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

NCT04440163 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: C35110012019-004313-13
• Study Type: interventional
• Target: 2,431
• Locations: 5 countries
• Sites: 78

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.

Conditions

Meningococcal Vaccine

Outcome Measures

Primary Outcomes (35)

• 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

  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'.

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

  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'.

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

• 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

  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.

  1 month after Vaccination 2

• 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

  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.

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

• 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)

  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.

  Within 7 days after Vaccination 1

• 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)

  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.

  Within 7 days after Vaccination 2

• 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)

  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.

  Within 7 days after Vaccination 1

• 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)

  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.

  Within 7 days after Vaccination 2

• 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)

  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.

  Within 7 days after Vaccination 1

• 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)

  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.

  Within 7 days after Vaccination 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)

  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.

  Within 30 days after Vaccination 1

• 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)

  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.

  Within 30 days after Vaccination 2

• 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)

  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.

  Within 30 days after any vaccination

• 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)

  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.

  From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)

• 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)

  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.

  Within 30 days after Vaccination 1

• 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)

  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.

  Within 30 days after Vaccination 2

• 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)

  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.

  Within 30 days after any vaccination

• 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)

  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.

  From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)

• 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)

  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.

  From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)

• 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)

  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.

  From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)

• 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)

  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.

  Within 30 days after Vaccination 1

• 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)

  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.

  Within 30 days after Vaccination 2

• 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)

  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.

  Within 30 days after any vaccination

• 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)

  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.

  From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)

• 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)

  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.

  From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)

• 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)

  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.

  From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)

• 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)

  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.

  Within 30 days after Vaccination 1

• 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)

  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.

  Within 30 days after Vaccination 2

• 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)

  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.

  Within 30 Days after any vaccination

• 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)

  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.

  From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)

• 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)

  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.

  From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)

• 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)

  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.

  From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)

• 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)

  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.

  Within 30 minutes after Vaccination 1

• 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)

  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.

  Within 30 minutes after Vaccination 2

• 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)

  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.

  From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)

Secondary Outcomes (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 1 Compared to Group 2

  Baseline (pre-vaccination on Day 1), 1 month after Vaccination 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 3 Compared to Group 4

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

Study Arms (8)

1-Immuno Subset (ACWY Naive,MenABCWY/Saline)

EXPERIMENTAL

ACWY Naive subjects, MenABCWY/Saline

Biological: MenABCWY; Biological: Saline

2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM)

EXPERIMENTAL

ACWY Naive subjects, Trumenba/MenACWY-CRM

Biological: Trumenba; Biological: MenACWY-CRM

3-Immuno Subset (ACWY Experienced,MenABCWY/Saline)

EXPERIMENTAL

ACWY Experienced subjects, MenABCWY/Saline

Biological: MenABCWY; Biological: Saline

4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM)

EXPERIMENTAL

ACWY Experienced subjects, Trumenba/MenACWY-CRM

Biological: Trumenba; Biological: MenACWY-CRM

5-Safety Subset (ACWY Naive,MenABCWY/Saline)

EXPERIMENTAL

ACWY Naive subjects, MenABCWY/Saline

Biological: MenABCWY; Biological: Saline

6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM)

EXPERIMENTAL

ACWY Naive subjects, Trumenba/MenACWY-CRM

Biological: Trumenba; Biological: MenACWY-CRM

7-Safety Subset (ACWY Experienced,MenABCWY/Saline)

EXPERIMENTAL

ACWY Experienced subjects, MenABCWY/Saline

Biological: MenABCWY; Biological: Saline

8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)

EXPERIMENTAL

ACWY Experienced subjects, Trumenba/MenACWY-CRM

Biological: Trumenba; Biological: MenACWY-CRM

Interventions

MenABCWY BIOLOGICAL

N meningitidis groups A, B, C, W, and Y vaccine

1-Immuno Subset (ACWY Naive,MenABCWY/Saline); 3-Immuno Subset (ACWY Experienced,MenABCWY/Saline); 5-Safety Subset (ACWY Naive,MenABCWY/Saline); 7-Safety Subset (ACWY Experienced,MenABCWY/Saline)

Saline BIOLOGICAL

Placebo

1-Immuno Subset (ACWY Naive,MenABCWY/Saline); 3-Immuno Subset (ACWY Experienced,MenABCWY/Saline); 5-Safety Subset (ACWY Naive,MenABCWY/Saline); 7-Safety Subset (ACWY Experienced,MenABCWY/Saline)

Trumenba BIOLOGICAL

Bivalent recombinant lipoprotein 2086 vaccine

2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM); 4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM); 6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM); 8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)

MenACWY-CRM BIOLOGICAL

Meningococcal group A, C, W-135, and Y conjugate vaccine

2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM); 4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM); 6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM); 8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (78)

Alabama Clinical Therapeutics, LLC, Birmington Pediatric Assocaites

Birmingham, Alabama, 35205, United States

Location

Central Research Associates, Inc.

Birmingham, Alabama, 35205, United States

Location

Fiel Family and Sports Medicine, PC/CCT Research

Tempe, Arizona, 85283, United States

Location

Velocity Clinical Research (Banning)

Banning, California, 92220, United States

Location

Madera Family Medical Group

Madera, California, 93637, United States

Location

Center for Clinical Trials, LLC

Paramount, California, 90723, United States

Location

Center for Clinical Trials

Paramount, California, 90723, United States

Location

Optumcare Colorado Springs, LLC

Colorado Springs, Colorado, 80922, United States

Location

ALL Medical Research, LLC

Cooper City, Florida, 33024, United States

Location

Alliance for MultiSpecialty Research, LLC - Miami

Coral Gables, Florida, 33134, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Acevedo Clinical Research Associates

Miami, Florida, 33142, United States

Location

Healthy Life Research, Inc.

Miami, Florida, 33175, United States

Location

Bio-Medical Research, LLC

Miami, Florida, 33184, United States

Location

Crystal Biomedical Research, LLC

Miami Lakes, Florida, 33014, United States

Location

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, 33014, United States

Location

Complete Health Research

Ormond Beach, Florida, 32174, United States

Location

Oviedo Medical Research, LLC

Oviedo, Florida, 32765, United States

Location

PAS Research

Tampa, Florida, 33613, United States

Location

Tekton Research, Inc.

Chamblee, Georgia, 30341, United States

Location

Velocity Clinical Research - Boise

Meridian, Idaho, 83642, United States

Location

Saltzer Health

Nampa, Idaho, 83686, United States

Location

MOC Research

Mishawaka, Indiana, 46544, United States

Location

The South Bend Clinic Center for Research

South Bend, Indiana, 46617, United States

Location

The Iowa Clinic

Ankeny, Iowa, 50023, United States

Location

The Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

Alliance for Multispecialty Research, LLC

El Dorado, Kansas, 67042, United States

Location

Alliance for Multispecialty Research, LLC

Newton, Kansas, 67114, United States

Location

Michael W. Simon, MD, PSC

Lexington, Kentucky, 40517, United States

Location

Meridian Clinical Research, LLC

Baton Rouge, Louisiana, 70806, United States

Location

Meridian Clinical Research, LLC

Baton Rouge, Louisiana, 70809, United States

Location

Acorn to Oak Pediatrics - ACC Pediatric Research

Haughton, Louisiana, 71037, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Skyline Medical Center, PC/CCT Research

Elkhorn, Nebraska, 68022, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68114, United States

Location

Meridian Clinical Research, LLC

Binghamton, New York, 13901, United States

Location

PMG Research of Salisbury, LLC

Salisbury, North Carolina, 28144, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

Accellacare - Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Velocity Clinical Research - Cleveland

Cleveland, Ohio, 44122, United States

Location

Dayton Clinical Research

Dayton, Ohio, 45409, United States

Location

Pediatric Associates of Fairfield, Inc.

Fairfield, Ohio, 45014, United States

Location

Senders Pediatrics

South Euclid, Ohio, 44121, United States

Location

Lynn Institute of Norman

Norman, Oklahoma, 73072, United States

Location

Tekton Research

Yukon, Oklahoma, 73099, United States

Location

Liberty Family Practice

Erie, Pennsylvania, 16508, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Accellacare US Inc.

Mt. Pleasant, South Carolina, 29464, United States

Location

Internal Medicine and Pediatric Associates of Bristol, PC

Bristol, Tennessee, 37620, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Family Medicine Associates of Texas

Carrollton, Texas, 75010, United States

Location

AIM Trials, LLC

Plano, Texas, 75093, United States

Location

North Texas Family Medicine

Plano, Texas, 75093, United States

Location

Tekton Research

San Antonio, Texas, 78229, United States

Location

Olympus Family Medicine/CCT Research

Holladay, Utah, 84117, United States

Location

Pediatric Care

Provo, Utah, 84604, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

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

Salt Lake City, Utah, 84121, United States

Location

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

South Jordan, Utah, 84095, United States

Location

SANARE s.r.o

České Budějovice, 37006, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, 377 01, Czechia

Location

MUDr. Katerina Stichhauerova s.r.o.

Pardubice, 530 03, Czechia

Location

Medicentrum 6 s.r.o.

Prague, 160 00, Czechia

Location

Praktik Pb s.r.o.

Příbram, 26101, Czechia

Location

Aarhus Universitetshospital

Aarhus N, 8200, Denmark

Location

DRC Gyógyszervizsgáló Központ Kft.

Balatonfüred, 8230, Hungary

Location

ClinTrial Audit Kft., Klinikai Farmakologiai Intezet, Vedooltasi Ambulancia

Debrecen, 4031, Hungary

Location

Coronella Orvosi Centrum / Trial Pharma Kft.

Gyula, 5700, Hungary

Location

CRU Hungary Kft.

Miskolc, 3529, Hungary

Location

Fejér Megyei Szent György Egyetemi Oktató Kórház

Székesfehérvár, 8000, Hungary

Location

Centrum Badan Klinicznych JCI

Krakow, 30-348, Poland

Location

Przylądek Zdrowia

Krakow, 30-644, Poland

Location

Niepubliczny Zaklad Lecznictwa Ambulatoryjnego MICHALKOWICE

Siemianowice Śląskie, 41-103, Poland

Location

Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy

Trzebnica, 55-100, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej "Salmed"

Łęczna, 21-010, Poland

Location

Related Links

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

MeSH Terms

Interventions

Sodium Chloride; MenB-FHbp vaccine; MenACWY-CRM vaccine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 19, 2020
• Study Start: June 17, 2020
• Primary Completion: July 24, 2022
• Study Completion: July 24, 2022
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

DK (1); US (61); PL (5); CZ (6); HU (5)