A Phase 3b, Open-Label, Randomized, Multicenter Study to Assess the Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 8
- 主要终点
- Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains
研究概览
简要总结
The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at 3, 5, 7 and 13 months of age, compared to either alone.
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
- 85 Days 至 119 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy 3-month old infants (85-119 days, inclusive) at time of Visit 1 whose parents/legal guardians have given written informed consent after the nature of the study has been explained.
- •Available for all the visits scheduled in the study.
- •In good health as determined by medical history, physical examination and clinical judgment of the investigator.
排除标准
- •History of any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) at the time of enrollment.
- •Previous known or suspected disease caused by N. meningitidis.
- •Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
- •History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine.
- •Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from, for ex-ample:
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth (3 months prior). (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day or ≥ 10 mcg/day for children below 2 years. Inhaled and topical steroids are allowed),
- •Immune deficiency disorder, or known HIV infection.
- •Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation since birth.
- •History of any progressive or severe neurologic disorder, or seizure disorder or Guillan Barré syndrome (exception: one self-limited febrile seizure is acceptable).
- •History of any bleeding disorder considered as a contraindication to intramuscular injection or blood draw.
- •Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
- •Receipt of any investigational or non-registered product since birth (3 month prior) or are expected to receive during the study period.
- •Family members or household members of site research staff.
- •Any clinically-significant chronic or progressive disease according to judgment of the investigator (pulmonary, cardiovascular, renal, hepatic or endocrine functional abnormality) or a congenital anomaly/known cytogenic disorder (e.g., Down's syndrome).
- •History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
研究组 & 干预措施
rMenB+ACWY
Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.
干预措施: Meningococcal group B Vaccine, rMenB+OMV NZ (Biological)
rMenB+ACWY
Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.
干预措施: Meningococcal ACWY Conjugate Vaccine, MenACWY (Biological)
rMENB
Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.
干预措施: Meningococcal group B Vaccine, rMenB+OMV NZ (Biological)
MenACWY
Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age.
干预措施: Meningococcal ACWY Conjugate Vaccine, MenACWY (Biological)
结局指标
主要结局
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains
时间窗: At Day 331 (one month after the fourth vaccination)
Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y
时间窗: At Day 331 (one month after the fourth vaccination)
hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs. This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.
次要结局
- hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.(At Day 331 (one month after the fourth vaccination))
- hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.(At Day 331 (one month after the fourth vaccination))
- hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y(At Day 151 (one month after the third vaccination))
- Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains(At Day 151 (one month after the third vaccination))
- Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.(At Day 331 (One month after the fourth vaccination))
- Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y(At Day 1)
- Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains(At Day 331 (one month after fourth vaccination))
- Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y(At Day 331 (one month after the fourth vaccination))
- Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y(At Day 331 (one month after the fourth vaccination))
- Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y(At Day 331 (one month after the fourth vaccination))
- Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)(From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301))
- Number of Subjects With Unsolicited Adverse Events(From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301))
- Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains(At Day 301 (before the fourth vaccination))
- Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains(At Day 331 (one month after the fourth vaccination))
- Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y(At Day 331 (one month after the fourth vaccination))
- Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains(At Day 331 (one month after the fourth vaccination))
- Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs)(Throughout the whole study period (from Day 1 upto Day 331))