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

• ClinicalTrials.gov Identifier: NCT04440163
• Recruitment Status: Completed
• First Posted: June 19, 2020
• Results First Posted: April 18, 2023
• Last Update Posted: April 18, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Meningococcal Vaccine	Biological: MenABCWY; Biological: Saline; Biological: Trumenba; Biological: MenACWY-CRM	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2431 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY PARTICIPANTS ≥10 TO <26 YEARS OF AGE
• Actual Study Start Date: June 17, 2020
• Actual Primary Completion Date: July 24, 2022
• Actual Study Completion Date: July 24, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1-Immuno Subset (ACWY Naive,MenABCWY/Saline); ACWY Naive subjects, MenABCWY/Saline	Biological: MenABCWY; N meningitidis groups A, B, C, W, and Y vaccine; Biological: Saline; Placebo
Experimental: 2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM); ACWY Naive subjects, Trumenba/MenACWY-CRM	Biological: Trumenba; Bivalent recombinant lipoprotein 2086 vaccine; Biological: MenACWY-CRM; Meningococcal group A, C, W-135, and Y conjugate vaccine
Experimental: 3-Immuno Subset (ACWY Experienced,MenABCWY/Saline); ACWY Experienced subjects, MenABCWY/Saline	Biological: MenABCWY; N meningitidis groups A, B, C, W, and Y vaccine; Biological: Saline; Placebo
Experimental: 4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM); ACWY Experienced subjects, Trumenba/MenACWY-CRM	Biological: Trumenba; Bivalent recombinant lipoprotein 2086 vaccine; Biological: MenACWY-CRM; Meningococcal group A, C, W-135, and Y conjugate vaccine
Experimental: 5-Safety Subset (ACWY Naive,MenABCWY/Saline); ACWY Naive subjects, MenABCWY/Saline	Biological: MenABCWY; N meningitidis groups A, B, C, W, and Y vaccine; Biological: Saline; Placebo
Experimental: 6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM); ACWY Naive subjects, Trumenba/MenACWY-CRM	Biological: Trumenba; Bivalent recombinant lipoprotein 2086 vaccine; Biological: MenACWY-CRM; Meningococcal group A, C, W-135, and Y conjugate vaccine
Experimental: 7-Safety Subset (ACWY Experienced,MenABCWY/Saline); ACWY Experienced subjects, MenABCWY/Saline	Biological: MenABCWY; N meningitidis groups A, B, C, W, and Y vaccine; Biological: Saline; Placebo
Experimental: 8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM); ACWY Experienced subjects, Trumenba/MenACWY-CRM	Biological: Trumenba; Bivalent recombinant lipoprotein 2086 vaccine; Biological: MenACWY-CRM; Meningococcal group A, C, W-135, and Y conjugate vaccine

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 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 (PV) 1 evaluable immunogenicity population (EIP) for Group 2 and PV2 evaluable immunogenicity population for Group 1. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.
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 [ Time Frame: 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'.
3. 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 [ Time Frame: 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.
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 [ Time Frame: 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.
5. 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) [ Time Frame: 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-sided CI was based on the Clopper and Pearson method.
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) [ Time Frame: 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 Clopper and Pearson method.
7. 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) [ Time Frame: 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 stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.
8. 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) [ Time Frame: 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 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.
9. 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) [ Time Frame: 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.
10. 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) [ Time Frame: 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.
11. 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) [ Time Frame: 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.
12. 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) [ Time Frame: Within 30 days after Vaccination 2 ]
    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.
13. Percentage of Participants With AEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: Within 30 days after any vaccination ]
    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.
14. Percentage of Participants With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months) ]
    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.
15. Percentage of Participants With Serious Adverse Events (SAEs) 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) [ Time Frame: Within 30 days after Vaccination 1 ]
    An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
16. Percentage of Participants With SAEs 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) [ Time Frame: Within 30 days after Vaccination 2 ]
    An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
17. Percentage of Participants With SAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: Within 30 days after any vaccination ]
    An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
18. Percentage of Participants With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months) ]
    An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
19. Percentage of Participants With SAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months) ]
    An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
20. Percentage of Participants With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months) ]
    An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
21. Percentage of Participants With Medically Attended Adverse Events (MAEs) 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) [ Time Frame: Within 30 days after Vaccination 1 ]
    MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
22. Percentage of Participants With MAEs 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) [ Time Frame: Within 30 days after Vaccination 2 ]
    MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
23. Percentage of Participants With MAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: Within 30 days after any vaccination ]
    MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
24. Percentage of Participants With MAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months) ]
    MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
25. Percentage of Participants With MAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months) ]
    MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
26. Percentage of Participants With MAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months) ]
    MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
27. Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) 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) [ Time Frame: Within 30 days after Vaccination 1 ]
    An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
28. Percentage of Participants With NDCMC 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) [ Time Frame: Within 30 days after Vaccination 2 ]
    An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
29. Percentage of Participants With NDCMC Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: Within 30 Days after any vaccination ]
    An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
30. Percentage of Participants With NDCMC During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months) ]
    An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
31. Percentage of Participants With NDCMC During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months) ]
    An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
32. Percentage of Participants With NDCMC Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months) ]
    An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
33. Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: Within 30 minutes after Vaccination 1 ]
    Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.
34. Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: Within 30 minutes after Vaccination 2 ]
    Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.
35. Percentage of Participants Who Missed Days of School or Work Due to AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) [ Time Frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months) ]
    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. Percentage of participants who missed days of school or work due to AEs during vaccination phase were reported in this outcome measure.

Secondary Outcome Measures :

1. 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 [ Time Frame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1 ]
   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.
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 [ Time Frame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1 ]
   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 >=4 times 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.

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 25 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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.
• Negative urine pregnancy test for all female subjects.
• ACWY-naïve participants: Participants who have never received a prior dose of a meningococcal vaccine containing ACWY serogroups.
• ACWY-experienced participants: Participants who have received not more than 1 prior dose, no sooner than 4 years prior to the date of randomization of Menactra or Menveo.

Exclusion Criteria:

• Previous vaccination with any meningococcal group B vaccine, any purely polysaccharide (nonconjugate) meningococcal vaccine, or monovalent/bivalent meningococcal vaccine.- Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
• A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
• Significant neurological disorder or history of seizure (excluding simple febrile seizure).
• Current chronic use of systemic antibiotics.
• Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.
• Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
• History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
• Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.

Contacts and Locations

Locations

United States, Alabama

Alabama Clinical Therapeutics, LLC, Birmington Pediatric Assocaites

Birmingham, Alabama, United States, 35205

Central Research Associates, Inc.

Birmingham, Alabama, United States, 35205

United States, Arizona

Fiel Family and Sports Medicine, PC/CCT Research

Tempe, Arizona, United States, 85283

United States, California

Velocity Clinical Research (Banning)

Banning, California, United States, 92220

Madera Family Medical Group

Madera, California, United States, 93637

Center for Clinical Trials, LLC

Paramount, California, United States, 90723

Center for Clinical Trials

Paramount, California, United States, 90723

United States, Colorado

Optumcare Colorado Springs, LLC

Colorado Springs, Colorado, United States, 80922

United States, Florida

ALL Medical Research, LLC

Cooper City, Florida, United States, 33024

Alliance for MultiSpecialty Research, LLC - Miami

Coral Gables, Florida, United States, 33134

Health Awareness, Inc.

Jupiter, Florida, United States, 33458

Altus Research

Lake Worth, Florida, United States, 33461

Crystal Biomedical Research, LLC

Miami Lakes, Florida, United States, 33014

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, United States, 33014

Acevedo Clinical Research Associates

Miami, Florida, United States, 33142

Healthy Life Research, Inc.

Miami, Florida, United States, 33175

Bio-Medical Research, LLC

Miami, Florida, United States, 33184

Complete Health Research

Ormond Beach, Florida, United States, 32174

Oviedo Medical Research, LLC

Oviedo, Florida, United States, 32765

PAS Research

Tampa, Florida, United States, 33613

United States, Georgia

Tekton Research, Inc.

Chamblee, Georgia, United States, 30341

United States, Idaho

Velocity Clinical Research - Boise

Meridian, Idaho, United States, 83642

Saltzer Health

Nampa, Idaho, United States, 83686

United States, Indiana

MOC Research

Mishawaka, Indiana, United States, 46544

The South Bend Clinic Center for Research

South Bend, Indiana, United States, 46617

United States, Iowa

The Iowa Clinic

Ankeny, Iowa, United States, 50023

The Iowa Clinic

West Des Moines, Iowa, United States, 50266

United States, Kansas

Alliance for Multispecialty Research, LLC

El Dorado, Kansas, United States, 67042

Alliance for Multispecialty Research, LLC

Newton, Kansas, United States, 67114

United States, Kentucky

Michael W. Simon, MD, PSC

Lexington, Kentucky, United States, 40517

United States, Louisiana

Meridian Clinical Research, LLC

Baton Rouge, Louisiana, United States, 70806

Meridian Clinical Research, LLC

Baton Rouge, Louisiana, United States, 70809

Acorn to Oak Pediatrics - ACC Pediatric Research

Haughton, Louisiana, United States, 71037

United States, Missouri

Sundance Clinical Research, LLC

Saint Louis, Missouri, United States, 63141

United States, Nebraska

Skyline Medical Center, PC/CCT Research

Elkhorn, Nebraska, United States, 68022

Quality Clinical Research

Omaha, Nebraska, United States, 68114

United States, New York

Meridian Clinical Research, LLC

Binghamton, New York, United States, 13901

United States, North Carolina

PMG Research of Salisbury, LLC

Salisbury, North Carolina, United States, 28144

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States, 28401

Accellacare - Winston-Salem

Winston-Salem, North Carolina, United States, 27103

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States, 27103

United States, Ohio

Velocity Clinical Research - Cleveland

Cleveland, Ohio, United States, 44122

Dayton Clinical Research

Dayton, Ohio, United States, 45409

Pediatric Associates of Fairfield, Inc.

Fairfield, Ohio, United States, 45014

Senders Pediatrics

South Euclid, Ohio, United States, 44121

United States, Oklahoma

Lynn Institute of Norman

Norman, Oklahoma, United States, 73072

Tekton Research

Yukon, Oklahoma, United States, 73099

United States, Pennsylvania

Liberty Family Practice

Erie, Pennsylvania, United States, 16508

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

United States, South Carolina

Accellacare US Inc.

Mount Pleasant, South Carolina, United States, 29464

United States, Tennessee

Internal Medicine and Pediatric Associates of Bristol, PC

Bristol, Tennessee, United States, 37620

Holston Medical Group

Kingsport, Tennessee, United States, 37660

United States, Texas

Family Medicine Associates of Texas

Carrollton, Texas, United States, 75010

AIM Trials, LLC

Plano, Texas, United States, 75093

North Texas Family Medicine

Plano, Texas, United States, 75093

Tekton Research

San Antonio, Texas, United States, 78229

United States, Utah

Olympus Family Medicine/CCT Research

Holladay, Utah, United States, 84117

Pediatric Care

Provo, Utah, United States, 84604

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, United States, 84109

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, United States, 84121

J. Lewis Research, Inc. / Jordan River Family Medicine

South Jordan, Utah, United States, 84095

Czechia

SANARE s.r.o

Ceske Budejovice, Czechia, 37006

Fakultni nemocnice Hradec Kralove

Hradec Kralove, Czechia, 50005

Ordinace praktickeho lekare pro deti a dorost

Jindrichuv Hradec, Czechia, 377 01

MUDr. Katerina Stichhauerova s.r.o.

Pardubice, Czechia, 530 03

Medicentrum 6 s.r.o.

Praha 6, Czechia, 160 00

Praktik Pb s.r.o.

Pribram, Czechia, 26101

Denmark

Aarhus Universitetshospital

Aarhus N, Denmark, 8200

Hungary

DRC Gyógyszervizsgáló Központ Kft.

Balatonfüred, Hungary, 8230

ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia

Debrecen, Hungary, 4031

Coronella Orvosi Centrum / Trial Pharma Kft.

Gyula, Hungary, 5700

CRU Hungary Kft.

Miskolc, Hungary, 3529

Fejér Megyei Szent György Egyetemi Oktató Kórház

Székesfehérvár, Hungary, 8000

Poland

Centrum Badan Klinicznych JCI

Krakow, Poland, 30-348

Przylądek Zdrowia

Krakow, Poland, 30-644

Niepubliczny Zaklad Opieki Zdrowotnej "Salmed"

Leczna, Poland, 21-010

Niepubliczny Zaklad Lecznictwa Ambulatoryjnego MICHALKOWICE

Siemianowice Slaskie, Poland, 41-103

Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy

Trzebnica, Poland, 55-100

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] June 13, 2022

Statistical Analysis Plan  [PDF] July 13, 2022

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04440163
• Other Study ID Numbers: C3511001; 2019-004313-13 ( EudraCT Number )
• First Posted: June 19, 2020
• Results First Posted: April 18, 2023
• Last Update Posted: April 18, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No