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A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years

NCT01299480 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1714

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 well it is tolerated. This study will also look at this vaccine being given 2 or 3 times. This study will be done in healthy adolescents.

Conditions

  • Meningococcal Vaccine

Interventions

BIOLOGICAL

Vaccine

rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3

BIOLOGICAL

Vaccine

rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2

BIOLOGICAL

Vaccine

rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3

BIOLOGICAL

Vaccine

rLP2086 at visits 1 and 3, saline at visits 2 and 5

BIOLOGICAL

Vaccine

rLP2086 at visits 3 and 5, saline at visits 1 and 2

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
2011-03-03
Primary Completion
2012-05-03
Completion
2012-09-18

Countries

  • Czechia
  • Denmark
  • Finland
  • Germany
  • Poland
  • Spain
  • Sweden

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 NCT01299480 on ClinicalTrials.gov