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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 7 days after each vaccination.
Awards & highlights
Summary
This trial aims to test the safety and effectiveness of a vaccine in people aged 10 and older who have weakened immune systems due to lack of a spleen or complement deficiencies. The vaccine helps their bodies produce antibodies to better fight meningococcal bacteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 7 days after each vaccination.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 7 days after each vaccination.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
1. The percentage of participants with serum bactericidal assay using human complement (hSBA) titer ≥ lower limit of quantitation (LLOQ) for each of the 4 primary Neisseria meningitidis serogroup B (MnB) test strains.
10. Percentage of participants with at least 1 SAE within 30 Days after any vaccination.
11. Percentage of participants with at least 1 SAE during the vaccination phase.
+19 moreSide effects data
From 2022 Phase 3 trial • 2431 Patients • NCT0444016395%
Injection site pain (PAIN AT INJECTION SITE)
67%
Fatigue (FATIGUE)
60%
Headache (HEADACHE)
36%
Myalgia (MUSCLE PAIN)
34%
Swelling (SWELLING)
33%
Erythema (REDNESS)
29%
Arthralgia (JOINT PAIN)
28%
Chills (CHILLS)
13%
Diarrhoea (DIARRHEA)
8%
Pyrexia (FEVER)
4%
Vomiting (VOMITING)
4%
COVID-19
2%
Upper respiratory tract infection
1%
Skin laceration
1%
Nausea
1%
Nasopharyngitis
1%
Pharyngitis
1%
Respiratory tract infection viral
1%
Tonsillitis
1%
Viral upper respiratory tract infection
1%
Fall
1%
SARS-CoV-2 test positive
1%
Anxiety
1%
Rhinitis allergic
100%
80%
60%
40%
20%
0%
Study treatment Arm
ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)
ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set)
ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set)
ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set)
ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set)
ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Bivalent recombinant lipoprotein 2086 vaccine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trumenba
2021
Completed Phase 4
~2490
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,625 Previous Clinical Trials
14,284,141 Total Patients Enrolled
12 Trials studying Meningococcal Vaccines
1,331,643 Patients Enrolled for Meningococcal Vaccines
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,518 Previous Clinical Trials
11,458,717 Total Patients Enrolled
11 Trials studying Meningococcal Vaccines
1,323,413 Patients Enrolled for Meningococcal Vaccines
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition that causes inflammation or an overactive immune system, such as multiple sclerosis, optic neuritis or uveitis.You have a medical or mental condition that could make it risky for you to participate in the study, or you have had thoughts of hurting yourself in the past year.You have already received a vaccine for meningococcal serogroup B in the past.You have a serious neurological disorder or a history of seizures, except for simple febrile seizures.You are currently taking antibiotics for a long period of time.You have a higher risk of getting meningococcal disease because of a condition that affects your immune system or certain blood disorders.You have participated in another study that involves testing new drugs within the past 28 days, or plan to participate in one during the current study.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
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