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GSK Biologicals' Pandemic influenza candidate vaccine · 1 trial · 1 indication
The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), in subjects aged between 6 months to 9 years and 10 to 17 years, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.
Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%. The CHMP criterion was fulfilled if the point estimate for SCR was \> 40%.
A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for seroprotection (SPR) was \> 70%. The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for GMFR was \> 2.5.
| Arm | Type | Description |
|---|---|---|
| GSK2340274A_F1 6M-9Y GROUP | EXPERIMENTAL | Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years. |
| GSK2340274A_F2 10Y-17Y GROUP | EXPERIMENTAL | Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A) | BIOLOGICAL | Two intramuscular injections |
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. * Japanese children, male or female, aged between 6 months and 17 years at the time of the first study vaccination....
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GSK Biologicals' Pandemic influenza candidate vaccine is an investigational vaccine developed by GSK plc for protection against pandemic influenza, specifically the H1N1 strain. It is a Phase 2 candidate studied in Japanese children. The vaccine is designed for use in the infectious disease therapeutic area and has been evaluated in a single completed clinical trial.
GSK Biologicals' Pandemic influenza candidate vaccine is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the vaccine division of the company. The candidate is part of GSK's pandemic influenza vaccine program.
GSK Biologicals' Pandemic influenza candidate vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved for use. The Phase 2 trial has been completed, and no active trials are currently listed for this candidate.
GSK Biologicals' Pandemic influenza candidate vaccine has been studied in one completed clinical trial, NCT01001169. The trial was titled "Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Japanese Children." It was a Phase 2 controlled study that enrolled 60 participants in Japan, aged 6 months and older, including healthy volunteers.
Yes, GSK Biologicals' Pandemic influenza candidate vaccine is also known as GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A). The alternative name refers to the same investigational vaccine developed by GSK plc for pandemic H1N1 influenza.
GSK Biologicals' Pandemic influenza candidate vaccine is intended for the prevention of pandemic influenza, specifically the H1N1 strain. It is being developed for use in children, with the completed Phase 2 trial enrolling Japanese children from 6 months of age. The vaccine remains investigational and is not approved.