EUCTR2012-001230-34-ES
Active, not recruiting
Phase 1
A phase III, open-label, multicentre study to evaluate the immunogenicity, safety and reactogenicity of a revaccination dose of the GlaxoSmithKline Biologicals' quadrivalent seasonal influenza candidate vaccine GSK2321138A, administered to children who previously participated in study 115345 (FLU D-QIV-004 PRI). - FLU D-QIV-009
ConditionsHealthy 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 infestationsMedDRA version: 14.1Level: LLTClassification code 10022003Term: Influenza B virus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10022002Term: Influenza A virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy volunteers (Immunization against influenza A and B in children aged 18 to 47 months)
- Sponsor
- GlaxoSmithKline S.A.
- Enrollment
- 470
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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