A Phase 3b, Randomized, Open Label, Feasibility Study of a Single Priming Dose of Meningococcal Group C Conjugate Vaccine (NeisVac-C) in Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 956
- 试验地点
- 24
- 主要终点
- Number of subjects with seroprotective antibody titers (rSBA titers >= 8) prior to the administration of the booster dose
研究概览
简要总结
The purpose of this study is to assess the feasibility of a single priming dose of NeisVac-C in infants (at either 4 or 6 months of age), as determined by immune response.
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
- 8 Weeks 至 11 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is an infant aged 8 to 11 weeks at the time of first vaccination
- •Subject is clinically healthy as determined by the investigator's clinical judgment through collection of medical history and physical examination
- •Subject was born at full term of pregnancy (>= 37 weeks) with a birth weight >= 2 kg
- •The parent(s) or legally authorized representative of the subject provides written consent for participation
- •The parent(s) or legally authorized representative of the subject has the ability to understand and comply with the requirements of the protocol
- •The parent(s) or legally authorized representative and the subject will be available for the duration of the study
- •The parent(s) or legally authorized representative of the subject agrees to keep a subject diary
排除标准
- •Subject has a history of severe allergic reactions or anaphylaxis, or has a known sensitivity or allergy to any components of the vaccines
- •Subject has had an acute or chronic infection requiring systemic therapy (antibiotic or antiviral) or other prescribed treatment within the 2 weeks prior to the first vaccination in this study
- •Subject has a rash or dermatologic condition which may interfere with injection site reaction rating
- •Subject currently has, or has a history of, any significant cardiovascular, respiratory, hepatic, renal, metabolic, autoimmune, rheumatic, hematological, neurological, or neurodevelopmental disorder
- •Subject has a disease, or is currently undergoing a form of treatment, or was undergoing a form of treatment within 30 days prior to study entry, that could be expected to influence immune response
- •Subject has received any blood products or immunoglobulins within 60 days of study entry
- •Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of the scheduled first vaccination
- •Subject has previously been vaccinated against meningococcal C disease
- •Subject has a known or suspected immune dysfunction
- •Subject has a functional or surgical asplenia (e.g. due to a pathologic hemoglobinopathy, leukemia, lymphoma, etc.)
- •Subject was administered an investigational drug within six weeks prior to study entry or is concurrently participating in a clinical study that includes the administration of an investigational product
- •Subject or his/her parent(s) / legally authorized representative are in a dependent relationship with the study investigator or with a study team member; dependent relationships include close relatives (i.e. children, partner/spouse, siblings) as well as employees of the investigator or site conducting the study
研究组 & 干预措施
Group 1
Single dose of NeisVac-C vaccine at 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
干预措施: Meningococcal group C polysaccharide conjugate vaccine (Biological)
Group 1
Single dose of NeisVac-C vaccine at 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
干预措施: Pneumococcal 13-valent conjugate vaccine (Biological)
Group 3
Two doses of NeisVac-C vaccine at 2 and 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
干预措施: Meningococcal group C polysaccharide conjugate vaccine (Biological)
Group 3
Two doses of NeisVac-C vaccine at 2 and 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
干预措施: Pneumococcal 13-valent conjugate vaccine (Biological)
Group 3
Two doses of NeisVac-C vaccine at 2 and 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
干预措施: Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Biological)
Group 1
Single dose of NeisVac-C vaccine at 4 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
干预措施: Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Biological)
Group 2
Single dose of NeisVac-C vaccine at 6 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
干预措施: Meningococcal group C polysaccharide conjugate vaccine (Biological)
Group 2
Single dose of NeisVac-C vaccine at 6 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
干预措施: Pneumococcal 13-valent conjugate vaccine (Biological)
Group 2
Single dose of NeisVac-C vaccine at 6 months of age - Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age - Booster vaccination with NeisVac-C, Infanrix hexa and Prevenar between 12 and 13 months of age
干预措施: Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Biological)
结局指标
主要结局
Number of subjects with seroprotective antibody titers (rSBA titers >= 8) prior to the administration of the booster dose
时间窗: 6 to 9 months (from 4-6 months of age until 12-13 months of age)
Number of subjects with seroprotective antibody titers (rSBA titers >= 128) 1 month after the administration of the booster dose
时间窗: 1 month after booster dose (administered between 12-13 months of age)
Number of subjects with seroprotective antibody titers (rSBA titers >= 8) 1 month after completion of the primary vaccination in single-dose groups compared to the two-dose group
时间窗: 1 month
次要结局
- Antibody titers (rSBA titers) prior to the administration of the booster dose(Prior to booster dose)
- Antibody titers (rSBA titers)one month after the administration of the booster dose(1 month after administration of booster dose)
- Frequency and severity of adverse events observed during the entire follow up period(Entire follow up period)
- Frequency and severity of local and systemic ractions with onset within 3 days after each vaccination(Within 3 days after vaccination)
- Antibody titers (rSBA) titers one month after completion of the primary vaccination(1 month after primary vaccination)