A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants

NCT04645966

Last updated date
Study Location
Hospital Clínico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna, 15706, Spain
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
2-6 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Male and female participants, 2 months of age (≥60 to ≤98 days) or 6 months of age (≥150 to ≤210 days) at the time of randomization.

2. Participant's parent(s)/legal guardian who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

3. Participant is available for the entire study period and the participant's parent(s)/legal guardian can be reached by telephone.

4. Healthy participant as determined by medical history, physical examination, and judgment of the investigator.

5. Body weight ≥4 kg for participants 2 months of age at the time of randomization.

6. Participants whose parent(s)/legal guardian are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

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


1. Prior adverse reaction to paracetamol use, including allergic reactions.


2. Participant was born prematurely (<37 weeks of gestation).


3. A previous anaphylactic reaction to any vaccine or vaccine-related component.


4. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.


5. 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. Please refer to
the SRM for additional details.


6. History of microbiologically proven disease caused by N meningitidis or Neisseria
gonorrhoeae.


7. Significant neurological disorder or history of seizure (including simple febrile
seizure).


8. Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.


9. Other acute or chronic medical or psychiatric condition or laboratory abnormality that
may increase the risk of study participation or, in the investigator's judgment, make
the participant inappropriate for the study.


10. Previous vaccination with any meningococcal vaccine. Written vaccination history must
be obtained prior to randomization.


11. For participants 2 months of age, prior vaccination with any of the following licensed
or investigational vaccines: pneumococcal vaccine and hexavalent DTPa-HBV-IPV-Hib or
its component, except for the birth dose of hepatitis B vaccine.


12. Participants receiving any allergen immunotherapy with a nonlicensed product or
receiving allergen immunotherapy with a licensed product and are not on stable
maintenance doses.


13. Receipt of any blood products, including immunoglobulin, before the first study
vaccination.


14. Current chronic use of systemic antibiotics.


15. Participation in other studies involving investigational drug(s) or investigational
vaccine(s) within 28 days prior to study entry and/or during study participation.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants
Official Title  ICMJE A PHASE 2b TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY INFANTS 2 AND 6 MONTHS OF AGE
Brief Summary The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Meningococcal Vaccine
Intervention  ICMJE
  • Biological: MenABCWY
    Neisseria mengitidis groups A, B, C W, and Y vaccine
  • Biological: Bivalent rLP2086 (60-µg Dose)
    Trumenba (half dose) - Meningococcal Group B vaccine
  • Biological: Bivalent rLP2086 (120-µg Dose)
    Trumenba - Meningococcal Group B vaccine
  • Biological: Bexsero
    Bexsero - Meningococcal Group B vaccine
  • Drug: Prophylactic Liquid Paracetamol (PLP)
    PLP administration during primary vaccinations 1 and 2
  • Biological: Nimenrix
    Nimenrix - Meningococcal Group A, C, W and Y vaccine
Study Arms  ICMJE
  • Experimental: MenABCWY with PLP - 6 months of age
    Participants 6 months of age vaccinated with MenABCWY on a 2+1 (2 primary vaccinations and a booster dose) schedule, and given Prophylactic Liquid Paracetamol (PLP) during primary vaccinations.
    Interventions:
    • Biological: MenABCWY
    • Drug: Prophylactic Liquid Paracetamol (PLP)
  • Experimental: MenABCWY - 6 months of age
    Participants 6 months of age vaccinated with MenABCWY on a 2+1 schedule
    Intervention: Biological: MenABCWY
  • Experimental: Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP - 2 months of age
    Participants 2 months of age vaccinated with Bivalent rLP2086 (60-µg Dose) and Nimenrix on a 2+1 schedule, with PLP during primary vaccinations
    Interventions:
    • Biological: Bivalent rLP2086 (60-µg Dose)
    • Drug: Prophylactic Liquid Paracetamol (PLP)
    • Biological: Nimenrix
  • Experimental: Bivalent rLP2086 (60-µg Dose) and Nimenrix - 2 months of age
    Participants 2 months of age vaccinated with Bivalent rLP2086 (60-mcg Dose) and Nimenrix on a 2+1 schedule
    Interventions:
    • Biological: Bivalent rLP2086 (60-µg Dose)
    • Biological: Nimenrix
  • Experimental: Bivalent rLP2086 (120-µg Dose) and Nimenrix, with PLP - 2 months of age
    Participants 2 months of age vaccinated with Bivalent rLP2086 (120-µg Dose) and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations.
    Interventions:
    • Biological: Bivalent rLP2086 (120-µg Dose)
    • Drug: Prophylactic Liquid Paracetamol (PLP)
    • Biological: Nimenrix
  • Experimental: Bivalent rLP2086 (120-µg Dose) and Nimenrix - 2 months of age
    Participants 2 months of age vaccinated with Bivalent rLP2086 (120-µg Dose) and Nimenrix on a 2+1 schedule
    Interventions:
    • Biological: Bivalent rLP2086 (120-µg Dose)
    • Biological: Nimenrix
  • Experimental: MenABCWY with PLP - 2 months of age
    Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, and given PLP during primary vaccinations.
    Interventions:
    • Biological: MenABCWY
    • Drug: Prophylactic Liquid Paracetamol (PLP)
  • Experimental: MenABCWY - 2 months of age
    Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule
    Intervention: Biological: MenABCWY
  • Experimental: Bexsero and Nimenrix with PLP - 2 months of age
    Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations
    Interventions:
    • Biological: Bexsero
    • Drug: Prophylactic Liquid Paracetamol (PLP)
    • Biological: Nimenrix
  • Experimental: Bexsero and Nimenrix - 2 months of age
    Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule
    Interventions:
    • Biological: Bexsero
    • Biological: Nimenrix
  • Experimental: MenABCWY with / without PLP - 2 months of age
    Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, with a determined ratio of participants given or not given PLP during primary vaccinations.
    Intervention: Biological: MenABCWY
  • Experimental: Bexsero and Nimenrix with / without PLP - 2 months of age
    Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule, with a determined ratio of participants given or not given PLP during primary vaccinations
    Interventions:
    • Biological: Bexsero
    • Biological: Nimenrix
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: March 1, 2021)
1325
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2020)
550
Estimated Study Completion Date  ICMJE April 4, 2023
Estimated Primary Completion Date April 4, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female participants, 2 months of age (?60 to ?98 days) or 6 months of age (?150 to ?210 days) at the time of randomization.
  2. Participant's parent(s)/legal guardian who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
  3. Participant is available for the entire study period and the participant's parent(s)/legal guardian can be reached by telephone.
  4. Healthy participant as determined by medical history, physical examination, and judgment of the investigator.
  5. Body weight ?4 kg for participants 2 months of age at the time of randomization.
  6. Participants whose parent(s)/legal guardian are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria:

  1. Prior adverse reaction to paracetamol use, including allergic reactions.
  2. Participant was born prematurely (<37 weeks of gestation).
  3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  5. 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. Please refer to the SRM for additional details.
  6. History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
  7. Significant neurological disorder or history of seizure (including simple febrile seizure).
  8. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
  9. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  10. Previous vaccination with any meningococcal vaccine. Written vaccination history must be obtained prior to randomization.
  11. For participants 2 months of age, prior vaccination with any of the following licensed or investigational vaccines: pneumococcal vaccine and hexavalent DTPa-HBV-IPV-Hib or its component, except for the birth dose of hepatitis B vaccine.
  12. Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
  13. Receipt of any blood products, including immunoglobulin, before the first study vaccination.
  14. Current chronic use of systemic antibiotics.
  15. Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Months to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04645966
Other Study ID Numbers  ICMJE C3511002
2020-000948-60 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
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 March 2021

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