A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules

NCT04440176 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: C35110042019-004923-19
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 20

Brief Summary

This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval.

Conditions

Meningococcal Vaccine

Keywords

pentavalent meningococcal vaccine

Outcome Measures

Primary Outcomes (46)

• Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MenB) Test Strains at Baseline: 0 and 12 Month Schedule

  Percentage of participants achieving hSBA titer \>=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at baseline were reported in this outcome measure. Here, 'Post Vaccination 2 Evaluable Population'=PV2 EP and "Number analyzed" = number of participants evaluable at specific rows.

  Baseline (before vaccination 1)

• Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 2: 0 and 12 Month Schedule

  Percentage of participants achieving hSBA titer \>=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at 1 month after vaccination 2 in participants who received MenABCWY at Month 0 and Month 12 were reported in this outcome measure. "Number analyzed" = number of participants evaluable at specific rows.

  1 month after vaccination 2 (second dose of MenABCWY)

• Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at Baseline: 0 and 36 Month Schedule

  Percentage of participants achieving hSBA titer \>=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at baseline were reported in this outcome measure. "Number of Participants Analyzed"= number of participants evaluable for this outcome measure and "Number analyzed" = number of participants evaluable at specific rows.

  Baseline (before vaccination 1)

• Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 3: 0 and 36 Month Schedule

  Percentage of participants achieving hSBA titer \>=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at 1 month after vaccination 3 (second dose of MenABCWY) in participants who received MenABCWY at Month 0 and Month 36. "Number of Participants Analyzed"= number of participants evaluable for this outcome measure and "Number analyzed" = number of participants evaluable at specific rows.

  1 Month After Vaccination 3 (second dose of MenABCWY)

• Percentage of Participants Reporting Adverse Events (AEs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule

  An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.

  Within 30 days after vaccination 1 (first dose of MenABCWY)

• Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule

  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. AEs included both serious and all non-serious adverse events.

  Within 30 days after vaccination 2 (second dose of MenABCWY)

• Percentage of Participants Reporting AEs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule

  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. AEs included both serious and all non-serious adverse events.

  Within 30 days after vaccination 1 (first dose of MenABCWY)

• Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule

  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. AEs included both serious and all non-serious adverse events.

  Within 30 days after vaccination 2 (saline)

• Percentage of Participants Reporting AEs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule

  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. AEs included both serious and all non-serious adverse events.

  Within 30 days after vaccination 3 (second dose of MenABCWY)

• Percentage of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Newly Diagnosed Chronic Medical Condition (NDCMCs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule

  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. 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. An MAE was defined as a non-serious AE (other than serious AE) that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  Within 30 days after vaccination 1 (First dose of MenABCWY)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  Within 30 days after vaccination 2 (Second dose of MenABCWY)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  Within 30 days after vaccination 1 (First dose of MenABCWY)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  Within 30 days after vaccination 2 (Saline)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  Within 30 days after vaccination 3 (Second dose of MenABCWY)

• Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule

  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. AEs included both serious and all non-serious adverse events.

  Within 30 Days after any MenABCWY vaccination

• Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule

  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. AEs included both serious and all non-serious adverse events.

  Within 30 days after any MenABCWY vaccination

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  Within 30 days after any MenABCWY vaccination

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  Within 30 days after any MenABCWY vaccination

• Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule

  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. AEs included both serious and all non-serious adverse events.

  From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)

• Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule

  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. AEs included both serious and all non-serious adverse events.

  Vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)

• Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule

  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. AEs included both serious and all non-serious adverse events.

  From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY)

• Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule

  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. AEs included both serious and all non-serious adverse events.

  From vaccination 2 through 1 month after vaccination 2 (Saline)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From vaccination 2 through 1 month after vaccination 2 (Saline)

• Percentage of Participants Reporting AEs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule

  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. AEs included both serious and all non-serious adverse events.

  From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From 1 month after vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From 1 month after vaccination 2 through 6 months after vaccination 2 (Saline)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY)

• Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule

  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. 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. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  From vaccination 2 through 6 months after vaccination 2 (Saline)

• Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 12 Month Schedule

  Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.

  30 minutes after vaccination 1 (First dose of MenABCWY)

• Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 12 Month Schedule

  Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.

  30 minutes after vaccination 2 (Second dose of MenABCWY)

• Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 36 Month Schedule

  Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.

  30 minutes after vaccination 1 (First dose of MenABCWY)

• Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 36 Month Schedule

  Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.

  30 minutes after vaccination 2 (Saline)

• Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 3: 0 and 36 Month Schedule

  Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.

  30 minutes after vaccination 3 (Second dose of MenABCWY)

• Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 12 Month Schedule

  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.

  Within 6 months after vaccination 1 (First dose of MenABCWY)

• Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 36 Month Schedule

  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.

  Within 6 months after vaccination 1 (First dose of MenABCWY)

• Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 12 Month Schedule

  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.

  Within 6 months after vaccination 2 (Second dose of MenABCWY)

• Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 36 Month Schedule

  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.

  Within 6 months after vaccination 2 (Saline)

• Percentage of Participants Who Missed School or Work Because of AEs Within 1 Month After Vaccination 3: 0 and 36 Month Schedule

  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.

  Within 1 month after vaccination 3 (Second dose of MenABCWY)

Secondary Outcomes (6)

• Percentage of Participants With hSBA Titer >= LLOQ for Each of the Meningococcal Group A, C, W, and Y (MenACWY) Test Strains at Baseline and 1 Month After the First Dose of MenABCWY: 0 and 12 Month Schedule-Post-Vaccination 1 Evaluable Population

  Baseline (before vaccination 1) and 1 month after the first dose of MenABCWY

• Percentage of Participants With hSBA Titer >= LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After the Second Dose of MenABCWY: 0 and 12 Month Schedule-Post-Vaccination 2 Evaluable Population

  Baseline (before vaccination 1) and 1 month after the second dose of MenABCWY

• Percentage of Participants With hSBA Titer >=LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After First Dose of MenABCWY: 0 and 36 Month Schedule-Post-Vaccination 1 Evaluable Population

  Baseline (before vaccination 1) and 1 month after first dose of MenABCWY

• Percentage of Participants With hSBA Titer >=LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After Second Dose of MenABCWY: 0 and 36 Month Schedule-Post-Vaccination 2 Evaluable Population

  Baseline (before vaccination 1) and 1 month after second dose of MenABCWY

• Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 12 Months and 24 Months After Vaccination 2: 0 and 12 Month Schedule

  At 12 months and 24 months after vaccination 2 (Second dose of MenABCWY)

Study Arms (2)

Group 1 (MenABCWY 0-, 12-months)

EXPERIMENTAL

MenABCWY administered at Month 0 and Month 12

Biological: MenABCWY

Group 2 (MenABCWY 0-, 36-months)

EXPERIMENTAL

MenABCWY administered at Month 0 and Month 36

Biological: MenABCWY; Biological: Saline

Interventions

MenABCWY BIOLOGICAL

Neisseria meningitidis group A, B, C, W, and Y vaccine

Also known as: pentavalent meningococcal vaccine

Group 1 (MenABCWY 0-, 12-months); Group 2 (MenABCWY 0-, 36-months)

Saline BIOLOGICAL

Placebo

Group 2 (MenABCWY 0-, 36-months)

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female participants 11 through \<15 years of age at the time of randomization.
• Participants who have never received a prior dose of any meningococcal vaccine. Written confirmation of vaccination history must be obtained prior to randomization.
• Available for the entire study period and can be reached by telephone.
• Healthy participant as determined by medical history, physical examination, and judgement of the investigator.
• Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants.

You may not qualify if:

• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
• A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy.
• History of microbiologically proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
• Significant neurological disorder or history of seizure (excluding simple febrile seizure).
• Any neuroinflammatory or autoimmune condition, including, but no limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
• Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
• Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
• Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date of enrollment (first vaccination).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (20)

AMR Clinical

Mobile, Alabama, 36608, United States

Location

California Research Foundation

San Diego, California, 92123, United States

Location

Nona Pediatric Center

Orlando, Florida, 32829, United States

Location

Velocity Clinical Research, Norfolk

Norfolk, Nebraska, 68701, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45206, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Ohio Pediatric Research Association Inc.

Dayton, Ohio, 45414, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

Texas Health Resources

Fort Worth, Texas, 76135, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

Wee Care Pediatrics

Kaysville, Utah, 84037, United States

Location

Wasatch Pediatrics, Cottonwood Office

Murray, Utah, 84107, United States

Location

Utah Valley Pediatrics - Timpanogos Office

Orem, Utah, 84057, United States

Location

AMR Clinical

Roy, Utah, 84067, 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

AMR Clinical

South Jordan, Utah, 84095, United States

Location

Wee Care Pediatrics

Syracuse, Utah, 84075, United States

Location

Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, 22902, United States

Location

Related Publications (1)

• Jones JC, Tipton MD, Zolotas L, Maguire JD, Belanger K, Liu Y, Maansson R, O'Neill RE, Balmer P, Peyrani P, Beeslaar J. Immunogenicity and Safety of Extended Dosing Intervals for Pfizer Pentavalent MenABCWY Meningococcal Vaccination in Healthy Adolescents: Results from a Randomized, Phase 2b Study. Vaccines (Basel). 2026 Apr 15;14(4):352. doi: 10.3390/vaccines14040352.

  PMID: 42042828 DERIVED

Related Links

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

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pfizer Clinical Trials.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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• 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: January 5, 2024
• Study Completion: January 5, 2024
• Last Updated: April 27, 2026
• Results First Posted: January 8, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (20)