跳至主要内容
临床试验/EUCTR2009-012701-19-CZ
EUCTR2009-012701-19-CZ进行中(未招募)不适用

A phase II, randomized, controlled, observer-blind study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ Streptococcus pneumoniae protein containing vaccine formulations when administered according to a 0-2-6 month schedule, in healthy children aged 12-23 months at the time of first vaccination. - SPNG-002

GlaxoSmithKline Biologicals0 个研究点目标入组 300 人开始时间: 2009年7月21日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
300

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 parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
  • Male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
  • 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.
  • 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(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) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccinedose. For corticosteroids, this will mean prednisone = 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s).
  • Previous vaccination against S. pneumoniae since birth.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease and/or fever at the time of enrolment.
  • - Fever is defined as temperature = 37.5°C on oral, axillary or tympanic setting, or = 38.0°C on rectal setting.
  • - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.
  • Child in care.
  • Please refer to the Glossary of Terms for the definition of a child in care.

研究者

相似试验

进行中(未招募)
不适用
A phase II, randomized, controlled, observer-blind study to assess the safety, reactogenicity and immunogenicity of two formulations of GlaxoSmithKline (GSK) Biologicals’ Streptococcus pneumoniae protein containing vaccine given as a 3-dose primary vaccination course co-administered with DTPa-HBV-IPV/Hib vaccine during the first 6 months of life and as a booster dose at 12-15 months of age. - SPNG-003Three-dose primary vaccination against Streptococcus pneumoniae (S pneumoniae) and Haemophilus influenzae (H influenzae) in healthy infants between 6-14 weeks (42-104 days) of age at the time of the first vaccination and 12-15 months of age at the time of booster vaccination.MedDRA version: 14.1Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: PTClassification code 10061190Term: Haemophilus infectionSystem Organ Class: 10021881 - Infections and infestations
EUCTR2010-019730-27-DEGlaxoSmithKline Biologicals600
进行中(未招募)
1 期
A phase II, randomized, controlled, observer-blind study to assess the safety, reactogenicity and immunogenicity of two formulations of GlaxoSmithKline (GSK) Biologicals’ Streptococcus pneumoniae protein containing vaccine given as a 3-dose primary vaccination course co-administered with DTPa-HBV-IPV/Hib vaccine during the first 6 months of life and as a booster dose at 12-15 months of age. - SPNG-003
EUCTR2010-019730-27-PLGlaxoSmithKline Biologicals600
进行中(未招募)
1 期
A phase II, randomized, controlled, observer-blind study to assess the safety, reactogenicity and immunogenicity of two formulations of GlaxoSmithKline (GSK) Biologicals’ Streptococcus pneumoniae protein containing vaccine given as a 3-dose primary vaccination course co-administered with DTPa-HBV-IPV/Hib vaccine during the first 6 months of life and as a booster dose at 12-15 months of age. - SPNG-003
EUCTR2010-019730-27-SEGlaxoSmithKline Biologicals600
进行中(未招募)
不适用
Impact of GSK Biologicals’ 2189242A vaccine on nasopharyngeal carriage, safety and immunogenicity when co-administered with routine EPI vaccines in infants following safety assessment in children aged 2-4 yrs in The Gambia.
EUCTR2012-002727-15-Outside-EU/EEAGlaxoSmithKline Biologicals1,320
进行中(未招募)
不适用
A phase II, randomized, controlled, observer-blind study to assess the safety, reactogenicity and immunogenicity of two formulations of GlaxoSmithKline (GSK) Biologicals’ Streptococcus pneumoniae protein containing vaccine given as a 3-dose primary vaccination course co-administered with DTPa-HBV-IPV/Hib vaccine during the first 6 months of life and as a booster dose at 12-15 months of age. - SPNG-003Three-dose primary vaccination against Streptococcus pneumoniae (S pneumoniae) and Haemophilus influenzae (H influenzae) in healthy infants between 6-14 weeks (42-104 days) of age at the time of the first vaccination and 12-15 months of age at the time of booster vaccination.MedDRA version: 14.0Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.0Level: PTClassification code 10061190Term: Haemophilus infectionSystem Organ Class: 10021881 - Infections and infestations
EUCTR2010-019730-27-CZGlaxoSmithKline Biologicals600