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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

Last updated on March 14, 2019

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Study Location
Espoo Vaccine Research Clinic
Espoo, , 02230 Finland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
MENINGOCOCCAL INFECTION
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
24 + months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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 stratified equally by age (≥24 months to

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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT02531698
Pfizer
Completed
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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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