Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

A study to assess the safety of an investigational meningitis vaccine in toddlers and their immune response to it.

Completed

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Key information

Conditions

Healthy

Age range

18 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Perth, Western Australia, 6840, Australia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Aged 18- to 36-months
Healthy male or female subjects

Exclusion criteria

Prior vaccination with a serogroup B meningococcal vaccine
Prior history of any invasive meningococcal disease

Treatment and study plan

MnB vaccine rLP8026

Biological

MnB vaccine at 20ug dose (0,1,6 months) or control (Hepatitis A vaccine, placebo, Hepatitis A vaccine at 0,1,6 months, respectively)

Primary outcomes

Local and systemic reactions through 14 days post-injection; Vaccinations at 0,1,6 months

Time frame: Vaccinations at 0,1,6 months

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Randomized, Observer-Blinded, Parallel-Group, Active-Control, Phase 1/2 Trial of the Safety, Immunogenicity, and Tolerability of 20 µg, 60 µg, and 200 µg of Meningococcal Group B rLP2086 Vaccine in Healthy Adolescents Aged 10 to 12 Years

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Oct 13, 2006
Registry last updated: May 8, 2008

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.

Published trials that share one or more normalized conditions with this study.

Completed