Evaluation of Immunological Persistence Following 3-dose Priming With GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine in Study NCT00808444 and Safety and Immunogenicity Following a Booster Dose of the Same Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 4
- 主要终点
- Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
研究概览
简要总结
This primary purpose of this study is the evaluation of the immunological persistence following completion of the 3-dose primary vaccination course with either a clinical or a commercial lot of pneumococcal conjugate vaccine GSK1024850A in study NCT00808444. In addition, the study will also assess the safety, reactogenicity and immunogenicity of a fourth dose of pneumococcal conjugate vaccine GSK1024850A (commercial lot) when co-administered with Infanrix-IPV/Hib at 18-21 months of age in children primed in study NCT00808444.
The primary vaccination study was conducted in Malaysia and Singapore. The booster vaccination study will not be performed in Malaysia since the pneumococcal conjugate vaccine GSK1024850A has been registered in September 2009. However, subjects in Malaysia will be offered a booster dose of the commercial pneumococcal conjugate vaccine licensed in Malaysia and Infanrix-IPV/Hib vaccine during the second year of life according to the nationally recommended regimen. Administration of the booster dose will be outside the set-up of a clinical trial. Hence no data will be collected, no blood samples will be taken in Malaysia.
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
- 18 Months 至 21 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
- •Male or female between, and including, 18 and 21 months of age at the time of booster vaccination.
- •Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00808444
- •Written informed consent obtained from the parents/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding vaccination, or planned use during the study period.
- •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 product.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- •A family history of congenital or hereditary immunodeficiency.
- •Administration of immunoglobulins and/ or any blood products within the 3 months preceding vaccination or planned use during the study period.
- •Administration of any pneumococcal and/or vaccine containing diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b antigens since the end of study NCT
- •Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before vaccination and ending 30 days after vaccination.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of any reaction or allergic disease likely to be exacerbated by any component of the study vaccines.
- •Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures. (Subjects who have had a single uncomplicated febrile convulsion in the past can be included)
- •Fever at the time of vaccination.
- •Fever is defined as rectal temperature >= 38.0°C or tympanic/axillary/ oral temperature >= 37.5°C.
- •Acute disease at the time of enrolment.
- •Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- •Child in care.
研究组 & 干预措施
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
干预措施: Pneumococcal vaccine GSK1024850A (Biological)
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
干预措施: Pneumococcal vaccine GSK1024850A (Biological)
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
干预措施: Infanrix-IPV/Hib (Biological)
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
干预措施: Infanrix-IPV/Hib (Biological)
结局指标
主要结局
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
时间窗: Before booster vaccination at Month 0
Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Concentrations of Antibodies Against Protein D (PD).
时间窗: Before booster vaccination at Month 0
Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).
次要结局
- Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).(Before and one month after booster vaccination (at Month 0 and Month 1))
- Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).(Within 4 days (Days 0-3) after booster vaccination.)
- Number of Subjects Reporting Serious Adverse Events (SAEs).(During the entire study period, from the booster vaccination, at Month 0, up to the study end, at Month 1)
- Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.(Before and one month after booster vaccination (at Month 0 and Month 1))
- Number of Subjects Reporting Unsolicited Adverse Events (AEs).(Within 31 days (Days 0-30) after booster vaccination)
- Concentrations of Antibodies Against Diphtheria and Tetanus.(Before and one month after booster vaccination (at Month 0 and Month 1))
- Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.(Before and one month after booster vaccination (at Month 0 and Month 1))
- Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).(Before and one month after booster vaccination (at Month 0 and Month 1))
- Concentrations of Antibodies Against Protein D (PD).(Before and one month after booster vaccination (at Month 0 and Month 1))
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).(Within 4 days (Days 0-3) after booster vaccination.)
- Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.(Before and one month after booster vaccination (at Month 0 and Month 1))
- Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A.(Before and one month after booster vaccination (at Month 0 and Month 1))
- Titers of Antibodies Against Poliovirus Types 1, 2 and 3.(Before and one month after booster vaccination (at Month 0 and Month 1))