A Phase 2 Partially Observer-Blind Randomized Controlled Multicenter Dose-Ranging and Formulation-Finding Study of a New Novartis Meningococcal B Recombinant Vaccine Evaluating the Safety and Immunogenicity When Given Concomitantly With Routine Vaccines in 2-month-old Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,507
- 试验地点
- 64
- 主要终点
- Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
研究概览
简要总结
This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.
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
- Single (Participant)
入排标准
- 年龄范围
- 55 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy, gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg
- •Available for all the visits scheduled in the study and for whom a parent/legal guardian is willing/able to comply with all protocol requirements
排除标准
- •Any meningococcal B or C vaccine administration
- •Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens;
- •Any ascertained or suspected disease caused by N. meningitidis
- •Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis
- •History of severe allergic reaction after previous vaccinations
- •Recent significant acute or chronic infection
- •Oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw;
- •Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition)
- •Any impairment/alteration of the immune system resulting from (for example):
- •Receipt of any immunosuppressive therapy at any time since birth
- •Receipt of immunostimulants at any time since birth
- •Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids at any time since birth
- •Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
- •Participation in another clinical trial
- •Family members and household members of research staff
- •History of seizure
- •Any contraindication to paracetamol
研究组 & 干预措施
4
Vaccine candidate formulation IV
干预措施: Meningococcal B vaccine (Biological)
3
Vaccine candidate formulation III
干预措施: Meningococcal B vaccine (Biological)
1
Vaccine candidate formulation I
干预措施: Meningococcal B vaccine (Biological)
2
Vaccine candidate formulation II
干预措施: Meningococcal B vaccine (Biological)
5
Vaccine candidate formulation V
干预措施: Meningococcal B vaccine (Biological)
6
Vaccine candidate formulation VI
干预措施: Meningococcal B vaccine (Biological)
7
Control
干预措施: Control (Biological)
8
Vaccine candidate formulation I with antipyretic
干预措施: Meningococcal B vaccine with antipyretic (Biological)
结局指标
主要结局
Percentages of Subjects With Serum Bactericidal Activity (hSBA) ≥ 1:5 at 1 Month After Third Vaccination
时间窗: At baseline (pre-vaccination) and 30 days after the third vaccination.
To assess the immunogenicity of seven different formulations of 4CMenB (groups I-VI and VIII) given to healthy infants at 2,3 and 4 months of age as measured by percentages of subjects with serum bactericidal activity (SBA) titer≥1:5 against 44/76-SL, 5/99 and NZ98/254 reference strains, at 1 month after the third vaccination.. The analysis was done on the Per Protocol Primary Population at one month after third injection.
Number of Subjects With Fever ≥ 38.5 °C (Rectal Temperature) Within 3 Days (Day 1-3) After First Vaccination
时间窗: Day 1 to day 3 after first vaccination.
To assess if any of six different formulations of vaccine groups (Group II to Group VI, Group VIII) reduced the incidence of fever \>=38.5C (rectal) occurring within three days (day 1-day3) following first vaccination. The analysis was done on the Safety Population.
次要结局
- Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (Pre-fourth Dose)(12 months (pre-fourth vaccination))
- Percentage of Subjects With hSBA ≥1:5, First Dose of Meningococcal B Vaccine (One Month After Booster)(1 month after booster)
- Geometric Mean Bactericidal Titers (GMTs), One Month After Third and Booster Vaccination (Men B at 12 Months of Age)(At baseline (pre-vaccination), 30 days after the third vaccination, at booster Baseline and at booster vaccination (12 months of age))
- Geometric Mean Bactericidal Titers,One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)(At Baseline (pre-vaccination), at 30 days after the third vaccination, at booster Baseline, at 30 days)
- Geometric Mean Ratios, One Month After Primary and Booster Vaccination (Men B at 12 Months of Age)(After the third and the booster vaccination.)
- Geometric Mean Bactericidal Titers, After Primary and Booster Vaccinations (Men B at 12 Months of Age)(At 13 months)
- Safety and Reactogenicity of Study Vaccines Within 7 Days After Second and Third Vaccination(Day 1 through day 7 after second and third vaccination.)
- Number of Subjects With Solicited Systemic Reactions Within 7 Days (Day 1-7) After Each Vaccination(Day 1 through day 7 after each vaccination.)
- Number of Subjects With Solicited Local Reactions Within 7 Days (Day 1-7) After Each Vaccination(Day 1 through day 7 after each vaccination.)
- Percentage of Subjects With hSBA≥1:5, Persistence of Bactericidal Antibodies at 12 Months of Age (One Month-post Fourth Dose)(1 month after fourth vaccination)
- Number of Subjects With Unsolicited Adverse Events Within 7 Days (Day 1-7) After Each Vaccination(Day 1 through day 7 after each vaccination.)
- Number of Subjects With Severe Adverse Events and Adverse Events Necessitating a Medical Office or Emergency Room (ER) Visit and/or Resulting in Premature Withdrawal of the Subject From the Study, Throughout the Study Period.(Overall study period.)
- Number of Subjects With Local and Systemic Reactions Within 7 Days (Day 1-7) After Second rMenB+OMV NZ Vaccination in MenC Group(Day 1 through day 7 at 13 months age.)