A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.
Full description
In this study Influenza vaccine GSK1562902A is the primary study vaccine and Havrix™ will be administered as the active comparator and not co-administered along with the study vaccine.Therefore, there exist no relation between the vaccines administered in this study. As the study will be carried out in Philippines, Havrix™ vaccine will be used as an active comparator instead of saline placebo to offer an advantage to the subjects.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
All subjects must satisfy ALL the following criteria at study entry:
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Subjects for whom the investigator believes that the parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol .
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A male or female child 3 to 17 years of age inclusive, at the time of the first vaccination.
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Written informed consent obtained from the subject's parent or guardian. Assent obtained from the subject when applicable.
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Good general health as established by medical history and clinical examination before entering into the study.
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Comprehension by the subject's parent or guardian of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
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Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
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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
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- Child in care
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
- Active participation in other clinical trials.
- 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.
- Acute disease and/or fever at the time of enrolment:
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
- Receipt of any immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to vaccine components or a history of severe adverse reaction to a previous influenza vaccine.
- History of seizures or progressive neurological disease.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Diagnosed with cancer or any chronic severe disease.
- Previous administration of any H5N1 vaccine.
Trial design
Primary purpose
Allocation
Interventional model
Masking
520 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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