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OpenTrials
Completed

NCT Number: NCT00297687

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

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

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Key information

Conditions

Meningitis, Meningococcal Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Gram-Negative Bacterial Infections Infections Meningitis Meningitis, Bacterial Meningococcal Infections Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Herson, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy 18-25 year olds

Exclusion criteria

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

Treatment and study plan

MnB rLP2086

Biological

Primary outcomes

  1. Local & systemic safety throughout the trial

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Feb 28, 2006
Registry last updated
Dec 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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