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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Protein Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01959945
First received: October 8, 2013
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Flublok® Quadrivalent Influenza Virus Vaccine
Biological: Fluarix Quadrivalent® Influenza Virus Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Protein Sciences Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Participants 6 Years to < 18 Years of Age: Solicited injection site reactions: Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia. Unsolicited adverse events, including serious adverse events will also be collected for all participants.


Secondary Outcome Measures:
  • Geometric mean titers of antibodies to vaccine antigens following vaccination with quadrivalent vaccine [ Time Frame: Day 0 and Day 28 after final vaccination ] [ Designated as safety issue: No ]
    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.

  • Seroconversion to vaccine antigens following vaccination with quadrivalent vaccine [ Time Frame: Day 28 after final vaccination ] [ Designated as safety issue: No ]
    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.

  • Seroprotection to vaccine antigens following vaccination with quadrivalent vaccine [ Time Frame: Day 28 after final vaccination ] [ Designated as safety issue: No ]
    Seroprotection is defined as: A titer ≥ 40 (l/dil) at pre vaccination and at Day 28 after the final vaccination.


Estimated Enrollment: 300
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group 1, Flublok
Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine
Biological: Flublok® Quadrivalent Influenza Virus Vaccine
Intramuscular (Relevant year formulation)
Other Names:
  • Recombinant Influenza Vaccine (RIV4)
  • Flublok Influenza Vaccine
  • rHA
  • rHA0
  • Recombinant Hemagglutinin
Active Comparator: Study Group 2, Fluarix
Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Biological: 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
Biological: Flublok® Quadrivalent Influenza Virus Vaccine
Intramuscular (Relevant year formulation)
Other Names:
  • Recombinant Influenza Vaccine (RIV4)
  • Flublok Influenza Vaccine
  • rHA
  • rHA0
  • Recombinant Hemagglutinin
Active Comparator: Study Group 4, Fluarix
Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine
Biological: Fluarix Quadrivalent® Influenza Virus Vaccine
Intramuscular (Relevant year formulation)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female age 6-17 years (Cohort A: 6-8 years of age; Cohort B: 9-17 years of age)
  2. 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.
  3. 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:

  1. Comprehend the study requirements and agree to comply with planned study procedures and visits
  2. 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:

  1. Known allergy to eggs, severe allergy (e.g. anaphylaxis) to other components of either vaccine or contraindications to receipt of the comparator IIV4
  2. Immunosuppression as a result of an underlying illness or treatment. Note: Subjects on nasal or topical steroids will be allowed
  3. Active neoplastic disease or a history of any malignancy.
  4. History of receiving influenza vaccine within the past 6 months or plans during the study to receive influenza vaccine outside of this study.
  5. History of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
  6. 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].
  7. 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
  8. History of severe reactions following immunization.
  9. An acute illness, including a body temperature greater than 100*F, within 3 days prior to immunization.
  10. 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.
  11. Developmental delay, neurologic disorder, or seizure disorder requiring ongoing medical management (note: history of seizure is not an exclusion criterion).
  12. 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.
  13. History of Guillain-Barré syndrome.
  14. Known pregnancy, positive urine or serum pregnancy test within 24 hours prior to planned study vaccination, or breast-feeding.
  15. Concurrent participation in another clinical trial (in active or follow-up phase).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959945

Locations
United States, Maine
Maine Research Associates, LLC
Auburn, Maine, United States, 04210
Sponsors and Collaborators
Protein Sciences Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT01959945     History of Changes
Other Study ID Numbers: PSC08
Study First Received: October 8, 2013
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Protein Sciences Corporation:
Prevention

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hemagglutinins
Agglutinins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014