NCT04618640Unknown3 期
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
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 249
- 试验地点
- 51
- 主要终点
- Seroconversion rate after boosting vaccination
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Seroconversion rate after boosting vaccination
时间窗: boosting vaccination after Day 28 [+14 days]
Antibodies will be measured by enzyme-linked immunosorbent assay (ELISA).
次要结局
- Pre-booster antibody level(Day 1 Pre-vaccination)
- Post-booster antibody level(boosting vaccination after Day 28 [+14 days])
- Minimal seroprotection rate for anti-DT and anti-TT (≥ 0.01 IU/mL) before boosting vaccination(Day 1 Pre-vaccination)
- 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])
- 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(Day 1 Pre-vaccination)
- 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])
研究者
研究点 (51)
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