Overview

This trial is active, not recruiting.

Conditions tetanus, diphtheria, pertussis, whooping cough
Treatments tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed formulation 1, tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed, formulation 2, tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed, formulation 3, tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed, formulation 4, licensed tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed, licensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
Phase phase 1/phase 2
Sponsor Sanofi Pasteur, a Sanofi Company
Start date October 2015
End date May 2017
Trial size 1365 participants
Trial identifier NCT02587520, ADC01, U1111-1161-3027

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Participants assigned to receive SP0173 vaccine formulation 1
tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed formulation 1 SP0173
0.5 mL, Intramuscular
(Experimental)
Participants assigned to receive SP0173 vaccine formulation 2
tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed, formulation 2 SP0173
0.5 mL, Intramuscular
(Experimental)
Participants assigned to receive SP0173 vaccine formulation 3
tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed, formulation 3 SP0173
0.5 mL, Intramuscular
(Experimental)
Participants assigned to receive SP0173 vaccine formulation 4
tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed, formulation 4 SP0173
0.5 mL, Intramuscular
(Active Comparator)
Participants assigned to receive a licensed Tdap vaccine 1
licensed tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed
0.5 mL, Intramuscular
(Active Comparator)
Participants assigned to receive a licensed Tdap vaccine 2
licensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
0.5 mL, Intramuscular

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 10 years old.

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.

Additional Information

Official title Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Sanofi.