Healthy volunteers (Immunization against influenza A and B in children aged 18 to 47 months) MedDRA version: 14.1 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10022003 Term: Influenza B virus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 1002188
Conditions
Interventions
Product Name: Vacuna antigripal estacional tetravalente (Flu D-QIV)
Product Code: GSK2321138A
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Virión fraccionad
Sponsors
GlaxoSmithKline S.A.
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immune response in terms of Haemagglutination Inhibition (HI) antibody titre at Day 7 after one dose of FLU D-QIV vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all strains included in the vaccine.;Secondary Objective: ?To assess the Geometric Mean Titre (GMT) ratio of primed to unprimed subjects, at Day 7 after one dose of FLU D-QIV vaccine. ?To assess the difference in Seroconversion rate (SCR) between primed and unprimed subjects, at Day 7 after one dose of FLU D-QIV vaccine. ?To assess the difference in Seroprotection rate (SPR) between primed and unprimed subjects, at Day 7 after one dose of FLU D-QIV vaccine. ?To categorize the risk profile by assessing the percentage of subjects with HI antibody titres = 1:40 or a pre-vaccination titre >= 1:10 and at least a four-fold increase in post-vaccination titre. **SPR is defined as the percentage of vaccinees with a serum HI titre >= 1:40 that usually is accepted as indicating protection in adults. ***MGI is defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.;Timepoint(s) of evaluation of this end point: Seropositivity rates, GMTs of HI antibody titres and SPR at Day 0. Seropositivity rates, GMTs of HI antibody titres, SCR, MGI and SPR at Day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Serum HI antibody titres against each of the vaccine strains after 1 dose of FLU D-QIV vaccine: ?GMTs ratios of primed versus unprimed subjects ?SCR difference between primed and unprimed subjects ?SPR difference between primed and unprimed subjects ?Percentage of subjects with HI antibody titres < 1:10, 1:10 to < 1:40 and ? 1:40 -Serum neutralising antibody titres and anti-neuraminidase antibody titres against each of the vaccine strains after 1 dose of FLU D-QIV vaccine: ?GMTs ?Vaccine Response Rates (VRRs)* ?MGIs** For neutralising antibodies: * VRR is defined as the percentage of vaccinees who have at least a 4-fold increase between pre and post-vaccination titres. ** MGI is defined as the fold increase in GMTs post-vaccination compared to Day Occurrence of solicited local and general adverse events (AEs). Occurrence of unsolicited AEs. Occurrence of AEs with Medically Attended Visits (MAV). Occurrence of serious adverse events (SAEs) and potential immune mediated diseases (pIMDs).;Timepoint(s) of evaluation of this end point: Serum HI antibody titres, serum neutralising antibody titres and anti-neuraminidase antibody titres at Day 0 and Day 7. Occurrence of solicited local and general AEs during a 7-day (Day 0 to 6) follow-up period after the first vaccination. Occurrence of unsolicited AEs Within 28 days after first vaccination (Day 0 ? Day 27). Occurrence of AEs with MAV, of SAEs and pIMDs during the entire study period (Day 0 ? Day 180). | — |
Countries
Czech Republic, Poland, Spain, United Kingdom
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed