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
- Prophylaxis for influenza virus infectionMedDRA version: 19.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2016-004753-33-Outside-EU/EEA
- Lead Sponsor
- Seqirus GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 2222
*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
Are the trial subjects under 18? yes
Number of subjects for this age range: 2222
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
*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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that vaccination with Seqirus QIV elicits an immune response that is not inferior to the US-licensed comparator QIV (Comparator QIV) containing the same virus strains as Seqirus QIV among a pediatric population 6 months through 59 months of age<br>;Secondary Objective: To assess the safety and tolerability of Seqirus QIV in two age strata: 6 months through 35 months, and 36 months through 59 months, as well as overall<br>To characterize the immunogenicity of Seqirus QIV and the US-licensed comparator QIV in two age strata: 6 months through 35 months, and 36 months through 59 months, as well as overall. <br><br>;Primary end point(s): 1. The Geometric Mean Titer (GMT) ratio of each virus strain<br>2. The difference in Seroconversion Rate (SCR) for each virus strain<br>;Timepoint(s) of evaluation of this end point: 1. 28 days after last vaccination<br>2. 28 days after last vaccination<br>
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 1. 7 days after each vaccination<br>2. 7 days after each vaccination<br>3. 28 days after each vaccination<br>4. 28 days after each vaccination<br>5. 180 days after the last vaccination dose<br>6. 28 days after last vaccination<br>7. 28 days after last vaccination<br>8. 28 days after last vaccination<br>9. 28 days after last vaccination;Secondary end point(s): 1. Frequency and severity of solicited local adverse reactions<br>2. Frequency and severity of solicited systemic adverse events (AEs)<br>3. Frequency of cellulitis-like reactions<br>4. Frequency and severity of unsolicited adverse events (AEs)<br>5. Frequency of serious adverse events (SAEs)<br>6. Geometric mean of hemagglutination titers (HI GMTs) prevaccination (Day 1) and postvaccination (Study Exit Visit)<br>7. Seroconversion rates (SCRs)<br>8. Seroprotection rate<br>9. Geometric mean fold increase (GMFI)<br><br><br><br><br><br><br>