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Vaccine
Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age
Phase 4
Waitlist Available
Research Sponsored by Pfizer
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 30 minutes post vaccination 2 (vaccination 2 at month 6)
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
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 ~ 30 minutes post vaccination 2 (vaccination 2 at month 6)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes post vaccination 2 (vaccination 2 at month 6)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Number of Days Participants Missed School or Work Because of AEs During the Vaccination Phase
Percentage of Participants Reporting AEs During 30 Days After Any Vaccination
Percentage of Participants Reporting AEs During 30 Days After Vaccination 2
+25 moreSide effects data
From 2023 Phase 4 trial • 53 Patients • NCT0489381191%
Injection site pain (PAIN AT INJECTION SITE)
58%
Fatigue (FATIGUE)
47%
Headache (HEADACHE)
32%
Swelling (SWELLING)
30%
Myalgia (MUSCLE PAIN)
26%
Arthralgia (JOINT PAIN)
26%
Erythema (REDNESS)
21%
Chills (CHILLS)
15%
Diarrhoea (DIARRHEA)
9%
Influenza
9%
COVID-19
8%
Tonsillitis
8%
Sickle cell anaemia with crisis
6%
Back pain
4%
SARS-CoV-2 test positive
4%
Vomiting (VOMITING)
4%
Upper respiratory tract infection
4%
Viral upper respiratory tract infection
4%
Pyrexia (FEVER)
2%
Wrist fracture
2%
Urticaria
2%
Chronic sinusitis
2%
Incisional hernia
2%
Bronchiectasis
2%
Viral pharyngitis
2%
Alanine aminotransferase increased
2%
Urinary tract infection
2%
Femoral neck fracture
2%
Eye haemorrhage
2%
Periorbital swelling
2%
Abdominal pain upper
2%
Nausea
2%
Aspartate aminotransferase increased
2%
Acne
2%
Nasopharyngitis
2%
Oral herpes
2%
Pharyngitis
2%
Soft tissue injury
2%
Secondary hypertension
2%
Thermal burn
2%
Hordeolum
2%
Acute myocardial infarction
2%
Cardiac arrest
2%
Pancreatitis chronic
2%
Vocal cord polyp
2%
Vomiting
2%
Pain in extremity
2%
Rash
2%
Hyperlipidaemia
2%
Type 2 diabetes mellitus
2%
Pharyngitis streptococcal
2%
Respiratory tract infection
2%
Fall
2%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trumenba (B1971060)
Trumenba (B1971057, Historical Age- and Sex-Matched Control)
Awards & Highlights
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.
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
4,675 Previous Clinical Trials
28,717,128 Total Patients Enrolled
12 Trials studying Meningococcal Vaccines
1,331,643 Patients Enrolled for Meningococcal Vaccines
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,757,984 Total Patients Enrolled
11 Trials studying Meningococcal Vaccines
1,323,413 Patients Enrolled for Meningococcal Vaccines
Media Library
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.