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

NCT04440176

Last updated date
Study Location
Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
11-14 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Meningococcal Vaccine
Intervention  ICMJE
  • Biological: MenABCWY
    Neisseria meningitidis group A, B, C, W, and Y vaccine
    Other Name: pentavalent meningococcal vaccine
  • Biological: Saline
    Placebo
Study Arms  ICMJE
  • Experimental: Group 1 (MenABCWY 0-, 12-months)
    MenABCWY administered at Month 0 and Month 12
    Intervention: Biological: MenABCWY
  • Experimental: Group 2 (MenABCWY 0-, 36-months)
    MenABCWY administered at Month 0 and Month 36
    Interventions:
    • Biological: MenABCWY
    • Biological: Saline
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 17, 2024
Estimated Primary Completion Date March 17, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 11 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04440176
Other Study ID Numbers  ICMJE C3511004
2019-004923-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2021

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