NCT04440163 is a Phase 3 clinical trial of MenABCWY in Meningococcal Vaccine, sponsored by Pfizer.

Who is sponsoring NCT04440163?

NCT04440163 is sponsored by Pfizer.

What drugs are being tested in NCT04440163?

Interventions in NCT04440163: MenABCWY, Saline, Trumenba, MenACWY-CRM.

What condition does NCT04440163 study?

NCT04440163 studies Meningococcal Vaccine.

Is NCT04440163 still recruiting?

NCT04440163 is currently completed. Last updated 18 April 2023.

Are results published for NCT04440163?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-04-18 · How we verify

NCT04440163

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age

Completed Phase 3 Results posted Last updated 18 April 2023

What this trial tests

Phase 3 trial testing MenABCWY in Meningococcal Vaccine in 2,431 participants. Completed in 24 July 2022.

Timeline

17 June 2020

Primary endpoint
24 July 2022

24 July 2022

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	prevention
Enrollment	2,431
Start date	17 June 2020
Primary completion	24 July 2022
Estimated completion	24 July 2022
Sites	78 locations across Denmark, Poland, Hungary, United States, Czechia

Drugs / interventions tested

MenABCWY (menabcwy) — full drug profile →
Saline
Trumenba (trumenba) — full drug profile →
MenACWY-CRM — full drug profile →

Conditions studied

Meningococcal Vaccine — all drugs for Meningococcal Vaccine →

Sponsor

Pfizer — full company profile →

Who can join

Adults 10 to 25, any sex, with Meningococcal Vaccine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 1 and 1 month after Vaccination 1 in Group 2

4-fold increase was defined as: 1) for participants with baseline hSBA titer below limit of detection (LOD) (or hSBA titer less than \[\<\] 1:4), 4-fold rise was defined as hSBA titer greater than or equal to (\>=) 1:16; 2) baseline hSBA titer \>=LOD and \< lower limit of quantitation (LLOQ) (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer \>=4 times LLOQ; 3) baseline hSBA titer \>=LLOQ, 4-fold rise was defined as hSBA titer \>=4 times baseline titer. Exact 2-sided confidence interval (CI) using Clopper and Pearson method was presented. Analysis was performed on post-vaccination

MenA

Group	Value	95% CI
ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)	97.8	95.9 – 98.9
ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)	95.3	91.9 – 97.5

MenC

Group	Value	95% CI
ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)	93.3	90.6 – 95.5
ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)	52.4	46.0 – 58.7

MenW

Group	Value	95% CI
ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)	97.3	95.3 – 98.6
ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)	73.0	66.9 – 78.4

MenY

Group	Value	95% CI
ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)	94.4	91.8 – 96.3
ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)	70.6	64.5 – 76.2

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 Primary · Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 3 and 1 month after Vaccination 1 in Group 4

4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer \<1:4), 4-fold rise was defined as hSBA titer \>=1:16; 2) baseline hSBA titer \>=LOD (i.e., hSBA titer of \>=1:4) and \< LLOQ (i.e., hSBA titer of 1:8), 4-fold rise was defined as hSBA titer \>=4times LLOQ; 3) baseline hSBA titer \>=LLOQ, 4-fold rise was defined as hSBA titer \>=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.

MenA

Group	Value	95% CI
ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)	93.8	90.9 – 96.0
ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)	96.9	93.7 – 98.8

MenC

Group	Value	95% CI
ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)	93.8	90.9 – 96.0
ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)	94.7	90.9 – 97.2

MenW

Group	Value	95% CI
ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)	97.1	94.8 – 98.5
ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)	96.4	93.0 – 98.4

MenY

Group	Value	95% CI
ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)	93.0	90.0 – 95.4
ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)	93.7	89.7 – 96.5

Percentage of Participants Achieving hSBA Titer Greater Than or Equal to (>=) LLOQ for All Primary Neisseria Meningitidis Group B (MenB) Test Strains Combined (Composite Response): Groups 1 and 3 Combined Versus Groups 2 and 4 Combined Primary · 1 month after Vaccination 2

Percentage of participants achieving hSBA titer \>= LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for all MenB test strains (A22, A56, B24 and B44) combined were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.

Group	Value	95% CI
Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set)	78.3	75.2 – 81.2
Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)	68.7	63.8 – 73.3

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 Primary · Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2

Percentage of participants achieving at least a 4-fold rise in hSBA titer for each primary MenB test strains (A22, A56, B24 and B44) were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.

A22

Group	Value	95% CI
Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set)	83.0	80.2 – 85.6
Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)	79.0	74.7 – 82.9

A56

Group	Value	95% CI
Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set)	95.9	94.3 – 97.2
Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)	94.5	91.8 – 96.5

B24

Group	Value	95% CI
Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set)	68.1	64.8 – 71.2
Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)	57.2	52.3 – 62.0

B44

Group	Value	95% CI
Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set)	86.5	84.0 – 88.7
Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)	79.2	75.0 – 83.0

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) Primary · Within 7 days after Vaccination 1

Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: \>2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2

Redness: Mild

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	8.8	7.5 – 10.3
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	7.3	5.4 – 9.6

Redness: Moderate

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	14.5	12.8 – 16.2
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	10.0	7.8 – 12.6

Redness: Severe

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	2.5	1.8 – 3.3
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	2.2	1.2 – 3.7

Swelling: Mild

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	10.5	9.0 – 12.0
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	8.3	6.2 – 10.7

Swelling: Moderate

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	13.3	11.7 – 15.0
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	12.4	9.9 – 15.2

Swelling: Severe

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	1.2	0.7 – 1.8
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	0.8	0.3 – 1.8

Pain at injection site: Mild

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	32.3	30.1 – 34.6
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	31.1	27.5 – 34.9

Pain at injection site: Moderate

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	49.5	47.1 – 51.9
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	47.6	43.7 – 51.6

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) Primary · Within 7 days after Vaccination 2

Local reactions included pain at injection site, redness and swelling and were recorded by participants in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: \>2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopp

Redness: Mild

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	7.7	6.4 – 9.2
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	6.6	4.7 – 9.1

Redness: Moderate

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	12.6	10.9 – 14.4
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	7.2	5.1 – 9.7

Redness: Severe

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	3.0	2.1 – 4.0
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	0.9	0.3 – 2.2

Swelling: Mild

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	10.4	8.9 – 12.1
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	6.4	4.5 – 8.9

Swelling: Moderate

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	12.8	11.1 – 14.6
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	8.1	5.9 – 10.8

Swelling: Severe

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	1.0	0.5 – 1.6
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	0.2	0.0 – 1.0

Pain at injection site: Mild

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	29.1	26.7 – 31.5
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	33.1	29.1 – 37.3

Pain at injection site: Moderate

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	48.8	46.2 – 51.4
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	40.3	36.1 – 44.6

Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) Primary · Within 7 days after Vaccination 1

Systemic events were recorded by participants in e-diary. Fever was defined as temperature \>=38.0 degrees (deg) Celsius (C) and was categorized as 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stoo

Fever: 38.0 deg C to 38.4 deg C

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	3.7	2.8 – 4.7
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	2.0	1.1 – 3.5

Fever: >38.4 deg C to 38.9 deg C

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	1.6	1.0 – 2.3
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	2.8	1.7 – 4.4

Fever: >38.9 deg C to 40.0 deg C

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	0.6	0.3 – 1.1
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	0.9	0.3 – 2.0

Fever: >40.0 deg C

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	0.0	0.0 – 0.2
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	0.0	0.0 – 0.6

Fatigue: Mild

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	23.5	21.5 – 25.5
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	25.7	22.4 – 29.3

Fatigue: Moderate

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	25.5	23.4 – 27.6
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	25.7	22.4 – 29.3

Fatigue: Severe

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	3.2	2.4 – 4.1
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	3.3	2.0 – 5.0

Headache: Mild

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	25.6	23.6 – 27.8
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	24.5	21.2 – 28.0

Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) Primary · Within 7 days after Vaccination 2

Systemic events were recorded by participants in e-diary. Fever was defined as temperature \>=38.0 deg C and was categorized as 38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C and \>40.0 deg C. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5

Fever: 38.0 deg C to 38.4 deg C

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	1.8	1.2 – 2.6
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	0.4	0.0 – 1.4

Fever: >38.4 deg C to 38.9 deg C

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	0.3	0.1 – 0.7
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	0.9	0.3 – 2.2

Fever: >38.9 deg C to 40.0 deg C

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	0.2	0.0 – 0.6
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	0.2	0.0 – 1.0

Fever: >40.0 deg C

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	0.0	0.0 – 0.3
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	0.0	0.0 – 0.7

Fatigue: Mild

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	22.8	20.7 – 25.1
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	22.0	18.5 – 25.8

Fatigue: Moderate

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	21.8	19.7 – 24.0
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	19.9	16.6 – 23.6

Fatigue: Severe

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	2.9	2.1 – 3.9
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	1.7	0.8 – 3.2

Headache: Mild

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	21.3	19.2 – 23.5
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	21.1	17.7 – 24.8

Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) Primary · Within 7 days after Vaccination 1

The use of antipyretic medication was recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	29.5	27.4 – 31.7
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	28.1	24.6 – 31.7

Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) Primary · Within 7 days after Vaccination 2

The use of antipyretic medication recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	25.1	22.9 – 27.4
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	20.5	17.1 – 24.2

Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) Primary · Within 30 days after Vaccination 1

An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	5.8	4.7 – 7.0
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	6.5	4.7 – 8.6

Percentage of Participants With AEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) Primary · Within 30 days after Vaccination 2

Group	Value	95% CI
Groups 1+3+5+7 Combined MenABCWY + Saline	5.3	4.3 – 6.6
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM	3.7	2.3 – 5.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Local reactions and systemic events recorded using systematic assessment within 7 days after Vaccination 1 and 2; SAEs and all-cause mortality recorded using non-systematic assessment from Day 1 up to 6 months after vaccination 2 (approximately 12 months) and other AEs recorded using non-systematic assessment from Day 1 up to 1 month after vaccination 2 (approximately 7 months). Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)

Serious: 6/547 (1%)

Deaths: 0/547

ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)

Serious: 1/274 (0%)

Deaths: 0/274

ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)

Serious: 3/526 (1%)

Deaths: 0/526

ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)

Serious: 2/260 (1%)

Deaths: 0/260

ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set)

Serious: 2/537 (0%)

Deaths: 0/537

ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set)

Serious: 1/56 (2%)

Deaths: 0/56

ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set)

Serious: 0/153 (0%)

Deaths: 0/153

ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set)

Serious: 0/59 (0%)

Deaths: 0/59

Serious adverse events (17 terms)

Reaction	System	ACWY-Naive: Group 1 MenABC…	ACWY-Naive: Group 2 Trumen…	ACWY-Experienced: Group 3 …	ACWY-Experienced: Group 4 …	ACWY-Naive: Group 5 MenABC…	ACWY-Naive: Group 6 Trumen…	ACWY-Experienced: Group 7 …	ACWY-Experienced: Group 8 …
Depression	Psychiatric disorders	—	—	—	—	—	—	—	—
Postural orthostatic tachycardia syndrome	Cardiac disorders	—	—	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—	—	—
Escherichia urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Gastroenteritis salmonella	Infections and infestations	—	—	—	—	—	—	—	—
Head injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Overdose	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Post procedural haemorrhage	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Spinal cord injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Tibia fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Food intolerance	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Status migrainosus	Nervous system disorders	—	—	—	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—	—	—	—
Depression suicidal	Psychiatric disorders	—	—	—	—	—	—	—	—
Disruptive mood dysregulation disorder	Psychiatric disorders	—	—	—	—	—	—	—	—
Suicide attempt	Psychiatric disorders	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—

Other adverse events (66 terms — click to expand)

Reaction	System	ACWY-Naive: Group 1 MenABC…	ACWY-Naive: Group 2 Trumen…	ACWY-Experienced: Group 3 …	ACWY-Experienced: Group 4 …	ACWY-Naive: Group 5 MenABC…	ACWY-Naive: Group 6 Trumen…	ACWY-Experienced: Group 7 …	ACWY-Experienced: Group 8 …
Injection site pain (PAIN AT INJECTION SITE)	General disorders	—	—	—	—	—	—	—	—
Fatigue (FATIGUE)	General disorders	—	—	—	—	—	—	—	—
Headache (HEADACHE)	Nervous system disorders	—	—	—	—	—	—	—	—
Myalgia (MUSCLE PAIN)	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Swelling (SWELLING)	General disorders	—	—	—	—	—	—	—	—
Erythema (REDNESS)	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Arthralgia (JOINT PAIN)	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Chills (CHILLS)	General disorders	—	—	—	—	—	—	—	—
Diarrhoea (DIARRHEA)	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Pyrexia (FEVER)	General disorders	—	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—
Vomiting (VOMITING)	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
SARS-CoV-2 test positive	Investigations	—	—	—	—	—	—	—	—
Acne	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Skin laceration	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Cerumen impaction	Ear and labyrinth disorders	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—
Pharyngitis streptococcal	Infections and infestations	—	—	—	—	—	—	—	—
Respiratory tract infection viral	Infections and infestations	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—
Viral infection	Infections and infestations	—	—	—	—	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Migraine	Nervous system disorders	—	—	—	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Depression, Postural orthostatic tachycardia syndrome, Appendicitis, Escherichia urinary tract infection, Gastroenteritis salmonella, Head injury, Overdose, Post procedural haemorrhage.

Data from ClinicalTrials.gov NCT04440163 adverse events section.

Sponsor's own description

The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10 to \<26 years of age.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Rationale for the Development of a Pentavalent Meningococcal Vaccine: A US-Focused Review.
Marshall GS, Fergie J, Presa J, Peyrani P. · · 2022 · cited 20× · PMID 35357651 · DOI 10.1007/s40121-022-00609-9
Carbohydrate based meningococcal vaccines: past and present overview.
Berti F, Romano MR, Micoli F, Adamo R. · · 2021 · cited 18× · PMID 33905086 · DOI 10.1007/s10719-021-09990-y

Verify or expand the search:

Other trials of MenABCWY

Trials testing the same drug.

NCT04645966 — A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants · Phase 2 · terminated
NCT04440176 — A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules · Phase 2 · completed
NCT03135834 — A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococ · Phase 3 · completed
NCT02212457 — Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared · Phase 2 · completed

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04440163 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 18 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04440163.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing