A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants
NCT ID: NCT04645966
Last Updated: 2024-03-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
326 participants
INTERVENTIONAL
2020-11-26
2022-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Study Groups
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MenABCWY with PLP - 6 months of age
Group 1 - 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.
MenABCWY
Neisseria meningitis groups A, B, C W, and Y vaccine
Prophylactic Liquid Paracetamol (PLP)
PLP administration during primary vaccinations 1 and 2
MenABCWY - 6 months of age
Group 2 - Participants 6 months of age vaccinated with MenABCWY on a 2+1 schedule
MenABCWY
Neisseria meningitis groups A, B, C W, and Y vaccine
Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP or SLP - 2 months of age
Group 3 - Participants 2 months of age vaccinated with Bivalent rLP2086 (60-µg Dose) and Nimenrix on a 2+1 schedule, with PLP or Scheduled Liquid Pracetamol (SLP) during primary vaccinations.
Bivalent rLP2086 (60-µg Dose)
Trumenba (half dose) - Meningococcal Group B vaccine
Prophylactic Liquid Paracetamol (PLP)
PLP administration during primary vaccinations 1 and 2
Nimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine
Scheduled Liquid Paracetamol (SLP)
SLP administration after primary vaccinations 1 and 2.
Bivalent rLP2086 (60-µg Dose) and Nimenrix - 2 months of age
Group 4 - Participants 2 months of age vaccinated with Bivalent rLP2086 (60-mcg Dose) and Nimenrix on a 2+1 schedule
Bivalent rLP2086 (60-µg Dose)
Trumenba (half dose) - Meningococcal Group B vaccine
Nimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine
Bivalent rLP2086 (120-µg Dose) and Nimenrix, with PLP - 2 months of age
Group 5 - 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.
Bivalent rLP2086 (120-µg Dose)
Trumenba - Meningococcal Group B vaccine
Prophylactic Liquid Paracetamol (PLP)
PLP administration during primary vaccinations 1 and 2
Nimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine
MenABCWY with SLP - 2 months of age
Group 7 - Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, and given SLP during primary vaccinations.
MenABCWY
Neisseria meningitis groups A, B, C W, and Y vaccine
Scheduled Liquid Paracetamol (SLP)
SLP administration after primary vaccinations 1 and 2.
Bexsero and Nimenrix with PLP - 2 months of age
Group 8 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations
Bexsero
Bexsero - Meningococcal Group B vaccine
Prophylactic Liquid Paracetamol (PLP)
PLP administration during primary vaccinations 1 and 2
Nimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine
Bexsero and Nimenrix - 2 months of age
Group 10 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule
Bexsero
Bexsero - Meningococcal Group B vaccine
Nimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine
MenABCWY with TLP - 2 months of age
Group 11 - Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, with Therapeutic Liquid Paracetamol (TLP) during primary vaccinations.
MenABCWY
Neisseria meningitis groups A, B, C W, and Y vaccine
Therapeutic Liquid Paracetamol (TLP)
TLP administration after primary vaccinations 1 and 2
Blinded: MenABCWY and placebo with SLP or TLP - 2 months of age
Group 13 - Participants 2 months of age vaccinated with MenABCWY and placebo on a 2+1 schedule, with a determined ratio of participants given SLP or TLP during primary vaccinations.
MenABCWY
Neisseria meningitis groups A, B, C W, and Y vaccine
Placebo
Normal Saline
Scheduled Liquid Paracetamol (SLP)
SLP administration after primary vaccinations 1 and 2.
Therapeutic Liquid Paracetamol (TLP)
TLP administration after primary vaccinations 1 and 2
Blinded: Bexsero and Nimenrix with PLP or TLP - 2 months of age
Group 14 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule with a determined ratio of participants given PLP or TLP during primary vaccinations.
Bexsero
Bexsero - Meningococcal Group B vaccine
Prophylactic Liquid Paracetamol (PLP)
PLP administration during primary vaccinations 1 and 2
Nimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine
Therapeutic Liquid Paracetamol (TLP)
TLP administration after primary vaccinations 1 and 2
Interventions
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MenABCWY
Neisseria meningitis groups A, B, C W, and Y vaccine
Bivalent rLP2086 (60-µg Dose)
Trumenba (half dose) - Meningococcal Group B vaccine
Bivalent rLP2086 (120-µg Dose)
Trumenba - Meningococcal Group B vaccine
Bexsero
Bexsero - Meningococcal Group B vaccine
Prophylactic Liquid Paracetamol (PLP)
PLP administration during primary vaccinations 1 and 2
Nimenrix
Nimenrix - Meningococcal Group A, C, W and Y vaccine
Placebo
Normal Saline
Scheduled Liquid Paracetamol (SLP)
SLP administration after primary vaccinations 1 and 2.
Therapeutic Liquid Paracetamol (TLP)
TLP administration after primary vaccinations 1 and 2
Eligibility Criteria
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Inclusion Criteria
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
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.
2 Months
6 Months
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Dr. med Falko Panzer Praxis fuer Kinder und Jugendliche
Mannheim, , Germany
P. & A. Kyriakou Children's Hospital
Athens, , Greece
University General Hospital "ATTIKON"
Athens, , Greece
"Ippokratio" General Hospital of Thessaloniki
Thessaloniki, , Greece
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario de Burgos
Burgos, Castille and León, Spain
Hospital Universitario HM Puerta del Sur
Móstoles, Madrid, Spain
Centro de Salud L'Eliana
L'Eliana, Valencia, Spain
Centro de Salud de Paiporta
Paiporta, Valencia, Spain
Hospital Vithas Virgen del Mar
Almería, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Grupo Pediatrico Uncibay
Málaga, , Spain
Instituto Hispalense de Pediatria
Seville, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
FISABIO
Valencia, , Spain
Centro de Salud la Serreria II
Valencia, , Spain
Centro de Salud Nazaret
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2020-000948-60
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C3511002
Identifier Type: -
Identifier Source: org_study_id
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