Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children
Status: | Completed |
---|---|
Conditions: | Influenza |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 3 - 17 |
Updated: | 9/23/2018 |
Start Date: | October 13, 2009 |
End Date: | June 17, 2010 |
Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
investigational vaccine GSK1557482A.
investigational vaccine GSK1557482A.
Inclusion Criteria:
- Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the
investigator believes can and will comply with the requirements of the protocol.
- A male or female child aged between 3 years and 17 years of age at the time of the
first vaccination; children who may or may not have had previous administration of
influenza vaccine in a previous season are acceptable.
- Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the
subject.
- Healthy subjects as established by medical history and history-directed clinical
examination before entering into the study.
- 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 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:
- Use of any investigational or non-registered product other than the study vaccines
within 30 days preceding the administration of the study vaccine, or planned use
during the study period. Routine, registered childhood vaccinations or registered and
recommended pandemic influenza vaccine are not an exclusion.
- Receipt of a seasonal influenza vaccine outside of this study, during current
(2009-2010) flu season.
- Child in care
- Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any
other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
Topical, intra-articular or inhaled glucocorticoids are allowed.
- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product.
- History of hypersensitivity to any vaccine.
- History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated
influenza virus vaccine.
- History of any reaction or hypersensitivity likely to be exacerbated by any component
of the vaccine(s).
- Acute disease and/or fever at the time of enrolment.
- 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.
- Pregnant or lactating female.
- History of chronic alcohol consumption and/or drug abuse.
- 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.
We found this trial at
28
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials