Status:
COMPLETED
Immunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
10-18 years
Phase:
PHASE4
Brief Summary
This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' FluarixTM vaccine in children who have previously been vaccinated with one do...
Eligibility Criteria
Inclusion
- Subjects having previously been immunized with only one single dose of Pandemrix at the age of 10-17 years inclusive.
- Subjects having received Pandemrix at least six months prior to study enrolment.
- Subjects who the investigator believes that subject and/or parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject/ the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects or Parent(s)/LAR(s) with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device
Exclusion
- Active participation in other clinical trials.
- 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 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:
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- 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.
- History of seizures or progressive neurological disease.
- Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
- 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.
- Child in care.
Key Trial Info
Start Date :
October 4 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2011
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01190215
Start Date
October 4 2010
End Date
July 7 2011
Last Update
September 7 2018
Active Locations (1)
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1
GSK Investigational Site
Tampere, Finland, 33100