A Phase II, Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter Study to Evaluate the Immunogenicity and Safety of DTaP-HepB-IPV-Hib Hexavalent Vaccine LR20062 Versus Hexaxim Administered Intramuscularly in Healthy Infants As Primary Series At 2, 4, 6 Months of Age
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 336
- 主要终点
- Seroprotection/vaccine-response rate
研究概览
简要总结
This is a phase II, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of DTaP-HepB-IPV-Hib hexavalent vaccine LR20062 in healthy infants as primary series at 2, 4, 6 months of age.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Any persons accompanying the subject for the site visits, including parents, other family members, and/or legally acceptable representatives, will be shielded from view by physical barriers while the study vaccine is administered. The unblinded site personnel for the preparation/administration of study vaccines will keep the unblinded information separate from those persons for any study related procedures/assessments after administration of study vaccines, which includes all safety follow-up procedures. Blinded site personnel will be responsible for all safety and immunogenicity follow-up procedures after study vaccine administration.
入排标准
- 年龄范围
- 50 Days 至 70 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine.
- •Is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg.
排除标准
- •Medical conditions:
- •Has a history of diphtheria, tetanus, pertussis, poliovirus, Hep B, or Hib infection.
- •Has a known SARS-CoV-2 infection at Screening.
- •Was born to a mother with a known history of Hep B infection based on HBsAg seropositivity.
- •Was born to a mother with a known history of HIV infection based on HIV antibody seropositivity.
- •Had a recent febrile illness, defined as axillary temperature ≥38.0℃ [≥100.4℉] occurring at or within 72 hours prior to receipt of study vaccine.
- •Prior/concomitant therapy:
- •Has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and/or Hib infections since birth.
- •Has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study.
- •Meets one or more of the following systemic corticosteroid exclusion criteria:
- •Has received systemic corticosteroids (equivalent of ≥0.5 mg/kg total daily dose of prednisone) for ≥14 consecutive days and has not completed treatment at least 30 days prior to Screening.
- •Is expected to require any systemic corticosteroids during conduct of the study.
- •Note: Topical, ophthalmic, and inhaled steroids are permitted at the discretion of the Investigator.
- •Has received any non-study vaccine within 30 days before the first dose of study vaccine or is scheduled to receive any other vaccine within one month after the third dose of study vaccine.
- •Exception: Vaccines against BCG and Hep B at birth, rotavirus, MMR, and PCV if received according to the routine immunization schedule, and inactivated influenza vaccine, are allowed.
研究组 & 干预措施
Test group 1
Low dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
干预措施: LR20062 (Biological)
Test group 2
Middle dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
干预措施: LR20062 (Biological)
Test group 3
High dose of candidate hexavalent vaccine (DTaP-HepB-IPV-Hib)
干预措施: LR20062 (Biological)
Test group 4
Control hexavalent vaccine (DTaP-HepB-IPV-Hib)
干预措施: DTaP-HepB-IPV-Hib vaccine (Biological)
结局指标
主要结局
Seroprotection/vaccine-response rate
时间窗: 1 month after the third dose primary series
* Proportion of subjects achieving seroprotection to each antigenic components * Proportion of subjects with vaccine response for pertussis antigens
次要结局
- Geometric mean concentration (GMC) or Geometric mean titer (GMT)(1 month after the third dose primary series)
- Seroconversion rate(1 month after the third dose primary series)
- Long-term seroprotection rate(1 month after the third dose primary series)
- Solicited adverse event(7 days after each vaccination)
- Unsolicited adverse event(1 month after each vaccinations)
- Immediate reactions after vaccination(30 minutes after each vaccination)