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

ID: NCT02587520
Status: Completed
Phase: Phase 1/Phase 2
Start Date: April 22, 2016
First Submitted: October 22, 2015
Last Updated: February 19, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi Pasteur, a Sanofi Company
Location: United States
Conditions: Tetanus, Diphtheria, Pertussis, Whooping Cough
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

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.

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.
Condition or disease Intervention/treatment Phase

Diphtheria

Pertussis

Tetanus

Whooping Cough

Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
Other Names
SP0173
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2
Other Names
SP0173
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3
Other Names
SP0173
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4
Other Names
SP0173
Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed
Other Names
Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine
Other Names
Phase 1/Phase 2

Tracking Information

First Submitted DateOctober 22, 2015
Last Update Posted DateFebruary 19, 2018
Actual Start DateApril 22, 2016
Actual Completion DateFebruary 22, 2017
Actual Primary Completion DateFebruary 22, 2017
Results First Submitted DateN/A
Received Results Disposit DateFebruary 19, 2018

Current Primary Outcome Measures

  • 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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleStudy of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects
Official TitleSafety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults
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.

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.

Study TypeInterventional
Study PhasePhase 1/Phase 2
Estimated Enrollment
1365
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Prevention
Conditions
Diphtheria
Pertussis
Tetanus
Whooping Cough
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1

0.5 mL, Intramuscular

Other Names
SP0173
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2

0.5 mL, Intramuscular

Other Names
SP0173
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3

0.5 mL, Intramuscular

Other Names
SP0173
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4

0.5 mL, Intramuscular

Other Names
SP0173
Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed

0.5 mL, Intramuscular

Other Names
Biological: Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine

0.5 mL, Intramuscular

Other Names
Study Groups/Cohorts
SP0173 Vaccine Formulation 1
Participants assigned to receive SP0173 vaccine formulation 1

SP0173 Vaccine Formulation 2
Participants assigned to receive SP0173 vaccine formulation 2

SP0173 Vaccine Formulation 3
Participants assigned to receive SP0173 vaccine formulation 3

SP0173 Vaccine Formulation 4
Participants assigned to receive SP0173 vaccine formulation 4

Control Vaccine Group 1
Participants assigned to receive a licensed Tdap vaccine 1

Control Vaccine Group 2
Participants assigned to receive a licensed Tdap vaccine 2

Study Arms
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

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

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

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

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

Arm Intervention/Treatment
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
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
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
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
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
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

Recruitment Information

Recruitment Status:Completed
Enrollment1365
Completion DateFebruary 22, 2017
Eligibility 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.
GenderAll
Age10 Years to N/A
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02587520
Other Study ID Numbers
ADC01
U1111-1161-3027
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Collaborators
Not Available
Investigators
Study Director
Medical Director
Sanofi Pasteur Inc.