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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Meningococcal Vaccine

Treatments: Biological: Bexsero; Other: Placebo; Biological: Nimenrix; Biological: Bivalent rLP2086 (60-µg Dose); Drug: Therapeutic Liquid Paracetamol (TLP); Drug: Prophylactic Liquid Paracetamol (PLP); Biological: Bivalent rLP2086 (120-µg Dose); Biological: MenABCWY; Drug: Scheduled Liquid Paracetamol (SLP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04645966

C3511002

2020-000948-60 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 326 patients

Sex: All

Ages: 2 to 6 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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326 participants in 11 patient groups

MenABCWY with PLP - 6 months of age

Experimental group

Description:

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.

Treatment:

Drug: Prophylactic Liquid Paracetamol (PLP)

Biological: MenABCWY

MenABCWY - 6 months of age

Experimental group

Description:

Group 2 - Participants 6 months of age vaccinated with MenABCWY on a 2+1 schedule

Treatment:

Biological: MenABCWY

Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP or SLP - 2 months of age

Experimental group

Description:

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.

Treatment:

Biological: Nimenrix

Drug: Scheduled Liquid Paracetamol (SLP)

Drug: Prophylactic Liquid Paracetamol (PLP)

Biological: Bivalent rLP2086 (60-µg Dose)

Bivalent rLP2086 (60-µg Dose) and Nimenrix - 2 months of age

Experimental group

Description:

Group 4 - Participants 2 months of age vaccinated with Bivalent rLP2086 (60-mcg Dose) and Nimenrix on a 2+1 schedule

Treatment:

Biological: Nimenrix

Biological: Bivalent rLP2086 (60-µg Dose)

Bivalent rLP2086 (120-µg Dose) and Nimenrix, with PLP - 2 months of age

Experimental group

Description:

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.

Treatment:

Biological: Nimenrix

Drug: Prophylactic Liquid Paracetamol (PLP)

Biological: Bivalent rLP2086 (120-µg Dose)

MenABCWY with SLP - 2 months of age

Experimental group

Description:

Group 7 - Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, and given SLP during primary vaccinations.

Treatment:

Drug: Scheduled Liquid Paracetamol (SLP)

Biological: MenABCWY

Bexsero and Nimenrix with PLP - 2 months of age

Experimental group

Description:

Group 8 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations

Treatment:

Biological: Nimenrix

Biological: Bexsero

Drug: Prophylactic Liquid Paracetamol (PLP)

Bexsero and Nimenrix - 2 months of age

Experimental group

Description:

Group 10 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule

Treatment:

Biological: Nimenrix

Biological: Bexsero

MenABCWY with TLP - 2 months of age

Experimental group

Description:

Group 11 - Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, with Therapeutic Liquid Paracetamol (TLP) during primary vaccinations.

Treatment:

Drug: Therapeutic Liquid Paracetamol (TLP)

Biological: MenABCWY

Blinded: MenABCWY and placebo with SLP or TLP - 2 months of age

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: Therapeutic Liquid Paracetamol (TLP)

Drug: Scheduled Liquid Paracetamol (SLP)

Biological: MenABCWY

Blinded: Bexsero and Nimenrix with PLP or TLP - 2 months of age

Experimental group

Description:

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.

Treatment:

Drug: Therapeutic Liquid Paracetamol (TLP)

Biological: Nimenrix

Biological: Bexsero

Drug: Prophylactic Liquid Paracetamol (PLP)