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临床试验/NCT00488683
NCT00488683已完成2 期

A Phase II, Single Center, Open-label, Randomized Study to Investigate Meningococcal Serogroup A, C, W-135 and Y Saccharide Specific B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants

Novartis Vaccines2 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2007年7月最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
216
试验地点
2
主要终点
Summary of Memory B Cells Per 2 x 105 LOC by Serogroup A, C, W-135 and Y
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is aimed to assess whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a primary vaccination series of Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age

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
None

入排标准

年龄范围
56 Days 至 83 Days（Child）
性别
All
接受健康志愿者
是

入选标准

  • •Subjects who were eligible to be enrolled in the study:
  • •healthy infants aged 2 months (56 - 83 days old, inclusive);
  • •available for the visits scheduled in the study;
  • •mother available for blood draw at Visit 1;
  • •good health as determined by the clinical judgement of the investigator;
  • •whose parents gave written informed consent for the infant to be enrolled in the study. The infant's parents must have been willing for the infant to receive the full primary immunization course.

排除标准

  • •Subjects who were not eligible for the study were those:
  • •whose parents had not given or were unwilling or unable to give written informed consent to their child's participation in the study
  • •with known hypersensitivity to any vaccines contained within the routine immunization schedule
  • •with unacceptable concurrent illnesses or conditions - e.g.:
  • •a severe acute or chronic illness; with any present or suspected serious disease such as metabolic, cardiac or autoimmune disease or insulin dependent diabetes or with any other serious disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
  • •a genetic anomaly, e.g. Down's syndrome;
  • •any immunodeficiency, including use of systemic corticosteroids;
  • •born at less than 36 weeks gestation;
  • •weighing less than 2.5 kg at birth;
  • •previous clinical or bacteriological diagnosis of meningitis, or with a history of household contact or intimate exposure to an individual with culture proven Neisseria meningitidis disease;
  • •known bleeding diathesis, or any condition associated with a prolonged bleeding time;
  • •who have received any prohibited prior or concomitant medications - e.g.:
  • •any immunizations within the 30 days prior to enrollment, with the exception of BCG or hepatitis B;
  • •immunoglobulin;
  • •any blood products;
  • •participating in any other clinical trial either currently or in the previous month;
  • •unable to adhere to the protocol, including plans to move from the area;
  • •Had any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

结局指标

主要结局

Summary of Memory B Cells Per 2 x 105 LOC by Serogroup A, C, W-135 and Y

时间窗: 1 month after primary vaccination and immediately before third dose at 12 months of age

The memory B cell response at one month after primary vaccinations (5 months of age) was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators. Serogroup A, C, W-135 and Y geometric mean titers (GMTs) were measured by serum bactericidal assay using human complement (hSBA) at 12 months of age (before third dose). Correlation and linear regression coefficients were determined between memory B cells at 1 month after primary vaccinations with MenACWY-CRM (5 months of age) and hSBA titers at 12 months of age (before third dose) for the serogroups A, C, W-135 and Y.

次要结局

  • Memory B Cells Per 2x100000 by Serogroup A,C, W-135 and Y at One Month After Primary MenACWY-CRM Vaccination and Third MenACWY-CRM Vaccination(1 month after primary vaccination and 1 month after third vaccination)
  • Memory B Cells 1 Month After Primary Vaccination and Rise From Pre-third Dose to 1 Month After Third Dose of MenACWY-CRM Vaccination(1 month after primary and pre-third and 1 month after third vaccination)
  • Memory B Cells 1 Month After Primary Vaccination and 1 Week After Third Vaccination by Serogroup A, C, W-135 and Y(One month after primary vaccination and 1 week after third vaccination)
  • CRM197 Specific Memory B Cells 1 Month After Primary Vaccination and at 12 Months of Age and One Month After MenACWY-CRM Third Vaccination(5 months (B cells), 12 months and 13 months (B cells and IgG) of age)
  • Increase in Serogroup A, C, W-135 and Y Specific Memory B Cells Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone(Before and one month after booster vaccination)
  • Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and Routine Infants Primary Vaccinations(7 days post vaccination at 2, 3, and 4 months of age)
  • Increase in Serogroup A, C, W-135 and Y Specific hSBA Titers Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone(Before and one month after booster vaccination)
  • Serogroup A, C, W-135 and Y Specific hSBA Titers After MenACWY-CRM Primary Vaccination(Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4)
  • Percentage of Subjects Who Reported Injection Site Local Reactions After Each MenACWY-CRM and Routine Infant Vaccinations.(7 days post each MenACWY-CRM and routine infant vaccination)
  • Serogroups A, C, W-135 and Y Specific Memory B Cell Response in Children Lacking a hSBA Titer of ≥1:8 One Month After MenACWY-CRM Primary Vaccination(One month after primary vaccination)
  • Serogroup A, C, W-135 and Y Specific Memory B Cells and Plasma B Cells After MenACWY-CRM Primary Vaccination(Day 0, 7, 14, 49, 90, and 120 after MenACWY-CRM vaccination at month 4)
  • Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and IgG Concentration at Day 1 in the Serum of Mothers of Infants(Day 1 (IgG) and one month after primary vaccination (B cells))
  • Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in hSBA Titers, (2) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in IgG, After Third Dose of MenACWY-CRM at 12 Months(1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG))
  • Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and PCV Vaccination at 12 Months of Age(7 days post 12 months vaccination)
  • Increase in Serogroup A, C, W-135 and Y Specific IgG Concentrations Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone(Before and one month after booster vaccination)
  • Serogroup A, C, W-135 and Y Specific IgG Concentrations After MenACWY-CRM Primary Vaccination(Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4)
  • Memory B Cells by Serogroup A, C, W-135 and Y(1 month after primary vaccination and immediately before third dose)
  • Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and hSBA Titers at 12 Months, (2) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and IgG at 12 Months, After a 2-Dose Primary Course of MenACWY-CRM(1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG))
  • Percentage of Subjects Who Reported Injection Site Local Reactions After MenACWY-CRM and PCV Vaccinations at 12 Months of Age(7 days post 12 month vaccination)

研究者

发起方
Novartis Vaccines
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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