← Back to Search

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
Male or female subject aged >=10 and <26 years at the time of randomization.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 minutes after vaccination 1
Awards & highlights

Study Summary

This trial is comparing the safety and effectiveness of a new vaccine to two existing vaccines for people ages 10-26.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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

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 At Least 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer From Baseline for Each MenACWY Strains: 1 Month After Vaccination 2 in Group 1 Compared to 1 Month After Vaccination 1 in Group 2
Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 3 Compared to 1 Month After Vaccination 1 in Group 4
Percentage of Participants Achieving At Least a 4-Fold Rise in hSBA Titer From Baseline For Each Primary MenB Test Strains at 1 Month After Vaccination 2: Groups 1 and 3 Combined Versus Groups 2 and 4 Combined
+32 more
Secondary outcome measures
Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 1 Compared to Group 2
Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 3 Compared to Group 4

Side effects data

From 2022 Phase 3 trial • 1610 Patients • NCT03135834
94%
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%
Upper respiratory tract infection
5%
Vomiting
4%
Nasopharyngitis
3%
Gastroenteritis viral
3%
Influenza
2%
Abdominal pain
2%
Gastroenteritis
2%
Ligament sprain
2%
Pharyngitis streptococcal
2%
Acute sinusitis
2%
Sinusitis
2%
Urinary tract infection
1%
Otitis externa
1%
Otitis media acute
1%
Ear infection
1%
Pharyngitis
1%
Rhinitis allergic
1%
Skin laceration
1%
Dysmenorrhoea
1%
Nausea
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 1: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
Stage 2: Group 1: MenABCWY + Saline (ACWY-Naive)
Stage 2: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)
Stage 2: Group 3: MenABCWY + Saline (ACWY-Experienced)
Stage 1: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)
Stage 2: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)
Stage 1: Group 3: MenABCWY + Saline (ACWY-Experienced)

Trial Design

8Treatment groups
Experimental Treatment
Group I: 8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)Experimental Treatment2 Interventions
ACWY Experienced subjects, Trumenba/MenACWY-CRM
Group II: 7-Safety Subset (ACWY Experienced,MenABCWY/Saline)Experimental Treatment2 Interventions
ACWY Experienced subjects, MenABCWY/Saline
Group III: 6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM)Experimental Treatment2 Interventions
ACWY Naive subjects, Trumenba/MenACWY-CRM
Group IV: 5-Safety Subset (ACWY Naive,MenABCWY/Saline)Experimental Treatment2 Interventions
ACWY Naive subjects, MenABCWY/Saline
Group V: 4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM)Experimental Treatment2 Interventions
ACWY Experienced subjects, Trumenba/MenACWY-CRM
Group VI: 3-Immuno Subset (ACWY Experienced,MenABCWY/Saline)Experimental Treatment2 Interventions
ACWY Experienced subjects, MenABCWY/Saline
Group VII: 2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM)Experimental Treatment2 Interventions
ACWY Naive subjects, Trumenba/MenACWY-CRM
Group VIII: 1-Immuno Subset (ACWY Naive,MenABCWY/Saline)Experimental Treatment2 Interventions
ACWY Naive subjects, MenABCWY/Saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MenACWY-CRM
2008
Completed Phase 4
~67860
Saline
2013
Completed Phase 4
~1050
Trumenba
2021
Completed Phase 4
~2490
MenABCWY
2017
Completed Phase 3
~5720

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,559 Previous Clinical Trials
10,905,445 Total Patients Enrolled
12 Trials studying Meningococcal Vaccines
22,886 Patients Enrolled for Meningococcal Vaccines
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,470 Previous Clinical Trials
8,086,930 Total Patients Enrolled
11 Trials studying Meningococcal Vaccines
14,656 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.
~512 spots leftby Mar 2025