IRCT20240626062259N1招募中3 期
The phase 3, randomized, two-arm, parallel group, double-blind, active controlled non-inferiority clinical trial evaluating the immunogenicity and safety of the 13-valent pneumococcal vaccine (PneumoConj®- manufactured by Nivad Pharmed Salamat), compared to the 13-valent pneumococcal vaccine (Prevnar®- manufactured by Pfizer) as the reference product, in infants aged 8 ± 2 weeks
ivadPharmed Salamat company0 个研究点目标入组 324 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 324
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 42 days 至 70 days（—）
- 性别
- All
入选标准
- •Infants aged 8±2 weeks.
- •Good general health (confirmed through clinical examinations and medical records, e.g., normal growth curve, normal head circumference).
- •Parents willing to provide informed and voluntary written consent for their infant's participation in the study.
- •Ability to accompany their infant for study visits and follow-up sessions.
排除标准
- •History of previous vaccination against pneumococcal strains.
- •History of severe hypersensitivity reactions following vaccine injection.
- •Infants with congenital abnormalities, growth disorders, genetic defects, or severe malnutrition.
- •Infants with pathological jaundice lasting 2 to 4 weeks and recurring.
- •History of confirmed respiratory infection at clinic or serology, especially due to Streptococcus pneumoniae.
- •History of HIV infection in mother or infant.
- •Presence of thrombocytopenia (platelets less than 150,000) or other coagulation disorders.
- •Axillary temperature above 37.8 degrees Celsius within 72 hours prior to the study.
- •Family history of seizures, epilepsy, or encephalopathy in first-degree relatives of the infant.
- •Preterm and low birth weight infants (born before 37 weeks of gestation with birth weight less than 2.5 kilograms).
- •Family history of congenital or hereditary immunodeficiency in first-degree relatives.
- •Receipt of vaccines outside of the national immunization schedule or medications prohibited simultaneously.
- •Conditions deemed by the principal investigator to prevent participation.
- •Participation in other clinical vaccine studies.
研究者
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