Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.

Pfizer

Status and phase: Completed; Phase 2

Conditions: Meningococcal B Disease

Treatments: Biological: Pediatric HAV vaccine; Biological: rLP2086 vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02534935

2011-004400-38 (EudraCT Number)

B1971035

Details and patient eligibility

About

The purpose of this study is to investigate the immunogenicity, safety and tolerability of a new vaccine that might prevent meningococcal B disease. The study will be conducted in healthy toddlers aged between 12 and 24 months.

Enrollment: 396 patients

Sex: All

Ages: 12 to 24 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female subject aged 12 to <15 months or 18 to <24 months during sentinel-cohort enrollment, Or,12 to <24 months during expanded-cohort enrollment.
• Subjects must have received all vaccinations in the relevant National Immunization Program (NIP) for their age group.
• Subject is determined to be in good health by medical history, physical examination, and judgment of the investigator.

Exclusion criteria

• Previous vaccination with any meningococcal serogroup B vaccine.
• Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine during Stage 1 of the study.
• Contraindication to vaccination with any HAV vaccine or known latex allergy.
• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
• A known or suspected disorder of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B-cell function or those receiving systemic immunosuppressive therapy. Subjects with terminal complement deficiency may be included.
• History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
• Significant neurologic disorder or history of seizure (excluding simple febrile seizure).
• Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination until the end of Stage 1.
• Current chronic use of systemic antibiotics.
• Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination and/or during study participation.
• Any neuroinflammatory or autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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396 participants in 2 patient groups

rLP2086 vaccine

Experimental group

Description:

Arm stratified by age: ≥12 to \<18 months and ≥18 to \<24 months

Treatment:

Biological: rLP2086 vaccine

Control

Active Comparator group

Description:

Arm stratified by age: ≥12 to \<18 months and ≥18 to \<24 months

Treatment:

Biological: Pediatric HAV vaccine