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Vaccine

MenABCWY for Meningococcal Vaccines

Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes after vaccination 2
Awards & highlights

Study Summary

This trial is examining the safety and effectiveness of two doses of Trumenba, given six months apart, for preventing bacterial meningitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes after vaccination 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes after vaccination 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)
Stage1: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= Lower Limit of Quantitation (LLOQ) for All 4 Primary Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined)
Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)
+45 more
Secondary outcome measures
Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase: Group 1 and Group 3
Stage1: Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MenB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MenB Strains Combined) From Baseline-1 Month After Vaccination 2 (Group 1 and 3 Combined;Group 2 and 4 Combined)
Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 1: Group 1 and Group 3
+54 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4 (ACWY Experienced subjects, rLP2086/MenACWY-CRM)Experimental Treatment2 Interventions
ACWY Experienced subjects, rLP2086/MenACWY-CRM
Group II: Group 3 (ACWY Experienced subjects, MenABCWY/Saline)Experimental Treatment2 Interventions
ACWY Experienced subjects, MenABCWY/Saline
Group III: Group 2 (ACWY Naive subjects, rLP2086/MenACWY-CRM)Experimental Treatment2 Interventions
ACWY Naive subjects, rLP2086/MenACWY-CRM
Group IV: Group 1 (ACWY Naive subjects, MenABCWY/Saline)Experimental Treatment2 Interventions
ACWY Naive subjects, MenABCWY/Saline
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
rLP2086
2013
Completed Phase 3
~11900
MenACWY-CRM
2008
Completed Phase 4
~67860

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,566 Previous Clinical Trials
10,906,313 Total Patients Enrolled
12 Trials studying Meningococcal Vaccines
23,707 Patients Enrolled for Meningococcal Vaccines
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,473 Previous Clinical Trials
8,087,481 Total Patients Enrolled
11 Trials studying Meningococcal Vaccines
15,477 Patients Enrolled for Meningococcal Vaccines

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
2017. "A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03135834.
~203 spots leftby Apr 2025
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