Study to evaluate the efficacy of GSK Biologicals’ quadrivalent influenza vaccine, GSK2282512A, (FLU Q-QIV) when administered in children 3 to 8 years of age

• Conditions: Healthy volunteers (Immunization against influenza in male and female subjects 3 to 8 years of age inclusive); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-001514-97-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-27
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 5200

Inclusion Criteria

•Subjects who the investigator believed that they and/or their parent(s) or Legally Acceptable Representative(s) (LAR) could and would comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, respects intervals between study visits).
•A male or female child aged between 3 years and 8 years inclusive (i.e., not having attained the 9th birthday) at the time of the first vaccination; children were eligible regardless of history of administration of influenza vaccine in a previous season. However, subjects who had received any seasonal or pandemic influenza vaccine (registered or investigational) within 6 months preceding the first dose of study vaccine would not be enrolled.
•Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
•Written assent obtained from the subject if/as required by local regulations.
•Subjects in stable health as determined by investigator’s clinical examination and assessment of subjects’ medical history.
•Access to a consistent means of telephone contact

Are the trial subjects under 18? yes
Number of subjects for this age range: 5175
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

•Child in care (i.e., a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian)
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations were permitted.
•Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.
•Prior receipt of more than one dose of a licensed hepatitis A vaccine, with the first dose administered at =12 months of age.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this was a dose equivalent to either > 2 mg/kg of body weight or maximum of 20 mg/day of pred-nisone or equivalent when administered for > 2 weeks. Inhaled and topical steroids were allowed.
•Administration of immunoglobulins and/or any blood prod-ucts within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
•History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine.
•Any known or suspected allergy to any constituent of in-fluenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
•Fever (temperature >= 38.0°C or 100.4°F by any method) at the time of enrolment.
•Acute disease (moderate or severe illness) at the time of enrolment.
•Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
•Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history and physical examination.
•Ongoing aspirin therapy (to avoid potential cases of Reye’s syndrome).
•Any other condition which, in the opinion of the Investigator, prevented the subject from participating in the study

Study & Design

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