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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959945
• Other study ID #: PSC08
• Status: Completed
• Phase: Phase 3
• First received: October 8, 2013
• Last updated: January 29, 2015
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: Protein Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Flublok® Quadrivalent Influenza Virus Vaccine
Intramuscular (Relevant year formulation)
• Fluarix Quadrivalent® Influenza Virus Vaccine
Intramuscular (Relevant year formulation)

Locations

Country	Name	City	State
United States	Maine Research Associates, LLC	Auburn	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Protein Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants reporting solicited injection site and systemic events and unsolicited adverse events following vaccination with quadrivalent vaccine.	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.	Day 0 up to Day 28 post vaccination	Yes
Secondary	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.	Day 0 and Day 28 after final vaccination	No
Secondary	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.	Day 28 after final vaccination	No
Secondary	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.	Day 28 after final vaccination	No

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