NCT00351923已完成3 期
Open, Multicenter, Randomised, Controlled Phase IIIb Study Evaluating the Immunogenicity and Safety of Subcutaneous Versus Alternative Administration Route of Combined MeMuRu-OKA Vaccine to Healthy Children Aged 11 to 21 Months.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 21
- 主要终点
- Seroconversion rates after vaccination
研究概览
简要总结
This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route.
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
- 11 Months 至 22 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children must be healthy and have a birth weight > 2000 g to participate
排除标准
- •confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
- •Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study.
- •Children must have received one dose (but not more) of MMR and of varicella at least 6 weeks before entering the study. They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days.
- •Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol within 30 days before vaccination.
- •Children must not have had measles, mumps, rubella or varicella/zoster, or have been exposed to those diseases within 30 days prior to study start.
- •New-born infants (< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child
结局指标
主要结局
Seroconversion rates after vaccination
次要结局
- Antibody titres; safety: solicited local/ general, unsolicited AEs (42 days), SAEs (whole study)
研究者
研究点 (21)
Loading locations...
相似试验
已完成
2 期
A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency DiseasesPrimary Immunodeficiency Diseases (PID)NCT05755035Takeda65
已完成
1 期
Phase 1/2 Study of TAK-850 Intramuscular Injection in Healthy Pediatric ParticipantsInfluenza InfectionNCT02367885Takeda99
已完成
3 期
Phase III Study to Evaluate the Immunogenicity and Safety of MG1109 in Healthy Adult VolunteersInfluenzaNCT01987011Green Cross Corporation420
已完成
1 期
Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System in Medically Stable AdultsInfluenza, HumanNCT05975840GlaxoSmithKline518
已完成
2 期
Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate VaccineInfections, MeningococcalNCT00126984GlaxoSmithKline508