MedTrace Logo

A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years

NCT01830855 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3596

Last updated 2016-06-14

Study results available
· View outcomes & findings →

Summary

This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.

Conditions

  • Meningococcal Vaccine

Interventions

BIOLOGICAL

rLP2086

0.5 mL dose, given at 0, 2 and 6 months (lot 1)

BIOLOGICAL

rLP2086

0.5 mL dose, given at 0, 2 and 6 months (lot 2)

BIOLOGICAL

rLP2086

0.5 mL dose, given at 0, 2 and 6 months (lot 3)

BIOLOGICAL

Havrix (HAV)

0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.

BIOLOGICAL

Saline

0.5 mL dose of sterile normal saline for injection.

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
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States
  • Canada
  • Czechia
  • Finland
  • Germany
  • Italy
  • Poland
  • United Kingdom

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 NCT01830855 on ClinicalTrials.gov