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

NCT02545543 | Completed Phase 3 Results DMC

• 1 other identifier: CSLCT-QIV-13-02
• Study Type: interventional
• Target: 2,278
• Locations: 1 country
• Sites: 32

Brief Summary

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.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (2)

• The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.

  Noninferiority of Seqirus QIV compared to comparator QIV was assessed by the eight co-primary endpoints of hemagglutination inhibition (HI) antibody geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV.

  28 days after last vaccination.

• The Difference in Seroconversion Rate (SCR) for Each Virus Strain.

  Noninferiority of Seqirus QIV compared to Comparator QIV was assessed by the eight co-primary endpoints of HI geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain. The rate of SCR is defined as the percentage of subjects with either a prevaccination HI titer \< 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each virus strain will be determined.

  28 days after last vaccination.

Secondary Outcomes (9)

• Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions.

  7 days after each vaccination.

• Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs).

  7 days after each vaccination.

• Safety Endpoint: The Frequency of Cellulitis-like Reaction.

  28 days after each vaccination.

• Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs).

  28 days after each vaccination.

• Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).

  180 days after the last vaccination dose.

Study Arms (2)

Seqirus Quadrivalent Inactivated Influenza Vaccine

EXPERIMENTAL

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).

Biological: Seqirus QIV

Comparator Quadrivalent Influenza Vaccine

ACTIVE COMPARATOR

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

Biological: Comparator QIV

Interventions

Seqirus QIV BIOLOGICAL

Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.

Seqirus Quadrivalent Inactivated Influenza Vaccine

Comparator QIV BIOLOGICAL

The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe. The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination.

Also known as: Fluarix Quadrivalent

Comparator Quadrivalent Influenza Vaccine

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seqirus: lead

Study Sites (32)

Site 296

Huntsville, Alabama, 35802, United States

Location

Site 401

Madera, California, 93637, United States

Location

Site 397

Ontario, California, 91762, United States

Location

Site 392

Redding, California, 96001, United States

Location

Site 402

Sacramento, California, 95822, United States

Location

Site 398

San Jose, California, 95127, United States

Location

Site 388

Hialeah, Florida, 33012, United States

Location

Site 293

Melbourne, Florida, 32934, United States

Location

Site 289

Boise, Idaho, 83642, United States

Location

Site 294

Peoria, Illinois, 61614, United States

Location

Site 390

Augusta, Kansas, 67010, United States

Location

Site 396

Newton, Kansas, 67114, United States

Location

Site 400

Park City, Kansas, 67219, United States

Location

Site 317

Wichita, Kansas, 67207, United States

Location

Site 386

Bardstown, Kentucky, 40004, United States

Location

Site 393

Metairie, Louisiana, 70002, United States

Location

Site 287

St Louis, Missouri, 63141, United States

Location

Site 316

Bellevue, Nebraska, 68005, United States

Location

Site 382

Omaha, Nebraska, 68114, United States

Location

Site 285

Binghamton, New York, 13901, United States

Location

Site 387

Cary, North Carolina, 27511, United States

Location

Site 385

Cincinnati, Ohio, 45246, United States

Location

Site 383

Cleveland, Ohio, 44122, United States

Location

Site 399

Dayton, Ohio, 45414, United States

Location

Site 384

Grove City, Ohio, 43123, United States

Location

Site 389

Gresham, Oregon, 97030, United States

Location

Site 283

Austin, Texas, 78705, United States

Location

Site 282

Fort Worth, Texas, 76135, United States

Location

Site 288

San Angelo, Texas, 76904, United States

Location

Site 394

San Antonio, Texas, 78229, United States

Location

Site 395

Layton, Utah, 84041, United States

Location

Site 300

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

• Airey J, Albano FR, Sawlwin DC, Jones AG, Formica N, Matassa V, Leong J. Immunogenicity and safety of a quadrivalent inactivated influenza virus vaccine compared with a comparator quadrivalent inactivated influenza vaccine in a pediatric population: A phase 3, randomized noninferiority study. Vaccine. 2017 May 9;35(20):2745-2752. doi: 10.1016/j.vaccine.2017.03.028. Epub 2017 Apr 5.

  PMID: 28390934 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Seqirus Clinical Trial Disclosure Lead
• Organization: Seqirus

Seqirus.ClinicalTrials@Seqirus.com

1-855-358-8966

Study Officials

• Clinical Development Physician Seqirus

  Seqirus

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 10, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 23, 2018
• Results First Posted: April 18, 2017

Record last verified: 2018-04

Locations

US (32)