Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals? influenza vaccine when administered in children who previously participated in study 115345

Phase 1

• Conditions: Healthy volunteers (Immunization against influenza A and B in children aged 18 to 47 months); MedDRA version: 14.1Level: LLTClassification code 10022001Term: Influenza (epidemic)System Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10022003Term: Influenza B virus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10022002Term: Influenza A virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-001230-34-ES
• Lead Sponsor: GlaxoSmithKline S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-09
• Study Completion: 2013-06-05
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

?Subjects who the investigator believes that parent(s)/LAR(s) can and will comply with the requirements of the protocol.
?Children, male or female who received a 2-dose vaccination in the study 115345 (NCT01439360).
?Written informed consent obtained from the parent(s)/LAR(s) of the subject.
?Subjects in stable health as determined by medical history and clinical examination before entering into the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 452
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
?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.
?Since the start of study 115345 (NCT01439360), receipt of any seasonal influenza vaccine other than the study vaccines of study 115345 or planned administration of any influenza vaccine other than the study vaccine during the study.
?Administration of any vaccine not foreseen by the study protocol within 4 weeks preceding the first dose of study vaccine or planned use until Visit 2.
?Laboratory confirmed influenza infection outside of the 115345 (NCT01439360) study.
?Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
?Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to enrolment in the study or planned administration during the study period. Inhaled and topical steroids are allowed.
?Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
?History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
?Any contraindication to intramuscular injection.
?Acute disease and/or fever at the time of enrolment:
- Fever is defined as temperature ? 37.5°C by any route.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
?Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Study & Design

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