Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Healthy Toddlers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00387569

Enrollment

Registered

2006-10-13

Start date

2006-10-31

Completion date

2008-03-31

Last updated

2008-05-08

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

Conditions

Healthy

Keywords

Toddlers, Vaccine, Safety

Brief summary

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

Interventions

BIOLOGICALMnB vaccine rLP8026

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Months to 36 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Australia

Outcome results

None listed

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