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.

NCT ID: NCT02914275

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-27
• Study Completion Date: 2017-08-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Seqirus QIV Cohort A

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

Group Type: EXPERIMENTAL

Seqirus Quadrivalent Inactivated Influenza Vaccine

Intervention Type: 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.

Seqirus QIV Cohort B

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

Group Type: EXPERIMENTAL

Seqirus Quadrivalent Inactivated Influenza Vaccine

Intervention Type: 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.

Comparator QIV Cohort A

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

Group Type: ACTIVE_COMPARATOR

Comparator Quadrivalent Inactivated Influenza Vaccine

Intervention Type: 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.

Comparator QIV Cohort B

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

Group Type: ACTIVE_COMPARATOR

Comparator Quadrivalent Inactivated Influenza Vaccine

Intervention Type: 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.

Interventions

Seqirus Quadrivalent Inactivated Influenza Vaccine

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.

Intervention Type: BIOLOGICAL

Comparator Quadrivalent Inactivated Influenza Vaccine

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Seqirus QIV; Comparator QIV

Eligibility Criteria

Inclusion Criteria

• 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

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 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.
• Family members of the employees of the Investigator or study center with direct involvement in the study, or with other clinical studies under the direction of that Investigator or study center.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seqirus

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Site 434

Birmingham, Alabama, United States

Site 442

Mobile, Alabama, United States

Site 430

Anaheim, California, United States

Site 437

Anaheim, California, United States

Site 423

Downey, California, United States

Site 397

Ontario, California, United States

Site 445

Paramount, California, United States

Site 402

Sacramento, California, United States

Site 425

San Diego, California, United States

Site 418

Miami, Florida, United States

Site 426

Miami, Florida, United States

Site 289

Meridian, Idaho, United States

Site 390

Augusta, Kansas, United States

Site 421

Newton, Kansas, United States

Site 422

Wichita, Kansas, United States

Site 443

Louisville, Kentucky, United States

Site 420

Louisville, Kentucky, United States

Site 441

Louisville, Kentucky, United States

Site 393

Metairie, Louisiana, United States

Site 436

Metairie, Louisiana, United States

Site 285

Binghamton, New York, United States

Site 429

Asheboro, North Carolina, United States

Site 446

Cincinnati, Ohio, United States

Site 427

Dayton, Ohio, United States

Site 419

Charleston, South Carolina, United States

Site 439

Spartanburg, South Carolina, United States

Site 308

Bristol, Tennessee, United States

Site 444

Kingsport, Tennessee, United States

Site 283

Austin, Texas, United States

Site 282

Fort Worth, Texas, United States

Site 288

San Angelo, Texas, United States

Site 395

Layton, Utah, United States

Site 431

Salt Lake City, Utah, United States

Site 424

Salt Lake City, Utah, United States

Site 428

Salt Lake City, Utah, United States

Site 440

West Jordan, Utah, United States

Site 433

West Jordan, Utah, United States

Site 435

West Jordan, Utah, United States

Site 438

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30057283 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CSLCT-QIV-15-03

Identifier Type: -

Identifier Source: org_study_id