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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.

NCT03135834 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1610

Last updated 2023-08-08

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-24
Primary Completion
2022-10-25
Completion
2022-10-25
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Finland
  • Poland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03135834 on ClinicalTrials.gov