OPEN-LABEL, RANDOMIZED, THREE-ARM, PHASE IIIB CLINICAL STUDY TO INVESTIGATE THE SAFETY AND IMMUNOGENICITY OF A CONCOMITANT ADMINISTRATION OF GROUP C MENINGOCOCCAL POLYSACCHARIDE-TETANUS TOXOID CONJUGATE (MENC-TT) VACCINE AND 7-VALENT PNEUMOCOCCAL CRM197-CONJUGATE VACCINE (PCV7) IN TODDLERS PREVIOUSLY IMMUNIZED DURING INFANCY WITH PCV7 - n.a.

Baxter Innovations GmbH0 个研究点开始时间: 2007年10月18日最近更新: 2013年2月11日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Baxter Innovations GmbH

研究概览入排标准研究者记录与标识符相似试验

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

Male and female subjects will be eligible for participation in this study if:·
they are toddlers, aged 12 to 18 months;
they are clinically healthy, (i.e. the physician would have no reservations vaccinating with a MenC conjugate vaccine, and/or PCV7 outside the scope of a clinical trial);
their parents/legal guardian(s) understand the nature of the study, agree to its provisions, and provide written informed consent;
their parents/legal guardian(s) agree to keep a Subject Diary;
they have received a complete primary series of pneumococcal conjugate vaccine (3 vaccinations with PCV7 in the first year of life according to the official vaccination calendar recommendations).
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

Subjects will be excluded from participation in this study if:
they have a history of any vaccine-related contraindicating event, e.g. serious reactions after first application of a PVC7 vaccine or high fever =40ºC associated with any vaccination, or generalized allergic reaction within 48 hours of a first application of vaccine;
they have a known sensitivity or allergy to any components of the vaccines;
they have previously been vaccinated with MenC vaccine;
they have already received a PVC 7 booster (4th vaccination);·
they have a rash or other dermatological condition at the injection site which could interfere with injection site reaction evaluation;
they suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
they have a history of meningococcal serogroup C and/or invasive pneumococcal infection;
they have received any blood products or immunoglobulins within 90 days of study entry or the administration of such products is planned during the study period;
currently have or had a history of any serious disease (e.g. cardiac, renal, autoimmune, neurologic);
were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product;
they or their parents/legal guardian(s) are in a dependent relationship with the study investigator or with a study team member. Dependent relationships include close relatives (i.e., children or grandchildren, partner/spouse, siblings) as well as employees of the investigator or site conducting the study.

研究者

发起方

Baxter Innovations GmbH

标识符

注册编号: EUCTR2007-004276-39-DE
其他研究编号: 670701, n.a.

日期

最近更新: 2013年2月11日 (13年前)

监管与共享

是否有结果: 否

相似试验

未知

不适用

A PHASE 3, RANDOMIZED, TWO-ARM, OPEN-LABEL, MULTICENTER, INTERNATIONAL TRIAL OF ALISERTIB (MLN8237) OR INVESTIGATOR´S CHOKE (SELECTED SINGLE AGENT) IN PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA

PER-061-12Millennium Pharmaceuticals, Inc.,4

已完成

不适用

A PHASE II STUDY OF EVEROLIMUS IN COMBINATION WITH EXEMESTANE VERSUS EVEROLIMUS ALONE VERSUS CAPECITABINE IN ADVANCE BREAST CANCER.-C50 Malignant neoplasm of breastMalignant neoplasm of breastC50

PER-024-13OVARTIS BIOSCIENSES PERU S.A.,9

进行中（未招募）

不适用

PHASE IIIb, MULTICENTRE, OPEN-LABEL, SINGLE-ARM, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL 120 mg ADMINISTERED EVERY 28 DAYS AS PRIMARY MEDICAL TREATMENT IN ACROMEGALIC PATIENTS WITH MACROADENOMA. Estudio en fase IIIb, multicéntrico, abierto, de un solo brazo, para evaluar la seguridad y eficacia de Lanreotida Autogel 120 mg, administrado cada 28 días, como tratamiento médico principal en pacientes acromegálicos con macroadenomaACROMEGALIA ASOCIADA A MACROADENOMA DE LA GLÁNDULA PITUITARIAMedDRA version: 9.1Level: LLTClassification code 10000599Term: Acromegaly

EUCTR2007-000155-34-ESBeaufour Ipsen Pharma100

进行中（未招募）

不适用

PHASE IIIb, MULTICENTRE, OPEN-LABEL, SINGLE-ARM, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL 120 mg ADMINISTERED EVERY 28 DAYS AS PRIMARY MEDICAL TREATMENT IN ACROMEGALIC PATIENTS WITH MACROADENOMA.ACROMEGALY ASSOCIATED WITH PITUITARY GLAND MACROADENOMAMedDRA version: 14.1Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disorders

EUCTR2007-000155-34-SEIpsen Pharma SAS100

进行中（未招募）

1 期

PHASE IIIb, MULTICENTRE, OPEN-LABEL, SINGLE-ARM, STUDY TO ASSESS THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL 120 mg ADMINISTERED EVERY 28 DAYS AS PRIMARY MEDICAL TREATMENT IN ACROMEGALIC PATIENTS WITH MACROADENOMA.ACROMEGALY ASSOCIATED WITH PITUITARY GLAND MACROADENOMAMedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly

EUCTR2007-000155-34-GBIpsen Pharma SAS90