A Phase 2, Partially Randomized, Open Label, Multicenter Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Young Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 6
- 主要终点
- Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule
研究概览
简要总结
To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 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
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for Groups I (MenACWY-CRM_6-12 M) and II (MenACWY-CRM_12 M)
- •Subjects eligible for enrollment in the study were healthy infants:
- •who were 6 months old and who were born after full-term pregnancy with an estimated gestational age of 37 weeks or greater and a birth weight 2.5 kg or greater;
- •who previously received two doses of PC7 and DTaP-Hib-IPV vaccines;
- •for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained;
- •who were available for all the visits scheduled in the study;
- •who were in good health as determined by medical history, physical examination, and clinical judgment of the investigator.
- •Inclusion criteria for Group III (MenC-CRM_12 M_MenACWY-CRM_18 M)
- •Subjects eligible for enrollment in the study were healthy infants:
- •who were 12 months old;
- •who previously received three doses of DTaP-Hib-IPV (Pentacel) vaccines;
- •for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained;
- •who were available for all the visits scheduled in the study;
- •who were in good health as determined by medical history, physical examination, and clinical judgment of the investigator.
- •Exclusion criteria:
- •Subjects were not to be included in this study if:
- •their parents/legal guardians were unwilling or unable to give written informed consent to participate in the study;
- •they previously received any meningococcal vaccine;
- •they had a previously ascertained or suspected disease caused by Neisseria meningitidis (N meningitidis);
- •they had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
- •they had experienced significant acute or chronic infection within the previous 7 days or had experienced fever (38.0ºC or greater) within the previous 3 days;
- •they had any present or suspected serious acute disease (e.g., leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac failure, renal failure, severe malnutrition, or insulin-dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome), or who had a diagnosed cardiac defect or abnormality of hemodynamic significance (e.g., ventricular septal defect, patent ductus arteriosus, or atrial septal defect);
- •they had a known or suspected autoimmune disease or impairment /alteration of immune function resulting from use of (for example):
- •any immunosuppressive therapy since birth;
- •immunostimulants since birth;
- •any systemic corticosteroid administered for more than 5 days or in a daily dose of greater than 1 mg/kg/day prednisone or equivalent for 5 days or less in the previous 30 days;
- •they had a suspected or known HIV infection or HIV-related disease;
- •they had received parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 90 days and were expected to receive it for the full length of the study;
- •they had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
- •they had a history of seizure disorder:
- •febrile seizure;
- •any other seizure disorder;
- •they had taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who had received an oral or parenteral β-lactam antibiotic [e.g.: penicillin, amoxicillin, ceftriaxone, cefuroxime or cephalexin] could have been enrolled 7 days following the last dose);
- •their parents/legal guardians were planning to leave the area of the study center before the end of the study period;
- •they had any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
排除标准
- 未提供
研究组 & 干预措施
MenACWY-CRM_12 M
Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
干预措施: MenACWY-CRM (Biological)
MenACWY-CRM_6-12 M
Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
干预措施: MenACWY-CRM (Biological)
MenACWY-CRM_12 M
Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
干预措施: MMR (Biological)
MenACWY-CRM_12 M
Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
干预措施: Varicella (Biological)
MenC-CRM_12 M_MenACWY-CRM_18 M
Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age).
Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)
干预措施: Varicella (Biological)
MenACWY-CRM_6-12 M
Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
干预措施: MMR (Biological)
MenACWY-CRM_6-12 M
Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
干预措施: Varicella (Biological)
MenACWY-CRM_6-12 M
Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
干预措施: DTaP-Hib-IPV (Biological)
MenACWY-CRM_6-12 M
Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
干预措施: PC7 (Biological)
MenACWY-CRM_12 M
Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
干预措施: DTaP-Hib-IPV (Biological)
MenACWY-CRM_12 M
Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
干预措施: PC7 (Biological)
MenC-CRM_12 M_MenACWY-CRM_18 M
Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age).
Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)
干预措施: DTaP-Hib-IPV (Biological)
MenC-CRM_12 M_MenACWY-CRM_18 M
Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age).
Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)
干预措施: PC7 (Biological)
MenC-CRM_12 M_MenACWY-CRM_18 M
Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age).
Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)
干预措施: MMR (Biological)
MenC-CRM_12 M_MenACWY-CRM_18 M
Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age).
Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)
干预措施: MenACWY-CRM (Biological)
MenC-CRM_12 M_MenACWY-CRM_18 M
Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age).
Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)
干预措施: MenC-CRM (Biological)
结局指标
主要结局
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule
时间窗: Before and 1 month after 2-dose or 1-dose schedule
Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM_12 M group)
次要结局
- Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age(Before and 1 month after MenC-CRM vaccination at 12 months)
- Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age(Before and 1 month after MenACWY-CRM vaccination at 18 months)
- Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule(Before and 1 month after 2-dose or 1-dose schedule)
- Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age(Before and 1 month after MenC-CRM vaccination at 12 months)
- Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination(From day 1 through day 7 after any vaccination)
- Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule(Before and 1 month after 2-dose or 1-dose schedule)
- hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age(Before and 1 month after MenACWY-CRM vaccination at 18 months)
- Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age(Before and 1 month after MenACWY-CRM vaccination at 18 months)
- hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age(Before and 1 month after MenACWY-CRM vaccination at 18 months)