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Placebo Controlled Study to Generate Data Characterising Safety Parameters and Immune Responses

NCT02555540 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2022-12-20

No results posted yet for this study

Summary

The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models.

240 healthy participants (18-45y) will be enrolled, 200 will be administered a dose of Boostrix on Day 0, 20 will receive a placebo on Day 0.

Conditions

  • Prevention of Infections With Bordetella Pertussis

Interventions

BIOLOGICAL

Boostrix

Randomised assignment

BIOLOGICAL

Placebo (Saline)

Randomised assignment

Sponsors & Collaborators

  • University of Surrey

    collaborator OTHER

  • Novartis Vaccines

    collaborator INDUSTRY

  • Max Planck Institute for Infection Biology

    collaborator OTHER

  • deCODE genetics

    collaborator INDUSTRY

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • Innovative Medicines Initiative

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Geert Leroux-Roels, Prof., MD · Center for Vaccinology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-24
Primary Completion
2015-12-15
Completion
2016-12-15

Countries

  • Belgium

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 NCT02555540 on ClinicalTrials.gov