Status:
COMPLETED
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief Summary
This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
- Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
- Healthy children as established by medical history and clinical examination when entering into the study.
- Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user.
Exclusion
- 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.
- Clinically or virologically confirmed influenza infection within six months preceding the study start.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- 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.
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- Previous administration of any H1N1 A/California-like vaccine.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
- Any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
- Child in Care.
Key Trial Info
Start Date :
September 10 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2010
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00964158
Start Date
September 10 2009
End Date
November 27 2010
Last Update
February 19 2018
Active Locations (5)
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1
GSK Investigational Site
Bilbao, Spain, 48013
2
GSK Investigational Site
Burgos, Spain, 09005
3
GSK Investigational Site
Madrid, Spain, 28046
4
GSK Investigational Site
Móstoles/Madrid, Spain, 28935