Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age
Status: | Completed |
---|---|
Conditions: | Influenza |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 9/9/2018 |
Start Date: | October 23, 2013 |
End Date: | July 3, 2014 |
Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) in Children 6 to 35 Months of Age
The purpose of this study is to evaluate the immunogenicity and safety of the new influenza
vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV)
in children 6 to 35 months of age.
vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV)
in children 6 to 35 months of age.
The subjects will be randomised (1:1) in the two treatment groups (Q-QIV and TIV-YB) to
explore response to vaccination.
explore response to vaccination.
Inclusion Criteria:
- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion
of the investigator, can and will comply, with the requirements of the protocol.
- A male or female between, and including, 6 and 35 months of age at the time of the
first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Subjects in stable health as determined by investigator's clinical examination and
assessment of subject's medical history.
- Subjects are eligible regardless of history of administration of influenza vaccine in
a previous season.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine
within 30 days preceding the first dose of study vaccine, or planned use during the
study period. Routine registered childhood vaccinations are permitted.
- Child in care.
- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose. For corticosteroids, this will mean
prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- Prior receipt of any seasonal or pandemic influenza vaccine within six months
preceding the first dose of study vaccine, or planned use during the study period.
- Administration of immunoglobulins and/or any blood products within the three months
preceding the first dose of study vaccine or planned administration during the study
period.
- History of Guillain-Barré syndrome within six weeks of receipt of prior influenza
vaccine.
- Any known or suspected allergy to any constituent of influenza vaccines; a history of
anaphylactic-type reaction to consumption of eggs; or a history of severe adverse
reaction to a previous influenza vaccine.
- Acute disease and/or fever at the time of enrollment.
- Fever is defined as temperature ≥ 38.0°C/100.4°F by any method.
- Subjects with a minor illness without fever may be enrolled at the discretion of
the investigator.
- Any significant disorder of coagulation or treatment with warfarin derivatives or
heparin.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.
- Any other condition which, in the opinion of the investigator, prevents the subject
from participating in the study.
We found this trial at
12
sites
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