NCT03135834

A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.

A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT RLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN STUDY TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A BIVALENT RLP2086-CONTAINING PENTAVALENT VACCINE (MENABCWY) IN HEALTHY SUBJECTS>=10 TO <26 YEARS OF AGE

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,610 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 10 Years – 25 Years
• Healthy volunteers: Accepted

Summary

This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.

Conditions

• Meningococcal Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	MenABCWY	N meningitidis group A, B, C, W, and Y vaccine
BIOLOGICAL	Saline	Placebo
BIOLOGICAL	rLP2086	Bivalent recombinant lipoprotein 2086 vaccine
BIOLOGICAL	MenACWY-CRM	meningococcal group A, C, W-135, and Y conjugate vaccine

Timeline

• Start date: 2017-04-24
• Primary completion: 2022-10-25
• Completion: 2022-10-25
• First posted: 2017-05-01
• Last updated: 2023-08-08
• Results posted: 2023-08-08

Locations

75 sites across 4 countries: United States, Czechia, Finland, Poland

Regulatory

• FDA-regulated drug study