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.
- Conditions
- Influenza, Human
- Interventions
- Biological: Comparator Quadrivalent Inactivated Influenza VaccineBiological: Seqirus Quadrivalent Inactivated Influenza Vaccine
- Registration Number
- NCT02914275
- Lead Sponsor
- Seqirus
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2250
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparator QIV Cohort B Comparator Quadrivalent Inactivated Influenza Vaccine Comparator Quadrivalent Inactivated Influenza Vaccine - Subjects 36 months through 59 months of age Comparator QIV Cohort A Comparator Quadrivalent Inactivated Influenza Vaccine Comparator Quadrivalent Inactivated Influenza Vaccine - Subjects 6 months through 35 months of age Seqirus QIV Cohort A Seqirus Quadrivalent Inactivated Influenza Vaccine Seqirus Quadrivalent Inactivated Influenza Vaccine - Subjects 6 months through 35 months of age Seqirus QIV Cohort B Seqirus Quadrivalent Inactivated Influenza Vaccine Seqirus Quadrivalent Inactivated Influenza Vaccine - Subjects 36 months through 59 months of age
- Primary Outcome Measures
Name Time Method The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. Postvaccination (28 days after last vaccination) 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/YamagataThe Difference in Seroconversion Rate (SCR) for Each Virus Strain. Postvaccination (28 days after last vaccination) 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.
- Secondary Outcome Measures
Name Time Method Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain 28 days after last vaccination. 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.
Seroconversion Rates (SCRs) of Each Virus Strain 28 days after last vaccination 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.
Number of Participants With Unsolicited AEs Postvaccination (up to 28 days after vaccination) Frequency and severity of unsolicited AEs for at least 28 days after each vaccination dose
Number of Participants With Serious Adverse Events (SAE) 180 days after the last vaccination dose. Frequency of SAEs for 180 days after the last vaccination dose. SAE = serious adverse events, AESI = adverse event of special interest
Seroprotection Rates of Each Virus Strain 28 days after last vaccination. 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.
Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE) Postvaccination (up to 7 days after vaccination) Frequency and severity of solicited local adverse reactions and systemic AEs for 7 days after each vaccination dose
Number of Participants With Cellulitis-like Reactions Postvaccination (up to 28 days after each vaccination) Frequency of cellulitis-like reactions for at least 28 days after each vaccination dose
Geometric Mean Fold Increase (GMFI) of Each Virus Strain Prevaccination (Day 1) and Postvaccination (28 days after last vaccination) 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.
Trial Locations
- Locations (39)
Site 402
🇺🇸Sacramento, California, United States
Site 289
🇺🇸Meridian, Idaho, United States
Site 434
🇺🇸Birmingham, Alabama, United States
Site 423
🇺🇸Downey, California, United States
Site 397
🇺🇸Ontario, California, United States
Site 445
🇺🇸Paramount, California, United States
Site 425
🇺🇸San Diego, California, United States
Site 443
🇺🇸Louisville, Kentucky, United States
Site 441
🇺🇸Louisville, Kentucky, United States
Site 285
🇺🇸Binghamton, New York, United States
Site 429
🇺🇸Asheboro, North Carolina, United States
Site 427
🇺🇸Dayton, Ohio, United States
Site 282
🇺🇸Fort Worth, Texas, United States
Site 288
🇺🇸San Angelo, Texas, United States
Site 283
🇺🇸Austin, Texas, United States
Site 431
🇺🇸Salt Lake City, Utah, United States
Site 395
🇺🇸Layton, Utah, United States
Site 424
🇺🇸Salt Lake City, Utah, United States
Site 428
🇺🇸Salt Lake City, Utah, United States
Site 433
🇺🇸West Jordan, Utah, United States
Site 438
🇺🇸Charlottesville, Virginia, United States
Site 442
🇺🇸Mobile, Alabama, United States
Site 430
🇺🇸Anaheim, California, United States
Site 418
🇺🇸Miami, Florida, United States
Site 426
🇺🇸Miami, Florida, United States
Site 437
🇺🇸Anaheim, California, United States
Site 440
🇺🇸West Jordan, Utah, United States
Site 435
🇺🇸West Jordan, Utah, United States
Site 439
🇺🇸Spartanburg, South Carolina, United States
Site 393
🇺🇸Metairie, Louisiana, United States
Site 436
🇺🇸Metairie, Louisiana, United States
Site 419
🇺🇸Charleston, South Carolina, United States
Site 444
🇺🇸Kingsport, Tennessee, United States
Site 422
🇺🇸Wichita, Kansas, United States
Site 390
🇺🇸Augusta, Kansas, United States
Site 421
🇺🇸Newton, Kansas, United States
Site 420
🇺🇸Louisville, Kentucky, United States
Site 446
🇺🇸Cincinnati, Ohio, United States
Site 308
🇺🇸Bristol, Tennessee, United States