CTRI/2022/04/041856已完成4 期
A phase 4, open-label, single-arm, multicenter study todescribe the safety of 13-valent pneumococcal conjugate vaccine in adults 18 To 49 years of age in India
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer Inc
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
入选标准
- •Generally healthy participants between the ages of =18 and <50 years, at Visit 1. Participants who are willing and able to comply with all scheduled visits, treatment plan, lifestyle considerations, and other study procedures. Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- •Note: Participants with preexisting stable disease, defined as disease not requiring
- •significant change in therapy or hospitalization for worsening disease during the 12 weeks before enrollment, can be included.
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions:
- •1. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, or to any other diphtheria toxoid–containing vaccine.
- •2. History of microbiologically-proven invasive disease caused by S pneumoniae.
- •3. Known or suspected immune deficiency or suppression.
- •4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- •5. Congenital, functional, or surgical asplenia.
- •6. Other medical or psychiatric condition including recent (within the past year) or
- •active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- •Prior/Concomitant Therapy:
- •7. Previous vaccination with any pneumococcal vaccine, or planned receipt of any pneumococcal vaccine through study participation.
- •8. Currently receives treatment with immunosuppressive therapy, including cytotoxic
- •agents or systemic corticosteroids, or planned receipt during the study. If systemic corticosteroids have been administered short term ( <14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention
- •administration. Inhaled/nebulized, intraarticular, intrabursal, or topical (skin, eyes, or ears) corticosteroids are permitted.
- •9. Receipt of blood/plasma products or immunoglobulin within the 60 days before study
- •intervention administration, or planned receipt during the study.
- •Prior/Concurrent Clinical Study Experience:
- •10. Participation in other studies involving investigational drugs, investigational vaccines
- •(with the exception of vaccines authorized by the DCGI for pandemic use), or investigational devices within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.
- •Diagnostic Assessments:
- •Not applicable.
- •Other Exclusions:
- •11. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
研究者
相似试验
尚未招募
4 期
Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age and in children 6 to 17 years of age in IndiaCTRI/2014/05/004608Pfizer Limited1,200
尚未招募
4 期
Phase IV study of Brentuximab Vedotin in Hodgkin LymphomaCTRI/2024/07/069820Baxalta US Inc
进行中（未招募）
4 期
A Study of Vedolizumab in People With Ulcerative Colitis and Crohns DiseaseCTRI/2021/11/037814Ms Takeda Pharmaceutical India Pvt Ltd
进行中（未招募）
1 期
A study on the immune response and safety of a vaccine against Neisseria meningitidis serogroup B infection in healthy infants from 2 months of ageHealthy volunteers (active immunization of infants against invasive meningococcal disease (IMD) due to N. meningitidis serogroup B infection).EUCTR2023-000764-58-Outside-EU/EEAGlaxoSmithKline Biologicals SA
进行中（未招募）
1 期
Study of quality of life in chronic Spontaneous Urticaria patients and treated by omalizumab (Xolair®)chronic spontaneous urticariaMedDRA version: 18.0Level: PTClassification code 10072757Term: Chronic spontaneous urticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2014-005424-97-FROVARTIS PHARMA SAS126