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Immunogenicity and Safety of Adacel Polio Vaccine

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
TdcP-IPV vaccine
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Diphtheria, Tetanus, Pertussis, Poliomyelitis

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 6 to 8 years on the day of inclusion
  • Informed consent form signed by the parent(s) or another legally acceptable representative
  • Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
  • Written documentation of complete primary series and fourth dose of diphtheria, tetanus, pertussis (DTP) and Polio vaccines
  • Parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire.

Exclusion Criteria:

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • 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
  • Known systemic hypersensitivity to any of the vaccine components (or residues carried over from manufacture, such as formaldehyde, glutaraldehyde, streptomycin, neomycin and polymyxin B ) or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances with specific focus on subjects who had, after previous administration of DTP vaccine, one of the pre-listed adverse events.
  • Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
  • Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy
  • Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine in the 4 weeks following the trial vaccination
  • Known Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity
  • History of diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
  • Previous fifth vaccination against diphtheria and/or tetanus and/or pertussis and/or poliomyelitis diseases with either the trial vaccine or another vaccine
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
  • Subject at high risk for diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection during the trial
  • Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
  • Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Group

Arm Description

Participants will receive one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0

Outcomes

Primary Outcome Measures

Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Diphtheria concentrations determined by diphtheria toxin neutralization assay (Dip SN); Tetanus concentrations determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection titer levels were defined as: Anti-diphtheria antibody titers ≥0.1 international unit (IU) per milliliter (mL); Anti-tetanus antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL; Anti-Polio (≥ 8 1/dilution).
Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
The anti-Pertussis concentration were determined by ELISA. The criteria for demonstrating booster response are: (i) Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) for each anti-pertussis antibody (PT, FHA, FIM, and PRN) but a post-vaccination levels ≥ 4 x LLOQ; or (ii) Pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ with a 4-fold rise rate; or (iii) Pre-vaccination antibody concentrations ≥ 4 x LLOQ but with a 2-fold rise rate.
Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination
Diphtheria antibody concentrations determined by diphtheria toxin neutralization assay; Tetanus antibody concentrations determined by enzyme-linked immunosorbent assay (ELISA).
Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
Pre- and post-vaccination GMTs for the Pertussis toxoid (PT), Pertussis filamentous hemagglutinin (FHA), Pertussis pertactin (PRN), and Pertussis Fimbriae types 2 and 3 (FIM), all determined by enzyme-linked immunosorbent assay (ELISA).

Secondary Outcome Measures

Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Solicited Injection Site Reactions: Pain, Erythema/redness, Swelling, and Extensive swelling of vaccinated limb. Solicited Systemic Reactions: Fever (temperature ≥ 37.5ºC), Headache, Malaise, and Myalgia.

Full Information

First Posted
November 24, 2008
Last Updated
October 24, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00797511
Brief Title
Immunogenicity and Safety of Adacel Polio Vaccine
Official Title
Immunogenicity and Safety of ADACEL POLIO (TdcP-IPV Vaccine) Administered at 6 to 8 Years of Age as a Fifth Dose in Healthy Children in Taiwan
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study is designed to meet the requirements of the Taiwanese Health Authorities for registration of ADACEL POLIO in Taiwan. Subjects will receive one dose of the study vaccine at 6 to 8 years of age. Blood samples will be taken for antibody titration. The expected total duration of follow-up for each subject will be 28 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Poliomyelitis
Keywords
Diphtheria, Tetanus, Pertussis, Poliomyelitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Participants will receive one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
Intervention Type
Biological
Intervention Name(s)
TdcP-IPV vaccine
Other Intervention Name(s)
ADACEL POLIO
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Description
Diphtheria concentrations determined by diphtheria toxin neutralization assay (Dip SN); Tetanus concentrations determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection titer levels were defined as: Anti-diphtheria antibody titers ≥0.1 international unit (IU) per milliliter (mL); Anti-tetanus antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL; Anti-Polio (≥ 8 1/dilution).
Time Frame
Day 28 post-vaccination
Title
Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Description
The anti-Pertussis concentration were determined by ELISA. The criteria for demonstrating booster response are: (i) Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) for each anti-pertussis antibody (PT, FHA, FIM, and PRN) but a post-vaccination levels ≥ 4 x LLOQ; or (ii) Pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ with a 4-fold rise rate; or (iii) Pre-vaccination antibody concentrations ≥ 4 x LLOQ but with a 2-fold rise rate.
Time Frame
Day 28 post-vaccination
Title
Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination
Description
Diphtheria antibody concentrations determined by diphtheria toxin neutralization assay; Tetanus antibody concentrations determined by enzyme-linked immunosorbent assay (ELISA).
Time Frame
Day 28 post-vaccination
Title
Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
Description
Pre- and post-vaccination GMTs for the Pertussis toxoid (PT), Pertussis filamentous hemagglutinin (FHA), Pertussis pertactin (PRN), and Pertussis Fimbriae types 2 and 3 (FIM), all determined by enzyme-linked immunosorbent assay (ELISA).
Time Frame
Day 0 (pre-vaccination) and Day 28 post-vaccination
Secondary Outcome Measure Information:
Title
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Description
Solicited Injection Site Reactions: Pain, Erythema/redness, Swelling, and Extensive swelling of vaccinated limb. Solicited Systemic Reactions: Fever (temperature ≥ 37.5ºC), Headache, Malaise, and Myalgia.
Time Frame
Day 0 up to Day 7 post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 6 to 8 years on the day of inclusion Informed consent form signed by the parent(s) or another legally acceptable representative Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures Written documentation of complete primary series and fourth dose of diphtheria, tetanus, pertussis (DTP) and Polio vaccines Parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire. Exclusion Criteria: Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination Planned participation in another clinical trial during the present trial period 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 Known systemic hypersensitivity to any of the vaccine components (or residues carried over from manufacture, such as formaldehyde, glutaraldehyde, streptomycin, neomycin and polymyxin B ) or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances with specific focus on subjects who had, after previous administration of DTP vaccine, one of the pre-listed adverse events. Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response Receipt of any vaccine in the 4 weeks preceding the trial vaccination Planned receipt of any vaccine in the 4 weeks following the trial vaccination Known Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity History of diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection (confirmed either clinically, serologically or microbiologically) Previous fifth vaccination against diphtheria and/or tetanus and/or pertussis and/or poliomyelitis diseases with either the trial vaccine or another vaccine Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination Subject at high risk for diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection during the trial Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

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Immunogenicity and Safety of Adacel Polio Vaccine

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