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

A PHASE 2b TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY INFANTS 2 AND 6 MONTHS OF AGE

The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age.

Study Overview

• Status: Terminated
• Conditions: Meningococcal Vaccine
• Intervention / Treatment: Other: Placebo; Biological: MenABCWY; Drug: Prophylactic Liquid Paracetamol (PLP); Biological: Bivalent rLP2086 (60-µg Dose); Biological: Nimenrix; Drug: Scheduled Liquid Paracetamol (SLP); Biological: Bivalent rLP2086 (120-µg Dose); Biological: Bexsero; Drug: Therapeutic Liquid Paracetamol (TLP)

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany, 68161
    • Dr. med Falko Panzer Praxis fuer Kinder und Jugendliche
• Greece
  • Athens, Greece, 11527
    • P. & A. Kyriakou Children's Hospital
  • Athens, Greece, 12462
    • University General Hospital "Attikon"
  • Thessaloniki, Greece, 54642
    • "Ippokratio" General Hospital of Thessaloniki
• Spain
  • Almeria, Spain, 04120
    • Hospital Vithas Virgen del Mar
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28040
    • Hospital Universitario Clinico San Carlos
  • Madrid, Spain, 28009
    • Hospital General Universitario Gregorio Maranon
  • Malaga, Spain, 29015
    • Grupo Pediatrico Uncibay
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Sevilla, Spain, 41012
    • Instituto Hispalense de Pediatria
  • Valencia, Spain, 46020
    • FISABIO
  • Valencia, Spain, 46022
    • Centro de Salud la Serreria II
  • Valencia, Spain, 46024
    • Centro de Salud Nazaret
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Hospital Clinico Universitario de Santiago de Compostela
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol
  • Castilla Y LEON
    • Burgos, Castilla Y LEON, Spain, 09006
      • Hospital Universitario de Burgos
  • Madrid
    • Móstoles, Madrid, Spain, 28938
      • Hospital Universitario Hm Puerta Del Sur
  • Valencia
    • L'Eliana, Valencia, Spain, 46183
      • Centro de Salud L'Eliana
    • Paiporta, Valencia, Spain, 46200
      • Centro de Salud de Paiporta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 6 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: MenABCWY; Neisseria meningitis groups A, B, C W, and Y vaccine; Drug: Prophylactic Liquid Paracetamol (PLP); PLP administration during primary vaccinations 1 and 2
Experimental: MenABCWY - 6 months of age; Group 2 - Participants 6 months of age vaccinated with MenABCWY on a 2+1 schedule	Biological: MenABCWY; Neisseria meningitis groups A, B, C W, and Y vaccine
Experimental: 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.	Drug: Prophylactic Liquid Paracetamol (PLP); PLP administration during primary vaccinations 1 and 2; Biological: Bivalent rLP2086 (60-µg Dose); Trumenba (half dose) - Meningococcal Group B vaccine; Biological: Nimenrix; Nimenrix - Meningococcal Group A, C, W and Y vaccine; Drug: Scheduled Liquid Paracetamol (SLP); SLP administration after primary vaccinations 1 and 2.
Experimental: 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	Biological: Bivalent rLP2086 (60-µg Dose); Trumenba (half dose) - Meningococcal Group B vaccine; Biological: Nimenrix; Nimenrix - Meningococcal Group A, C, W and Y vaccine
Experimental: 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.	Drug: Prophylactic Liquid Paracetamol (PLP); PLP administration during primary vaccinations 1 and 2; Biological: Nimenrix; Nimenrix - Meningococcal Group A, C, W and Y vaccine; Biological: Bivalent rLP2086 (120-µg Dose); Trumenba - Meningococcal Group B vaccine
Experimental: 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.	Biological: MenABCWY; Neisseria meningitis groups A, B, C W, and Y vaccine; Drug: Scheduled Liquid Paracetamol (SLP); SLP administration after primary vaccinations 1 and 2.
Experimental: 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	Drug: Prophylactic Liquid Paracetamol (PLP); PLP administration during primary vaccinations 1 and 2; Biological: Nimenrix; Nimenrix - Meningococcal Group A, C, W and Y vaccine; Biological: Bexsero; Bexsero - Meningococcal Group B vaccine
Experimental: Bexsero and Nimenrix - 2 months of age; Group 10 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule	Biological: Nimenrix; Nimenrix - Meningococcal Group A, C, W and Y vaccine; Biological: Bexsero; Bexsero - Meningococcal Group B vaccine
Experimental: 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.	Biological: MenABCWY; Neisseria meningitis groups A, B, C W, and Y vaccine; Drug: Therapeutic Liquid Paracetamol (TLP); TLP administration after primary vaccinations 1 and 2
Experimental: 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.	Other: Placebo; Normal Saline; Biological: MenABCWY; Neisseria meningitis groups A, B, C W, and Y vaccine; Drug: Scheduled Liquid Paracetamol (SLP); SLP administration after primary vaccinations 1 and 2.; Drug: Therapeutic Liquid Paracetamol (TLP); TLP administration after primary vaccinations 1 and 2
Experimental: 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.	Drug: Prophylactic Liquid Paracetamol (PLP); PLP administration during primary vaccinations 1 and 2; Biological: Nimenrix; Nimenrix - Meningococcal Group A, C, W and Y vaccine; Biological: Bexsero; Bexsero - Meningococcal Group B vaccine; Drug: Therapeutic Liquid Paracetamol (TLP); TLP administration after primary vaccinations 1 and 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Percentage of participants achieving hSBA titer greater than or equal to (>=) lower limit of quantitation (LLOQ) (i.e.,1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided confidence interval (CI) using the Clopper and Pearson method was presented. Analysis was performed on Post-primary vaccination 2 (post-PV2) evaluable immunogenicity population (EIP). No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.	1 month after primary vaccination 2
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	Percentage of participants achieving hSBA titer >= LLOQ (1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination.	1 month after booster vaccination
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	Percentage of participants achieving hSBA titer>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.	1 month After primary vaccination 2
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	Percentage of participants achieving hSBA titer>= LLOQ for each MenB test strain(1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented.	1 month after primary vaccination 2
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	Percentage of participants achieving hSBA titer>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination.	1 Month after booster vaccination
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Groups 3, 4 and 5	Percentage of participants achieving hSBA titer >= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. Groups 4 and 5 had no serum samples collected post-booster for serology testing due to study termination.	1 Month after booster vaccination
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined	Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.	Within 7 days after primary vaccination 1
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined	Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: 0.5 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.	Within 7 Days after primary Vaccination 2
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	Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 degrees (deg) Celsius(C) and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method	Within 7 Days after primary Vaccination 1
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined	Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 deg C and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness was graded as Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method.	Within 7 days after primary vaccination 2
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	An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Medically attended adverse event (MAE) was defined as a nonserious AE that resulted in an evaluation at a medical facility. Newly diagnosed chronic medical condition (NDCMC) was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	Within 30 days after primary vaccination 1
Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that wasis expected to be persistent or otherwise long-lasting in its effects.	Within 30 days after primary vaccination 2
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	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that is was expected to be persistent or otherwise long-lasting in its effects.	Within 30 days after any primary vaccination
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	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	From day of primary vaccination 1 at Day 1 up to 1 month after primary vaccination 2
Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	From 1 month after primary vaccination 2 up to booster vaccination
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined	Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.	From the date of primary vaccination 1 up to 8 months after primary vaccination 2 (maximum up to 9 months)
Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 1: Groups 7 and 11 Combined Versus Groups 8 and 10 Combined	Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.	Within 30 minutes After primary vaccination 1
Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 2: Group 7 Versus Groups 8 and 10 Combined	Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.	Within 30 minutes After primary vaccination 2
Percentage of Participants With Immediate AEs After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined	Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.	Within 30 minutes after booster vaccination
Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined	Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement.	Within 7 Days after booster vaccination
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	Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 deg C, categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite was graded as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method.	Within 7 days after booster vaccination
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	From date of booster vaccination through 1 month after booster vaccination
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	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 5 months)
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined	An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.	From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	GMTs were calculated by exponentiating mean logarithm of titers and CIs were calculated by exponentiating confidence limits based on the Student t distribution for the mean logarithm of the titers.	1 Month after primary Vaccination 2
hSBA GMTs for Each of the MenB Test Strains: 1 Month After Booster Vaccination in Groups 3, 4 and 5	GMTs were calculated by exponentiating the mean logarithm of the titers and CIs were calculated by exponentiating the confidence limits based on the Student t distribution for the mean logarithm of the titers. No serum samples were collected after booster dose for groups 4 and 5 due to study termination.	1 month after booster vaccination
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5	Local reactions included pain at injection site, redness and swelling and were recorded by participant's in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site on left arm were reported in this outcome measure.	Within 7 Days after primary Vaccination(Vac) 1 and 2
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5	Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 degrees (deg) Celsius(C) and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Exact 2-sided CI was based on the Clopper and Pearson method. Decreased appetite was categorized as Grade 1:decreased interest in eating, Grade 2:decreased oral intake, Grade3: refusal to feed. Drowsiness: Grade 1 Increased or prolonged sleeping bouts,Grade2: Slightly subdued interfering with daily activity, Grade3; Disabling, not interested in usual daily activity. Irritability; Grade1: Easily consolable, Grade2: requiring increased attention, Grade 3: Inconsolable; crying could not be comforted.	Within 7 Days after primary Vaccination 1 and 2
Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5	Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.	Within 30 days after any vaccination

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2020
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Meningococcal Vaccine; Invasive Meningococcal Disease; Meningococcal Serogroups A, B, C W and Y; MenABCWY Vaccine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: C3511002; 2020-000948-60 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No