The purpose of this study is to assess the safety and immune responses of rMenB+OMV NZ vaccine when administered to healthy infants from 2 months in the Republic of Korea according to a 2-dose primary schedule and 1 booster dose.
As a post-approval commitment to the Ministry of Food and Drug Safety, Bexsero, which is approved in the Republic of Korea for active immunization against MenB, participants will receive a primary series of 2 doses of rMenB+OMV NZ vaccine, with the first dose given at 2 to 5 months of age and the second dose 2 months later. A third dose (booster) will be administered at 12 to 15 months of age. Routine infant vaccines may be administered as per the Korean Routine Immunization Schedule. However, there will be a minimum interval of 14 days before and after the administration of rMenB+OMV NZ vaccine or any other vaccine (21 days for live attenuated vaccines and 7 days for influenza vaccines).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
50
3 doses of rMenB+OMV NZ vaccine administered intramuscularly on Day 1, Day 61, and any day between Day 241 - Day 391.
GSK Investigational Site
Incheon, South Korea
RECRUITINGGSK Investigational Site
Jeonju, South Korea
RECRUITINGGSK Investigational Site
Percentage of participants with hSBA titers equal to or higher than (≥) Lower Limit of Quantitation (LLOQ) against all MenB indicator strains for the vaccine antigens at Day 91
The assessed strains are M14459, 96217, NZ98/254 and M13520.
Time frame: At Day 91 (30 days after completion of the primary series)
Percentage of participants with hSBA titers equal to or higher than (≥) Lower Limit of Quantitation (LLOQ) against all MenB indicator strains for the vaccine antigens before the third (booster dose) vaccination
The assessed strains are M14459, 96217, NZ98/254 and M13520.
Time frame: At any day between Day 241-391 (before the booster dose)
Percentage of participants with hSBA titers equal to or higher than (≥) Lower Limit of Quantitation (LLOQ) against all MenB indicator strains for the vaccine antigens 30 days after the booster dose
The assessed strains are M14459, 96217, NZ98/254 and M13520.
Time frame: At any day between Day 271 - 421 (30 days after the booster dose)
Percentage of participants with any unsolicited adverse events (AEs)
An AE is defined as an untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An unsolicited AE (including both serious and nonserious AEs) is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs must have been communicated by participant's parent(s)/Legally acceptable representative(s) who has signed the informed consent.
Time frame: Within 30 days after each vaccination and after any vaccination (vaccine administered at Day 1, Day 61, and any day between Day 241 - Day 391)
Percentage of participants with AEs of special interest (AESI), Serious adverse events (SAEs), AEs leading to withdrawal and Medically attended AEs (MAAEs)
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Junggu, South Korea
GSK Investigational Site
Kyungki-do, South Korea
RECRUITINGGSK Investigational Site
Seongnam-si Gyeonggi-do, South Korea
RECRUITINGGSK Investigational Site
Seoul, South Korea
RECRUITINGGSK Investigational Site
Seoul, South Korea
RECRUITINGGSK Investigational Site
Seoul, South Korea
RECRUITINGGSK Investigational Site
Seoul, South Korea
RECRUITINGGSK Investigational Site
Seoul, South Korea
RECRUITINGAESIs includes seizures: febrile seizure and arthritis. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity. Any AE is defined as untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.
Time frame: From Day 1 to any day between Day 421- Day 571 (throughout the study period)