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

Phase 1

Completed

• Conditions: Diphtheria; Pertussis; Whooping Cough; Tetanus
• Interventions: 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: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine; Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed; Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4

• Registration Number: NCT02587520
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-10-22
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-27
• Primary Completion: 2017-02-21
• Study Completion: 2017-02-21
• Disposition First Submitted: 2018-02-19
• Disposition First Submitted QC: 2018-02-19
• Disposition First Posted: 2018-02-22
• Results First Submitted: 2020-02-18
• Results First Submitted QC: 2020-02-18
• Results First Posted: 2020-03-04
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1363

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adolescents: SP0173 Formulation 1	Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed 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.
Adolescents: SP0173 Formulation 2	Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2	Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Adolescents: SP0173 Formulation 3	Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3	Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Adolescents: Boostrix®	Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine	Healthy participants aged 10-18 years received Boostrix®.
Adults: Boostrix®	Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine	Healthy participants aged 19-64 years received Boostrix®.
Adults: SP0173 Formulation 1	Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1	Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Adults: SP0173 Formulation 3	Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3	Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Adults: Adacel®	Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed	Healthy participants aged 19-64 years received Adacel®.
Older Adults: Adacel®	Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed	Healthy participants aged \>=65 years received Adacel®.
Older Adults: Boostrix®	Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine	Healthy participants aged \>=65 years received Boostrix®.
Older Adults: SP0173 Formulation 4	Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4	Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine.
Adolescents: SP0173 Formulation 4	Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4	Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine.
Adolescents: Adacel®	Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed	Healthy participants aged 10-18 years received Adacel®.
Adults: SP0173 Formulation 2	Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2	Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Adults: SP0173 Formulation 4	Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4	Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine.
Older Adults: SP0173 Formulation 1	Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1	Healthy participants aged greater than equal to (\>=65) years received a single dose of the SP0173 Tdap vaccine.
Older Adults: SP0173 Formulation 2	Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2	Healthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine.
Older Adults: SP0173 Formulation 3	Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3	Healthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years	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	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	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.