A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Three Different Formulations of GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups C and Y- Conjugate Vaccine and One Formulation of GSK Biologicals' Haemophilus Influenzae Type B-meningococcal Serogroup C Conjugate Vaccine Each Given Concomitantly With InfanrixTM Penta, Versus MeningitecTM, Given Concomitantly With InfanrixTM Hexa in Infants According to a 2-3-4 Month Schedule
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 388
- 试验地点
- 27
- 主要终点
- Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
研究概览
简要总结
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.
详细描述
Primary & booster vaccination study to evaluate the immuno,reacto & safety of 3 diff. formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C & Y-conjugate vaccine & one formulation of GSKBio' Haemophilus influenzae typeb-meningococcal serogroup C conjugate vaccine each given concomitantly With Infanrix penta (DTaP-IPV-HepB vaccine), vs Meningitec meningococcal SerogroupC conj.vaccine) given concomitantly With Infanrix hexa (DTaP-IPV-HepB-Hib vaccine) in infants according a 2-3-4 mth schedule
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrollment, and vaccinated against hepatitis B at birth.
排除标准
- •Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.
研究组 & 干预措施
Menhibrix F1/Infanrix-penta Group
Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
干预措施: Hib-MenCY-TT vaccine (Biological)
Menhibrix F1/Infanrix-penta Group
Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
干预措施: Infanrix penta ® (Biological)
Menhibrix F2/Infanrix-penta Group
Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
干预措施: Hib-MenCY-TT vaccine (Biological)
Menhibrix F2/Infanrix-penta Group
Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
干预措施: Infanrix penta ® (Biological)
Menhibrix F3/Infanrix-penta Group
Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
干预措施: Hib-MenCY-TT vaccine (Biological)
Menhibrix F3/Infanrix-penta Group
Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
干预措施: Infanrix penta ® (Biological)
Menitorix/Infanrix-penta Group
Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
干预措施: Hib-MenC-TT vaccine (Biological)
Menitorix/Infanrix-penta Group
Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
干预措施: Infanrix penta ® (Biological)
Menjugate/Infanrix-hexa Group
Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
干预措施: Menjugate ® (Biological)
Menjugate/Infanrix-hexa Group
Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
干预措施: Infanrix hexa ® (Biological)
结局指标
主要结局
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
时间窗: One month after the booster vaccination (at study Month 1 - booster phase)
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
时间窗: One month after the booster vaccination (at study Month 1 - booster phase)
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
时间窗: One month after the booster vaccination (at study Month 1 - booster phase)
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
次要结局
- rSBA-MenC Antibody Titres(Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase))
- Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL)(Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase))
- Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL)(Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase))
- Anti-diphtheria Antibody Concentrations(One month after the third dose (at study Month 3 - primary phase))
- Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations(One month after the third dose (at study Month 3 - primary phase))
- Number of Seroprotected Subjects for Anti-hepatitis B Antibodies(One month after the third dose (at study Month 3 - primary phase))
- Anti-PRP Antibody Concentrations(Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase))
- Anti-PSY Antibody Concentrations(Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase))
- Anti-poliovirus Types 1, 2, 3 Antibody Titres(One month after the third dose (at study Month 3 - primary phase))
- Number of Subjects With Solicited Local Symptoms(During the 8-day (Day 0-7) follow-up period (during the booster phase))
- Number of Subjects Reporting Serious Adverse Events (SAEs)(Over the full course of the booster phase (up to study Month 1 - booster phase))
- Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8(Prior to the booster vaccination (at study Month 0 - booster phase))
- Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8(Prior to the booster vaccination (at study Month 0 - booster phase))
- rSBA-MenY Antibody Titres(Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase))
- Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).(Prior to the booster vaccination (at study Month 0 - booster phase))
- Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)(Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase))
- Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)(Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase))
- Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).(Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase))
- Anti-PSC Antibody Concentrations(Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase))
- Anti-tetanus Antibody Concentrations(Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase))
- Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128(Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase))
- Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies(One month after the third dose (at study Month 3 - primary phase))
- Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations(Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase))
- Number of Seroprotected Subjects for Anti-tetanus Antibodies(Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase))
- Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128(Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase))
- Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL).(Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase))
- Anti-T Antibody Concentrations(Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase))
- Number of Subjects With Solicited General Symptoms(During the 8-day (Day 0-7) follow-up period (during the booster phase))
- Number of Seroprotected Subjects for Anti-diphtheria Antibodies(One month after the third dose (at study Month 3 - primary phase))
- Number of Subjects With Vaccine Response to PT, FHA and PRN(One month after the third dose (at study Month 3 - primary phase))
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-day (Day 0-30) follow-up period (during the booster phase))