CTRI/2010/091/000498已完成2 期
A randomized, multicenter, open label, comparative study to evaluate the immunogenicity and reactogenicity of a new fully liquid pentavalent DTwP-Hib-IPV vaccine (EasyfourPolTM, Panacea Biotec Ltd.) with tetravalent DTwP/Hib vaccine (TetrAct-HibTM), co-administered with Imovax Polio® (Salk Based Inactivated Polio Vaccine) of sanofi pasteur India Pvt. Ltd. in Healthy Infants. - EasyfourPol PHASE III
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 622
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
入选标准
- •1.Newborn infants (subject age upto 27 days) whose parents/LAR are willing to give written informed consent prior to the study entry.
- •2.Born at full term pregnancy (≥37 weeks) with a birth weight(≥2.5 Kg.
- •3.Infants with good health as determined by:
- •? Medical history
- •? Physical examination
- •? Clinical judgment of the investigator
- •4.Infants who are not seroprotected against diphtheria tetanus, pertussis, H. influenzae type b or Polio by virtue of previous immunization and/or antigen exposure.
- •5.Judged to be able to attend all scheduled study visits and to comply with trial procedures
排除标准
- •At the time of enrollment
- •1.Parents or legal guardians are unwilling or unable to give written informed consent for infant's participation in the study.
- •2.Newborns requiring hospitalization for more than 1 day,
- •3.Known history of HBsAg positivity in mother.
- •4.Infants born before the 37th week of gestation or weighing < 2.5 kg at birth.
- •5.History of immunization with 'zero dose' of OPV,
- •6.Planning to leave the area of the study site before completion of the study
- •Before randomization
- •1.Subject is less than 6 weeks or more than 7 weeks of age.
- •2.Infants having history of previous immunization or infection with one of the vaccine constituents.
- •3.Infants who have presented a previous disease potentially related to any of the
- •agents targeted by the DPT-Hib-IPV vaccine
- •4.Presence of evolving or changing neurological disorder or Infants with history of seizures before receiving the vaccine. Initiation or continuation of pertussis vaccination should be deferred until an evolving neurological disorder can be excluded.
- •5.History of household contact and/or intimate exposure to an individual with suspected poliomyelitis.
- •6.Fever > 38°C in past 3 days
- •7.Any evidence of acute illness or infection within past 7 days.
- •8.Planned or elective surgery during the course of the study.
- •9.Infants with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or received immunosuppressive therapy within 1 month prior to study entry (including systemic or inhaled cortiosteroids) or those who have received a parenteral immunoglobulin preparation
- •10.Infants who have received any blood products, cytotoxic agents or radiotherapy.
- •11.Infants with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component.
- •12.Have any clinically significant chronic disease (for example, cardiac, pulmonary, renal, gastrointestinal, hepatic, endocrine, cancer, skin or psychiatric disease or disorder or autoimmune disease under treatment) such that it would endanger the volunteer?s well being or which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •13.Any evidence of thrombocytopenia or a bleeding disorder.
- •14.Infants who have participated in another trial of an investigational agent within 30 days of enrolment.
- •15. Infants whose families are planning to leave the area of the study site before the end of the study period.
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