Status:
COMPLETED
Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18-47 years
Phase:
PHASE2
Brief Summary
The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.
Eligibility Criteria
Inclusion
- For all subjects:
- Subjects who the investigator believes that they and/or their Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject/from the LAR(s).
- For unprimed subjects:
- A male or female child aged 18 to 47 months at the time of the first vaccination.
- Children who did not have influenza vaccine in a previous season.
- For primed subjects from study NCT00764790:
- • Children who received Fluarix™ in the 111751 study NCT00764790.
Exclusion
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- History of hypersensitivity to any vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending 28 days after each dose of vaccine(s).
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- Acute disease at the time of enrolment.
- History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- Receipt of another seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
- 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.
Key Trial Info
Start Date :
October 8 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2010
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT00985790
Start Date
October 8 2009
End Date
May 21 2010
Last Update
September 21 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Ecatepec de Morelos, State of Mexico, Mexico, 55075
2
GSK Investigational Site
Mexico City, Mexico, 04530