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A Study to Describe the Safety Profile and Compare the Immune Response of 4 Different Formulations of an Investigational Tdap Vaccine When Compared to Licensed Tdap Vaccine in Young Adults in Canada

NCT03958799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2022-04-25

No results posted yet for this study

Summary

The primary objectives of this study are:

* To describe the safety profile of each of the investigational vaccine formulations for all participants
* To describe the humoral and cell-mediated immune responses to all of the investigational vaccine formulations
* To evaluate the dose response to vaccine components
* To describe the magnitude, quality, and longevity of immune responses to each of the investigational vaccine formulations

Conditions

  • Tetanus Immunisation (Healthy Volunteers)
  • Diphtheria Immunisation (Healthy Volunteers)
  • Pertussis Immunisation (Healthy Volunteers)

Interventions

BIOLOGICAL

Investigational Tdap vaccine Formulation B

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Investigational Tdap vaccine Formulation C

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Investigational Tdap vaccine Formulation A

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Investigational Tdap vaccine Formulation D

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Licensed Tdap vaccine

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2021-04-06
Completion
2021-04-06

Countries

  • Canada

Study Locations

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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 NCT03958799 on ClinicalTrials.gov