At a glance
ClinicalIndex Comparison Record- ✓Age 6 months through 59 months at first vaccination
- ✓Born between 36-42 weeks of gestation
- ✓Generally good health per investigator judgment
- ✓Parent or legally acceptable representative able to provide written informed consent and adhere to protocol
- ✕Allergy to egg proteins or vaccine components
- ✕History of serious adverse reactions to any influenza vaccine
- ✕History of Guillain-Barré syndrome or other demyelinating disease (encephalomyelitis, transverse myelitis)
- ✕Influenza vaccination within last 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Multicenter, Observer-blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) With a US-licensed Quadrivalent Inactivated Comparator Influenza Virus Vaccine (Comparator QIV) in a Pediatric Population 6 Months Through 59 Months of Age
In Brief
A Phase 3 clinical trial evaluating Seqirus Quadrivalent Inactivated Influenza Vaccine and Comparator Quadrivalent Inactivated Influenza Vaccine for Influenza, Human. Completed, enrolled 2,250 participants across 39 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.