NCT01993173

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,440

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

November 19, 2013

Last Update Submit

May 18, 2015

Conditions

DiphtheriaTetanusPertussis

Keywords

DiphtheriaTetanusPertussisADACEL®Tdap vaccine

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • Percentage of participants with anti diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL at baseline

    Day 0 (pre-vaccination)

  • Percentage of participants with anti-tetanus antibody concentrations ≥ 0.1 IU/mL at baseline

    Day 0 (pre-vaccination)

  • Percentage of participants with anti-diphtheria antibody concentrations ≥ 1.0 international unit (IU)/mL at baseline and post booster vaccination

    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

    Day 0 (pre-vaccination) and Day 28 post-vaccination

  • Geometric mean of individual antibody concentrations at baseline and post-booster vaccination

    Day 0 (pre-vaccination) and Day 28 post-vaccination

  • +1 more secondary outcomes

Study Arms (2)

ADACEL Vaccine Group

EXPERIMENTAL

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)

Local DT/Td Vaccine Group

ACTIVE COMPARATOR

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)Biological: Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed)

Interventions

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap (ADACEL)BIOLOGICAL

0.5 mL, Intramuscular

Also known as: ADACEL
ADACEL Vaccine Group
DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed)BIOLOGICAL

0.5 mL, Intramuscular

Local DT/Td Vaccine Group
Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed)BIOLOGICAL

0.5 mL, Intramuscular

Local DT/Td Vaccine Group

Eligibility Criteria

Age4 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Yandu, China

Location

Related Links

MeSH Terms

Conditions

DiphtheriaTetanusWhooping Cough

Interventions

Tetanus ToxoidadacelDiphtheria-Tetanus Vaccine

Condition Hierarchy (Ancestors)

Corynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsClostridium InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ToxoidsVaccinesBiological ProductsComplex MixturesBacterial VaccinesDiphtheria ToxoidVaccines, Combined

Study Officials

  • Medical Director

    Sanofi Pasteur Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 25, 2013

Study Start

November 1, 2013

Primary Completion

February 1, 2014

Study Completion

April 1, 2015

Last Updated

May 19, 2015

Record last verified: 2015-05

Locations

CN(1)