Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.

Official Title
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An Open Label, Randomized, Phase 1/2 Trial Of The Safety, Tolerability, And Immunogenicity Of Meningococcal Group B Rlp2086 Vaccine In Healthy Infants

Conditions
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Meningitis, Meningococcal

Intervention / Treatment
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* Biological: meningococcal B rLP2086 vaccine
* Biological: Routine age appropriate childhood vaccines
* Biological: meningococcal B rLP2086 vaccine
* Biological: Routine age appropriate childhood vaccines
* Biological: Routine age appropriate childhood vaccines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Investigators should always use good clinical judgment in considering a subject's overall fitness for trial participation. In addition, any condition that in the opinion of the investigator may interfere with the evaluation of study objectives should be carefully considered prior to enrolling subjects. Male or female subjects aged 2 months (42 to 98 days of age) at the time of enrollment. Available for the entire consented period and whose parent/legal guardian can be reached by telephone. Healthy infant as determined by medical history, physical examination, and judgment of the investigator. Parent/legal guardian must be able to complete all relevant study procedures during study participation. Exclusion Criteria: Previous vaccination with licensed or investigational vaccines: meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, poliovirus, rotavirus, varicella, measles, mumps, or rubella. Any of the following illnesses/conditions that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study: A previous anaphylactic reaction to any vaccine or vaccine-related component. Contraindication to vaccination with meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), poliovirus, rotavirus, varicella, measles, mumps, or rubella. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. Known or suspected immune deficiency or suppression. History of culture-proven invasive disease caused by N meningitidis or Neisseria gonorrhoea. Major known congenital malformation or serious chronic disorder. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Does not include resolving syndromes due to birth trauma such as Erb palsy. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies). Received any investigational drugs, vaccines or devices (aside from those specified in the protocol) within 4 weeks before administration of the first dose of test article or at any time throughout the study. Participation in purely observational studies is acceptable. Infant who is a direct descendant (child, grandchild) of the study site personnel.

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 98 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines | Biological: meningococcal B rLP2086 vaccine<br>* vaccination<br>Biological: Routine age appropriate childhood vaccines<br>* vaccination<br>|
| Experimental: 2<br>Dose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines | Biological: meningococcal B rLP2086 vaccine<br>* vaccination<br>Biological: Routine age appropriate childhood vaccines<br>* vaccination<br>|
| Experimental: 3<br>Control group | Biological: Routine age appropriate childhood vaccines<br>* vaccination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain |  | 1 month after Dose 3 | 
| Percentage of Participants With at Least One Adverse Event (AE) |  | From signing of informed consent form to completion of study (up to 2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain |  | 1 month after Dose 2, Dose 3; before Dose 4 | 
| Percentage of Participants Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain |  | 1 month after Dose 2, Dose 3; before Dose 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningococcal B vaccine, infants, safety, immunogenicity