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.
The U.S. Advisory Committee on Immunization Practices (ACIP) recommends that all people ≥6 months of age receive influenza vaccine annually. Recommendations for influenza immunization of children vary somewhat among countries in the European Union, but immunization of children at high risk for complications of influenza infection is recommended by WHO and according to criteria in most countries. Currently, the immunization practices are progressing to quadrivalent formulations of inactivated influenza vaccines (IIV4) which are approved in the US for most of the indicated population. Additionally, live attenuated vaccine (LAIV4) is approved in the U.S. for individuals aged 2-49 years and Flublok®(RIV3), a purified trivalent recombinant hemagglutinin protein vaccine is approved in the U.S. for adults 18-49 years of age. Children are at particular risk of complications of influenza, including the B lineages, so expansion of the Flublok indication into the pediatric age group with a quadrivalent formulation is warranted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
219
Intramuscular (Relevant year formulation)
Intramuscular (Relevant year formulation)
Maine Research Associates, LLC
Auburn, Maine, United States
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.
Time frame: Day 0 up to Day 28 post vaccination
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
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.
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)
Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
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.
Time frame: Day 28 after final vaccination
Seroprotection to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Seroprotection is defined as: A titer ≥ 40 (l/dil) at pre vaccination and at Day 28 after the final vaccination.
Time frame: Day 28 after final vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.