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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 minutes after vaccination 2
Awards & highlights
Study Summary
This trial looks at the effectiveness and safety of a meningitis vaccine in adolescents, and how long the immunity from the vaccine lasts.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 minutes after vaccination 3 in group 2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 minutes after vaccination 3 in group 2
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 • NCT0313583494%
Injection site pain (PAIN AT INJECTION SITE)
66%
Fatigue
60%
Headache
38%
Myalgia (MUSCLE PAIN)
30%
Chills
29%
Arthralgia (JOINT PAIN)
28%
Swelling
27%
Erythema (REDNESS)
20%
Diarrhoea (DIARRHEA)
11%
Pyrexia (FEVER)
5%
Vomiting
5%
Upper respiratory tract infection
4%
Nasopharyngitis
3%
Gastroenteritis viral
3%
Influenza
2%
Acute sinusitis
2%
Ligament sprain
2%
Abdominal pain
2%
Pharyngitis streptococcal
2%
Gastroenteritis
2%
Sinusitis
2%
Urinary tract infection
1%
Ear infection
1%
Otitis media acute
1%
Dysmenorrhoea
1%
Otitis externa
1%
Pharyngitis
1%
Skin laceration
1%
Nausea
1%
Rhinitis allergic
1%
Anxiety
1%
Dermatitis contact
1%
Eczema
1%
Urticaria
1%
Arthralgia
1%
Constipation
1%
Bronchitis
1%
Tonsillitis
1%
Viral pharyngitis
1%
Viral upper respiratory tract infection
1%
Syncope
1%
Depression
1%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stage 1: Group 1: MenABCWY + Saline (ACWY-Naive)
Stage 2: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)
Stage 2: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
Stage 1: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
Stage 1: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)
Stage 1: Group 3: MenABCWY + Saline (ACWY-Experienced)
Stage 2: Group 1: MenABCWY + Saline (ACWY-Naive)
Stage 2: Group 3: MenABCWY + Saline (ACWY-Experienced)
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
~1050
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,565 Total Patients Enrolled
12 Trials studying Meningococcal Vaccines
25,008 Patients Enrolled for Meningococcal Vaccines
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,733 Total Patients Enrolled
11 Trials studying Meningococcal Vaccines
16,778 Patients Enrolled for Meningococcal Vaccines
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition or take medication that weakens my immune system.I have never received a meningococcal vaccine.I am not on long-term antibiotics.I have had an infection caused by Neisseria bacteria.I have a condition like MS or inflammation of the optic nerve.I am between 11 and 14 years old.I am on an experimental allergy treatment or not on a stable dose of a licensed allergy treatment.I do not have a significant neurological disorder or history of seizures, except for simple febrile seizures.I have not received blood products or immunoglobulin in the last 6 months.I am available for the study duration and can be contacted by phone.I am not pregnant, as confirmed by a urine test.I have a bleeding condition that makes injections unsafe for me.You had a severe allergic reaction to a vaccine or any part of a vaccine in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2 (MenABCWY 0-, 36-months)
- Group 2: Group 1 (MenABCWY 0-, 12-months)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many distinct venues is this trial being coordinated?
"Over 20 clinical sites have been chosen for this medical trial, including the Cincinnati Children's Hospital Medical Center in Cincinnati, Texas Health Resources of Mobile and Alliance for Multispecialty Research LLC in Orlando. The remaining locations are dispersed across the United States."
Answered by AI
Am I eligible to join this research initiative?
"This medical trial requires 300 patients aged 11-14 to have received a meningococcal vaccine. Furthermore, individuals must possess the following attributes: No prior history of any such vaccination, Male or female in this age range at randomization time, Reachable by telephone during the study duration and judged as having good health through physical examination and documentation of their medical background."
Answered by AI
Are there any available vacancies for participants in this experiment?
"According to the information on clinicialtrials.gov, this medical trial is no longer recruiting participants; its initial posting was June 17th 2020 and most recent update September 22nd 2022. Fortunately, there are two other clinical studies that are currently actively accepting patients."
Answered by AI
Does this medical research accommodate seniors aged eighty and above?
"At this time, the trial is open to those between 11 and 14 years old."
Answered by AI
Has MenABCWY met the regulatory standards set by the FDA?
"MenABCWY has been evaluated with a score of 2 as it is in Phase 2, meaning there are some clinical data points that prove safety but none to demonstrate efficacy."
Answered by AI
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