Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- PT Bio Farma
- 入组人数
- 465
- 试验地点
- 3
- 主要终点
- Phase I: Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose
研究概览
简要总结
This trial is open label, comparative, randomized, phase I/II study, experimental, randomized, open-label, three arm parallel group study. The primary objective for phase I is to evaluate the safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose. The primary objective for phase II is to evaluate protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine.
详细描述
This trial is open label, comparative, randomized, phase I/II study. For phase I, approximately 75 subjects will be recruited and will seamlessly continue to phase II recruiting 390 subject, in total 465 subjects.
In this study, DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine will be compared to an active control (Registered DTwP-Hepatitis B-Hib Vaccine and Registered Inactivated Polio Vaccine). There are 2 formulas of DTwP-Hepatitis B-Hib-IPV Vaccine which will be used in the study. The regimen of the vaccine is 0,5 ml injected three-dose regimen with 28 days interval between doses. On the other hand, the control group will receive 0,5 ml of Registered DTwP-Hepatitis B-Hib vaccine and 0,5 ml Inactivated Bio Farma vaccine injected in three-dose regimen with 28 days interval between doses.
The safety and immunogenicity result of the Phase I study will determine the continuation of the next phase clinical trial. Clinical trial of phase II can be conducted after safety observation within 28 days after the third dose in phase I. Three hundred and ninety (390) healthy subjects aged 6-11 weeks of age will be recruited in Phase II trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Weeks 至 11 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant 6-11 weeks of age.
- •Infant born after 37-42 weeks of pregnancy.
- •Infant weighing more than 2.5 kg at birth.
- •Father or mother, or legally acceptable representative properly informed about the study and signed the informed consent form.
- •Parents will commit themselves to comply with the indications of the investigators and with the schedule of the trial.
排除标准
- •Child concomitantly enrolled or scheduled to be enrolled in another trial.
- •Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥37.5°C on Day 0).
- •Known history of allergy to any component of the vaccines.
- •History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- •Known history of congenital or acquired immunodeficiency (including HIV infection).
- •Child who has received in the previous 4 weeks of a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks).
- •Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis.
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
- •Infant with a known history of diphtheria, tetanus, pertussis, Hib, hepatitis B infection.
研究组 & 干预措施
DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A
0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A injected three-dose regimen with 28 days interval between doses
干预措施: DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A (Biological)
DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B
0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B injected three-dose regimen with 28 days interval between doses.
干预措施: DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B (Biological)
Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac) ®
0,5 ml of DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)® injected three-dose regimen with 28 days interval between doses.
干预措施: Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)® (Biological)
结局指标
主要结局
Phase I: Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose
时间窗: From enrollment to 7 days after first dose
Safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose
Phase II: Immunogenicity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine
时间窗: From enrollment up to 28 days after third dose
Protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine
次要结局
- Phase I: Safety of the vaccine within 28 days after last dose(From enrollment to 28 days after each dose)
- Phase I: Safety of the vaccine within 6 months after last dose(From enrollment up to 6 months after the last dose)
- Phase I: Comparison of safety within 28 days after each dose between vaccines and active control(From enrollment to 28 days after each dose)
- Phase I: Comparison of safety until 6 months after last dose between vaccines and active control(From enrollment to 6 months after last dose)
- Phase I: Routine laboratory evaluation that probably related to the vaccination(From enrollment to 7 days after first dose)
- Phase I: Serological response to diphteria toxoid and tetanus toxoid(28 days after the last dose immunization)
- Phase I: Serological response to the pertussis component (agglutinins)(28 days after the last dose immunization)
- Phase I: Geometric mean of anti-HbsAg(28 days after the last dose immunization)
- Phase I: Serological response to Hib/PRP(28 days after the last dose immunization)
- Phase I: Serological response to polio type 1, 2, and 3 (humoral immunity)(28 days after the last dose immunization)
- Phase II: Serological response to diphtheria toxoid, tetanus toxoid(28 days after the last dose immunization)
- Phase II: Serological response to the pertussis component (agglutinins)(28 days after the last dose immunization)
- Phase II: Geometric mean of anti-HbsAg(28 days after the last dose immunization)
- Phase II: Serological response to Hib/PRP(28 days after the last dose immunization)
- Phase II: Serological response to polio type 1, 2, and 3 (humoral immunity)(28 days after the last dose immunization)
- Phase II: Safety of vaccine within 30 minutes after immunization(30 minutes after immunization)
- Phase II: Safety of vaccine within 7 days after immunization(Within 7 days after immunization)
- Phase II: Safety of vaccine after 7 days to 28 days following the vaccination(From 7 days to 28 days following the vaccination)