NCT00861744已完成2 期
A Phase II, Randomized, Observer Blind, Controlled, Multicenter Study to Assess Immunogenicity and Antibody Persistence Following Vaccination With GSK's Candidate Combined Measles, Mumps, and Rubella Vaccine (MMR) Versus M-M-R® II as a First Dose, Both Administered Subcutaneously at 12-15 Months of Age, Concomitantly With Hepatitis A Vaccine (HAV), Varicella Vaccine (VV) and Pneumococcal Conjugate Vaccine (PCV) But at Separate Sites.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,259
- 试验地点
- 49
- 主要终点
- Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.
研究概览
简要总结
The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine.
The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- •Male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of vaccination.
- •Written informed consent obtained from the parent/guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Have previously received three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine and Hib vaccine.
- •Previous vaccination against measles, mumps, rubella and/or varicella.
- •Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
- •History of measles, mumps, rubella, varicella/zoster and hepatitis A diseases.
- •Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus (HIV) infection.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •Hypersensitivity to latex
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures, including febrile seizures.
- •Acute disease at the time of enrolment.
- •Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
结局指标
主要结局
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.
时间窗: At Day 42 after administration of a dose of Priorix vaccine.
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<150 mIU/mL prior to vaccination.
Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.
时间窗: At Day 42 after administration of a dose of Priorix vaccine.
Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<24 ED50 prior to vaccination.
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
时间窗: At Day 42 after administration of a dose of Priorix vaccine.
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
次要结局
- Anti-S. Pneumoniae Antibody Concentrations (by Serotype).(At Day 0 before vaccination)
- Anti-varicella Antibody Concentrations.(At Day 42 after administration of a dose of Varivax vaccine.)
- Anti-hepatitis A Virus Antibody Concentrations.(At Day 42 after administration of a dose of Havrix vaccine.)
- Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.(At Day 42 after administration of a dose of Havrix vaccine.)
- Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.(At Day 42 after administration of a dose of Varivax vaccine.)
- Number of Subjects Reporting Other Rash.(During the 43-day (Days 0-42) post-vaccination period)
- Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.(During the 43-day (Days 0-42) post-vaccination period)
- Anti-measles Virus Antibody Concentrations(At 1 year post-vaccination)
- Anti-mumps Virus Antibody Concentrations(At Day 42 after administration of a dose of Priorix vaccine.)
- Anti-rubella Virus Antibody Concentrations(At 2 years post-vaccination)
- Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value(At 2 years post-vaccination)
- Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.(During the 43-day (Days 0-42) post-vaccination period)
- Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))(At 1 year post-vaccination)
- Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.(At 2 years post-vaccination)
- Number of Subjects Reporting Fever.(During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period)
- Number of Subjects With Solicited Local Symptoms.(During the 4-day (Days 0-3) post-vaccination period)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(From Day 0 to Day 180 after vaccination)
- Number of Subjects Reporting Febrile Convulsions(During the 43-day (Days 0-42) post-vaccination period)
- Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)(At 1 year post-vaccination)
- Number of Subjects With Solicited General Symptoms.(During the 15-day (Days 0-14) post-vaccination period)
- Number of Subjects Reporting Medically Attended Visit (MAEs)(During the 43-day (Days 0-42) post-vaccination period)
- Number of Subjects With Unsolicited Adverse Events (AEs).(During the 43-day (Days 0-42) post-vaccination period)
- Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)(At 2 years post-vaccination)
- Number of Subjects Reporting Serious Adverse Events (SAEs).(From Day 180 to Day 730 after vaccination)
- Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).(From Day 0 to Day 180 after vaccination)
- Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.(From Day 0 to Day 180 after vaccination)
- Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)(At 1 year post-vaccination)
- Anti-mumps Virus Antibody Titers (Unenhanced PRN)(At 2 years post-vaccination)
- Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)(At 2 years post-vaccination)
- Anti-mumps Virus Antibody Concentrations (PPD ELISA)(At 2 years post-vaccination)
研究者
研究点 (49)
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