Study to evaluate the immunogenicity and safety of GSK Biologicals’ thimerosal-free TIV Flu vaccine versus a licensed comparator in childre

• Conditions: Healthy volunteers (immunisation against influenza in male and female subjects 6 to 35 months of age inclusive); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-001258-13-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-11
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 3318

Inclusion Criteria

•A male or female child aged 6 to 35 months at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season were acceptable.
•Subjects having a parent/LAR (Legally Appointed Repre-sentative) who the investigator believed could and would comply with the requirements of the protocol (e.g., return their child for follow-up visit and completion of diary cards) were to be enrolled in the study.
•Written informed consent obtained from the subject’s parent/LAR.

Are the trial subjects under 18? yes
Number of subjects for this age range: 3318
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations were not an exclusion criterion.
•History of hypersensitivity to any vaccine.
•History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, gentamicin sulfate or sodium deoxycholate.
•Acute disease at the time of enrolment. (Acute disease was defined as the presence of a moderate or severe illness with or without fever. All vaccines could be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/axillary temperature <37.5°C (99.5°F) or rectal temperature <38.0°C (100.4°F).
•History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
•Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.
•Administration of immunoglobulins and/or blood products within the 3 month period preceding the first dose of study vaccine or planned administration during the study period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified