Infections, MeningococcalPhase 2NCT05082285
A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants
A Phase 2 study testing MenACWY-7B low dose vaccine, MenACWY-7B high dose vaccine and MenABCWY-1Gen vaccine in people with Infections, Meningococcal, run by GlaxoSmithKline at 33 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 89 daysHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- MenACWY-7B low dose vaccine, MenACWY-7B high dose vaccine and MenABCWY-1Gen vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 726 participants
- Where
- 33 sitesin 8 countries
- Study dates
- 29 Nov 2021to 31 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 89 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 27Show fewer
- 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.
Trial locations and contacts
33 sites in 8 countries.
33 sites in 8 countries
Spain10 sites
GSK Investigational Site
Almería, 04120
GSK Investigational Site
Burgos, 09006
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Madrid, 28222
GSK Investigational Site
Málaga, 29004
GSK Investigational Site
Marbella, 29600
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Seville, 41013
Poland9 sites
GSK Investigational Site
Bydgoszcz, 85-048
GSK Investigational Site
Krakow, 30-348
GSK Investigational Site
Krakow, 30-644
GSK Investigational Site
Luboń, 62-030
GSK Investigational Site
Siemianowice Śląskie, 41-103
GSK Investigational Site
Torun, 87-100
GSK Investigational Site
Trzebnica, 55-100
GSK Investigational Site
Warsaw, 02-647
GSK Investigational Site
Wroclaw, 50368
Finland6 sites
GSK Investigational Site
Espoo, 02230
GSK Investigational Site
Helsinki, 00100
GSK Investigational Site
Jarvenpaa, 04400
GSK Investigational Site
Kokkola, 67100
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Seinäjoki, 60100
Germany2 sites
GSK Investigational Site
Gilching, 82205
GSK Investigational Site
Schönau am Königssee, 83471
South Africa2 sites
GSK Investigational Site
Parow Valley, 7505
GSK Investigational Site
Soweto Gauteng, 2013
United Kingdom2 sites
GSK Investigational Site
Exeter, EX2 5DW
GSK Investigational Site
Oxford, OX3 7LE
Dominican Republic1 site
GSK Investigational Site
Santo Domingo Este
About this study
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
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.
- Conditions
- Infections, Meningococcal
- Being tested
- MenACWY-7B low dose vaccine, MenACWY-7B high dose vaccine, MenABCWY-1Gen vaccine, MenB vaccine, MenACWY-TT vaccine
- Keywords
- MenACWY-7B, MenABCWY-1Gen, Bexsero, Nimenrix, Safety, Tolerability, Immunogenicity, Invasive Meningococcal Disease, Healthy infants
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenACWY-7B low dose vaccineCombination product
MenACWY-7B low dose vaccine is administered intramuscularly in the upper thigh region of the right leg.
MenACWY-7B high dose vaccineCombination product
MenACWY-7B high dose vaccine is administered intramuscularly in the upper thigh region of the right leg.
MenABCWY-1Gen vaccineCombination product
MenABCWY-1Gen vaccine is administered intramuscularly in the upper thigh region of the right leg.
MenB vaccineCombination product
Also called Bexsero
MenB vaccine is administered intramuscularly in the upper thigh region of the right leg.
MenACWY-TT vaccineCombination product
Also called Nimenrix
MenACWY-TT vaccine is administered intramuscularly in the lower thigh region of the right leg.
| Study group | Role | What they receive |
|---|---|---|
| MenACWY-7B low dose Group | Experimental | Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301. Receives: Combination Product: MenACWY-7B low dose vaccine |
| MenB+MenACWY-TT Group | Active comparator | Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301. Receives: Combination Product: MenB vaccine; Combination Product: MenACWY-TT vaccine |
| MenACWY-7B high dose Group | Experimental | Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301. Receives: Combination Product: MenACWY-7B high dose vaccine |
| ABCWY-1Gen Group | Experimental | Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301. Receives: Combination Product: MenABCWY-1Gen vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered on Day 1
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.
Measured: From Day 1 to Day 7
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1
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.
Measured: From Day 1 to Day 7
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered on Day 61
Measured: From Day 61 to Day 67
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61
Measured: From Day 61 to Day 67
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered on Day 301
Measured: From Day 301 to Day 307
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301
Measured: From Day 301 to Day 307
Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After the First Vaccination Administered on Day 1
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.
Measured: From Day 1 to Day 30
Number of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered on Day 61
Measured: From Day 61 to Day 90
Number of Participants Reporting Any Unsolicited AEs After the Third Vaccination Administered on Day 301
Measured: From Day 301 to Day 330
Number of Participants Reporting MAAEs, SAEs, AEs Leading to Withdrawal, and AESIs
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.
Measured: From Day 1 to Day 481
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
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.
Measured: At Day 91 (1 month after the second vaccination)
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at Pre-third Vaccination
Measured: At Day 301 (pre-third vaccination)
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
Measured: At Day 331 (1 month after the third vaccination)
hSBA Geometric Mean Titers (GMTs) for Each Serogroup B Indicator Strain at 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.
Measured: At Day 91 (1 month after the second vaccination)
hSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination
Measured: At Day 301 (pre-third vaccination)
hSBA GMTs for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
Measured: At Day 331 (1 month after the third vaccination)
hSBA Geometric Mean Ratios (GMRs) for Each Serogroup B Indicator Strain
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.
Measured: At Day 331 (1 month after the third vaccination) compared to Day 301 (pre-third vaccination)
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 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.
Measured: At Day 91 (1 month after the second vaccination)
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at Pre-third Vaccination
Measured: At Day 301 (pre-third vaccination)
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination
Measured: At Day 331 (1 month after the third vaccination)
hSBA GMTs for Each A, C, W and Y Serogroup at 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.
Measured: At Day 91 (1 month after the second vaccination)
hSBA GMTs for Each A, C, W and Y Serogroup at Pre-third Vaccination
Measured: At Day 301 (pre-third vaccination)
hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination
Measured: At Day 331 (1 month after the third vaccination)
hSBA GMRs for Each A, C, W and Y Serogroup
Measured: At Day 331 (1 month after the third vaccination) compared to Day 301 (pre-third vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start29 Nov 2021
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infections, MeningococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 726 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082285
- Sponsor's protocol ID
- 217043
- Other IDs
- 2021-001367-24, 2023-506449-40-00, 2023
- Status last verified
- Jun 2026
- First submitted
- 7 Oct 2021
- Last updated
- 26 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05082285
- Acronym / sponsor ID
- 217043
- Conditions
- Infections, Meningococcal
- Keywords
- MenACWY-7B, MenABCWY-1Gen, Bexsero, Nimenrix, Safety, Tolerability, Immunogenicity, Invasive Meningococcal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 726 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Posted 26 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MenACWY-7B low dose Group | Experimental | Combination Product: MenACWY-7B low dose vaccineParticipants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301. |
| MenB+MenACWY-TT Group | Active comparator | Combination Product: MenB vaccine, Combination Product: MenACWY-TT vaccineParticipants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301. |
| MenACWY-7B high dose Group | Experimental | Combination Product: MenACWY-7B high dose vaccineParticipants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301. |
| ABCWY-1Gen Group | Experimental | Combination Product: MenABCWY-1Gen vaccineParticipants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301. |
Who may qualify
- Ages
- 55 to 89 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MenACWY-7B low dose vaccineMenACWY-7B low dose vaccine is administered intramuscularly in the upper thigh region of the right leg. | Combination product | MenACWY-7B low dose Group |
| MenACWY-7B high dose vaccineMenACWY-7B high dose vaccine is administered intramuscularly in the upper thigh region of the right leg. | Combination product | MenACWY-7B high dose Group |
| MenABCWY-1Gen vaccineMenABCWY-1Gen vaccine is administered intramuscularly in the upper thigh region of the right leg. | Combination product | ABCWY-1Gen Group |
| MenB vaccineAlso: BexseroMenB vaccine is administered intramuscularly in the upper thigh region of the right leg. | Combination product | MenB+MenACWY-TT Group |
| MenACWY-TT vaccineAlso: NimenrixMenACWY-TT vaccine is administered intramuscularly in the lower thigh region of the right leg. | Combination product | MenB+MenACWY-TT Group |
Primary outcome
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered on Day 1
Time frame: 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.
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1
Time frame: 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.
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered on Day 61
Time frame: From Day 61 to Day 67
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61
Time frame: From Day 61 to Day 67
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered on Day 301
Time frame: From Day 301 to Day 307
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301
Time frame: From Day 301 to Day 307
Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After the First Vaccination Administered on Day 1
Time frame: 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.
Number of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered on Day 61
Time frame: From Day 61 to Day 90
Number of Participants Reporting Any Unsolicited AEs After the Third Vaccination Administered on Day 301
Time frame: From Day 301 to Day 330
Number of Participants Reporting MAAEs, SAEs, AEs Leading to Withdrawal, and AESIs
Time frame: 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.
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
Time frame: 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.
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at Pre-third Vaccination
Time frame: At Day 301 (pre-third vaccination)
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
Time frame: At Day 331 (1 month after the third vaccination)
hSBA Geometric Mean Titers (GMTs) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
Time frame: 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.
hSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination
Time frame: At Day 301 (pre-third vaccination)
hSBA GMTs for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
Time frame: At Day 331 (1 month after the third vaccination)
hSBA Geometric Mean Ratios (GMRs) for Each Serogroup B Indicator Strain
Time frame: 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.
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination
Time frame: 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.
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at Pre-third Vaccination
Time frame: At Day 301 (pre-third vaccination)
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination
Time frame: At Day 331 (1 month after the third vaccination)
hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination
Time frame: 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.
hSBA GMTs for Each A, C, W and Y Serogroup at Pre-third Vaccination
Time frame: At Day 301 (pre-third vaccination)
hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination
Time frame: At Day 331 (1 month after the third vaccination)
hSBA GMRs for Each A, C, W and Y Serogroup
Time frame: At Day 331 (1 month after the third vaccination) compared to Day 301 (pre-third vaccination)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MenACWY-7B low dose vaccine, MenACWY-7B high dose vaccine and MenABCWY-1Gen vaccine in people with Infections, Meningococcal, run by GlaxoSmithKline at 33 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Spain, Poland, Finland, Germany, South Africa and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered on Day 1 (time frame: From Day 1 to Day 7). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.