A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years

Pfizer

Status and phase: Completed; Phase 2

Conditions: MENINGOCOCCAL INFECTION

Treatments: Biological: Licensed pediatric hepatits A vaccine; Biological: Bivalent rLP2086 Vaccine; Other: Normal Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT02531698

B1971017

6108K2-3012 (Other Identifier)

2014-000933-21 (EudraCT Number)

Details and patient eligibility

About

This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young children. The study will also look at the safety of the new vaccine as well as how it is tolerated.

Enrollment: 400 patients

Sex: All

Ages: 24 months to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject's parent(s)/legal guardian has been informed of all pertinent aspects of the study.
2. Parent(s)/legal guardian and subject who are willing and able to comply with scheduled visits, vaccine regimen, laboratory tests, and other study procedures.
3. Male or female subjects aged ≥24 months and <10 years at time of randomization, stratified equally by age (≥24 months to <4 years or ≥4 years to <10 years).
4. Subject is available for the entire study period and subject's parent(s)/legal guardian can be reached by telephone.
5. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
6. Subject must have received all vaccinations in the relevant national immunization program (NIP) for their age group.
7. Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
8. Negative urine pregnancy test for all female subjects who are biologically capable of having children.

Exclusion criteria

1. Previous vaccination with any meningococcal serogroup B vaccine.
2. Subjects who have received prior HAV vaccination.
3. Contraindication to vaccination with any HAV vaccine or known latex allergy.
4. Subjects receiving any allergen immunotherapy with a nonlicensed product or subjects receiving allergen immunotherapy with a licensed product and who are not on stable maintenance doses.
5. A previous anaphylactic reaction to any vaccine or vaccine-related component.
6. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
7. A known or suspected defect 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, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency may be included. Additional details will be provided in the study reference manual (SRM).
8. History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
9. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
10. Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
11. Current chronic use of systemic antibiotics.
12. Participation in other studies involving investigational product(s)/device(s) (Phases 1-4) within 28 days before administration of the first study vaccination. Participation in purely observational studies is acceptable.
13. Any neuroinflammatory or autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
14. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
15. Pregnant female subjects, breastfeeding female subjects, male subjects with partners who are currently pregnant, or male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study.
16. Subjects who are children of investigational site staff members directly involved in the conduct of the study and their family members, subjects who are children of site staff members otherwise supervised by the investigator, or subjects who are children of Pfizer employees directly involved in the conduct of the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

400 participants in 2 patient groups

Bivalent rLP2086

Experimental group

Description:

Bivalent rLP2086 (containing 60 μg each of a purified subfamily A and subfamily B rLP2086 protein, adsorbed to aluminum in a sterile buffered isotonic suspension) in a 0.5-mL dose for injection.

Treatment:

Biological: Bivalent rLP2086 Vaccine

Licensed pediatric hepatitis A vaccine

Other group

Treatment:

Other: Normal Saline

Biological: Licensed pediatric hepatits A vaccine