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A Protocol to Collect Human Serum Samples From Healthy Adults for Use as Quality Controls Samples in GlaxoSmithKline (GSK) Biologicals' Assays

NCT02072525 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 359

Last updated 2017-11-27

No results posted yet for this study

Summary

The purpose of this study is to collect serum samples for use as quality control samples in GSK assays. The serum samples need to include samples with low, medium and high antibody titers/concentrations, which cover the assay range.

Conditions

  • Meningococcal

Interventions

BIOLOGICAL

Menveo®

One dose administered intramuscularly (IM) in the upper left deltoid of the arm.

BIOLOGICAL

Boostrix®

One dose administered intramuscularly (IM) in the upper right deltoid of the arm.

BIOLOGICAL

Pneumovax 23®

One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.

BIOLOGICAL

Prevnar 13®

One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-04-01
Primary Completion
2015-06-02
Completion
2015-06-02

Countries

  • Canada

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 NCT02072525 on ClinicalTrials.gov