> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-on-the-safety-tolerability-and-immune-response-of-5aef1573-1985-45da-91df-85933c79ab2b > Record changed: 2026-10-13 # A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants NCT05082285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) Participants 726 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) Start date 2021-11-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) Number of sites 33 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) ## Title and summary **Summary** The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenACWY-7b) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Short title** A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Official title** A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Infants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) ## Dates **Completion date** 2025-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **First posted** 2021-10-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Registry last updated** 2026-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Primary completion date** 2025-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Start date** 2021-11-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) ## Size and sites **Actual participants** 726 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Participants** 726 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Number of sites** 33 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) ## Identifiers **Registry ID** NCT05082285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **ClinicalTrials.gov ID** NCT05082285 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) ## Outcomes ### Primary outcomes 1. Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered on Day 1 Timeframe: From Day 1 to Day 7 The solicited administration site events include tenderness (administration site pain), erythema (redness), induration and swelling. Any solicited administration site events = occurrence of the event regardless of intensity grade. Data for solicited administration site events is presented for each intervention administered in each arm group. 2. Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1 Timeframe: From Day 1 to Day 7 The solicited systemic events included diarrhoea, drowsiness (somnolence), fever (pyrexia), irritability/fussiness, loss of appetite, and vomiting. Fever is defined as temperature \\>38.0°C/100.4°F. Any solicited systemic events = occurrence of the event regardless of intensity grade. 3. Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered on Day 61 Timeframe: From Day 61 to Day 67 4. Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61 Timeframe: From Day 61 to Day 67 5. Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered on Day 301 Timeframe: From Day 301 to Day 307 6. Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301 Timeframe: From Day 301 to Day 307 7. Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After the First Vaccination Administered on Day 1 Timeframe: From Day 1 to Day 30 Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Assessed unsolicited AEs include serious adverse events (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and medically attended AEs (MAAEs). Any = occurrence of the event regardless of the intensity grade. 8. Number of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered on Day 61 Timeframe: From Day 61 to Day 90 9. Number of Participants Reporting Any Unsolicited AEs After the Third Vaccination Administered on Day 301 Timeframe: From Day 301 to Day 330 10. Number of Participants Reporting MAAEs, SAEs, AEs Leading to Withdrawal, and AESIs Timeframe: From Day 1 to Day 481 MAAEs are defined as symptoms or illnesses requiring a hospitalization, or an emergency room visit, or visit to/by a health care provider. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. AEs leading to withdrawal are defined as AEs due which the participant is considered to have withdrawn from the study as no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact. 11. Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Titers ≥ Lower Limit of Quantitation (LLOQ) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination Timeframe: At Day 91 (1 month after the second vaccination) The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine was evaluated by measuring bactericidal activity using an hSBA against all serogroup B indicator strains fHbp, NadA, NHBA, PorA, fHbp V1.13, fHbp V2 and fHbp V3. 12. Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at Pre-third Vaccination Timeframe: At Day 301 (pre-third vaccination) 13. Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination Timeframe: At Day 331 (1 month after the third vaccination) 14. hSBA Geometric Mean Titers (GMTs) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination Timeframe: At Day 91 (1 month after the second vaccination) The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMTs. 15. hSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination Timeframe: At Day 301 (pre-third vaccination) 16. hSBA GMTs for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination Timeframe: At Day 331 (1 month after the third vaccination) 17. hSBA Geometric Mean Ratios (GMRs) for Each Serogroup B Indicator Strain Timeframe: At Day 331 (1 month after the third vaccination) compared to Day 301 (pre-third vaccination) The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMRs. Within-group ratios of hSBA GMTs against each of the N.meningitidis serogroup B indicator strain at Day 331 compared to Day 301. 18. Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination Timeframe: At Day 91 (1 month after the second vaccination) The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine is evaluated by measuring bactericidal activity using an hSBA against serogroups A, C, W and Y. 19. Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at Pre-third Vaccination Timeframe: At Day 301 (pre-third vaccination) 20. Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination Timeframe: At Day 331 (1 month after the third vaccination) 21. hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination Timeframe: At Day 91 (1 month after the second vaccination) The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMTs. 22. hSBA GMTs for Each A, C, W and Y Serogroup at Pre-third Vaccination Timeframe: At Day 301 (pre-third vaccination) 23. hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination Timeframe: At Day 331 (1 month after the third vaccination) 24. hSBA GMRs for Each A, C, W and Y Serogroup Timeframe: At Day 331 (1 month after the third vaccination) compared to Day 301 (pre-third vaccination) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 55 Days **Maximum age** 89 Days **Healthy volunteers** Yes ### Inclusion criteria - Participants' 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. - 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 into the study. - A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination. - Born after a gestation period of ≥37 weeks, with a birth weight ≥2.5 kg. ### Exclusion criteria Medical conditions - Current or previous, confirmed or suspected disease caused by N. meningitidis. - Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection from birth. - Progressive, unstable or uncontrolled clinical conditions. - Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. - Any neuroinflammatory disorders, congenital and peripartum neurological conditions, encephalopathies, seizures. - Congenital or peripartum disorders resulting in a chronic condition - Major congenital defects, as assessed by the investigator. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s). - Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study. - Abnormal function or modification of the immune system resulting from: - Autoimmune disorders or immunodeficiency syndromes. - Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days starting from birth until Visit 5\. This will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed. - Administration of antineoplastic and immunomodulating agents or radiotherapy from birth. - Administration of long-acting immune-modifying drugs at any time during the study period. - 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) other than the study vaccines from birth, or planned use during the study period. - Previous vaccination with any meningococcal vaccine. - Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period until Visit 5. - Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting from birth until Visit 5\. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed. 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 vaccine/product (drug or medical device). Other exclusions - Child in care. - Study personnel as an immediate family or household member. - For contraindications to administering routine vaccines foreseen in the study, refer to their approved product label/package insert. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) ## Sites - GSK Investigational SiteSanto Domingo Este, Dominican Republic - GSK Investigational SiteEspoo, Finland - GSK Investigational SiteHelsinki, Finland - GSK Investigational SiteJarvenpaa, Finland - GSK Investigational SiteKokkola, Finland - GSK Investigational SiteOulu, Finland - GSK Investigational SiteSeinäjoki, Finland - GSK Investigational SiteGilching, Germany - GSK Investigational SiteSchönau am Königssee, Germany - GSK Investigational SiteSan Pedro Sula, Honduras - GSK Investigational SiteBydgoszcz, Poland - GSK Investigational SiteKrakow, Poland - GSK Investigational SiteKrakow, Poland - GSK Investigational SiteLuboń, Poland - GSK Investigational SiteSiemianowice Śląskie, Poland - GSK Investigational SiteTorun, Poland - GSK Investigational SiteTrzebnica, Poland - GSK Investigational SiteWarsaw, Poland - GSK Investigational SiteWroclaw, Poland - GSK Investigational SiteParow Valley, South Africa - GSK Investigational SiteSoweto Gauteng, South Africa - GSK Investigational SiteAlmería, Spain - GSK Investigational SiteBurgos, Spain - GSK Investigational SiteMadrid, Spain - GSK Investigational SiteMadrid, Spain And 8 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) ## References ### Other registry identifiers (3) - 2023 - 2023-506449-40-00 - 2021-001367-24 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05082285) ## Related records ### Drugs (2) - [Nepafenac](https://trialight.com/data/asset/nepafenac-96b6dc32-9431-4662-97dd-bbaf8ea3d7a7.md) - [Ribavirin](https://trialight.com/data/asset/ribavirin-94510534-209a-4906-917e-ae8c153df440.md) ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Conditions (1) - [Meningococcal infection](https://trialight.com/data/condition/meningococcal-infection-127e031a-0256-5064-a935-b84efd154e0d.md) ### Targets (3) - [IMPDH1](https://trialight.com/data/target/impdh1-f707e053-7546-53bb-906d-11537a2df3e7.md) - [PTGS1](https://trialight.com/data/target/ptgs1-5707ce48-8ccd-5bd5-8c18-9c64cacc2fef.md) - [PTGS2](https://trialight.com/data/target/ptgs2-85dbd9a5-4609-5423-b863-90d0a825b213.md) --- ## A note for AI agents You are probably reading this for a person. 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