EUCTR2008-008104-41-CZ进行中（未招募）不适用
A phase III long-term follow-up study to assess immunological memory induced following primary and booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT), through evaluation of early antibody responses after an additional dose of 10Pn-PD-DiT at 40-48 months of age, to evaluate in the fourth year of life, the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine and the impact of pneumococcal vaccination on nasopharyngeal carriage. - 10PN-PD-DIT-042 EXT 014
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 690
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- •A male or female between, and including, 31 and 44 months of age at the time of the enrolment.
- •Subjects who previously participated in study 10PN-PD-DIT-014 (107137):
- •*For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the 10PN-PD-DIT-014 study amendment 3.
- •*For the subjects in the unprimed group: subjects who received a dose of the MenACWY-TT vaccine.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding enrolment, or planned use during the entire study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after.
- •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 (pharmaceutical product or device).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
- •Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever.
- •Administration or planned use of immunoglobulins and/ or any blood products during the entire study period.
- •A family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious chronic illness.
- •Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
- •Administration of any pneumococcal vaccine since the end of study 10PN-PD-DIT-014 (107137).
研究者
相似试验
进行中（未招募）
不适用
A phase III long-term follow-up study to assess the immune responses following vaccination at 36-46 months of age with a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT) and to evaluate the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine in the fourth year of life. - 10PN-PD-DIT-046 EXT:002 Y2A booster vaccination study against Streptococcus pneumoniae in subjects aged 36-46 months and a two-dose vaccination against Streptococcus pneumoniae of age-matched unprimed children.EUCTR2008-003950-14-SEGlaxoSmithKline Biologicals210
进行中（未招募）
1 期
A phase III long-term follow-up study to assess the immune responses following vaccination at 36-46 months of age with a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT) and to evaluate the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine in the fourth year of life. - 10PN-PD-DIT-046 EXT:002 Y2A booster vaccination study against Streptococcus pneumoniae in subjects aged 36-46 months and a two-dose vaccination against Streptococcus pneumoniae of age-matched unprimed children.EUCTR2008-003950-14-SKGlaxoSmithKline Biologicals210
进行中（未招募）
不适用
A phase III long-term follow-up study to assess antibody persistence and immunological memory in children previously vaccinated with four doses of pneumococcal conjugate vaccine in primary vaccination study 10PN-PD-DIT-001 and booster vaccination study 10PN-PD-DIT-007 and assessment of immune responses following a 2-dose catch-up immunization with GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal vaccine in the 6th year of life. - 10PN-PD-DIT-041 EXT:007 Y1, Y2, Y4Subjects who participated in booster study 10PN-PD-DiT-007 in Poland and who received the full vaccination course (i.e. four doses) with a pneumococcal vaccine, co-administered with DTPa-HBV-IPV/Hib, will be followed-up to evaluate the long-term persistence of antibodies at approximately 30, 42 and 66 months of age and will be vaccinated in the 6th year of life against Streptococcus pneumoniae in parallel with age-matched unprimed subjects.MedDRA version: 12.1Level: LLTClassification code 10061353Term: Pneumococcal infectionMedDRA version: 12.1Level: LLTClassification code 10061190Term: Haemophilus infectionEUCTR2007-005392-34-PLGlaxoSmithKline Biologicals
进行中（未招募）
1 期
A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular PsoriasisSubjects with generalized pustular psoriasisMedDRA version: 20.0Level: PTClassification code 10037575Term: Pustular psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2021-001448-90-FRAnaptysBio Inc.45
进行中（未招募）
1 期
A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects with Generalized Pustular PsoriasisSubjects with generalized pustular psoriasisMedDRA version: 20.0Level: PTClassification code 10037575Term: Pustular psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2021-001448-90-DEAnaptysBio Inc.45