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Study Evaluating the Safety, Immunogenicity and Tolerability of Meningococcal Group B Vaccine in Healthy Adults

A Randomized, Placebo-Controlled, Double Blind, Phase 1 Trial of the Safety, Immunogenicity, and Tolerability of Ascending Doses of Meningococcal Group B rLP2086 Vaccine in Healthy Adults

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00297687
Enrollment
108
Registered
2006-02-28
Start date
2006-03-31
Completion date
2007-03-31
Last updated
2007-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningitis, Meningococcal

Keywords

Vaccines, Healthy Adults, Health, Adult, Meningococcal Vaccines

Brief summary

To determine the safety & immunogenicity of a potential vaccine against meningococcal B disease

Interventions

BIOLOGICALMnB rLP2086

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy 18-25 year olds

Exclusion criteria

* Prior history of vaccination with any meningococcal vaccine * Prior history of any invasive meningococcal disease

Design outcomes

Primary

MeasureTime frame
Local & systemic safety throughout the trial

Secondary

MeasureTime frame
Evidence of an immune response 1 month after dose 2 & 1 month after dose 3

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026