Status:
TERMINATED
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Influenza Vaccines
Eligibility:
All Genders
6-35 years
Phase:
PHASE2
Brief Summary
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months of age.
Eligibility Criteria
Inclusion
- All subjects must satisfy ALL the following criteria at study entry:
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol
- Children, male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Age appropriate scheduled childhood vaccinations completed to the best of parent(s)/LAR(s) knowledge.
- Born after gestation period of 36 to 42 weeks inclusive
Exclusion
- 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(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Prior receipt of any influenza vaccination or planned administration 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 six months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- A family history of febrile seizures or/and epilepsy
- Any known or suspected allergy to any constituent of influenza or routine paediatric vaccines, a history of severe adverse reaction to any previous vaccination; or a history of anaphylactic-type reaction to any constituent of influenza vaccine.
- History of any progressive neurological disorders or seizures.
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination.
- Acute disease and/or fever at the time of enrolment:
- \- Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥38.0°C on rectal setting.
- Subjects with a minor illness without fever might be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/or any blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
- Any condition which, in the opinion of the investigator, render the subject unfit for participation in the study.
Key Trial Info
Start Date :
September 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2011
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01195779
Start Date
September 30 2010
End Date
March 22 2011
Last Update
October 30 2020
Active Locations (1)
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1
GSK Investigational Site
Seville, Spain, 41013