CTRI/2011/06/001787已完成3 期
A phase III, multicentric, randomized single-blind study to evaluate the safety and the immunogenicity of El-Shaddai Biologicals’ varicella zoster vaccine in comparison to GlaxoSmithKline Biologicals’ Varilrix® in healthy subjects aged 1 to 12 years.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 4
- 主要终点
- Percentage of subjects achieving seroconversion (defined as rise in post vaccination test value in comparison with pre vaccination)
研究概览
简要总结
The purpose of the study is to compare immunogenicityand safety of El-ShaddaiBiologicals’ lyophilised live attenuated varicella zoster vaccine withGlaxoSmithKline Biologicals’ Varilrix® in healthy subjects aged 1 to12 years.
Objectives
1. To assess the immunogenicity of thelyophilised live attenuated varicella vaccine in comparison to Varilrix® inhealthy subjects.
2. To assess the safety of thelyophilised live attenuated varicella vaccine in comparison to Varilrix®in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Indian males and females aged 1 to 12 years at the time of vaccination.
- •2.Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- •3.Subject or subject’s parent/guardian must understand and sign a written informed consent.
- •4.Subjects who are willing to comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) and are available for all clinic visits scheduled in the study.
排除标准
- •1.Individuals with history or any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study.
- •2.History of hypersensitivity, convulsion, epilepsy, psychosis, thrombocytopenia, coagulation disorder, and contraindications to subcutaneous injection.
- •3.History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •4.Individuals who have had chickenpox vaccine prior to Day 0 or documented confirmed or suspected chickenpox disease.
- •5.Hypersensitivity or intolerance to erythromycin and kanamycin.
- •6.Receipt of another investigational product within 4 weeks prior to enrollment or before completion of the safety follow-up period in this or in another study, unwilling to refuse a participation in another clinical study through the end of this study.
- •7.Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the trial vaccination 8.Known or suspected impairment/alteration of immune function, for example resulting from: a.receipt of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis or chronic use of inhaled high-potency corticosteroids within 6 months prior to Visit 1 b.cancer chemotherapy c.receipt of immunostimulants within 6 months prior to Visit 1 d.receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study e.known HIV infection or HIV-related disease.
- •9.Individuals with axillary temperature ≥ 38.0°C within 3 days/on the day of intended study vaccination and/or moderate to severe acute illness/infection on the day of vaccination.
- •10.History of progressive or severe neurologic disorder (including Guillain-Barré syndrome and convulsions, but excluding febrile convulsions).
- •11.Individuals with any serious chronic or progressive disease and congenital malformation or maldevelopment according to judgment of the investigator (including, but not limited to neoplasm, insulin dependent diabetes, cardiac, renal, hepatic or respiratory disease, Down’s syndrome).
- •12.Bleeding diathesis.
- •13.Suffering from serious dermatoses (such as allergy, herpes, suppuration and fungal infection.
- •14.Planned surgery during the study period that in the Investigator’s opinion would interfere with the study visits schedule.
- •15.Relatives of research staff (The families of the site staff who are not involved in this trial are allowed their participation to this trial).
结局指标
主要结局
Percentage of subjects achieving seroconversion (defined as rise in post vaccination test value in comparison with pre vaccination)
时间窗: At day 42 to 47, in comparison to baseline
次要结局
- Percentage of subjects with test value less than 0.60.(Percentage of subjects with test value greater than or equal to 0.60 to less than or equal to 0.90.)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
3 期
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy InfantsSerogroup B Meningococcal MeningitisNCT00657709Novartis Vaccines3,630
已完成
2 期
Comparison of the Safety and Immune Response of Three Different Lots of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2004/2005InfluenzaNCT00161811Alachua Government Services, Inc.1,400
已完成
3 期
Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly SubjectsInfluenza, HumanNCT02344134SK Chemicals Co., Ltd.1,155
已完成
3 期
Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza VaccineInfluenzaNCT00999206Abbott Biologicals3,138
已完成
3 期
Comparison Study of SIBP's MMR Vaccine Versus GSK MMR Vaccine in Children Aged 9-11 MonthsMeasles-Mumps-RubellaNCT06399003Shanghai Institute Of Biological Products1,200