Clinical trial NCT04645966: A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants
Official title: A PHASE 2b TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY INFANTS 2 AND 6 MONTHS OF AGE
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Meningococcal Vaccine
Keywords: Meningococcal Vaccine
Invasive Meningococcal Disease
Meningococcal Serogroups A, B, C W and Y
MenABCWY Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-11-27
Enrollment: 326
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: 1 month after primary vaccination 2
measure: Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: 1 month after booster vaccination
measure: Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: 1 month After primary vaccination 2
measure: Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 3 and 4 Combined Versus Group 5
timeFrame: 1 month after primary vaccination 2
measure: Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: 1 Month after booster vaccination
measure: Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Groups 3, 4 and 5
timeFrame: 1 Month after booster vaccination
measure: Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: Within 7 days after primary vaccination 1
measure: Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
timeFrame: Within 7 Days after primary Vaccination 2
measure: Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: Within 7 Days after primary Vaccination 1
measure: Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
timeFrame: Within 7 days after primary vaccination 2
measure: Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: Within 30 days after primary vaccination 1
measure: Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
timeFrame: Within 30 days after primary vaccination 2
measure: Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: Within 30 days after any primary vaccination
measure: Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: From day of primary vaccination 1 at Day 1 up to 1 month after primary vaccination 2
measure: Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined
timeFrame: From 1 month after primary vaccination 2 up to booster vaccination
measure: Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: From the date of primary vaccination 1 up to 8 months after primary vaccination 2 (maximum up to 9 months)
measure: Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 1: Groups 7 and 11 Combined Versus Groups 8 and 10 Combined
timeFrame: Within 30 minutes After primary vaccination 1
measure: Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 2: Group 7 Versus Groups 8 and 10 Combined
timeFrame: Within 30 minutes After primary vaccination 2
measure: Percentage of Participants With Immediate AEs After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: Within 30 minutes after booster vaccination
measure: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: Within 7 Days after booster vaccination
measure: Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: Within 7 days after booster vaccination
measure: Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: From date of booster vaccination through 1 month after booster vaccination
measure: Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 5 months)
measure: Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
timeFrame: From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 6 months)
Secondary outcomes:
measure: hSBA Geometric Mean Titers (GMTs) for Each of the MenB Test Strains: 1 Month After Primary Vaccination 2 in Group 3 and 4 Combined Versus Group 5
timeFrame: 1 Month after primary Vaccination 2
measure: hSBA GMTs for Each of the MenB Test Strains: 1 Month After Booster Vaccination in Groups 3, 4 and 5
timeFrame: 1 month after booster vaccination
measure: Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
timeFrame: Within 7 Days after primary Vaccination(Vac) 1 and 2
measure: Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
timeFrame: Within 7 Days after primary Vaccination 1 and 2
measure: Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5
timeFrame: Within 30 days after any vaccination
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Dr. med Falko Panzer Praxis fuer Kinder und Jugendliche
city: Athens
country: Greece
facility: P. & A. Kyriakou Children's Hospital
city: Athens
country: Greece
facility: University General Hospital "ATTIKON"
city: Thessaloniki
country: Greece
facility: "Ippokratio" General Hospital of Thessaloniki
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago de Compostela
state: A Coruna
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
state: Castilla Y LEON
city: Móstoles
country: Spain
facility: Hospital Universitario HM Puerta del Sur
state: Madrid
city: L'Eliana
country: Spain
facility: Centro de Salud L'Eliana
state: Valencia
city: Paiporta
country: Spain
facility: Centro de Salud de Paiporta
state: Valencia
city: Almeria
country: Spain
facility: Hospital Vithas Virgen del Mar
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Grupo Pediatrico Uncibay
city: Sevilla
country: Spain
facility: Instituto Hispalense de Pediatria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valencia
country: Spain
facility: FISABIO
city: Valencia
country: Spain
facility: Centro de Salud la Serreria II
city: Valencia
country: Spain
facility: Centro de Salud Nazaret
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: