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.

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

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

Study Overview

• Status: Completed
• Conditions: Pertussis; Tetanus; Diphtheria
• Intervention / Treatment: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap (ADACEL); Biological: DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed); Biological: Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed)

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.

• Study Type: Interventional
• Enrollment (Actual): 1440
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Yandu, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 64 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ADACEL Vaccine Group; Children, adolescents and adults randomized to receive a single booster dose of ADACEL (Tdap vaccine)	Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap (ADACEL); 0.5 mL, Intramuscular; Other Names: ADACEL
ACTIVE_COMPARATOR: Local DT/Td Vaccine Group; Participants randomized to receive either a single booster dose of local DT vaccine (children aged 4 through 11 years) or local Td vaccine (adolescents and adults aged 12 through 64 years)	Biological: DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed); 0.5 mL, Intramuscular; Biological: Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed); 0.5 mL, Intramuscular

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with anti-diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL	Anti-diphtheria antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)	28 Days post-vaccination
Percentage of participants with anti-tetanus antibody concentrations ≥ 0.1 IU/mL	Anti-tetanus antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)	28 Days post-vaccination
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	Booster response for antibodies to Pertussis Toxoid (PT), Filamentous hemagglutinin (FHA), pertactin (PRN), Fimbriae types 2 and 3 (FIM) will be determined by enzyme-linked immunosorbent assay (ELISA)	Day 0 (pre-vaccination) and Day 28 post-vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with anti diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL at baseline	Anti-diphtheria antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)	Day 0 (pre-vaccination)
Percentage of participants with anti-tetanus antibody concentrations ≥ 0.1 IU/mL at baseline	Anti-tetanus antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)	Day 0 (pre-vaccination)
Percentage of participants with anti-diphtheria antibody concentrations ≥ 1.0 international unit (IU)/mL at baseline and post booster vaccination	Anti-diphtheria antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)	Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of participants with anti-tetanus antibody concentrations ≥ 1.0 IU/mL at baseline and post booster vaccination	Anti-tetanus antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)	Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric mean of individual antibody concentrations at baseline and post-booster vaccination	Antibody concentrations to all vaccine antigens will be determined by enzyme-linked immunosorbent assay (ELISA)	Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse reactions, and serious adverse events occurring during the trial	Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia	Day 0 up to Day 28 post-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: November 1, 2013
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (ESTIMATE): November 25, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 19, 2015
• Last Update Submitted That Met QC Criteria: May 18, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Pertussis; Diphtheria; Tetanus; Tdap vaccine; ADACEL®
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Clostridium Infections; Corynebacterium Infections; Whooping Cough; Tetanus; Diphtheria; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: Td528; U1111-1127-7835 (OTHER: WHO)