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Vaccine

MenABCWY Vaccine for Meningococcal Disease Prevention

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who have never received a prior dose of any meningococcal vaccine. Written confirmation of vaccination history must be obtained prior to randomization
Male or female participants 11 through <15 years of age at the time of randomization
Must not have
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection
Significant neurological disorder or history of seizure (excluding simple febrile seizure)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 minutes after vaccination 2
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a vaccine for meningitis in adolescents. The vaccine helps the body build defenses against five types of bacteria that cause meningitis.

Who is the study for?
This trial is for healthy boys and girls aged 11 to less than 15 who haven't had a meningococcal vaccine before. They must be available for the whole study, reachable by phone, and not pregnant. They can't join if they have bleeding issues, unstable allergies, are on certain immune system drugs or antibiotics, have had meningitis or similar diseases, neurological disorders or seizures (except simple febrile seizure), received blood products recently, had severe reactions to vaccines before, or have autoimmune conditions.
What is being tested?
The trial tests two schedules of the MenABCWY vaccine against meningitis: one group gets two doses with a gap of either 12 months or another with a gap of 36 months. The safety and body's defense response right after vaccination and up to 24 months later are being studied.
What are the potential side effects?
Possible side effects from the MenABCWY vaccine may include pain at injection site, fever, fatigue, headache and muscle pain. These are common responses to vaccines as the body builds immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never received a meningococcal vaccine.
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I am between 11 and 14 years old.
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I am not pregnant, as confirmed by a urine test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a bleeding condition that makes injections unsafe for me.
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I do not have a significant neurological disorder or history of seizures, except for simple febrile seizures.
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I have a condition like MS or inflammation of the optic nerve.
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I have not received blood products or immunoglobulin in the last 6 months.
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I am not on long-term antibiotics.
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I have had an infection caused by Neisseria bacteria.
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I am on an experimental allergy treatment or not on a stable dose of a licensed allergy treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 minutes after vaccination 3 in group 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 minutes after vaccination 3 in group 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of participants achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains
Percentage of participants achieving an hSBA titer >= LLOQ for 4 primary MenB test strains
Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 1 vaccination phase
+16 more
Secondary study objectives
Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains
Complement System Proteins
Percentage of participants in Group 2 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain

Side effects data

From 2022 Phase 3 trial • 1610 Patients • NCT03135834
68%
Injection site pain (PAIN AT INJECTION SITE)
51%
Fatigue
42%
Headache
19%
Erythema (REDNESS)
18%
Myalgia (MUSCLE PAIN)
14%
Swelling
12%
Arthralgia (JOINT PAIN)
11%
Chills
10%
Diarrhoea (DIARRHEA)
4%
SARS-CoV-2 test positive
3%
COVID-19
1%
Abortion spontaneous
1%
Oropharyngeal pain
1%
Vomiting
1%
Eye injury
1%
Psychophysiologic insomnia
1%
Pyrexia (FEVER)
1%
Skin laceration
1%
Scoliosis
1%
Haematoma
1%
Psychotic disorder
1%
Abdominal pain
1%
Pain
1%
Upper respiratory tract infection
1%
Urinary tract infection
1%
Depression
1%
Dysmenorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stage 2: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
Stage 1: Group 1: MenABCWY + Saline (ACWY-Naive)
Stage 1: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)
Stage 1: Group 3: MenABCWY + Saline (ACWY-Experienced)
Stage 1: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
Stage 2: Group 1: MenABCWY + Saline (ACWY-Naive)
Stage 2: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)
Stage 2: Group 3: MenABCWY + Saline (ACWY-Experienced)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2 (MenABCWY 0-, 36-months)Experimental Treatment2 Interventions
MenABCWY administered at Month 0 and Month 36
Group II: Group 1 (MenABCWY 0-, 12-months)Experimental Treatment1 Intervention
MenABCWY administered at Month 0 and Month 12
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MenABCWY
2017
Completed Phase 3
~5720
Saline
2013
Completed Phase 4
~2130

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Meningococcal vaccines, such as the MenABCWY vaccine, work by introducing inactivated or subunit components of Neisseria meningitidis groups A, B, C, W, and Y to the immune system. These components stimulate the body to produce specific antibodies against these bacterial groups without causing disease. This immune response prepares the body to recognize and fight off actual infections if exposed in the future. For patients, this is crucial as it provides broad protection against multiple strains of meningococcal bacteria, significantly reducing the risk of severe infections like meningitis and septicemia.
Seasonal upsurge of pneumococcal meningitis in the Central African Republic.

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,669 Previous Clinical Trials
17,861,615 Total Patients Enrolled
12 Trials studying Meningococcal Vaccines
1,331,387 Patients Enrolled for Meningococcal Vaccines
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,902,617 Total Patients Enrolled
11 Trials studying Meningococcal Vaccines
1,323,157 Patients Enrolled for Meningococcal Vaccines

Media Library

MenABCWY (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04440176 — Phase 2
Meningococcal Vaccines Research Study Groups: Group 2 (MenABCWY 0-, 36-months), Group 1 (MenABCWY 0-, 12-months)
Meningococcal Vaccines Clinical Trial 2023: MenABCWY Highlights & Side Effects. Trial Name: NCT04440176 — Phase 2
MenABCWY (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04440176 — Phase 2
~57 spots leftby Dec 2025