A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.

NCT02914275 | Completed Phase 3 Results DMC

• 1 other identifier: CSLCT-QIV-15-03
• Study Type: interventional
• Target: 2,250
• Locations: 1 country
• Sites: 39

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 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 6 months through 59 months 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 hemagglutination inhibition (HI) antibody geometric mean titer (GMT) 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. B/VIC = B/Victoria B/YAM = B/Yamagata

  Postvaccination (28 days after last vaccination)

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

  Noninferiority of Seqirus QIV compared to comparator QIV will be assessed by seroconversion rate (SCR) for each viral strain. 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 vaccine (for each strain) will be determined.

  Postvaccination (28 days after last vaccination)

Secondary Outcomes (8)

• Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE)

  Postvaccination (up to 7 days after vaccination)

• Number of Participants With Cellulitis-like Reactions

  Postvaccination (up to 28 days after each vaccination)

• Number of Participants With Unsolicited AEs

  Postvaccination (up to 28 days after vaccination)

• Number of Participants With Serious Adverse Events (SAE)

  180 days after the last vaccination dose.

• Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain

  28 days after last vaccination.

Study Arms (4)

Seqirus QIV Cohort A

EXPERIMENTAL

Seqirus Quadrivalent Inactivated Influenza Vaccine - Subjects 6 months through 35 months of age

Biological: Seqirus Quadrivalent Inactivated Influenza Vaccine

Seqirus QIV Cohort B

EXPERIMENTAL

Seqirus Quadrivalent Inactivated Influenza Vaccine - Subjects 36 months through 59 months of age

Biological: Seqirus Quadrivalent Inactivated Influenza Vaccine

Comparator QIV Cohort A

ACTIVE COMPARATOR

Comparator Quadrivalent Inactivated Influenza Vaccine - Subjects 6 months through 35 months of age

Biological: Comparator Quadrivalent Inactivated Influenza Vaccine

Comparator QIV Cohort B

ACTIVE COMPARATOR

Comparator Quadrivalent Inactivated Influenza Vaccine - Subjects 36 months through 59 months of age

Biological: Comparator Quadrivalent Inactivated Influenza Vaccine

Interventions

Seqirus Quadrivalent Inactivated Influenza Vaccine BIOLOGICAL

The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season). Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle of the arm if muscle mass is adequate) in children 12 months through 35 months of age.

Also known as: Seqirus QIV

Seqirus QIV Cohort A; Seqirus QIV Cohort B

Comparator Quadrivalent Inactivated Influenza Vaccine BIOLOGICAL

The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season. Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection of the non-dominant arm in children 36 months through 59 months of age.

Also known as: Comparator QIV

Comparator QIV Cohort A; Comparator QIV Cohort B

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female subject 6 months through to 59 months of age at the time of first vaccination and born between 36 and 42 weeks of gestation;
• 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.
• Subject is in generally good health as per the Investigator's medical judgment

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 such as encephalomyelitis and transverse myelitis;
• History of licensed or investigational influenza vaccination in the last 6 months;
• Clinical signs of active infection and/or an axillary temperature of ≥ 99.5°F / (≥ 37.5 °C) on the day of vaccination 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
• 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
• Current or medical history of malignant neoplasms;
• Administration of immunoglobulin and/or any blood products within the previous 90 days preceding the administration of the Study Vaccine or planned administration during the study;
• Participation in a clinical trial or use of an investigational compound within 28 days prior to or 28 days after receiving the Study Vaccine, or plans to enter a study during this period;
• Vaccination with a licensed vaccine 21 days (for live or inactivated vaccines) prior to receiving the Study Vaccine, or plans to receive any licensed vaccine prior to the Study Exit Visit.
• Medical conditions or treatment contraindicating intramuscular vaccination due to increased risk of bleeding.

Sponsors & Collaborators

• Seqirus: lead

Study Sites (39)

Site 434

Birmingham, Alabama, 35205, United States

Location

Site 442

Mobile, Alabama, 36608, United States

Location

Site 430

Anaheim, California, 92804, United States

Location

Site 437

Anaheim, California, 92804, United States

Location

Site 423

Downey, California, 90241, United States

Location

Site 397

Ontario, California, 91762, United States

Location

Site 445

Paramount, California, 90723, United States

Location

Site 402

Sacramento, California, 95822, United States

Location

Site 425

San Diego, California, 92103, United States

Location

Site 418

Miami, Florida, 33175, United States

Location

Site 426

Miami, Florida, 33176, United States

Location

Site 289

Meridian, Idaho, 83642, United States

Location

Site 390

Augusta, Kansas, 67010, United States

Location

Site 421

Newton, Kansas, 67114, United States

Location

Site 422

Wichita, Kansas, 67205, United States

Location

Site 443

Louisville, Kentucky, 40202, United States

Location

Site 420

Louisville, Kentucky, 40291, United States

Location

Site 441

Louisville, Kentucky, 40291, United States

Location

Site 393

Metairie, Louisiana, 70002, United States

Location

Site 436

Metairie, Louisiana, 70006, United States

Location

Site 285

Binghamton, New York, 13901, United States

Location

Site 429

Asheboro, North Carolina, 27203, United States

Location

Site 446

Cincinnati, Ohio, 45229, United States

Location

Site 427

Dayton, Ohio, 45419, United States

Location

Site 419

Charleston, South Carolina, 29407, United States

Location

Site 439

Spartanburg, South Carolina, 29303, United States

Location

Site 308

Bristol, Tennessee, 37620, United States

Location

Site 444

Kingsport, Tennessee, 37660, 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 395

Layton, Utah, 84041, United States

Location

Site 431

Salt Lake City, Utah, 84109, United States

Location

Site 424

Salt Lake City, Utah, 84121, United States

Location

Site 428

Salt Lake City, Utah, 84124, United States

Location

Site 440

West Jordan, Utah, 84084, United States

Location

Site 433

West Jordan, Utah, 84088, United States

Location

Site 435

West Jordan, Utah, 84088, United States

Location

Site 438

Charlottesville, Virginia, 22902, United States

Location

Related Publications (1)

• Statler VA, Albano FR, Airey J, Sawlwin DC, Graves Jones A, Matassa V, Heijnen E, Edelman J, Marshall GS. Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in children 6-59 months of age: A phase 3, randomized, noninferiority study. Vaccine. 2019 Jan 7;37(2):343-351. doi: 10.1016/j.vaccine.2018.07.036. Epub 2018 Jul 26.

  PMID: 30057283 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: Clinical Study Disclosure Manager
• Organization: Seqirus

Seqirus.ClinicalTrials@Seqirus.com

1-855-358-8966

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 22, 2016
• First Posted: September 26, 2016
• Study Start: September 27, 2016
• Primary Completion: March 9, 2017
• Study Completion: August 11, 2017
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2018-11

Locations

US (39)