Meningitis, Meningococcal Clinical Trial
Official title:
A Phase 4, Single-arm, Open-label, Multi-center Study to Assess the Immune Response and Safety of the Meningococcal Group B Vaccine MenB+OMV NZ When Administered to Healthy Infants From 2 Months of Age in the Republic of Korea
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | September 8, 2026 |
Est. primary completion date | April 10, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Months to 5 Months |
Eligibility | Inclusion Criteria: - Participant's parent(s)/Legally acceptable representative(s) [LAR(s)], who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., return for follow-up visits). - Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. - Healthy participants as established by medical history and clinical examination before entering the study. - Born full term (i.e., after a gestation period of =37 weeks). Exclusion Criteria: - Current or previous, confirmed or suspected disease caused by N. meningitidis. - Known exposure from birth to an individual with laboratory confirmed N. meningitidis infection. - Progressive, unstable or uncontrolled clinical conditions. - Any contraindications to group B meningococcal vaccine, including but not limited to: history of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. - Medical conditions representing a contraindication to intramuscular vaccination and blood draws. - Any neuroinflammatory condition (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), any congenital neurological condition, encephalopathies, seizures (including all subtypes such as: absence seizures, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures). - Congenital or peripartum disorders resulting in a chronic illness (including but not limited to: chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders). - Other serious chronic illness. - Hypersensitivity to latex. - Abnormal function of the immune system resulting from clinical conditions, or administration of antineoplastic and immunomodulating agents or radiotherapy for any duration from birth or autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes). - Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior/Concomitant Therapy: - Use of any investigational or non-registered product (drug, vaccine or medical device) since birth, or their planned use during the study period. - Previous vaccination with any group B meningococcal vaccine at any time prior to informed consent. - Administration of long acting (defined as administered once per week or less frequently) immunosuppressants, including monoclonal antibodies (e.g., infliximab) since birth and/or planned use at any time during the study period. - Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) since birth and/or planned use of long-acting immune-modifying treatments at any time during the study period. For corticosteroids, this will mean prednisone equivalent 0.5 mg/kg/day. Inhaled and topical steroids are allowed. - Administration of immunoglobulins and/or any blood products or plasma derivatives since birth and/or planned use at any time during the study period. Prior/Concurrent Clinical Study Experience • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device). Other Exclusion Criteria - Child in care. - Any immediate dependents, family, or household member of study personnel. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | GSK Investigational Site | Anyang-Si, Gyeonggi-do | |
Korea, Republic of | GSK Investigational Site | Jeonju-si, Jeollabuk-do | |
Korea, Republic of | GSK Investigational Site | Seongnam-si, Gyeonggi-do | |
Korea, Republic of | GSK Investigational Site | Seoul | |
Korea, Republic of | GSK Investigational Site | Seoul | |
Korea, Republic of | GSK Investigational Site | Seoul | |
Korea, Republic of | GSK Investigational Site | Seoul |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At Day 91 (30 days after completion of the primary series) | |
Primary | 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. | At any day between Day 241-391 (before the booster dose) | |
Primary | 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. | At any day between Day 271 - 421 (30 days after the booster dose) | |
Secondary | 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. | 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) | |
Secondary | Percentage of participants with AEs of special interest (AESI), Serious adverse events (SAEs), AEs leading to withdrawal and Medically attended AEs (MAAEs) | AESIs 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. | From Day 1 to any day between Day 421- Day 571 (throughout the study period) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04689191 -
A Phase III Clinical Trial of the Group A and C Meningococcal Polysaccharide Vaccine
|
Phase 3 | |
Recruiting |
NCT04689165 -
A Phase III Clinical Trial of the Group A Meningococcal Polysaccharide Vaccine
|
Phase 3 | |
Completed |
NCT00780806 -
Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults
|
Phase 1/Phase 2 | |
Completed |
NCT03378258 -
Petechiae In Children (PIC) Study: Defining A Clinical Decision Rule for The Management Of Fever and Non-Blanching Rashes In Children Including The Role Of Point Of Care Testing For Procalcitonin & Neisseria Meningitidis DNA.
|
||
Completed |
NCT03205371 -
Immunogenicity and Safety of a Meningococcal Conjugate Vaccine Given Concomitantly With Other Vaccines in Toddlers
|
Phase 3 | |
Completed |
NCT01352793 -
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
|
Phase 3 | |
Completed |
NCT03295318 -
Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds
|
Phase 2 | |
Completed |
NCT03493919 -
A Sourcing Study to Collect Human Blood Samples From Healthy Adults
|
Phase 4 | |
Completed |
NCT00474526 -
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
|
Phase 3 | |
Completed |
NCT00297687 -
Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults
|
Phase 1 | |
Recruiting |
NCT04665791 -
A Human Controlled Infection Study With Neisseria Lactamica in Malian Adults
|
N/A | |
Withdrawn |
NCT03431675 -
Ciprofloxacin for the Prevention of Meningococcal Meningitis 2018
|
Phase 4 | |
Recruiting |
NCT02878291 -
Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
|
Phase 1 | |
Completed |
NCT00314041 -
Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants
|
Phase 2 | |
Recruiting |
NCT04685850 -
Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans
|
||
Completed |
NCT03587207 -
Study to Assess Potential Immune Interference When GlaxoSmithKline (GSK) Biologicals' MenABCWY Vaccine is Administered to Healthy Subjects Aged 10-25 Years
|
Phase 2 | |
Completed |
NCT03824093 -
High and Low Resource Interventions to Promote HPV Vaccines
|
N/A | |
Completed |
NCT04707391 -
Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine
|
Phase 3 | |
Terminated |
NCT00798304 -
Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
|
Phase 2 | |
Recruiting |
NCT03682939 -
Evaluation of Safety and Immunogenicity of Meningococcal B and Meningococcal ACWY Vaccine in at Risk Population
|
Phase 4 |