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

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.

Study Overview

• Status: Completed
• Conditions: Pertussis; Whooping Cough; Tetanus; Diphtheria
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 1363
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

18

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2015
• Primary Completion (Actual): February 21, 2017
• Study Completion (Actual): February 21, 2017

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Pertussis; Diphtheria; Tetanus; SP0173; Tdap vaccine
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neurologic Manifestations; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Actinomycetales Infections; Clostridium Infections; Hypocalcemia; Calcium Metabolism Disorders; Corynebacterium Infections; Whooping Cough; Tetanus; Diphtheria; Tetany; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: ADC01; U1111-1161-3027 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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://vivli.org