Immunogenicity and Safety of Adacel Polio Vaccine

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797511
• Other study ID #: TD525
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2008
• Last updated: October 24, 2012
• Start date: November 2008
• Est. completion date: July 2009

Study information

• Verified date: October 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 8 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Poliomyelitis
• Tetanus

Intervention

Biological:
• TdcP-IPV vaccine
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 28 post-vaccination	No
Primary	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.	Day 28 post-vaccination	No
Primary	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).	Day 28 post-vaccination	No
Primary	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).	Day 0 (pre-vaccination) and Day 28 post-vaccination	No
Secondary	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.	Day 0 up to Day 7 post-vaccination	No

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