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

Last updated on March 14, 2019

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Study Location
The Canberra Hospital
Canberra, Garran, Australian Capital T, 2605 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal B Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-24 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male or female subject aged 12 to sentinel-cohort enrollment, Or,12 to

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

NCT02534935
Pfizer
Active, not recruiting
Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.

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[email protected]

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