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A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years.

NCT01323270 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 753

Last updated 2022-10-27

Study results available
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Summary

This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how it is tolerated when given together with Repevax. The study will be done in healthy adolescents.

Conditions

  • Meningococcal Vaccine
  • rLP2086
  • Repevax
  • N Meningitidis Serogroup B
  • Meningitis

Interventions

BIOLOGICAL

rLP2086

0.5 mL dose, given at 0, 2 and 6 months.

BIOLOGICAL

Repevax

0.5 mL dose, given at 0 months.

BIOLOGICAL

Saline

0.5 mL dose, given at 0, 2 and 6 months.

BIOLOGICAL

Repevax

0.5 mL dose, given at 0 months.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-18
Primary Completion
2012-10-08
Completion
2013-02-19

Countries

  • Finland
  • Germany
  • Poland

Study Locations

More Related Trials

Entities

Diseases
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 NCT01323270 on ClinicalTrials.gov