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Trial record 1 of 2 for:    ADC01
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Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02587520
Recruitment Status : Completed
First Posted : October 27, 2015
Results First Posted : March 4, 2020
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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.

Condition or disease Intervention/treatment Phase
Tetanus Diphtheria Pertussis Whooping Cough 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 Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults
Actual Study Start Date : October 22, 2015
Actual Primary Completion Date : February 21, 2017
Actual Study Completion Date : February 21, 2017


Arm Intervention/treatment
Experimental: Adolescents: SP0173 Formulation 1
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.
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
0.5 milliliter (mL), Intramuscular
Other Name: SP0173

Experimental: Adolescents: SP0173 Formulation 2
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
0.5 mL, Intramuscular
Other Name: SP0173

Experimental: Adolescents: SP0173 Formulation 3
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
0.5 mL, Intramuscular
Other Name: SP0173

Experimental: Adolescents: SP0173 Formulation 4
Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
0.5 mL, Intramuscular
Other Name: SP0173

Active Comparator: Adolescents: Adacel®
Healthy participants aged 10-18 years received Adacel®.
Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
0.5 mL, Intramuscular

Active Comparator: Adolescents: Boostrix®
Healthy participants aged 10-18 years received Boostrix®.
Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
0.5 mL, Intramuscular

Experimental: Adults: SP0173 Formulation 1
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
0.5 milliliter (mL), Intramuscular
Other Name: SP0173

Experimental: Adults: SP0173 Formulation 2
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
0.5 mL, Intramuscular
Other Name: SP0173

Experimental: Adults: SP0173 Formulation 3
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
0.5 mL, Intramuscular
Other Name: SP0173

Experimental: Adults: SP0173 Formulation 4
Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
0.5 mL, Intramuscular
Other Name: SP0173

Active Comparator: Adults: Adacel®
Healthy participants aged 19-64 years received Adacel®.
Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
0.5 mL, Intramuscular

Active Comparator: Adults: Boostrix®
Healthy participants aged 19-64 years received Boostrix®.
Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
0.5 mL, Intramuscular

Experimental: Older Adults: SP0173 Formulation 1
Healthy participants aged greater than equal to (>=65) years received a single dose of the SP0173 Tdap vaccine.
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
0.5 milliliter (mL), Intramuscular
Other Name: SP0173

Experimental: Older Adults: SP0173 Formulation 2
Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine.
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
0.5 mL, Intramuscular
Other Name: SP0173

Experimental: Older Adults: SP0173 Formulation 3
Healthy participants aged >=65 years received a single dose of the SP0173 Tdap vaccine.
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
0.5 mL, Intramuscular
Other Name: SP0173

Experimental: Older Adults: SP0173 Formulation 4
Healthy participants aged >= 65 years received a single dose of the SP0173 Tdap vaccine.
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
0.5 mL, Intramuscular
Other Name: SP0173

Active Comparator: Older Adults: Adacel®
Healthy participants aged >=65 years received Adacel®.
Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
0.5 mL, Intramuscular

Active Comparator: Older Adults: Boostrix®
Healthy participants aged >=65 years received Boostrix®.
Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
0.5 mL, Intramuscular




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587520


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35205
United States, Arkansas
Fayetteville, Arkansas, United States, 72703
Jonesboro, Arkansas, United States, 72401
United States, California
San Diego, California, United States, 92108
United States, Florida
DeLand, Florida, United States, 32720
Miami, Florida, United States, 33143
Orlando, Florida, United States, 32806
United States, Idaho
Meridian, Idaho, United States, 83642
United States, Kentucky
Bardstown, Kentucky, United States, 40004
Nicholasville, Kentucky, United States, 40356
United States, Nebraska
Lincoln, Nebraska, United States, 68516
United States, Nevada
Las Vegas, Nevada, United States, 89109
United States, New Mexico
Albuquerque, New Mexico, United States, 87108
United States, New York
Rochester, New York, United States, 14609
United States, Ohio
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
Erie, Pennsylvania, United States, 16505
United States, South Carolina
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Utah
Salt Lake City, Utah, United States, 84109
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.
  Study Documents (Full-Text)

Documents provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Statistical Analysis Plan  [PDF] December 13, 2016
Study Protocol  [PDF] May 13, 2016

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02587520    
Other Study ID Numbers: ADC01
U1111-1161-3027 ( Other Identifier: WHO )
First Posted: October 27, 2015    Key Record Dates
Results First Posted: March 4, 2020
Last Update Posted: March 4, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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://www.clinicalstudydatarequest.com/.
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Tetanus
Diphtheria
Pertussis
SP0173
Tdap vaccine
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Tetany
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs