Clinical trial NCT01993173: Sanofi Pasteur's Tdap Combined Vaccine as a Booster Versus Local DT Vaccine in Children or Versus Local Td Vaccine in Adolescents and Adults in China.
Official title: Immunogenicity and Safety of Sanofi Pasteur's Tdap Combined Vaccine (ADACEL) as a Booster Dose, Versus Local DT Vaccine in Healthy Children or Versus Local Td Vaccine in Healthy Adolescents and Adults in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Keywords: Diphtheria
Tetanus
Pertussis
ADACEL®
Tdap vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 1440
Sex: ALL
Minimum age (years): 4
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to assess the immunogenicity and safety profile of ADACEL compared to local adsorbed diphtheria and tetanus combined vaccine (local DT or local Td vaccine in participants in China.

Primary objective:

* To describe diphtheria and tetanus seroprotection rates and pertussis booster response rates induced by each of the study vaccines: ADACEL vaccine (in all study age groups), local DT vaccine (in children), and local Td vaccine (in adolescents and adults).

Secondary Objectives:

* To further describe in each group the immunogenicity of the study vaccines at baseline and 1 month after vaccination.
* To describe the safety of the study vaccines

Detailed description: Study participants will receive a single booster dose of ADACEL (Tdap vaccine) or a single booster dose of local DT or local Td vaccine, depending on the age subgroup.

Immunogenicity will be assessed before and 28 days post-vaccination; safety profile will be assessed in all subjects up to Day 35 post vaccination.

Eligibility criteria: Inclusion Criteria:

* Aged 4 through 64 years on day of inclusion
* For children and adolescents (4 through 17 years): Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and assent form has been signed and dated by the subject if aged 8 through 17 years

For adults (18 years and over): Informed consent form has been signed and dated by the subject

* Subject and parent / legally acceptable representative (for subjects up to 17 years) are able to attend all schedule visits and to comply with all trial procedures
* According to China National Immunization Recommendations, written documentation of complete primary series and fourth dose of diphtheria, tetanus, pertussis (DTP) vaccine for subjects aged 4 through 7 years and a written documentation or oral confirmation of complete primary series and fourth dose of DTP vaccine for subjects aged 8 through 64 years

Exclusion Criteria:

* Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination.
* Previous vaccination against diphtheria and tetanus disease with either the trial vaccine or another vaccine (except Tetanus-prone wound management for adults) in the past 12 months.
* Previous fifth vaccination against pertussis disease.
* Receipt of immune globulins, blood or blood-derived products in the past 3 months.
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy.
* Known (laboratory-confirmed / self-reported) Human Immunodeficiency Virus (HIV) or Hepatitis C seropositivity.
* History of diphtheria, tetanus, or pertussis infection (confirmed either clinically, serologically or microbiologically).
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
* Laboratory-confirmed / self-reported thrombocytopenia, contraindicating intramuscular vaccination.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
* History of contra-indication to vaccination with pertussis containing vaccine, including:

  * Encephalopathy (e.g, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause
  * Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy
  * Axillary temperature \>39.4°C within 48 hours not attributable to another identifiable cause
  * Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.
* Prior personal history of Guillain-Barré syndrome.
* 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.
* Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche 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 the vaccination and until at least 4 weeks after the vaccination.

Primary outcomes:
measure: Percentage of participants with anti-diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL
timeFrame: 28 Days post-vaccination
measure: Percentage of participants with anti-tetanus antibody concentrations ≥ 0.1 IU/mL
timeFrame: 28 Days post-vaccination
measure: Percentage of participants with a booster response for antibodies to Pertussis Toxoid (PT), Filamentous hemagglutinin (FHA), pertactin (PRN), Fimbriae types 2 and 3 (FIM) following vaccination with ADACEL or Local DT or Local Td Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Secondary outcomes:
measure: Percentage of participants with anti diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL at baseline
timeFrame: Day 0 (pre-vaccination)
measure: Percentage of participants with anti-tetanus antibody concentrations ≥ 0.1 IU/mL at baseline
timeFrame: Day 0 (pre-vaccination)
measure: Percentage of participants with anti-diphtheria antibody concentrations ≥ 1.0 international unit (IU)/mL at baseline and post booster vaccination
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Percentage of participants with anti-tetanus antibody concentrations ≥ 1.0 IU/mL at baseline and post booster vaccination
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Geometric mean of individual antibody concentrations at baseline and post-booster vaccination
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse reactions, and serious adverse events occurring during the trial
timeFrame: Day 0 up to Day 28 post-vaccination
Other outcomes:
Locations:
city: Yandu
country: China
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: