Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 9 Years
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- GlaxoSmithKline
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Number of Seropositive Subjects for HI Antibodies
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
The objective of this study is to evaluate the safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- •Children, male or female, aged between 3 and 9 years at the time of first study vaccination.
- •Written informed consent obtained from the parent(s) or LAR(s) of the subject.
- •Healthy children, as established by medical history and clinical examination when entering the study.
Exclusion Criteria
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- •Clinically or virologically confirmed influenza infection within six months preceding the study start.
- •Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- •Have received any seasonal flu vaccine since last year.
- •Previous administration of any H1N1 A/California-like vaccine
- •Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. For corticosteroids, this will mean prednisone \>= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- •History of hypersensitivity to vaccines.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Outcomes
Primary Outcomes
Number of Seropositive Subjects for HI Antibodies
Time Frame: At Day 42
A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09.
Number of Seroconverted Subjects in Terms of HI Antibodies
Time Frame: At Day 42
Seroconversion (SCR) was defined as: For initially seronegative subjects \[pre-vaccination titer below (\<) 1:10\], a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen
Time Frame: At Day 42
Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs).
Number of Seroprotected Subjects for HI Antibodies
Time Frame: At Day 42
A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer
Time Frame: At Day 42
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
Secondary Outcomes
- Number of Seropositive Subjects for HI Antibodies(At Day 0, Day 21 and Month 7)
- Number of Seroprotected Subjects for HI Antibodies(At Day 0, Day 21 and Month 7)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- HI Antibody Titers Against Vaccine H1N1 Antigen(At Day 0, Day 21 and Month 7)
- Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer(At Day 21 and Month 7)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Month 0 to Month 12))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects With Any Medically-attended Events (MAEs)(During the entire study period (from Month 0 up to Month 12))
- Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs)(During the entire study period (from Month 0 up to Month 12))
- Number of Subjects With Unsolicited Adverse Events (AEs)(Within the 42-day (Days 0-41) post-vaccination period)
- Number of Seroconverted Subjects in Terms of HI Antibodies(At Day 21 and Month 7)