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

Meningococcal Vaccine Clinical Trial

Official title:

A PHASE 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY PARTICIPANTS ≥11 TO <15 YEARS OF AGE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440176
• Other study ID #: C3511004
• Secondary ID: 2019-004923-19
• Status: Completed
• Phase: Phase 2
• Start date: June 17, 2020
• Est. completion date: January 5, 2024

Study information

• Verified date: February 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Meningococcal Vaccine

Intervention

Biological:
• MenABCWY
Neisseria meningitidis group A, B, C, W, and Y vaccine
• Saline
Placebo

Locations

Country	Name	City	State
United States	Pediatric Research of Charlottesville, LLC	Charlottesville	Virginia
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Ohio Pediatric Research Association Inc.	Dayton	Ohio
United States	Benchmark Research	Fort Worth	Texas
United States	Texas Health Resources	Fort Worth	Texas
United States	Alliance for Multispecialty Research, LLC	Kaysville	Utah
United States	Alliance for Multispecialty Research, LLC	Mobile	Alabama
United States	Wasatch Pediatrics, Cottonwood Office	Murray	Utah
United States	Velocity Clinical Research, Norfolk	Norfolk	Nebraska
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Utah Valley Pediatrics - Timpanogos Office	Orem	Utah
United States	Nona Pediatric Center	Orlando	Florida
United States	Alliance for Multispecialty Research, LLC	Roy	Utah
United States	J. Lewis Research, Inc. / Foothill Family Clinic	Salt Lake City	Utah
United States	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah
United States	Diagnostics Research Group	San Antonio	Texas
United States	California Research Foundation	San Diego	California
United States	Alliance for Multispecialty Research, LLC	South Jordan	Utah
United States	Wee Care Pediatrics	Syracuse	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains	Describe the immune response for MenB induced by 2 doses of MenABCWY administered on a 0- and 12-month schedule	1 month after second dose of MenABCWY in Group 1
Primary	Percentage of participants achieving an hSBA titer >= LLOQ for 4 primary MenB test strains	Describe the immune response for MenB induced by 2 doses of MenABCWY administered on a 0- and 36-month schedule	1 month after second dose of MenABCWY in Group 2
Primary	Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the first MenABCWY vaccination	Describe frequency of AE, SAE, MAE, and NDCMC after first dose of MenABCWY	within 30 days after first MenABCWY vaccination
Primary	Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the second MenABCWY vaccination	Describe frequency of AE, SAE, MAE, and NDCMC after second dose of MenABCWY	within 30 days after second MenABCWY vaccination
Primary	Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the placebo vaccination in Group 2	Describe frequency of AE, SAE, MAE, and NDCMC after placebo vaccination in Group 2	within 30 days after placebo vaccination in Group 2
Primary	Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after any MenABCWY vaccination	Describe frequency of AE, SAE, MAE, and NDCMC after any dose of MenABCWY	within 30 days after any MenABCWY vaccination
Primary	Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 1 vaccination phase	Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 1 vaccination phase	from Vaccination 1 through 1 month after Vaccination 1
Primary	Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 2 vaccination phase	Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 2 vaccination phase	from Vaccination 2 through 1 month after Vaccination 2
Primary	Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 3 vaccination phase in Group 2	Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 3 vaccination phase in Group 2	from Vaccination 3 through 1 month after Vaccination 3 in Group 2
Primary	Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 1 follow-up phase	Describe frequency of SAE, MAE, and NDCMC during the Vaccination 1 follow-up phase	from 1 month after Vaccination 1 through 6 months after Vaccination 1
Primary	Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 2 follow-up phase	Describe frequency of SAE, MAE, and NDCMC during the Vaccination 2 follow-up phase	from 1 month after Vaccination 2 through 6 months after Vaccination 2
Primary	Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 6 months after Vaccination 1	Describe frequency of SAE, MAE, and NDCMC within 6 months after Vaccination 1	from Vaccination 1 through 6 months after Vaccination 1
Primary	Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 6 months after Vaccination 2	Describe frequency of SAE, MAE, and NDCMC within 6 months after Vaccination 2	from Vaccination 2 through 6 months after Vaccination 2
Primary	Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 1	Describe the frequency of immediate AE after Vaccination 1	within 30 minutes after Vaccination 1
Primary	Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 2	Describe the frequency of immediate AE after Vaccination 2	within 30 minutes after Vaccination 2
Primary	Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 3 in Group 2	Describe the frequency of immediate AE after Vaccination 3 in Group 2	within 30 minutes after Vaccination 3 in Group 2
Primary	Percentage of participants reporting missed days of school or work due to adverse events within 6 months after Vaccination 1	Describe frequency of missed days of school or work due to AEs within 6 months after Vaccination 1	within 6 months after Vaccination 1
Primary	Percentage of participants reporting missed days of school or work due to adverse events within 6 months after Vaccination 2	Describe frequency of missed days of school or work due to AEs within 6 months after Vaccination 2	within 6 months after Vaccination 2
Primary	Percentage of participants reporting missed days of school or work due to adverse events within 1 month after Vaccination 3 in Group 2	Describe frequency of missed days of school or work due to AEs within 1 month after Vaccination 3 in Group 2	within 1 month after Vaccination 3 in Group 2
Secondary	Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain	Describe the immune response for ACWY induced by 1 dose of MenABCWY administered on a 0-, 12-month schedule	1 month after the first dose of MenABCWY in Group 1
Secondary	Percentage of participants in Group 2 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain	Describe the immune response for ACWY induced by 1 dose of MenABCWY administered on a 0-, 36-month schedule	1 month after the first dose of MenABCWY in Group 2
Secondary	Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain	Describe the immune response for ACWY induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule	1 month after the second dose of MenABCWY in Group 1
Secondary	Percentage of participants in Group 2 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain	Describe the immune response for ACWY induced by 2 doses of MenABCWY administered on a 0-, 36-month schedule	1 month after the second dose of MenABCWY in Group 2
Secondary	Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains	Describe the persistence of the MenB immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule	12 months after the second dose of MenABCWY in Group 1
Secondary	Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains	Describe the persistence of the MenB immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule	24 months after the second dose of MenABCWY in Group 1
Secondary	Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain	Describe the persistence of the ACWY immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule	12 months after the second dose of MenABCWY in Group 1
Secondary	Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain	Describe the persistence of the ACWY immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule	24 months after the second dose of MenABCWY in Group 1

External Links

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