CTRI/2011/12/002218Other2 期
A Randomized, Multicenter, Open Label, Comparative Study to Evaluate the Immunogenicity and Reactogenicity of a Fully Liquid Pentavalent DTwP-HepB-Hib Vaccine (MyFiveTM, Panacea Biotec Ltd.) with Pentavalent DTwP-HepB/Hib Vaccine (Tritanrix-HBTM Reconstituted With HiberixTM, GSK) in Healthy Infants.
试验速览
- 阶段
- 2 期
- 状态
- Other
- 入组人数
- 600
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.Infants of 6-10 weeks of age whose parents/LAR give written informed consent/oral witnessed consent prior to the study entry.
- •2.Infants with good health as determined by:
- •? Medical history
- •? Physical examination
- •? Clinical judgment of the investigator
- •3.Infants who are not seroprotected against Diptheria, tetanus, pertussis, Hepatitis B or H. influenzae type b by virtue of previous immunization and/or antigen exposure
排除标准
- •1.The parents or LAR are unwilling or unable to give written informed consent to participate in the study
- •2. Infants having history of previous immunization or infection with one of the vaccine constituents.
- •3.Known HBsAg positivity in mother.
- •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.Fever 38°C in past 3 days
- •6.Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 7 days.
- •7.Planned or elective surgery during the course of the study.
- •8.Infants who have presented a previous disease potentially related to any of the
- •agents targeted by the DPT-Hep B-Hib vaccine
- •9. Infants born before the 37th week of gestation
- •10.Birth weight less than 2.5 kg at birth or weight 3.3Kg at the time of screening.
- •11. Infants with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or having received immunosuppressive therapy within 1 month prior to study entry (including systemic or inhaled corticosteroids) or those who have received a parenteral immunoglobulin preparation
- •12.Infants who have received any blood products, cytotoxic agents or radiotherapy.
- •13.Infants with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component.
- •14.Infants with 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) or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives.
- •15.Any evidence of thrombocytopenia or a bleeding disorder.
- •16.Infants who have participated in another trial of an investigational agent within 30 days of enrolment.
- •17.Infants whose families are planning to leave the area of the study site before the end of the study period.
研究者
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