EUCTR2004-000397-31-DE进行中（未招募）不适用
A Randomized Controlled Open-Label Phase IV Multi Center Study to Assess the Effect of Antipyretic Prophylactic Treatment on the Rate of Febrile Reactions Following Concomitant Contralateral Administration of a 7-Valent Pneumococcal Conjugate Vaccine (Prevenar®) and DTPa-HBV-IPV+Hib Vaccine (Infanrix hexa®) in Children at 2, 3, 4 and 11-14 Months of Age. - Prevenar Antipyretic Trial
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
- 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
- •1. Aged 56 to 112 days of age at time of enrolment.
- •2. Satisfactory health as determined by a physical examination, medical history and subject’s development.
- •3. Subject and parents(s)/legal guardian(s) are available for the entire study period.
- •4. Subject’s parent(s) or legal guardian(s) have adequate literacy to understand and undertake the required study related procedures and have agreed to participate.
- •5. Subject’s parent(s) or legal guardian(s) have provided written informed consent after the study has been adequately and fully explained.
- •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
- •1. Prematurely born subjects (infants born at <37 weeks gestation and/or birth weight <2,500 g).
- •2. Subjects who are not well developed according to age or are underweight in the opinion of the investigator.
- •3. Body weight <4,000 g at time of enrolment.
- •4. Known or suspected disease of the immune system or receiving immunosuppressive therapy, including systemic corticosteroids.
- •5. Receipt of blood products within 12 weeks prior to study entry.
- •6. Bleeding diathesis or condition associated with prolonged bleeding time.
- •7. Significant evolving neurological disorder.
- •8. Seizure disorders or a prior history of febrile seizures.
- •9. Major known congenital malformation or serious chronic disorder or genetically determined disease.
- •10. Any previous anaphylactic reaction or serious vaccine-associated adverse reactions.
- •11. Known or suspected hypersensitivity to any vaccine or vaccine component.
- •12. Any medical condition that would in the opinion of the investigator interfere with the evaluation of the study objectives.
- •13. Vaccination with any licensed or investigational vaccine (other than study vaccines allowed by this protocol): a. before enrolment (visit 1) up to visit 4. b. two (2) weeks before booster vaccination (visit 5) up to visit 6.
- •14. Intention to immunize with any investigational agent other than those specified in this protocol.
- •15. Other indications for prophylactic antipyretic treatment.
- •16. Subject has any contraindication to immunization with DTPa-HBV-IPV+Hib (Infanrix hexa®), or 7vPnC (Prevenar®).
- •17. Subject has any contraindication to treatment with paracetamol (e.g. known sensitivity to paracetamol or other components of the suppositories, functional impairment of the liver or kidney, Gilbert Syndrome, or current treatment with medication that interferes with paracetamol as described in the paracetamol SPC).
- •18. Participation in another investigational study.
研究者
相似试验
进行中（未招募）
不适用
A Randomized Controlled Open-Label Phase IV Mono Center Study to Compare the Reponse Profiles of Montelukast versus Fluticason in Children with Preschool Asthma - leucotrienantagonists or steroids in preschool asthmaEUCTR2007-004541-15-DEJohann Wolfgang Goethe-Universität Frankfurt am Main
进行中（未招募）
1 期
Acalabrutinib Monotherapy vs Investigator’s Choice of Treatment in Patients with Chronic Lymphocytic Leukaemia and Moderate to Severe Cardiac ImpairmentChronic Lymphocytic Leukaemia and Moderate to Severe Cardiac ImpairmentCTIS2023-510147-37-00AstraZeneca AB55
尚未招募
4 期
To compare the effectiveness of two types of laxatives namely Polyethylene Glycol 3350 vs. Lactulose for treatment of constipation in Indian ChildreCTRI/2018/01/011061Fourrts India Laboratories Pvt Ltd
已完成
4 期
An open label, multicentre, randomized phase IV clinical trial to evaluate the safety and efficacy of MaxioCel compared with Aquacel Extra for the management of exuding chronic wounds.CTRI/2022/04/041745Axio Biosolutions Pvt Ltd
已完成
4 期
A study to check whether addition of Resveratrol is beneficial and safe in patients with Diabetes, Dyslipidemia and Hypertension (who are already on standard therapy)CTRI/2017/04/008384Rakesh Ojha180