EUCTR2006-001481-17-CZ进行中（未招募）不适用
A phase IIIb, open, controlled study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant booster administration of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine with GSK Biologicals’ Infanrix hexa vaccine in children at 12-15 months of age following a 3-dose primary vaccination in study 10PN-PD-DIT-010 (107017) and to evaluate the impact of pneumococcal vaccination on nasopharyngeal carriage compared to a pneumococcal vaccine unprimed control group receiving GSK iologicals' meningococcal serogroup ACWY conjugate vaccine. - 10PN-PD-DIT-014 BST:010
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 860
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
- •All subjects must satisfy the following criteria at study entry:
- •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, 12-15 months of age at the time of the booster vaccination.
- •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.
- •Subjects in the primed antipyretic and primed non-antipyretic group:
- •A male or female who previously participated in study 10PN-PD-DIT-010 and received three doses of pneumococcal conjugate vaccine.
- •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
- •For all subjects:
- •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).
- •Indication, other than specified in the protocol, for prophylactic antipyretic treatment.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month (30 days) preceding the dose of study vaccines, or planned use during the entire study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the dose of study vaccines. (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 one month (30 days) before the dose of study vaccines (Visit 1) and up to one month after the dose of study vaccines (Visit 2).
- •History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •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.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- •A family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious chronic illness.
- •Administration of immunoglobulins and/or any blood products within three months preceding dose of study vaccines or planned administration during the study period.
- •Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema).
- •The following conditions are temporary or self-limiting and a subject may be included in the study and/or vaccinated once the condition has resolved and no other exclusion criteria are met:
- •Subject has received systemic antibiotic therapy for acute illness within 24 hours prior to the vaccination.
- •Subject is likely to receive antipyretic treatment as a result of a concomitant illness or has been treated with paracetamol within the past 24 hours.
- •DTPa-HBV-IPV/Hib vaccine
- •The following adverse events constitute absolute contraindications to administration of DTPa-HBV-IPV/Hib; if any of these adverse events occur during the study, the investigator must decide which vaccine to give to the subject for these antigens.
- •Known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, polio, hepatitis B and Hib vaccines or to any component of the vaccines.
- •Encephalopathy, defined as an acute, severe central nervous system disorder occurring within 7 days following pertussis vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
- •As with other vaccines, administration of DTPa-HBV-IPV/Hib should be postponed in subjects suffering from acute mild, moderate or severe illness.
- •N.B. Contraindication to the administratio
研究者
相似试验
进行中（未招募）
不适用
A phase IIIb open, controlled study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine when given as a catch-up immunization in children older than 7 months of age or given as a 3-dose primary immunization in children before 6 months of age. - 10PN-PD-DIT-013Catch-up immunization against Streptococcus pneumoniae in children older than 7 months at the time of the first vaccination and subdivided according to the age:•7 to 11 months of age.•12 to 23 months of age.•24 months to 5 years of age.EUCTR2006-001482-42-FIGlaxoSmithKline Biologicals600
进行中（未招募）
不适用
A phase III, open, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar when given as a booster dose between 11-18 months of age in children previously vaccinated in the primary study 10PN-PD-DIT-011 (107005) with either GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar. - 10PN-PD-DIT-017 BST 011EUCTR2006-005733-38-DEGlaxoSmithKline Biologicals800
进行中（未招募）
1 期
A phase III, open, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar when given as a booster dose between 11-18 months of age in children previously vaccinated in the primary study 10PN-PD-DIT-011 (107005) with either GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar. - 10PN-PD-DIT-017 BST 011Booster vaccination against Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae type b in healthy infants 11 to18 months of age who were previously primed with three doses of pneumococcal conjugate vaccine co-administered with three doses of DTPa-combined and MenC or Hib-MenC vaccines.EUCTR2006-005733-38-PLGlaxoSmithKline Biologicals1,437
进行中（未招募）
不适用
Persistence of antibodies after vaccination with GSK Biologicals’ menin-gococcal vaccine GSK 134612 in adolescents and young adultsEUCTR2012-005641-21-Outside-EU/EEAGlaxoSmithKline Biologicals689
进行中（未招募）
不适用
Immunization of Children Between 8 Weeks and 2 Years of Age With a pneumococcal conjugate vaccineActive immunization against disease caused by Streptococcus pneumoniae in children from 8 weeks up to 2 years of age.MedDRA version: 17.1Level: PTClassification code 10061190Term: Haemophilus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 17.1Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-000254-64-Outside-EU/EEAGlaxoSmithKline Biologicals300