Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    ADC01
Previous Study | Return to List | Next Study

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
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

This is a dose and formulation ranging study to assess the safety and immunogenicity of SP0173 in healthy adolescents, adults, and older adults in the 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 subjects will receive a single dose of vaccine, and will be assessed for immunogenicity at baseline (pre-vaccination) and at 30 days post-vaccination. They will also be monitored for safety from day of vaccination up to Day 180 post-vaccination.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1365 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 : April 22, 2016
Actual Primary Completion Date : February 22, 2017
Actual Study Completion Date : February 22, 2017


Arm Intervention/treatment
Experimental: SP0173 Vaccine Formulation 1
Participants assigned to receive SP0173 vaccine formulation 1
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
0.5 mL, Intramuscular
Other Name: SP0173

Experimental: SP0173 Vaccine Formulation 2
Participants assigned to receive SP0173 vaccine formulation 2
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
0.5 mL, Intramuscular
Other Name: SP0173

Experimental: SP0173 Vaccine Formulation 3
Participants assigned to receive SP0173 vaccine formulation 3
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
0.5 mL, Intramuscular
Other Name: SP0173

Experimental: SP0173 Vaccine Formulation 4
Participants assigned to receive SP0173 vaccine formulation 4
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
0.5 mL, Intramuscular
Other Name: SP0173

Active Comparator: Control Vaccine Group 1
Participants assigned to receive a licensed Tdap vaccine 1
Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
0.5 mL, Intramuscular

Active Comparator: Control Vaccine Group 2
Participants assigned to receive a licensed Tdap vaccine 2
Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
0.5 mL, Intramuscular




Primary Outcome Measures :
  1. Number of participants reporting solicited reactions, unsolicited adverse events and serious adverse events following vaccination in all groups. [ Time Frame: Day 0 up to Day 180 post-vaccination ]
    Solicited injection-site: Pain, Redness, Swelling, Change in limb circumference and Extensive limb swelling. Solicited systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia. Unsolicited adverse events; medically-attended adverse events and serious adverse events will also be collected


Other Outcome Measures:
  1. Percentage of subjects with antibody response to the vaccine pertussis antigens post-vaccination [ Time Frame: Day 0 (pre-vaccination) and Day 30 post-vaccination ]
    Anti-pertussis antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)

  2. Percentage of subjects with antibody responses to vaccine diphtheria antigens post-vaccination [ Time Frame: Day 0 (pre-vaccination) and Day 30 post-vaccination ]
    Anti-diphtheria antitoxin concentration will be assessed by toxin neutralization assay.

  3. Percentage of subjects with antibody responses to vaccine tetanus antigens post-vaccination [ Time Frame: Day 0 (pre-vaccination) and Day 30 post-vaccination ]
    Anti-tetanus antitoxin concentration will be measured by enzyme-linked immunosorbent assay (ELISA)



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.


Layout table for eligibility information
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 has been signed and dated by the subject, or assent form has been signed and dated by the subject and informed consent form has been signed and dated by the parent/guardian
  • Subject or subject and parent/guardian able to attend all scheduled visits and to comply with all study procedures.

Exclusion Criteria:

  • Subject is 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 is 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
Layout table for location information
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
Layout table for investigator information
Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
Layout table for additonal information
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02587520     History of Changes
Other Study ID Numbers: ADC01
U1111-1161-3027 ( Other Identifier: WHO )
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available the company continue to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi".

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Tetanus
Diphtheria
Pertussis
SP0173
Tdap vaccine

Additional relevant MeSH terms:
Layout table for MeSH terms
Whooping Cough
Tetanus
Tetany
Diphtheria
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