跳至主要内容
临床试验/NL-OMON38271
NL-OMON38271已完成3 期

A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals* HPV 16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above. - Evaluation of HPV-vaccine efficacy in healthy women of 26 years or above

GlaxoSmithKline0 个研究点目标入组 360 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
360

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - A women of at least 26 years of age at the time of the first vaccination
  • - Free of obvious health problems as established by medical history and clinical examination before entering into the study
  • - Subject must have intact cervix (e.g. no history of cauterization or surgical treatment involving damage to the transformation zone of the cervix).

排除标准

  • See page 58-60 of the study protocol for a complete list of the in- and exclusion criteria.

研究者

相似试验

进行中(未招募)
不适用
A phase III, double-blind, randomized, controlled study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine administered intramuscularly according to a 0, 1, 6 month schedule in healthy female subjects aged 10 – 14 years.Sponsor’s protocol code number, version, and date: , Final version, 17th March 2004Name or abbreviated title of the trial where available: HPV-013 - HPV-013cervical cancer: the study is conducted in healthy female adolescents
EUCTR2004-000518-37-NOGlaxoSmithKline AS2,000
进行中(未招募)
不适用
A study to evaluate safety, immunogenicity and efficacy of GSK Biologicals HPV-16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above.For active immunization of girls and women from 10 years of age onwards for the prevention of persistent human papillomavirus (HPV) infections and related clinical outcomes (cytological abnormalities and pre-cancerous lesions) caused by oncogenic HPV types 16 and 18.MedDRA version: 14.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862
EUCTR2005-002546-20-PTGlaxoSmithKline Biologicals5,751
进行中(未招募)
1 期
Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GSK Biologicals' (GSK Bio) HPV-16/18 Vaccinecervical cancer: the study is conducted in healthy female adolescentsMedDRA version: 14.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 10021881 - Infections and infestations
EUCTR2004-000518-37-ESGlaxoSmithKline SA
进行中(未招募)
不适用
Immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Human Papillomavirus (HPV) 580299 vaccine in healthy Chinese female subjects.Healthy volunteers
EUCTR2012-003025-25-Outside-EU/EEAGlaxoSmithKline Biologicals750
进行中(未招募)
1 期
A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals’ HPV 16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above. - HPV-015
EUCTR2005-002546-20-GBGlaxoSmithKline Biologicals5,782
A phase III, double-blind, randomized, controlled... | 临床试验