A Phase II/III randomised, single blind, comparative, multicentre study to evaluate the safety and immunogenicity of Biological E’s live, attenuated Measles-Rubella vaccine (MR) in 9-12 months old healthy infants.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 3,500
- 试验地点
- 35
- 主要终点
- At Phase II:
研究概览
简要总结
This is a randomized comparative, single blind, multicentre phase-II/III study to assess safety and immunogenicity of Biological E’s Measles-Rubella Vaccine. The safety and immunogenicity of this vaccine will be compared with licensed MR-Vaccine.
The target population for this study would be healthy male and female infants between 9 to 12 months of age at the time of vaccination. The total sample size to be enrolled will be 3500 healthy eligible subjects. All study subjects (N=3500) will be followed up for 6 months for long term safety assessment, post vaccination.
The study will be conducted in compliance with New Drugs and Clinical Trials Rules, ICH and Indian good clinical practice guidelines in force at the time of study conduct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 9.00 Month(s) 至 12.00 Month(s)（—）
- 性别
- All
入选标准
- •Healthy male or female infants between 9-12 months of age at the time of the vaccination;
- •Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, with access to a consistent means of telephone contact, either residential land line or mobile).
- •Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
- •Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature) as judged by the principal investigator
- •Subjects not participating in any other clinical trials.
排除标准
- •Subject had a history of previous measles or rubella infection or Measles Rubella containing vaccination.
- •Family history of any hypersensitivity reactions to Measles, MR or MMR vaccination(s) or allergy to any of their components.
- •Child in care, defined as a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
- •Acute disease and/or fever at the time of vaccination.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the administration of study vaccine or planned use during the study period.
- •Any medical condition that in the judgment of the investigator would make subcutaneous injection unsafe.
- •Known or suspected allergy to any of the vaccine components.
- •History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity likely to be exacerbated by any component of the study vaccines.
- •Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS)
- •Known family history of SIDS (Sudden Infant Death Syndrome).
- •Planned or elective surgery during the course of the study.
- •Infants with a known or suspected impairment of the immune function (congenital or hereditary), or those receiving immunosuppressive therapy, or received immunosuppressive therapy prior to study entry (including systemic or high doses of inhaled corticosteroids) or those who have received a parenteral immunoglobulin preparation
- •Infants who have received any blood products, cytotoxic agents, corticosteroids or radiotherapy
- •Subjects who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course.
- •Inability or unwillingness of the subject’s parent/LAR to abide by the requirements of the protocol.
- •Subjects with congenital abnormalities.
- •Administration of immunoglobulins and/or any blood products during the period starting three months before the administration of study vaccine or planned administration during the study period.
- •Administration of long-acting immune-modifying drugs at any time during the study period.
- •Any criteria, which in the judgement of the Investigator, suggests that the subject would not be compliant with the study protocol.
结局指标
主要结局
At Phase II:
时间窗: At Phase II: | 1. First 60 minutes of post vaccination observation period. | 2. 7 consecutive days and for systemic adverse events during 14 days post vaccination. | 3. 14 days post vaccination | 4. 14 days post vaccination. | At Phase III: | 1. 42 days post vaccination
1. Number and proportion of subjects with solicited local and systemic adverse events
时间窗: At Phase II: | 1. First 60 minutes of post vaccination observation period. | 2. 7 consecutive days and for systemic adverse events during 14 days post vaccination. | 3. 14 days post vaccination | 4. 14 days post vaccination. | At Phase III: | 1. 42 days post vaccination
2.Number and proportion of subjects with solicited local adverse events and systemic adverse events
时间窗: At Phase II: | 1. First 60 minutes of post vaccination observation period. | 2. 7 consecutive days and for systemic adverse events during 14 days post vaccination. | 3. 14 days post vaccination | 4. 14 days post vaccination. | At Phase III: | 1. 42 days post vaccination
3. Number and proportion of subjects with unsolicited adverse events
时间窗: At Phase II: | 1. First 60 minutes of post vaccination observation period. | 2. 7 consecutive days and for systemic adverse events during 14 days post vaccination. | 3. 14 days post vaccination | 4. 14 days post vaccination. | At Phase III: | 1. 42 days post vaccination
4. Number and proportion of subjects with any serious adverse events (SAEs)or AEs SAEs
时间窗: At Phase II: | 1. First 60 minutes of post vaccination observation period. | 2. 7 consecutive days and for systemic adverse events during 14 days post vaccination. | 3. 14 days post vaccination | 4. 14 days post vaccination. | At Phase III: | 1. 42 days post vaccination
At Phase III:
时间窗: At Phase II: | 1. First 60 minutes of post vaccination observation period. | 2. 7 consecutive days and for systemic adverse events during 14 days post vaccination. | 3. 14 days post vaccination | 4. 14 days post vaccination. | At Phase III: | 1. 42 days post vaccination
Proportion of subjects seropositive with anti-Measles IgG antibodies and anti-Rubella IgG antibodies.
时间窗: At Phase II: | 1. First 60 minutes of post vaccination observation period. | 2. 7 consecutive days and for systemic adverse events during 14 days post vaccination. | 3. 14 days post vaccination | 4. 14 days post vaccination. | At Phase III: | 1. 42 days post vaccination
次要结局
- At Phase III:
- Number & proportion of subjects with solicited local adverse events & and systemic adverse events(7 days & systemic adverse events during 14 days post vaccination)
- Number & proportion of subjects with unsolicited adverse events (AEs)(42 days post vaccination.)
- Number & proportion of subjects with Medically attended adverse events (MAAEs), & serious adverse events (SAEs), if any,(42 days post vaccination.)
- Geometric mean concentrations/titres (GMCs/GMTs) of anti-Measles IgG and anti-Rubella IgG antibodies(estimated both at baseline and again at day 42.)
- Geometric mean fold rise (GMFR) for anti-measles IgG & anti-Rubella IgG antibody concentrations/titres(42 days from baseline i.e Day 0.)
- Number & proportion of subjects seropositive with anti-Measles & anti-rubella antibodies(42 days post vaccination)
- Number & proportion of subjects with unsolicited AEs, MAAEs, & SAEs(6 months follow up period after the vaccination)
研究者
Dr Subhash Thuluva
Biological E.Limited