Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects
Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults
2 other identifiers
interventional
1,363
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2015
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2015
CompletedStudy Start
First participant enrolled
October 22, 2015
CompletedFirst Posted
Study publicly available on registry
October 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2017
CompletedResults Posted
Study results publicly available
March 4, 2020
CompletedMarch 23, 2022
March 1, 2022
1.3 years
October 22, 2015
February 18, 2020
March 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Within 7 days after vaccination
Study Arms (18)
Adolescents: SP0173 Formulation 1
EXPERIMENTALHealthy 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
EXPERIMENTALHealthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Adolescents: SP0173 Formulation 3
EXPERIMENTALHealthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Adolescents: SP0173 Formulation 4
EXPERIMENTALHealthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Adolescents: Adacel®
ACTIVE COMPARATORHealthy participants aged 10-18 years received Adacel®.
Adolescents: Boostrix®
ACTIVE COMPARATORHealthy participants aged 10-18 years received Boostrix®.
Adults: SP0173 Formulation 1
EXPERIMENTALHealthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Adults: SP0173 Formulation 2
EXPERIMENTALHealthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Adults: SP0173 Formulation 3
EXPERIMENTALHealthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Adults: SP0173 Formulation 4
EXPERIMENTALHealthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Adults: Adacel®
ACTIVE COMPARATORHealthy participants aged 19-64 years received Adacel®.
Adults: Boostrix®
ACTIVE COMPARATORHealthy participants aged 19-64 years received Boostrix®.
Older Adults: SP0173 Formulation 1
EXPERIMENTALHealthy participants aged greater than equal to (\>=65) years received a single dose of the SP0173 Tdap vaccine.
Older Adults: SP0173 Formulation 2
EXPERIMENTALHealthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine.
Older Adults: SP0173 Formulation 3
EXPERIMENTALHealthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine.
Older Adults: SP0173 Formulation 4
EXPERIMENTALHealthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine.
Older Adults: Adacel®
ACTIVE COMPARATORHealthy participants aged \>=65 years received Adacel®.
Older Adults: Boostrix®
ACTIVE COMPARATORHealthy participants aged \>=65 years received Boostrix®.
Interventions
0.5 milliliter (mL), Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Birmingham, Alabama, 35205, United States
Unknown Facility
Fayetteville, Arkansas, 72703, United States
Unknown Facility
Jonesboro, Arkansas, 72401, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Miami, Florida, 33143, United States
Unknown Facility
Orlando, Florida, 32806, United States
Unknown Facility
Meridian, Idaho, 83642, United States
Unknown Facility
Bardstown, Kentucky, 40004, United States
Unknown Facility
Nicholasville, Kentucky, 40356, United States
Unknown Facility
Lincoln, Nebraska, 68516, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Albuquerque, New Mexico, 87108, United States
Unknown Facility
Rochester, New York, 14609, United States
Unknown Facility
Cleveland, Ohio, 44122, United States
Unknown Facility
Erie, Pennsylvania, 16505, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Salt Lake City, Utah, 84109, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi Pasteur
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2015
First Posted
October 27, 2015
Study Start
October 22, 2015
Primary Completion
February 21, 2017
Study Completion
February 21, 2017
Last Updated
March 23, 2022
Results First Posted
March 4, 2020
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
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