ClinicalTrials.gg
Sign In
CompletedNCT05082285Updated Jun 26, 2026Results posted

A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants

A Phase 2 interventional study of MenACWY-7B low dose vaccine and MenACWY-7B high dose vaccine in Infections, Meningococcal, sponsored by GlaxoSmithKline. Completed at 33 sites in 8 countries. Open to participants aged 55 Days to 89 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-26.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
726
Allocation
Randomized
Ages
55 Days to 89 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Infections, Meningococcal

Keywords

  • MenACWY-7B
  • MenABCWY-1Gen
  • Bexsero
  • Nimenrix
  • Safety
  • Tolerability
  • Immunogenicity
  • Invasive Meningococcal Disease
  • Healthy infants
03

In context

Meningococcal Infections

243 studies on the registry are indexed under Meningococcal Infections; 8 are open to participants now.

This study's enrollment of 726 is above the median of 456 across 214 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Days to 89 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 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 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:
  • disorders or immunodeficiency syndromes.
  • Systemic administration of (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 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 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
726 participants (actual)

Study arms

  • Experimental
    MenACWY-7B low dose Group

    Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.

    Combination Product: MenACWY-7B low dose vaccine

  • Active comparator
    MenB+MenACWY-TT Group

    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.

    Combination Product: MenB vaccine · Combination Product: MenACWY-TT vaccine

  • Experimental
    MenACWY-7B high dose Group

    Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.

    Combination Product: MenACWY-7B high dose vaccine

  • Experimental
    ABCWY-1Gen Group

    Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.

    Combination Product: MenABCWY-1Gen vaccine

Interventions

  • Combination productMenACWY-7B low dose vaccine

    MenACWY-7B low dose vaccine is administered intramuscularly in the upper thigh region of the right leg.

  • Combination productMenACWY-7B high dose vaccine

    MenACWY-7B high dose vaccine is administered intramuscularly in the upper thigh region of the right leg.

  • Combination productMenABCWY-1Gen vaccine

    MenABCWY-1Gen vaccine is administered intramuscularly in the upper thigh region of the right leg.

  • Combination productMenB vaccine

    MenB vaccine is administered intramuscularly in the upper thigh region of the right leg.

    Also known as: Bexsero

  • Combination productMenACWY-TT vaccine

    MenACWY-TT vaccine is administered intramuscularly in the lower thigh region of the right leg.

    Also known as: Nimenrix

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From Day 1 to Day 7

  2. 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.

    Time frame: From Day 1 to Day 7

  3. 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

  4. Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61

    Time frame: From Day 61 to Day 67

  5. 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

  6. Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301

    Time frame: From Day 301 to Day 307

  7. 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.

    Time frame: From Day 1 to Day 30

  8. Number of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered on Day 61

    Time frame: From Day 61 to Day 90

  9. Number of Participants Reporting Any Unsolicited AEs After the Third Vaccination Administered on Day 301

    Time frame: From Day 301 to Day 330

  10. 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.

    Time frame: From Day 1 to Day 481

  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

    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.

    Time frame: At Day 91 (1 month after the second vaccination)

  12. 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)

  13. 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)

  14. 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.

    Time frame: At Day 91 (1 month after the second vaccination)

  15. hSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination

    Time frame: At Day 301 (pre-third vaccination)

  16. 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)

  17. 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.

    Time frame: At Day 331 (1 month after the third vaccination) compared to Day 301 (pre-third vaccination)

  18. 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.

    Time frame: At Day 91 (1 month after the second vaccination)

  19. 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)

  20. 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)

  21. 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.

    Time frame: At Day 91 (1 month after the second vaccination)

  22. hSBA GMTs for Each A, C, W and Y Serogroup at Pre-third Vaccination

    Time frame: At Day 301 (pre-third vaccination)

  23. 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)

  24. 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)

07

Results

Posted Jun 26, 2026

Participant flow

Participant flow — Overall Study
MilestoneMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
Started188179175182
Completed183163169170
Not completed516612
Withdrew: Adverse event (ae) requiring expedited reporting0111
Withdrew: Lost to follow-up0101
Withdrew: Consent withdrawal not due to ae3838
Withdrew: Migrated / moved from the study area1512
Withdrew: Other1110

Outcome measures

PrimaryNumber 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.

Time frame:
From Day 1 to Day 7
Reported as:
Count of participants · Participants
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered on Day 1
ParticipantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB GroupMenACWY-TT Group
Erythema7474848139
Induration93801089143
Swelling5557706632
Tenderness1081009510377
PrimaryNumber 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.

Time frame:
From Day 1 to Day 7
Reported as:
Count of participants · Participants
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered on Day 1
ParticipantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
Diarrhoea30363236
Drowsiness939579112
Fever50433941
Irritability/Fussiness127132118140
Loss of appetite54473654
Vomiting24302629
PrimaryNumber of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered on Day 61
Time frame:
From Day 61 to Day 67
Reported as:
Count of participants · Participants
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered on Day 61
ParticipantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB GroupMenACWY-TT Group
Erythema7762617235
Induration8165747938
Swelling5745435932
Tenderness7361537151
PrimaryNumber of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61
Time frame:
From Day 61 to Day 67
Reported as:
Count of participants · Participants
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered on Day 61
ParticipantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
Diarrhea13201525
Drowsiness48423951
Fever46452743
Irritability/Fussiness93786992
Loss of appetite35232635
Vomiting17141413
PrimaryNumber of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered on Day 301
Time frame:
From Day 301 to Day 307
Reported as:
Count of participants · Participants
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered on Day 301
ParticipantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB GroupMenACWY-TT Group
Erythema6362586037
Induration7763757446
Swelling5748436239
Tenderness7067637252
PrimaryNumber of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301
Time frame:
From Day 301 to Day 307
Reported as:
Count of participants · Participants
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered on Day 301
ParticipantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
Diarrhea15141514
Drowsiness39382742
Fever34363041
Irritability/Fussiness62626372
Loss of appetite39372743
Vomiting1214109
PrimaryNumber 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.

Time frame:
From Day 1 to Day 30
Reported as:
Count of participants · Participants
Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After the First Vaccination Administered on Day 1
ParticipantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After the First Vaccination Administered on Day 135354836
PrimaryNumber of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered on Day 61
Time frame:
From Day 61 to Day 90
Reported as:
Count of participants · Participants
Number of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered on Day 61
ParticipantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
Number of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered on Day 6136293830
PrimaryNumber of Participants Reporting Any Unsolicited AEs After the Third Vaccination Administered on Day 301
Time frame:
From Day 301 to Day 330
Reported as:
Count of participants · Participants
Number of Participants Reporting Any Unsolicited AEs After the Third Vaccination Administered on Day 301
ParticipantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
Number of Participants Reporting Any Unsolicited AEs After the Third Vaccination Administered on Day 30132383428
PrimaryNumber 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.

Time frame:
From Day 1 to Day 481
Reported as:
Count of participants · Participants
Number of Participants Reporting MAAEs, SAEs, AEs Leading to Withdrawal, and AESIs
ParticipantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
MAAEs130116123119
SAEs17113017
AEs leading to withdrawal0111
AESIs1640
PrimaryPercentage 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.

Time frame:
At Day 91 (1 month after the second vaccination)
Reported as:
Number · Percentage of participants
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
Percentage of participantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
fHbp96.5 (90.0 to 99.3)91.7 (82.7 to 96.9)77.8 (66.4 to 86.7)91.1 (82.6 to 96.4)
NadA88.2 (79.4 to 94.2)88.2 (78.1 to 94.8)82.1 (70.8 to 90.4)96.1 (89.0 to 99.2)
NHBA95.3 (88.5 to 98.7)92.9 (84.1 to 97.6)42.0 (30.2 to 54.5)68.4 (56.9 to 78.4)
PorA94.2 (87.0 to 98.1)85.7 (75.3 to 92.9)84.3 (73.6 to 91.9)82.3 (72.1 to 90.0)
fHbp V1.1378.1 (60.0 to 90.7)78.8 (61.1 to 91.0)13.3 (3.8 to 30.7)21.7 (7.5 to 43.7)
fHbp V294.6 (81.8 to 99.3)91.7 (77.5 to 98.2)3.3 (0.1 to 17.2)3.8 (0.1 to 19.6)
fHbp V391.9 (78.1 to 98.3)100 (90.3 to 100)6.7 (0.8 to 22.1)3.8 (0.1 to 19.6)
PrimaryPercentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at Pre-third Vaccination
Time frame:
At Day 301 (pre-third vaccination)
Reported as:
Number · Percentage of participants
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at Pre-third Vaccination
Percentage of participantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
fHbp4.1 (0.9 to 11.5)6.7 (2.2 to 14.9)4.1 (0.9 to 11.5)3.9 (0.8 to 11.1)
NadA9.0 (3.4 to 18.5)13.7 (6.8 to 23.8)18.5 (9.9 to 30.0)18.3 (10.1 to 29.3)
NHBA9.3 (3.8 to 18.3)13.3 (6.6 to 23.2)2.7 (0.3 to 9.5)1.3 (0.0 to 6.9)
PorA8.0 (3.0 to 16.6)8.0 (3.0 to 16.6)8.1 (3.0 to 16.8)3.8 (0.8 to 10.8)
fHbp V1.133.0 (0.1 to 15.8)6.5 (0.8 to 21.4)9.7 (2.0 to 25.8)4.0 (0.1 to 20.4)
fHbp V20.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)
fHbp V30.0 (0.0 to 0.0)0.0 (0.0 to 0.0)6.5 (0.8 to 21.4)0.0 (0.0 to 0.0)
PrimaryPercentage 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)
Reported as:
Number · Percentage of participants
Percentage of Participants With hSBA Titers ≥ LLOQ for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
Percentage of participantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
fHbp85.1 (75.0 to 92.3)89.0 (79.5 to 95.1)73.2 (61.4 to 83.1)81.8 (71.4 to 89.7)
NadA88.6 (78.7 to 94.9)91.4 (82.3 to 96.8)91.3 (82.0 to 96.7)98.6 (92.6 to 100)
NHBA100 (95.3 to 100)100 (95.1 to 100)83.1 (72.3 to 91.0)92.1 (83.6 to 97.0)
PorA96.0 (88.8 to 99.2)97.3 (90.5 to 99.7)79.2 (68.0 to 87.8)88.2 (78.7 to 94.4)
fHbp V1.1390.6 (75.0 to 98.0)96.0 (79.6 to 99.9)34.5 (17.9 to 54.3)65.2 (42.7 to 83.6)
fHbp V285.3 (68.9 to 95.0)92.6 (75.7 to 99.1)6.9 (0.8 to 22.8)8.3 (1.0 to 27.0)
fHbp V385.3 (68.9 to 95.0)92.6 (75.7 to 99.1)20.7 (8.0 to 39.7)16.7 (4.7 to 37.4)
PrimaryhSBA 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.

Time frame:
At Day 91 (1 month after the second vaccination)
Reported as:
Geometric mean · Titer
hSBA Geometric Mean Titers (GMTs) for Each Serogroup B Indicator Strain at 1 Month After the Second Vaccination
TiterMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
fHbp118.6 (94.0 to 149.6)111.8 (86.2 to 145.1)30.2 (23.2 to 39.3)45.7 (35.4 to 59.0)
NadA65.6 (48.1 to 89.4)79.9 (56.3 to 113.5)65.7 (46.1 to 93.8)148.3 (105.4 to 208.8)
NHBA45.4 (37.4 to 55.2)45.4 (36.5 to 56.6)4.5 (3.6 to 5.7)7.5 (6.1 to 9.3)
PorA15.0 (11.9 to 18.8)14.3 (11.1 to 18.5)6.4 (5.0 to 8.3)8.6 (6.7 to 11.1)
fHbp V1.1339.5 (24.6 to 63.4)36.2 (23.4 to 55.9)3.8 (2.3 to 6.1)3.9 (2.3 to 6.7)
fHbp V217.4 (13.6 to 22.2)17.4 (13.7 to 22.1)2.1 (1.6 to 2.8)2.0 (1.5 to 2.7)
fHbp V323.1 (17.6 to 30.4)23.1 (17.7 to 30.2)1.5 (1.1 to 2.1)1.5 (1.1 to 2.1)
PrimaryhSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination
Time frame:
At Day 301 (pre-third vaccination)
Reported as:
Geometric mean · Titer
hSBA GMTs for Each Serogroup B Indicator Strain at Pre-third Vaccination
TiterMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
fHbp6.3 (5.8 to 6.8)6.5 (6.0 to 7.1)6.1 (5.6 to 6.7)6.0 (5.5 to 6.6)
NadA4.5 (3.4 to 5.9)5.6 (4.3 to 7.2)6.8 (5.2 to 8.9)6.6 (5.0 to 8.5)
NHBA4.0 (3.5 to 4.5)4.2 (3.7 to 4.8)3.5 (3.0 to 4.0)3.4 (2.9 to 3.8)
PorA2.9 (2.6 to 3.2)2.7 (2.4 to 2.9)2.8 (2.5 to 3.1)2.6 (2.4 to 2.8)
fHbp V1.133.2 (3.0 to 3.5)3.3 (3.1 to 3.6)3.4 (3.2 to 3.7)3.1 (2.8 to 3.4)
fHbp V22.5 (2.5 to 2.5)2.5 (2.5 to 2.5)2.5 (2.5 to 2.5)2.5 (2.5 to 2.5)
fHbp V32.0 (1.6 to 2.3)2.0 (1.7 to 2.3)2.4 (2.0 to 2.9)2.0 (1.7 to 2.5)
PrimaryhSBA 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)
Reported as:
Geometric mean · Titer
hSBA GMTs for Each Serogroup B Indicator Strain at 1 Month After the Third Vaccination
TiterMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
fHbp106.9 (76.5 to 149.2)149.3 (106.0 to 210.3)47.0 (33.0 to 67.1)60.1 (42.6 to 84.9)
NadA277.4 (182.7 to 421.1)417.2 (272.1 to 639.9)395.2 (252.9 to 617.6)816.3 (525.4 to 1268.5)
NHBA70.8 (57.8 to 86.7)83.2 (67.5 to 102.6)13.2 (10.6 to 16.4)21.2 (17.1 to 26.2)
PorA30.3 (22.5 to 40.7)34.0 (25.1 to 46.1)11.4 (8.3 to 15.7)18.9 (13.9 to 25.8)
fHbp V1.13116.1 (71.9 to 187.5)144.5 (87.2 to 239.4)7.5 (4.6 to 12.3)18.7 (10.7 to 32.6)
fHbp V219.3 (13.9 to 26.8)22.5 (15.8 to 31.9)2.8 (2.0 to 4.0)3.0 (2.0 to 4.4)
fHbp V323.1 (15.1 to 35.4)39.2 (24.9 to 61.9)3.7 (2.3 to 5.8)3.0 (1.8 to 4.9)
PrimaryhSBA 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.

Time frame:
At Day 331 (1 month after the third vaccination) compared to Day 301 (pre-third vaccination)
Reported as:
Geometric mean · Ratio
hSBA Geometric Mean Ratios (GMRs) for Each Serogroup B Indicator Strain
RatioMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
fHbp15.3 (10.9 to 21.5)21.0 (14.9 to 29.6)7.3 (5.1 to 10.4)10.0 (7.1 to 14.2)
NadA44.1 (27.0 to 72.0)59.6 (37.0 to 96.0)45.2 (27.2 to 75.0)100.7 (61.3 to 165.4)
NHBA16.6 (13.5 to 20.3)19.3 (15.7 to 23.8)3.6 (2.9 to 4.4)6.3 (5.2 to 7.8)
PorA9.8 (7.2 to 13.2)12.2 (9.0 to 16.5)4.2 (3.1 to 5.7)7.2 (5.3 to 9.8)
fHbp V1.1337.8 (22.3 to 64.1)41.3 (24.5 to 69.4)2.2 (1.3 to 3.7)6.2 (3.5 to 10.9)
fHbp V28.1 (5.7 to 11.6)8.7 (6.0 to 12.7)1.2 (0.8 to 1.7)1.2 (0.8 to 1.8)
fHbp V312.0 (7.9 to 18.2)19.9 (13.1 to 30.3)1.6 (1.1 to 2.5)1.5 (0.9 to 2.3)
PrimaryPercentage 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.

Time frame:
At Day 91 (1 month after the second vaccination)
Reported as:
Number · Percentage of participants
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination
Percentage of participantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
Men A95.3 (90.2 to 98.3)93.8 (87.5 to 97.5)94.4 (88.3 to 97.9)100 (96.8 to 100)
Men C99.2 (95.7 to 100)98.2 (93.8 to 99.8)98.2 (93.5 to 99.8)98.2 (93.6 to 99.8)
Men W99.2 (95.8 to 100)99.1 (95.2 to 100)98.1 (93.5 to 99.8)99.1 (95.1 to 100)
Men Y86.8 (79.7 to 92.1)89.7 (82.6 to 94.5)89.8 (82.5 to 94.8)96.5 (91.3 to 99.0)
PrimaryPercentage 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)
Reported as:
Number · Percentage of participants
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at Pre-third Vaccination
Percentage of participantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
Men A11.6 (6.3 to 19.0)12.8 (7.2 to 20.6)9.7 (5.0 to 16.8)76.6 (67.5 to 84.3)
Men C44.7 (35.4 to 54.3)47.7 (38.1 to 57.5)54.1 (44.3 to 63.6)84.1 (75.8 to 90.5)
Men W44.7 (35.4 to 54.3)53.7 (43.8 to 63.3)34.5 (25.8 to 44.0)93.5 (87.1 to 97.4)
Men Y24.6 (17.0 to 33.5)30.3 (21.8 to 39.8)23.0 (15.6 to 31.9)88.0 (80.3 to 93.4)
PrimaryPercentage 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)
Reported as:
Number · Percentage of participants
Percentage of Participants With hSBA Titers ≥ LLOQ for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination
Percentage of participantsMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
Men A98.2 (93.8 to 99.8)99.0 (94.7 to 100)94.4 (88.2 to 97.9)99.0 (94.7 to 100)
Men C99.1 (95.2 to 100)100 (96.4 to 100)97.2 (92.0 to 99.4)99.0 (94.7 to 100)
Men W100 (96.8 to 100)100 (96.4 to 100)98.1 (93.4 to 99.8)100 (96.4 to 100)
Men Y99.1 (95.2 to 100)100 (96.4 to 100)98.2 (93.5 to 99.8)100 (96.5 to 100)
PrimaryhSBA 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.

Time frame:
At Day 91 (1 month after the second vaccination)
Reported as:
Geometric mean · Titer
hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Second Vaccination
TiterMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
Men A89.8 (74.9 to 107.5)98.1 (80.7 to 119.3)74.4 (60.8 to 91.1)266.5 (218.2 to 325.5)
Men C277.0 (228.9 to 335.3)280.1 (228.7 to 342.9)265.5 (214.6 to 328.4)233.1 (187.9 to 289.1)
Men W388.9 (320.5 to 471.8)365.5 (296.2 to 451.1)207.8 (167.1 to 258.2)226.8 (182.3 to 282.0)
Men Y51.5 (41.7 to 63.7)52.6 (42.1 to 65.8)56.7 (44.7 to 71.7)94.4 (74.7 to 119.3)
PrimaryhSBA GMTs for Each A, C, W and Y Serogroup at Pre-third Vaccination
Time frame:
At Day 301 (pre-third vaccination)
Reported as:
Geometric mean · Titer
hSBA GMTs for Each A, C, W and Y Serogroup at Pre-third Vaccination
TiterMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
Men A6.4 (5.5 to 7.5)6.7 (5.7 to 7.8)6.2 (5.3 to 7.2)37.0 (31.5 to 43.5)
Men C7.8 (6.4 to 9.6)8.3 (6.8 to 10.3)8.1 (6.6 to 10.0)25.1 (20.2 to 31.2)
Men W8.6 (7.0 to 10.7)11.9 (9.6 to 14.9)6.8 (5.4 to 8.4)54.4 (43.3 to 68.3)
Men Y6.9 (5.8 to 8.1)7.7 (6.5 to 9.1)6.5 (5.5 to 7.7)35.2 (29.6 to 41.9)
PrimaryhSBA 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)
Reported as:
Geometric mean · Titer
hSBA GMTs for Each A, C, W and Y Serogroup at 1 Month After the Third Vaccination
TiterMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
Men A133.7 (110.0 to 162.5)174.6 (142.1 to 214.6)113.8 (93.1 to 139.0)1028.1 (832.2 to 1270.0)
Men C511.0 (407.0 to 641.6)681.9 (536.7 to 866.4)487.3 (386.1 to 614.9)1356.6 (1060.5 to 1735.3)
Men W975.4 (810.2 to 1174.3)1260.8 (1034.6 to 1536.6)652.0 (537.8 to 790.4)1826.0 (1488.2 to 2240.5)
Men Y522.6 (419.5 to 651.0)601.6 (476.5 to 759.6)485.7 (387.7 to 608.5)1230.2 (969.3 to 1561.3)
PrimaryhSBA 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)
Reported as:
Geometric mean · Ratio
hSBA GMRs for Each A, C, W and Y Serogroup
RatioMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
Men A20.6 (16.3 to 26.1)25.9 (20.3 to 33.1)18.7 (14.8 to 23.7)27.1 (21.1 to 34.8)
Men C63.7 (50.5 to 80.3)85.3 (66.9 to 108.7)62.1 (49.0 to 78.6)54.7 (42.7 to 70.2)
Men W113.6 (90.5 to 142.5)109.3 (86.1 to 138.8)102.4 (81.3 to 128.9)36.5 (28.6 to 46.6)
Men Y76.3 (60.9 to 95.7)82.8 (65.4 to 104.8)78.2 (62.3 to 98.2)37.0 (29.1 to 47.0)

Adverse events

Collected over Solicited AEs: Day 1 to Day 7 after each vaccination, Unsolicited AEs: Day 1 to Day 30 after each vaccination. All-cause mortality, all SAEs, MAAEs, AEs leading to withdrawal, & AESIs: Day 1 to Day 481. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MenACWY-7B Low Dose Group0/188 (0%)17/188 (9%)186/188 (98.9%)
MenACWY-7B High Dose Group1/179 (0.6%)11/179 (6.1%)177/179 (98.9%)
ABCWY-1Gen Group1/175 (0.6%)30/175 (17.1%)173/175 (98.9%)
MenB+MenACWY-TT Group1/182 (0.5%)17/182 (9.3%)181/182 (99.5%)
Most frequent serious events
Showing 10 of 52
Most frequent serious events
EventMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
PneumoniaInfections and infestations2/1882/1794/1755/182
GastroenteritisInfections and infestations3/1880/1794/1753/182
Febrile convulsionNervous system disorders0/1884/1794/1750/182
BronchiolitisInfections and infestations2/1881/1792/1751/182
COVID-19Infections and infestations0/1880/1792/1750/182
Urinary tract infectionInfections and infestations0/1881/1792/1751/182
Bronchial obstructionRespiratory, thoracic and mediastinal disorders0/1880/1790/1752/182
Cardiopulmonary failureCardiac disorders0/1880/1791/1750/182
PyrexiaGeneral disorders0/1880/1791/1751/182
HypersensitivityImmune system disorders0/1880/1791/1750/182
Most frequent other events
Showing 10 of 293
Most frequent other events
EventMenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT Group
IrritabilityPsychiatric disorders158/188152/179144/175162/182
Administration site indurationGeneral disorders139/188118/179137/175138/182
Administration site painGeneral disorders143/188127/179125/175139/182
SomnolenceNervous system disorders111/188120/17989/175135/182
Administration site erythemaGeneral disorders126/188116/179121/175129/182
Administration site swellingGeneral disorders100/18887/17996/175119/182
PyrexiaGeneral disorders88/18885/17973/17596/182
Decreased appetiteMetabolism and nutrition disorders89/18882/17961/17596/182
DiarrhoeaGastrointestinal disorders49/18859/17952/17562/182
Upper respiratory tract infectionInfections and infestations43/18831/17948/17544/182

Baseline characteristics

Age, Continuous
Age, Continuous(DAYS)MenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT GroupTotal
Mean62.2 ± 10.762.3 ± 10.063.6 ± 10.664.5 ± 11.363.2 ± 10.7
Sex: Female, Male
Sex: Female, Male(Participants)MenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT GroupTotal
Female95978684362
Male93828998362
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)MenACWY-7B Low Dose GroupMenACWY-7B High Dose GroupABCWY-1Gen GroupMenB+MenACWY-TT GroupTotal
White133132124131520
Black or African American35293733134
Asian01023
American Indian or Alaska Native10203
Other1917121664
08

Study locations

33 sites
  • GSK Investigational Site
    Santo Domingo Este, Dominican Republic
  • GSK Investigational Site
    Espoo, 02230, Finland
  • GSK Investigational Site
    Helsinki, 00100, Finland
  • GSK Investigational Site
    Jarvenpaa, 04400, Finland
  • GSK Investigational Site
    Kokkola, 67100, Finland
  • GSK Investigational Site
    Oulu, 90220, Finland
  • GSK Investigational Site
    Seinäjoki, 60100, Finland
  • GSK Investigational Site
    Gilching, 82205, Germany
  • GSK Investigational Site
    Schönau am Königssee, 83471, Germany
  • GSK Investigational Site
    San Pedro Sula, 21101, Honduras
  • GSK Investigational Site
    Bydgoszcz, 85-048, Poland
  • GSK Investigational Site
    Krakow, 30-348, Poland
  • GSK Investigational Site
    Krakow, 30-644, Poland
  • GSK Investigational Site
    Luboń, 62-030, Poland
  • GSK Investigational Site
    Siemianowice Śląskie, 41-103, Poland
  • GSK Investigational Site
    Torun, 87-100, Poland
  • GSK Investigational Site
    Trzebnica, 55-100, Poland
  • GSK Investigational Site
    Warsaw, 02-647, Poland
  • GSK Investigational Site
    Wroclaw, 50368, Poland
  • GSK Investigational Site
    Parow Valley, 7505, South Africa
  • GSK Investigational Site
    Soweto Gauteng, 2013, South Africa
  • GSK Investigational Site
    Almería, 04120, Spain
  • GSK Investigational Site
    Burgos, 09006, Spain
  • GSK Investigational Site
    Madrid, 28040, Spain
  • GSK Investigational Site
    Madrid, 28041, Spain
  • GSK Investigational Site
    Madrid, 28046, Spain
  • GSK Investigational Site
    Madrid, 28222, Spain
  • GSK Investigational Site
    Marbella, 29600, Spain
  • GSK Investigational Site
    Málaga, 29004, Spain
  • GSK Investigational Site
    Santiago de Compostela, 15706, Spain
  • GSK Investigational Site
    Seville, 41013, Spain
  • GSK Investigational Site
    Exeter, EX2 5DW, United Kingdom
  • GSK Investigational Site
    Oxford, OX3 7LE, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.

Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Mar 2025, 40 months.

Results were first posted in Jun 2026, 1 year 2 months after primary completion.

Of 18 phase 2 interventional studies under Meningococcal Infections, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 17. This study's 40 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2021
First posted
Oct 18, 2021
StartActual
Nov 29, 2021
Primary completionActual
Mar 31, 2025
CompletionActual
Mar 31, 2025
Results first posted
Jun 26, 2026
Last update
Jun 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05082285
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Oct 18, 2021
Start date
Nov 29, 2021
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025
Results posted
Jun 26, 2026
Last update
Jun 26, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Meningococcal Infections →

Other studies from this sponsor

GlaxoSmithKline →

Start the discussion