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Vaccine

Adacel® Vaccine Group for Whooping Cough

Phase 4
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to 7 post-vaccination
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.

Eligible Conditions
  • Whooping Cough
  • Tetanus
  • Diphtheria

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to 7 post-vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to 7 post-vaccination for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®

Side effects data

From 2008 Phase 4 trial • 647 Patients • NCT00319553
81%
Solicited injection site Pain
52%
Solicited Myalgia
34%
Solicited Headache
25%
Solicited Malaise
21%
Solicited injection site Erythema
14%
Solicited injection site Swelling
3%
Solicited Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Boostrix® Vaccine Group
Adacel® Vaccine Group

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Adacel® Vaccine GroupExperimental Treatment1 Intervention
Group II: BOOSTRIX® Vaccine GroupActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated)
FDA approved

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,195 Previous Clinical Trials
4,034,486 Total Patients Enrolled
21 Trials studying Whooping Cough
378,080 Patients Enrolled for Whooping Cough
Medical DirectorStudy DirectorSanofi Pasteur Inc.
2,870 Previous Clinical Trials
8,083,506 Total Patients Enrolled
56 Trials studying Whooping Cough
459,165 Patients Enrolled for Whooping Cough
~33 spots leftby Oct 2025
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