To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years

Study Overview
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Brief Summary
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The study objective is to assess the immunogenicity and safety of DTaP-IPV combination vaccine administered as a boosting dose to healthy 4 to 6-year-old children who received three doses of primary immunization against diphtheria, tetanus, pertussis, and polio.

Official Title
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A Multicenter, Single-group, Phase III Study to Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years Who Completed the Primary Vaccination Against Diphtheria, Tetanus, Pertussis, and Poliomyelitis by Participating in the Phase III Study, BR-DTPP-CT-301, or by Receiving Routine Vaccination

Conditions
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Diphtheria, Tetanus, Pertussis, Poliomyelitis

Intervention / Treatment
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* Biological: DTaP-IPV combination vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A subject's parent/legal representative provides a written consent after being informed about the study objective, methods, effect of the study vaccine, and other relevant information Documented record of the three doses of primary immunization against diphtheria, tetanus, pertussis, and polio either by participating in the previous study, BR-DTPP-CT-301 or by following the national immunization schedule under usual clinical setting (the primary immunization should have been initiated after 6 weeks of age and at minimal interval of 4 weeks) Receipt of a boosting dose against diphtheria, tetanus, and pertussis until 2 years of age; therefore, total of four vaccination records against diphtheria, tetanus, and pertussis and three against polio Healthy male or female children, aged 4 to 6 years on the day of the vaccination Exclusion Criteria: Children aged 7 years or older Previously received DTaP vaccine five times or more, including the doses received in the BR-DTPP-CT-301 study, either by a combination vaccine or a separate vaccine Previously received IPV vaccine four times or more, including the doses received in the BR-DTPP-CT-301 study, either by a combination vaccine or a separate vaccine The fourth dose of DTaP vaccine was postponed and administered after 4 years of age Acute febrile illness with fever ≥ 38.0°C (tympanic) on the day of the vaccination Moderate to severe systemic acute illness with or without fever History of diphtheria, tetanus, pertussis, or polio (poliomyelitis) Dysfunctional immune system or congenital or acquired immunodeficiency Had encephalopathy of unknown etiology within 7 days following a previous dose of DTaP vaccine Received a vaccine other than the protocol-permitted vaccines within 28 days from the study vaccination day or are planned to receive such a vaccine during the study period Received systemic corticosteroid treatment at immunosuppressive dosage within 28 days from the study vaccination day or are planned to receive such a treatment during the study period (exceptionally, administration of prednisolone ≤ 0.5 mg/kg/day for up to 14 continuous days is allowed) Received immunoglobulins or blood products within 90 days before the study vaccination day or are planned to receive such products during the study period Had severe allergic reaction (e.g. anaphylaxis) to ingredients of the investigational product or bears such a possibility Currently enrolled in another clinical trial or planned to participate in another clinical trial Any other reasons that preclude the eligibility of the subject, based on investigator's decision

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: DTaP-IPV combined vaccine, 0.5mL, imtramuscular
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DTaP-IPV combination vaccine<br>DTaP-IPV 0.5ml IM boosting | Biological: DTaP-IPV combination vaccine<br>* Dosage and administration: A single intramuscular injection of 0.5 mL will be given to healthy children aged 4 to 6 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate after boosting vaccination | Antibodies will be measured by enzyme-linked immunosorbent assay (ELISA). | boosting vaccination after Day 28 [+14 days] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroprotection rate for anti-DT, anti-TT, and anti-poliovirus or seropositive (>30 IU/mL) rate for anti-PT and anti-FHA before boosting vaccination | Seroprotection rate | Day 1 Pre-vaccination | 
| Minimal seroprotection rate for anti-DT and anti-TT (≥ 0.01 IU/mL) before boosting vaccination | Seroprotection rate (≥ 0.01 IU/mL) | Day 1 Pre-vaccination | 
| Pre-booster antibody level |  | Day 1 Pre-vaccination | 
| Post-booster antibody level |  | boosting vaccination after Day 28 [+14 days] | 
| Geometric mean ratio (GMR) between the pre- and post-booster antibody level |  | Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days] | 
| GMR between the pre- and post-booster antibody level in each subgroup depending on the pre-booster antibody level (≥ seroprotective/seropositive level or < seroprotective/seropositive level) |  | Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days] | 
| Reverse cumulative distribution curves for pre- and post-booster antibody level |  | Day 1 Pre-vaccination and boosting vaccination after Day 28 [+14 days] | 
| Seroprotection rate for anti-DT, anti-TT, and anti-poliovirus or seropositive (>30 IU/mL) rate for anti-PT and anti-FHA after boosting vaccination |  | boosting vaccination after Day 28 [+14 days] | 
| Proportion of subjects with post-booster antibody levels for anti-DT and anti-TT ≥1.0 IU/mL |  | boosting vaccination after Day 28 [+14 days] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DTaP-IPV, Boosting Dose