TetanusPhase 1/2NCT02587520

Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects

A Phase 1/2 study testing Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1, Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2 and Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3 in people with Tetanus and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 10 years and olderHealthy volunteers can take part
Conditions the study is for: Tetanus, Diphtheria, Pertussis
What is being tested?: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1, Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2 and Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,363 participants
Where: 20 sitesUnited States
Study dates: 22 Oct 2015to 21 Feb 2017
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Aged 10 to 18 years, 19 to 64 years, or >= 65 years on the day of inclusion.
Informed consent form had been signed and dated by the participant, or assent form had been signed and dated by the participant and informed consent form had been signed and dated by the parent/guardian
Participant or participant and parent/guardian able to attend all scheduled visits and to comply with all study procedures.

Who cannot join

Participant was pregnant, or lactating, or of childbearing potential, (to be considered of non-childbearing potential, a female must be premenarche or post-menopausal for at least 1 year) surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.
Participation at the time of study enrollment or planned participation during the present study period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
Received any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine between Visit 1 and Visit 2.
Known or suspected receipt of a tetanus toxoid, reduced diphtheria toxoid, and Acellular pertussis (Tdap) vaccine or Tdap-containing vaccine at any point in time, or receipt of a tetanus and diphtheria containing vaccine in the preceding 5 years.
Receipt of immune globulins, blood or blood-derived products in the past 3 months.
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.

Show all 16Show fewer

History of diphtheria, tetanus, or pertussis infection (confirmed either serologically or microbiologically).
Known or suspected systemic hypersensitivity to any of the vaccine components or history of life-threatening reaction to the study vaccine or a vaccine containing the same substances.
Laboratory-confirmed / self-reported thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
History of encephalopathy (e.g., coma, decreased level of consciousness, or prolonged seizures) not attributable to another identifiable cause within 7 days of administration of a previous dose of diphtheria and tetanus toxoids and pertussis (DTP), or diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine.
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
Current alcohol abuse or drug addiction.
Chronic illness that was at a stage where it might interfere with trial conduct or completion.
Moderate or severe acute illness/infection on the day of vaccination or febrile illness (temperature >= 100.4°F).
Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Study site
Albuquerque, New Mexico, 87108
Study site
Bardstown, Kentucky, 40004
Study site
Birmingham, Alabama, 35205
Study site
Cleveland, Ohio, 44122
Study site
DeLand, Florida, 32720
Study site
Erie, Pennsylvania, 16505
Study site
Fayetteville, Arkansas, 72703
Study site
Jonesboro, Arkansas, 72401
Study site
Las Vegas, Nevada, 89109
Study site
Lincoln, Nebraska, 68516
Study site
Meridian, Idaho, 83642
Study site
Miami, Florida, 33143
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Nashville, Tennessee, 37203
Study site
Nicholasville, Kentucky, 40356
Study site
Orlando, Florida, 32806
Study site
Rochester, New York, 14609
Study site
Salt Lake City, Utah, 84109
Study site
Salt Lake City, Utah, 84121
Study site
San Diego, California, 92108

Other trials in United States

About this study

Official title: Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults

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.

Read the detailed description

All participants received a single dose of vaccine, and were assessed for immunogenicity at baseline (pre-vaccination) and at 30 days post-vaccination. They were also monitored for safety from day of vaccination up to Day 180 post-vaccination.

Conditions: Tetanus, Diphtheria, Pertussis, Whooping Cough
Being tested: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1, Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2, Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3, Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4, Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
Keywords: Tetanus, Diphtheria, Pertussis, SP0173, Tdap vaccine
Medical subject headings: Tetanus, Diphtheria, Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1Biological
Also called SP0173
0.5 milliliter (mL), Intramuscular
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2Biological
Also called SP0173
0.5 mL, Intramuscular
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3Biological
Also called SP0173
0.5 mL, Intramuscular
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4Biological
Also called SP0173
0.5 mL, Intramuscular
Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine AdsorbedBiological
0.5 mL, Intramuscular
Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis VaccineBiological
0.5 mL, Intramuscular

Study groups in NCT02587520
Study group	Role	What they receive
Adolescents: SP0173 Formulation 1	Experimental	Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine. Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
Adolescents: SP0173 Formulation 2	Experimental	Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
Adolescents: SP0173 Formulation 3	Experimental	Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
Adolescents: SP0173 Formulation 4	Experimental	Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
Adolescents: Adacel®	Active comparator	Healthy participants aged 10-18 years received Adacel®. Receives: Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
Adolescents: Boostrix®	Active comparator	Healthy participants aged 10-18 years received Boostrix®. Receives: Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
Adults: SP0173 Formulation 1	Experimental	Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
Adults: SP0173 Formulation 2	Experimental	Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
Adults: SP0173 Formulation 3	Experimental	Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
Adults: SP0173 Formulation 4	Experimental	Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
Adults: Adacel®	Active comparator	Healthy participants aged 19-64 years received Adacel®. Receives: Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
Adults: Boostrix®	Active comparator	Healthy participants aged 19-64 years received Boostrix®. Receives: Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
Older Adults: SP0173 Formulation 1	Experimental	Healthy participants aged greater than equal to (>=65) years received a single dose of the SP0173 Tdap vaccine. Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
Older Adults: SP0173 Formulation 2	Experimental	Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine. Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
Older Adults: SP0173 Formulation 3	Experimental	Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine. Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
Older Adults: SP0173 Formulation 4	Experimental	Healthy participants aged >= 65 years received a single dose of the SP0173 Tdap vaccine. Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
Older Adults: Adacel®	Active comparator	Healthy participants aged >=65 years received Adacel®. Receives: Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
Older Adults: Boostrix®	Active comparator	Healthy participants aged >=65 years received Boostrix®. Receives: Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years
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, Erythema, Swelling, Upper limb edema, Extensive limb swelling and solicited systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
Measured: Within 7 days after vaccination
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years
An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and 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, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
Measured: Within 7 days after vaccination
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years
An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and 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, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
Measured: Within 7 days after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Oct 201521 Feb 2017

First posted27 Oct 2015 (estimated)
Study start22 Oct 2015
Primary completion21 Feb 2017
Study completion21 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for TetanusStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,363 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02587520
Sponsor's protocol ID: ADC01
Other IDs: U1111-1161-3027
Status last verified: Mar 2022
First submitted: 22 Oct 2015
Last updated: 23 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
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Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
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All Tetanus trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults
ClinicalTrials.gov ID: NCT02587520
Acronym / sponsor ID: ADC01
Conditions: Tetanus, Diphtheria, Pertussis, Whooping Cough
Keywords: Tetanus, Diphtheria, Pertussis, SP0173, Tdap vaccine
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,363 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 22 Oct 2015 (actual)
Primary completion: 21 Feb 2017 (actual)
Study completion: 21 Feb 2017 (actual)
First posted: 27 Oct 2015 (estimated)
Results: Posted 4 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 18

Arm	Type	Receives
Adolescents: SP0173 Formulation 1	Experimental	Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
Adolescents: SP0173 Formulation 2	Experimental	Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Adolescents: SP0173 Formulation 3	Experimental	Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Adolescents: SP0173 Formulation 4	Experimental	Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Adolescents: Adacel®	Active comparator	Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine AdsorbedHealthy participants aged 10-18 years received Adacel®.
Adolescents: Boostrix®	Active comparator	Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis VaccineHealthy participants aged 10-18 years received Boostrix®.
Adults: SP0173 Formulation 1	Experimental	Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Adults: SP0173 Formulation 2	Experimental	Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Adults: SP0173 Formulation 3	Experimental	Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Adults: SP0173 Formulation 4	Experimental	Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Adults: Adacel®	Active comparator	Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine AdsorbedHealthy participants aged 19-64 years received Adacel®.
Adults: Boostrix®	Active comparator	Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis VaccineHealthy participants aged 19-64 years received Boostrix®.
Older Adults: SP0173 Formulation 1	Experimental	Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1Healthy participants aged greater than equal to (>=65) years received a single dose of the SP0173 Tdap vaccine.
Older Adults: SP0173 Formulation 2	Experimental	Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine.
Older Adults: SP0173 Formulation 3	Experimental	Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine.
Older Adults: SP0173 Formulation 4	Experimental	Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4Healthy participants aged >= 65 years received a single dose of the SP0173 Tdap vaccine.
Older Adults: Adacel®	Active comparator	Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine AdsorbedHealthy participants aged >=65 years received Adacel®.
Older Adults: Boostrix®	Active comparator	Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis VaccineHealthy participants aged >=65 years received Boostrix®.

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Aged 10 to 18 years, 19 to 64 years, or >= 65 years on the day of inclusion.
Informed consent form had been signed and dated by the participant, or assent form had been signed and dated by the participant and informed consent form had been signed and dated by the parent/guardian
Participant or participant and parent/guardian able to attend all scheduled visits and to comply with all study procedures.

Key exclusion criteria (16 listed)

Participant was pregnant, or lactating, or of childbearing potential, (to be considered of non-childbearing potential, a female must be premenarche or post-menopausal for at least 1 year) surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.
Participation at the time of study enrollment or planned participation during the present study period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
Received any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine between Visit 1 and Visit 2.
Known or suspected receipt of a tetanus toxoid, reduced diphtheria toxoid, and Acellular pertussis (Tdap) vaccine or Tdap-containing vaccine at any point in time, or receipt of a tetanus and diphtheria containing vaccine in the preceding 5 years.
Receipt of immune globulins, blood or blood-derived products in the past 3 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1Also: SP01730.5 milliliter (mL), Intramuscular	Biological	Adolescents: SP0173 Formulation 1, Adults: SP0173 Formulation 1, Older Adults: SP0173 Formulation 1
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2Also: SP01730.5 mL, Intramuscular	Biological	Adolescents: SP0173 Formulation 2, Adults: SP0173 Formulation 2, Older Adults: SP0173 Formulation 2
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3Also: SP01730.5 mL, Intramuscular	Biological	Adolescents: SP0173 Formulation 3, Adults: SP0173 Formulation 3, Older Adults: SP0173 Formulation 3
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4Also: SP01730.5 mL, Intramuscular	Biological	Adolescents: SP0173 Formulation 4, Adults: SP0173 Formulation 4, Older Adults: SP0173 Formulation 4
Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed0.5 mL, Intramuscular	Biological	Adolescents: Adacel®, Adults: Adacel®, Older Adults: Adacel®
Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine0.5 mL, Intramuscular	Biological	Adolescents: Boostrix®, Adults: Boostrix®, Older Adults: Boostrix®

Primary outcome

Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years
Time frame: Within 7 days after vaccination
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, Erythema, Swelling, Upper limb edema, Extensive limb swelling and solicited systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years
Time frame: Within 7 days after vaccination
An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and 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, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years
Time frame: Within 7 days after vaccination
An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and 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, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.

Results and safety

Results posted to the registry on 4 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adolescents: SP0173 Formulation 1	80	78
Adolescents: SP0173 Formulation 2	71	69
Adolescents: SP0173 Formulation 3	78	77
Adolescents: SP0173 Formulation 4	79	74
Adolescents: Adacel®	75	75
Adolescents: Boostrix®	75	72
Adults: SP0173 Formulation 1	76	73
Adults: SP0173 Formulation 2	73	71
Adults: SP0173 Formulation 3	76	73
Adults: SP0173 Formulation 4	76	71
Adults: Adacel®	76	73
Adults: Boostrix®	73	69
Older Adults: SP0173 Formulation 1	77	77
Older Adults: SP0173 Formulation 2	74	73
Older Adults: SP0173 Formulation 3	78	78
Older Adults: SP0173 Formulation 4	72	72
Older Adults: Adacel®	76	76
Older Adults: Boostrix®	78	78

Primary outcome: Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years

Time frame: Within 7 days after vaccination. Count of participants. Unit: Participants

Measure	Adolescents: SP0173 Formulation 1 n = 79	Adolescents: SP0173 Formulation 2 n = 71	Adolescents: SP0173 Formulation 3 n = 77	Adolescents: SP0173 Formulation 4 n = 77	Adolescents: Adacel® n = 75	Adolescents: Boostrix® n = 75
Injection site pain	59	51	50	49	59	48
Injection site erythema	9	4	10	1	4	2
Injection site swelling	7	4	8	0	1	4
Upper limb edema	45	41	49	46	48	33
Extensive limb swelling	0	0	0	0	0	0
Fever	1	0	1	0	0	1
Headache	21	14	19	25	20	27
Malaise	14	17	14	18	12	17

Population analysed: Safety analysis set that was defined as those participants who had received study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Here, "number analyzed"= number of participants with available data for each specified category.

Primary outcome: Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years

Time frame: Within 7 days after vaccination. Count of participants. Unit: Participants

Measure	Adults: SP0173 Formulation 1 n = 76	Adults: SP0173 Formulation 2 n = 73	Adults: SP0173 Formulation 3 n = 76	Adults: SP0173 Formulation 4 n = 76	Adults: Adacel® n = 76	Adults: Boostrix® n = 72
Injection site pain	38	34	49	42	49	35
Injection site erythema	2	1	2	0	5	2
Injection site swelling	1	3	4	1	3	1
Upper limb edema	28	37	41	37	35	31
Extensive limb swelling	0	0	0	0	1	0
Fever	0	0	0	0	2	1
Headache	16	11	19	19	19	19
Malaise	18	9	16	19	23	15

Population analysed: Analysis was performed on safety analysis set. Here, "number analyzed"=number of participants with available data for each specified category.

Primary outcome: Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years

Time frame: Within 7 days after vaccination. Count of participants. Unit: Participants

Measure	Older Adults: SP0173 Formulation 1 n = 77	Older Adults: SP0173 Formulation 2 n = 73	Older Adults: SP0173 Formulation 3 n = 78	Older Adults: SP0173 Formulation 4 n = 72	Older Adults: Adacel® n = 76	Older Adults: Boostrix® n = 78
Injection site pain	21	34	34	34	28	25
Injection site erythema	0	1	2	2	3	1
Injection site swelling	1	6	6	2	1	2
Upper limb edema	38	43	36	38	32	40
Extensive limb swelling	0	0	0	0	0	0
Fever	0	1	0	0	0	0
Headache	6	10	20	12	11	14
Malaise	6	12	14	9	8	6

Population analysed: Analysis was performed on safety analysis set. Here, "number analyzed"=number of participants with available data for each specified category.

Adverse events

Time frame: Non-serious AEs were collected from Day 0 to Day 7 (SRs) or Day 30 (unsolicited AEs) after vaccination. Serious AEs were collected from Day 0 up to Month 6 after vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adolescents: SP0173 Formulation 1	0 of 79 (0%)	71 of 79 (89.9%)	0 of 79
Adolescents: SP0173 Formulation 2	0 of 71 (0%)	64 of 71 (90.1%)	0 of 71
Adolescents: SP0173 Formulation 3	0 of 77 (0%)	67 of 77 (87%)	0 of 77
Adolescents: SP0173 Formulation 4	1 of 77 (1.3%)	68 of 77 (88.3%)	0 of 77
Adolescents: Adacel®	0 of 75 (0%)	71 of 75 (94.7%)	0 of 75
Adolescents: Boostrix®	0 of 75 (0%)	66 of 75 (88%)	0 of 75
Adults: SP0173 Formulation 1	1 of 76 (1.3%)	52 of 76 (68.4%)	0 of 76
Adults: SP0173 Formulation 2	1 of 73 (1.4%)	53 of 73 (72.6%)	0 of 73
Adults: SP0173 Formulation 3	1 of 76 (1.3%)	67 of 76 (88.2%)	0 of 76
Adults: SP0173 Formulation 4	1 of 76 (1.3%)	54 of 76 (71.1%)	0 of 76
Adults: Adacel®	0 of 76 (0%)	62 of 76 (81.6%)	0 of 76
Adults: Boostrix®	2 of 72 (2.8%)	50 of 72 (69.4%)	1 of 72
Older Adults: SP0173 Formulation 1	0 of 77 (0%)	53 of 77 (68.8%)	0 of 77
Older Adults: SP0173 Formulation 2	3 of 73 (4.1%)	60 of 73 (82.2%)	0 of 73
Older Adults: SP0173 Formulation 3	4 of 78 (5.1%)	58 of 78 (74.4%)	0 of 78
Older Adults: SP0173 Formulation 4	1 of 72 (1.4%)	53 of 72 (73.6%)	0 of 72
Older Adults: Adacel®	2 of 76 (2.6%)	49 of 76 (64.5%)	0 of 76
Older Adults: Boostrix®

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Sanofi Pasteur Inc.

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years (time frame: Within 7 days after vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02587520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.