A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children
Status: | Completed |
---|---|
Conditions: | Influenza |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any - 17 |
Updated: | 9/23/2018 |
Start Date: | October 1, 2010 |
End Date: | July 1, 2011 |
Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children
This study is designed to test the immunogenicity and safety of an investigational influenza
vaccine, in children compared to two other influenza vaccines.
vaccine, in children compared to two other influenza vaccines.
Inclusion Criteria:
- Subjects who the investigator believes that they and/or their parent(s) or legally
acceptable representative(s) can and will comply with the requirements of the
protocol.
- A male or female child aged between 6 months and 17 years inclusive at the time of the
first vaccination; children are eligible regardless of history of administration of
influenza vaccine in a previous season.
- Written informed consent obtained from the subject/from the parent(s)/legally
acceptable representative(s) of the subject.
- Written informed assent obtained from the subject if/as required by local regulations.
- Subjects in stable health as determined by investigator's clinical examination and
assessment of subjects' medical history.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject
- Has practiced adequate contraception for 30 days prior to vaccination, and
- Has a negative pregnancy urine test on the day of vaccination, and
- Has agreed to continue adequate contraception during the entire treatment period
and for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Child in care
- Use of any investigational or non-registered product other than the study vaccines
within 30 days preceding the first dose of study vaccine, or planned use during the
study period.Prior receipt of any seasonal or pandemic influenza vaccine within 6
months preceding the first dose of study vaccine, or planned use during the study
period.
- Chronic administration of immunosuppressants or other immune modifying drugs within
six months prior to the first vaccine dose.
- Administration of immunoglobulins and/or any blood products within the 3 months
preceding the first dose of study vaccine or planned administration during the study
period.
- History of Guillain-Barré syndrome within 6 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.
- Fever at the time of enrolment.
- Acute disease at the time of enrolment.
- Any significant disorder of coagulation or treatment with Coumadin derivatives or
heparin.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive
precautions.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.
- Ongoing aspirin therapy.
- Any other condition which, in the opinion of the Investigator, prevents the subject
from participating in the study.
We found this trial at
17
sites
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