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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 15, 2020
First Posted Date  ICMJE June 19, 2020
Results First Submitted Date  ICMJE March 22, 2023
Results First Posted Date  ICMJE April 18, 2023
Last Update Posted Date April 18, 2023
Actual Study Start Date  ICMJE June 17, 2020
Actual Primary Completion Date July 24, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2023)
  • 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'.
  • 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'.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2020)
  • Percentage of participants achieving at least a 4-fold rise hSBA titer from baseline for each ACWY test strain - Group 1 and 2 [ Time Frame: 1 month after Vaccination 2 in Group 1 compared to 1 month after Vaccination 1 in Group 2 ]
    Demonstrate immune response for Men A, C, W, Y after 2 doses of Men ABCWY is non-inferior to immune response after 1 dose of Men ACWY-CRM in naïve participants
  • Percentage of participants achieving at least a 4-fold rise in hSBA titer from baseline for each ACWY test strain - Group 3 and 4 [ Time Frame: 1 month after Vaccination 2 in Group 3 compared to 1 month after Vaccination 1 in Group 4 ]
    Demonstrate immune response for Men A, C, W, Y after 2 doses of Men ABCWY is non-inferior to immune response after 1 dose of Men ACWY-CRM in experienced participants
  • Percentage of participants achieving an hSBA titer ≥ LLOQ for all 4 primary MenB test strains combined (composite response), in Groups 1 and 3 combined compared to Groups 2 and 4 combined [ Time Frame: 1 month after Vaccination 2 ]
    Non Inferiority of 2 doses of Men ABCWY compared to 2 doses of Trumenba
  • Percentage of participants achieving at least a 4-fold rise in hSBA titer from baseline for each of the 4 primary MenB test strains, in Groups 1 and 3 combined compared to Groups 2 and 4 combined [ Time Frame: 1 month after Vaccination 2 ]
    Non Inferiority of 2 doses of Men ABCWY compared to 2 doses of Trumenba
  • Percentage of participants reporting local reactions within 7 days after each vaccination [ Time Frame: Within 7 days after each vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting systemic events within 7 days after each vaccination [ Time Frame: Within 7 days after each vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting use of antipyretic medication within 7 days after each vaccination [ Time Frame: Within 7 days after each vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 SAE within 30 Days after each vaccination [ Time Frame: Within 30 days after each vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 SAE within 30 Days after any vaccination [ Time Frame: Within 30 days after any vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 SAE during the vaccination phase [ Time Frame: During vaccination phase (From study entry through one month after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 SAE during the follow-up phase [ Time Frame: During Follow-up phase (From one month after 2nd vaccination through 6 months after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 SAE throughout the study. [ Time Frame: Throughout the study (From study entry through 6 months after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 MAE within 30 Days after each vaccination [ Time Frame: Within 30 days after each vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 MAE within 30 Days after any vaccination [ Time Frame: Within 30 days after any vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 MAE during the vaccination phase [ Time Frame: During vaccination phase (From study entry through one month after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 MAE during the follow-up phase [ Time Frame: During Follow-up phase (From one month after 2nd vaccination through 6 months after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 MAE throughout the study. [ Time Frame: Throughout the study (From study entry through 6 months after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 NDCMC within 30 Days after each vaccination [ Time Frame: Within 30 days after each vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 NDCMC within 30 Days after any vaccination [ Time Frame: Within 30 days after any vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 NDCMC during the vaccination phase [ Time Frame: During vaccination phase (From study entry through one month after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 NDCMC during the follow-up phase [ Time Frame: During Follow-up phase (From one month after 2nd vaccination through 6 months after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 NDCMC throughout the study. [ Time Frame: Throughout the study (From study entry through 6 months after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 AE 30 Days after each vaccination [ Time Frame: Within 30 days after each vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 AE 30 Days after any vaccination [ Time Frame: Within 30 days after any vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 AE during the vaccination phase [ Time Frame: During vaccination phase (From study entry through one month after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 immediate AE [ Time Frame: Throughout the study (From the time of vaccine administration until 30 minutes post vaccine administration) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants who missed days of school or work because of AEs [ Time Frame: Throughout the study (From study entry through 6 months after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2023)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2020)
  • Percentage of participants achieving at least a 4-fold rise in hSBA titer from baseline for each ACWY test strain in Group 1 compared to Group 2. [ Time Frame: 1 month after Vaccination 1 ]
    Non-inferiority of immune response after 1 dose of Men ABCWY compared to 1 dose of Men ACWY-CRM in naïve participants
  • Percentage of participants achieving at least a 4-fold rise in hSBA titer from baseline for each ACWY test strain in Group 3 compared to Group 4. [ Time Frame: 1 month after Vaccination 1 ]
    Non-inferiority of immune response after 1 dose of Men ABCWY compared to 1 dose of Men ACWY-CRM in Experienced participants
  • Percentage of participants achieving an hSBA titer ≥ LLOQ for each secondary MenB test strain in Groups 1 and 3 combined [ Time Frame: At baseline and 1 month after Vaccination 2 ]
    Immune response for MenB, induced by 2 doses of MenABCWY
  • Percentage of participants with hSBA titers ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for each secondary MenB test strain in Groups 1 and 3 combined [ Time Frame: At baseline and 1 month after Vaccination 2 ]
    Immune response for MenB, induced by 2 doses of MenABCWY
  • hSBA GMTs for the secondary MenB test strains in Groups 1 and 3 combined [ Time Frame: At baseline and 1 month after Vaccination 2 ]
    Immune response for MenB, induced by 2 doses of MenABCWY
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Meningococcal Vaccine
Intervention  ICMJE
  • Biological: MenABCWY
    N meningitidis groups A, B, C, W, and Y vaccine
  • Biological: Saline
    Placebo
  • Biological: Trumenba
    Bivalent recombinant lipoprotein 2086 vaccine
  • Biological: MenACWY-CRM
    Meningococcal group A, C, W-135, and Y conjugate vaccine
Study Arms  ICMJE
  • Experimental: 1-Immuno Subset (ACWY Naive,MenABCWY/Saline)
    ACWY Naive subjects, MenABCWY/Saline
    Interventions:
    • Biological: MenABCWY
    • Biological: Saline
  • Experimental: 2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM)
    ACWY Naive subjects, Trumenba/MenACWY-CRM
    Interventions:
    • Biological: Trumenba
    • Biological: MenACWY-CRM
  • Experimental: 3-Immuno Subset (ACWY Experienced,MenABCWY/Saline)
    ACWY Experienced subjects, MenABCWY/Saline
    Interventions:
    • Biological: MenABCWY
    • Biological: Saline
  • Experimental: 4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM)
    ACWY Experienced subjects, Trumenba/MenACWY-CRM
    Interventions:
    • Biological: Trumenba
    • Biological: MenACWY-CRM
  • Experimental: 5-Safety Subset (ACWY Naive,MenABCWY/Saline)
    ACWY Naive subjects, MenABCWY/Saline
    Interventions:
    • Biological: MenABCWY
    • Biological: Saline
  • Experimental: 6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM)
    ACWY Naive subjects, Trumenba/MenACWY-CRM
    Interventions:
    • Biological: Trumenba
    • Biological: MenACWY-CRM
  • Experimental: 7-Safety Subset (ACWY Experienced,MenABCWY/Saline)
    ACWY Experienced subjects, MenABCWY/Saline
    Interventions:
    • Biological: MenABCWY
    • Biological: Saline
  • Experimental: 8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)
    ACWY Experienced subjects, Trumenba/MenACWY-CRM
    Interventions:
    • Biological: Trumenba
    • Biological: MenACWY-CRM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 29, 2022)		 2431
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2020)		 2413
Actual Study Completion Date  ICMJE July 24, 2022
Actual Primary Completion Date July 24, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Denmark,   Hungary,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04440163
Other Study ID Numbers  ICMJE C3511001
2019-004313-13 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP