Study to Compare Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001)
研究概览
简要总结
The primary aim of the study is to demonstrate that an investigational 4-dose presentation of the 10Pn-PD-DiT vaccine with preservative is non-inferior to the licensed presentation of Synflorix (preservative-free) in terms of immune responses to the 10 vaccine pneumococcal serotypes (primary objective) and to the vaccine-related pneumococcal serotype 19A (first secondary objective), after administration of a 3-dose primary vaccination course at 6, 10 and 18 weeks of age co-administered with the first 2 doses of DTPw-HBV/Hib vaccine given at 6, 10 and 14 weeks of age (according to the Expanded Program on Immunization (EPI) schedule).
In addition, the study will also assess the safety, reactogenicity, immunogenicity and antibody persistence (approximately 7 months following primary vaccination) of the 4-dose presentation of the 10Pn-PD-DiT vaccine given as primary vaccination schedule at 6, 10 and 18 weeks of age followed by a booster dose at 38 weeks.
This study also aims at assessing the safety, reactogenicity and immunogenicity of the 4-dose presentation of the 10Pn-PD-DiT vaccine when given as a booster dose at approximately 9 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 42 Days 至 76 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects for whom, in the opinion of the investigator, the parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g., return for vaccination and follow-up visits).
- •A male or female between, and including 6-10 weeks (42-76 days) of age at the time of the first vaccination.
- •Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the subject. For all subjects, the consent form should be countersigned by a witness.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Born full-term (i.e., after a gestation period from 37 to 42 weeks).
排除标准
- •Child in care.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. Inhaled and topical steroids are allowed.
- •Planned administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
- •Administration or planned administration of a vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of study vaccines and ending 30 days after with the following exceptions:
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
- •Previous vaccination against diphtheria, tetanus, pertussis, H. influenzae type b and/or S. pneumoniae.
- •History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, and H. influenzae type b disease.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious chronic illness.
- •History of any neurological disorders or seizures.
- •Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary.
- •Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
- •Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.
研究组 & 干预措施
10Pn_4d Group
Subjects received 10Pn-PD-DIT, in its investigational 4-dose presentation (4 doses in total with each single dose injected at Study Months 0, 1, 3 and 8), co administered with DTPw-HBV/Hib vaccine (3 doses injected at Study Months 0, 1 and 2).
干预措施: Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation) (Biological)
10Pn_4d Group
Subjects received 10Pn-PD-DIT, in its investigational 4-dose presentation (4 doses in total with each single dose injected at Study Months 0, 1, 3 and 8), co administered with DTPw-HBV/Hib vaccine (3 doses injected at Study Months 0, 1 and 2).
干预措施: DTPw-HBV/Hib (Biological)
10Pn Group
Subjects received 10Pn-PD-DIT, in its licensed 1-dose presentation (4 doses in total with each single dose injected at Study Months 0, 1, 3 and 8), co administered with DTPw-HBV/Hib vaccine (3 doses injected at Study Months 0, 1 and 2).
干预措施: Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation) (Biological)
10Pn Group
Subjects received 10Pn-PD-DIT, in its licensed 1-dose presentation (4 doses in total with each single dose injected at Study Months 0, 1, 3 and 8), co administered with DTPw-HBV/Hib vaccine (3 doses injected at Study Months 0, 1 and 2).
干预措施: DTPw-HBV/Hib (Biological)
结局指标
主要结局
Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001)
时间窗: At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine
Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for the 10 vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
次要结局
- Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001)(At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine)
- Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002)(At study Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002)(Within the 4-day (Days 0-3) period after booster vaccination)
- Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002)(At Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine)
- Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 002)(At study Month 9, e.g.: at one month post booster vaccination with pneumococcal vaccine)
- Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 001)(At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine)
- Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002)(Within the 4-day (Days 0-3) period after booster vaccination)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001)(Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine)
- Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 001)(Within the 31-day (Days 0-30) period post primary vaccination, across doses)
- Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001)(Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine)
- Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 002)(Within the 31-day (Days 0-30) period post booster vaccination)
- Number of Subjects With Any Serious Adverse Events (SAEs) (Epoch 001)(From Month 0 to Month 4)
- Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study(From Day 0 to Month 9)