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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02914275
Other study ID # CSLCT-QIV-15-03
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 27, 2016
Est. completion date August 11, 2017

Study information

Verified date November 2018
Source Seqirus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 2250
Est. completion date August 11, 2017
Est. primary completion date March 9, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 59 Months
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
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.
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.

Locations

Country Name City State
United States Site 430 Anaheim California
United States Site 437 Anaheim California
United States Site 429 Asheboro North Carolina
United States Site 390 Augusta Kansas
United States Site 283 Austin Texas
United States Site 285 Binghamton New York
United States Site 434 Birmingham Alabama
United States Site 308 Bristol Tennessee
United States Site 419 Charleston South Carolina
United States Site 438 Charlottesville Virginia
United States Site 446 Cincinnati Ohio
United States Site 427 Dayton Ohio
United States Site 423 Downey California
United States Site 282 Fort Worth Texas
United States Site 444 Kingsport Tennessee
United States Site 395 Layton Utah
United States Site 420 Louisville Kentucky
United States Site 441 Louisville Kentucky
United States Site 443 Louisville Kentucky
United States Site 289 Meridian Idaho
United States Site 393 Metairie Louisiana
United States Site 436 Metairie Louisiana
United States Site 418 Miami Florida
United States Site 426 Miami Florida
United States Site 442 Mobile Alabama
United States Site 421 Newton Kansas
United States Site 397 Ontario California
United States Site 445 Paramount California
United States Site 402 Sacramento California
United States Site 424 Salt Lake City Utah
United States Site 428 Salt Lake City Utah
United States Site 431 Salt Lake City Utah
United States Site 288 San Angelo Texas
United States Site 425 San Diego California
United States Site 439 Spartanburg South Carolina
United States Site 433 West Jordan Utah
United States Site 435 West Jordan Utah
United States Site 440 West Jordan Utah
United States Site 422 Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Seqirus

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE) Frequency and severity of solicited local adverse reactions and systemic AEs for 7 days after each vaccination dose Postvaccination (up to 7 days after vaccination)
Secondary Number of Participants With Cellulitis-like Reactions Frequency of cellulitis-like reactions for at least 28 days after each vaccination dose Postvaccination (up to 28 days after each vaccination)
Secondary Number of Participants With Unsolicited AEs Frequency and severity of unsolicited AEs for at least 28 days after each vaccination dose Postvaccination (up to 28 days after vaccination)
Secondary Number of Participants With Serious Adverse Events (SAE) Frequency of SAEs for 180 days after the last vaccination dose. SAE = serious adverse events, AESI = adverse event of special interest 180 days after the last vaccination dose.
Secondary Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate geometric mean of HI titers prevaccination & postvaccination. 28 days after last vaccination.
Secondary Seroconversion Rates (SCRs) of Each Virus Strain The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate SCRs defined as the % of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer = 1:40 or a prevaccination titer = 1:10 and a = 4-fold increase in postvaccination titer. 28 days after last vaccination
Secondary Seroprotection Rates of Each Virus Strain The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate the percentage of subjects with a titer =40 (seroprotection rates) at Day 1 and at Study Exit Visit. 28 days after last vaccination.
Secondary Geometric Mean Fold Increase (GMFI) of Each Virus Strain The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate GMFIs, defined as the geometric mean fold titer change (rise) from Day 1 to Study Exit Visit. Prevaccination (Day 1) and Postvaccination (28 days after last vaccination)
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