A Phase 2, Open Label, Multi-Center, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine±OMV, When Administered to Healthy Infants at 2, 4, 6 and/or 12 Months of Age

Novartis Vaccines3 个研究点分布在 1 个国家目标入组 147 人开始时间: 2006年9月最近更新: 2015年10月9日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 147
试验地点: 3
主要终点: Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study was aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants.

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: 55 Days 至 89 Days（Child）
性别: All
接受健康志愿者: 是

入选标准

•Subjects eligible to be enrolled in the study:
•healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy with an estimated gestational age ≥37 weeks and a birth weight ≥2.5 kg;
•for whom a parent/legal guardian had provided written informed consent after the nature of the study had been explained;
•those available for all the visits scheduled in the study;
•those in good health as determined by:
•medical history
•physical examination
•clinical judgment of the investigator

排除标准

•Individuals were not to be enrolled into the study:
•whose parents/legal guardians were unwilling or unable to give written informed consent to participate in the study;
•who had previously received any meningococcal B vaccine;
•who had received prior vaccination with Diphtheria Tetanus Pertussis (DTP) (acellular or whole cell), Inactivated Polio Vaccine (IPV) or Oral Polio Vaccine (OPV), H influenzae type b (Hib) or Heptavalent Pneumococcal Conjugate (PC7) vaccine;
•who had a previous ascertained or suspected disease caused by N meningitidis, S pneumoniae, C diphtheriae, tetani, Poliovirus, Hib, or B pertussis (history of laboratory confirmed, or clinical condition of spasmodic cough for a period ≥2weeks associated with apnea or whooping);
•who had household contact with and/or intimate exposure to an individual with laboratory confirmed N meningitidis, B pertussis, Hib, C diphtheriae or Polio infection since birth;
•who had a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
•who had experienced significant acute or chronic infection within the previous 7 days or had experienced fever (≥38.0°C) within the previous 3 days;
•who had any present or suspected serious acute or chronic disease (e.g., with signs of cardiac, renal failure, hepatic disease, or severe malnutrition or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome);
•who had leukemia, lymphomas;
•who had a known or suspected autoimmune disease or impairment/alteration of immune function resulting from (for example):
•receipt of any immunosuppressive therapy since birth
•receipt of immunostimulants since birth
•receipt of any systemic corticosteroid since birth
•with a suspected or known HIV infection or HIV related disease;
•who had ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation from birth and for the full length of the study;
•with a known bleeding diathesis, or any condition that might be associated with a prolonged bleeding time;
•who had experienced any seizure, either associated with fever or as part of an underlying neurological disorder or syndrome
•who had taken antibiotics within 7 days prior to enrollment (exception: antibiotics taken once daily within 14 days after the last dose);
•who had either received, or for whom there was intent to immunize with any other vaccine(s), with respect to the study vaccines, within 30 days prior and throughout the study period;
•who had ever received another investigational agent from birth prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study;
•whose parents/legal guardians, were planning to leave the area of the study site before the end of the study period;
•with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

结局指标

主要结局

Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine