Trial intelligence / Profile preview

Safety and Immunogenicity of Trumenba in Adolescents

NCT00808028Phase 2

Key facts

Status: Completed
Start: Feb 2009
Primary completion: Mar 2014
Countries: 3
Sponsor: Pfizer
Modality: Vaccines & Immunotherapeutics

Drugs: meningococcal group B vaccine
Conditions: invasive meningococcal disease (IMD)

Overview

Phase 2, randomised, single-blind trial of meningococcal group B vaccine in invasive meningococcal disease (IMD) (4 arms), sponsored by Pfizer. Primary endpoints: Percentage of Participants With at Least 4-fold Rise in rLP2086 Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer and Percentage of Participants With At Least One Adverse Event. Started Feb 2009; status: completed.

Design

4 arms

Study design: RandomizedSingle-blind

60 mcg rLP2086
Trumenba 60 mcg
120 mcg rLP2086
Trumenba 120 mcg
200 mcg rLP2086
Trumenba 200 mcg
Placebo
Normal saline

Who it enrols

Healthy adolescents aged 11-18 years without history of invasive meningococcal disease or severe vaccine reactions.

Endpoints

Primary

Percentage of Participants With at Least 4-fold Rise in rLP2086 Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer1 month after Vaccination 3
Percentage of Participants With At Least One Adverse Event6 months after Vaccination 3 to 48 months

Secondary

Percentage of Participants Achieving hSBA Titer Level >= Prespecified Titer Level1 month after Vaccination 3

Results

Not all primary endpoints met

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