV4), Flublok Influenza Vaccine, rHA, rHA0, Recombinant Hemagglutinin

Study Group 1, Flublok; Study Group 3, Flublok

Fluarix Quadrivalent® Influenza Virus Vaccine BIOLOGICAL

Intramuscular (Relevant year formulation)

Study Group 2, Fluarix; Study Group 4, Fluarix

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Protein Sciences Corporation: lead

Study Sites (1)

Maine Research Associates, LLC

Auburn, Maine, 04210, United States

Location

Related Publications (1)

• Dunkle LM, Izikson R, Patriarca PA, Goldenthal KL, Cox M, Treanor JJ. Safety and Immunogenicity of a Recombinant Influenza Vaccine: A Randomized Trial. Pediatrics. 2018 May;141(5):e20173021. doi: 10.1542/peds.2017-3021. Epub 2018 Apr 2.

  PMID: 29610401 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

The numbers of subjects available for analysis in Cohort B (age 6-8 years) was fewer than anticipated due to early termination of enrollment.

Results Point of Contact

• Title: Lisa M. Dunkle, M.D., Chief Medical Officer
• Organization: Protein Sciences Corporation

ldunkle@proteinsciences.com

203-599-6064

Study Officials

• Lisa Dunkle, MD

  Protein Sciences Corporation

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 23, 2016
• Results First Posted: August 2, 2016

Record last verified: 2016-08

Locations

US (1)