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NCT02587520 · ClinicalTrials.gov registry record · Phase 1
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 1,363
- Enrollment target
NCT02587520: Completed Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT02587520 is a Phase 1 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,363 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2172% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02587520, a Phase 1 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,363 participants
- Enrollment target
Study Summary
This was a dose and formulation ranging study to assess the safety and immunogenicity of SP0173 in healthy adolescents, adults, and older adults in the United States (US). Primary Objective * To describe the safety profile of each SP0173 investigational formulation. Observational Objective: * To describe the immunogenicity of each SP0173 investigational formulation.
Primary Outcome
A solicited reaction (SR) is an adverse event (AE) that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. An SR is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature \& onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Eryt
Interventions
- BIOLOGICAL Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
- BIOLOGICAL Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
- BIOLOGICAL Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
- BIOLOGICAL Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
- BIOLOGICAL Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,363 participants |
| Start Date | 2015-10-22 |
| Est. Completion | 2017-02-21 |
| Phase | Phase 1 |
What the finished NCT02587520 record still lists
NCT02587520 is an interventional study that assigns participants to a tested intervention. Its 1,363 participants enrollment target places it among the larger protocols in the corpus, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2172% higher).
The record links to 0 conditions, and to 5 interventions - of which Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1 is the first listed.
NCT02587520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02587520 about?
NCT02587520 is a clinical study titled "Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects". This was a dose and formulation ranging study to assess the safety and immunogenicity of SP0173 in healthy adolescents, adults, and older adults in the United States (US). Primary Objective * To describe the safety profile of each SP0173 investigational formulation. Observational Objective: * To...
What is the current status of trial NCT02587520?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,363 participants. The study started on 2015-10-22. Estimated completion is 2017-02-21.
What interventions are being tested in trial NCT02587520?
The interventions under investigation include: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1 (BIOLOGICAL), Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2 (BIOLOGICAL), Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3 (BIOLOGICAL), Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4 (BIOLOGICAL), Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (BIOLOGICAL).
Who is sponsoring clinical trial NCT02587520?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02587520's enrollment target sits among peer trials
1,363 4th of 2000 higher than 1,997 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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