A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age

Seqirus

Status and phase: Completed; Phase 3

Conditions: Influenza, Human

Treatments: Biological: Seqirus QIV; Biological: Comparator QIV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02545543

CSLCT-QIV-13-02

Details and patient eligibility

About

This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2015/2016 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 5 through 17 years of age.

Enrollment: 2,278 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males or females 5 through 17 years of age on the day of first study vaccination.
• Parent or legally acceptable representative able to provide written informed consent and be willing and able to adhere to all protocol requirements including blood draws. Participant assent will also be obtained if required.
• If applicable, females of childbearing potential (ie, ovulating, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen until at least 28 days after the last Study Vaccine. Females of childbearing potential must return a negative urine pregnancy test result, prior to any vaccination dose with the Study Vaccine.

Exclusion criteria

• History of allergic reactions to egg proteins or any components of the Study Vaccines.

• History of serious adverse reactions to any influenza vaccines.

• History of Guillain-Barré syndrome or other demyelinating disease.

• History of licensed or investigational influenza vaccination in the last 6 months.

• Clinical signs of active infection and/or an oral temperature of ≥ 100°F (37.8°C) on the day of planned Study Vaccine administration or within 48 hours preceding vaccination.

• Current or recent, acute or chronic medical conditions that in the opinion of the Investigator are clinically significant and/or unstable (such as illness exacerbations) within the preceding 30 days.

• History of any seizures, with the exception of a single febrile seizure.

• Self-reported or known seropositivity suggestive of acute or chronic viral infection for human immunodeficiency virus, hepatitis B or hepatitis C.

• Known or suspected congenital or acquired immunosuppressive conditions.

• Current or recent immunosuppressive or immunomodulatory therapy, as follows:

  • Chronic or long-term systemic corticosteroids: ≥ 0.125 mg/kg/day of oral prednisolone or equivalent daily;
  • Sporadic systemic corticosteroids: ≥ 0.5 mg/kg/day of oral prednisolone or equivalent for two or more short courses of > 3 days in the 3 months preceding vaccination;
  • Antineoplastic chemotherapy or radiation therapy within the 6 months preceding vaccination.

Note: Use of topical, inhalant or localised tissue injections of corticosteroids prior to administration of the Study Vaccine or throughout the study are acceptable.

• Administration of immunoglobulin and/or any blood products within the 3 months preceding vaccination, or planned administration during the study.
• Participation in a clinical trial or use of an investigational compound within 28 days prior to the first dose of Study Vaccine, or within 28 days after receiving the final indicated dose of Study Vaccine, or plans to enter a study during this period.
• Vaccination with a licensed vaccine 28 days (for live or inactivated vaccines) prior to receiving the first dose of Study Vaccine, or plans to receive any licensed vaccine prior to the Study Exit Visit.
• Pregnant or lactating females.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,278 participants in 2 patient groups

Seqirus Quadrivalent Inactivated Influenza Vaccine

Experimental group

Description:

The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).

Treatment:

Biological: Seqirus QIV

Comparator Quadrivalent Influenza Vaccine

Active Comparator group

Description:

The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.

Treatment:

Biological: Comparator QIV