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Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ influenza vaccine when administered in children who previously participated in study 115345
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Immunogenicity, safety and reactogenicity study of GSK Biologicals’ quadrivalent seasonal influenza candidate vaccine GSK2321138A, administered to children who previously participated in study 115345
Trial description: The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals’ investigational vaccine GSK2321138A in children who previously participated in study 115345 (FLU D-QIV-004 PRI) (NCT01439360).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Serum Hemagglutination Inhibition (HI) antibody titers against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine
Timeframe: At Day 0 and Day 7
Number of seropositive subjects against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine
Timeframe: At Day 0 and Day 7
Number of subjects seroconverted for HI antibodies against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine.
Timeframe: At Day 7 post dose 1
Mean geometric increase (MGI) for HI antibody titer against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine.
Timeframe: At Day 7 post dose 1
Number of subjects seroprotected for anti-HA antibodies against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine.
Timeframe: At Day 0 and Day 7
Serum Hemagglutination Inhibition (HI) antibody titers against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine.
Timeframe: At Day 0 and Day 7
Number of subjects seropositive for HI antibody titers against each of the four vaccine strains after dose 1 of Fluarix Quadrivalent vaccine
Timeframe: At Day 0 and Day 7
Number of subjects seroconverted for HI antibodies against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine.
Timeframe: At Day 7 post dose 1
Mean geometric increase (MGI) for HI antibody titers against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine.
Timeframe: At Day 7 post dose 1
Number of subjects seroprotected for HI antibodies against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine.
Timeframe: At Day 0 and Day 7
Secondary outcomes:
Number of subjects with HI antibody titers against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine.
Timeframe: At Day 0 and Day 7
Serum neutralising antibody titers against each of the vaccine strains after 1 dose of Fluarix Quadrivalent vaccine
Timeframe: At Day 0 and Day 7
Serum anti-neuraminidase antibody titers against each of the vaccine strains after 1 dose of Fluarix Quadrivalent vaccine
Timeframe: At Day 0 and Day 7
Vaccine response rate (VRR) for neutralising antibody titers against each of the four vaccine strains.
Timeframe: At Day 7 post dose 1
MGI for neutralising antibodies titers against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine.
Timeframe: At Day 7 post dose 1
Vaccine response rate(VRR) for anti-neuraminidase antibody titers against each of the four vaccine strains.
Timeframe: At Day 7 post dose 1
MGI for anti-neuraminidase antibodies titers against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine.
Timeframe: At Day 7 post dose 1
Number of subjects with HI antibody titers against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent Vaccine.
Timeframe: At Day 0 and Day 7
Serum micro neutralizing(MN) antibody titers against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine.
Timeframe: At Day 0 and Day 7
Serum anti-neuraminidase antibody titers against each of the vaccine strains after 1 dose of Fluarix Quadrivalent vaccine
Timeframe: At Day 0 and Day 7
Vaccine response rate(VRR) for serum neutralising antibody titers against each of the four vaccine strains
Timeframe: At Day 7 post dose 1
MGI for neutralising antibodies titers against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine.
Timeframe: At Day 7 post dose 1
Vaccine response rate(VRR) for anti-neuraminidase antibodies against each of the four vaccine strains.
Timeframe: At Day 7 post dose 1
MGI for anti-neuraminidase antibodies titers against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine
Timeframe: At Day 7 post dose 1
Serum neutralising antibody titers against each of the vaccine strains after 1 dose of Fluarix Quadrivalent vaccine by age strata.
Timeframe: At Day 0 and Day 7
Serum anti-neuraminidase antibody titers against each of the vaccine strains after 1 dose of Fluarix Quadrivalent vaccine by age strata
Timeframe: At Day 0 and Day 7
Vaccine response rate(VRR) for serum neutralising antibody titers against each of the four vaccine strains by age strata
Timeframe: At Day 7 post dose 1
MGI for neutralising antibodies titers against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine by age strata
Timeframe: At Day 7 post dose 1
Vaccine response rate(VRR) for anti-neuraminidase antibody titers against each of the four vaccine strains by age strata.
Timeframe: At Day 7 post dose 1
MGI for anti-neuraminidase antibodies titers against each of the four vaccine strains after 1 dose of Fluarix Quadrivalent vaccine by age strata.
Timeframe: At Day 7 post dose 1
Number of subjects reporting any and grade 3 solicited local adverse events (AEs)
Timeframe: During a 7-day (Day 0 to 6) follow-up period after first vaccination
Duration of solicted symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination Dose 1 period
Number of subjects reporting any, grade 3 and related solicited general symptoms.
Timeframe: During the 7 days (Days 0 – 6) post dose 1 vaccination
Number of subjects reporting AEs with Medically Attended Visits (MAV)
Timeframe: During the entire study period (Day 0 – Day 179)
Number of subjects reporting Potential Immune-Mediated Diseases (pIMDs)
Timeframe: During the entire study period (Days 0 - 179)
Number of subjects reporting any, grade 3 and related unsolicited AEs.
Timeframe: Within 28 days (Days 0-27) after first vaccination
Number of subjects reporting any and related serious adverse events (SAEs)
Timeframe: During the entire study period (Day 0 – Day 179)
Interventions:
Biological/vaccine: Fluarix Quadrivalent
Enrollment:
470
Observational study model:
Not applicable
Primary completion date:
2013-06-05
Time perspective:
Not applicable
Clinical publications:
Claeys C et al. (2018) Anamnestic Immune Response and Safety of an Inactivated Quadrivalent Influenza Vaccine in Primed Versus Vaccine-Naïve Children. Pediatr Infect Dis J. doi: 10.1097/INF.0000000000002217.
Medical condition
Influenza
Product
GSK2321138A
Collaborators
Not applicable
Study date(s)
October 2012 to June 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
17 - 48 months
Accepts healthy volunteers
Yes
- 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).
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects who the investigator believes that parent(s)/LAR(s) can and will comply with the requirements of the protocol.
Exclusion criteria:
- 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 enrollment:
- Fever is defined as temperature ≥ 37.5°C by any route.
- Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
Child in care.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Trial location(s)
Location
GSK Investigational Site
Coventry, Warwickshire, United Kingdom, CV6 4DD
Status
Study Complete
Location
GSK Investigational Site
Jindrichuv Hradec, Czech Republic, 37701
Status
Study Complete
Location
GSK Investigational Site
Lipnik nad Becvou, Czech Republic, 75131
Status
Study Complete
Location
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 70800
Status
Study Complete
Location
GSK Investigational Site
Quart de Poblet, Valencia, Spain, 46930
Status
Study Complete
Location
GSK Investigational Site
St Austell, Cornwall, United Kingdom, PL26 7RL
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-06-05
Actual study completion date
2013-05-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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