A Phase 2, Non-Randomized, Controlled, Open-Label, Parallel-Group, Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-pregnant Subjects

GlaxoSmithKline Biologicals S.A.0 个研究点开始时间: 2016年2月11日最近更新: 2016年12月12日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: GlaxoSmithKline Biologicals S.A.

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: Female

入选标准

•In order to participate in this study, all subjects must meet ALL of the inclusion criteria
•1. Healthy, non-pregnant subjects who have received a single 5 µg dose of GBS Trivalent Vaccine or placebo in the V98_06 study and healthy non-pregnant female subjects aged 22-46 years inclusive on the day of informed consent who have not received any GBS vaccine in the past.
•2. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
•3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
•4. Individuals who can comply with study procedures including follow-up.
•5. Females of childbearing potential who are using an effective birth control method which they intend to use until the end of the study (day 181 visit) or females of nonchildbearing potential
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 220
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

排除标准

•1. Progressive, unstable or uncontrolled clinical conditions.
•2. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
•3. Abnormal function of the immune system resulting from:
•a. Clinical conditions, including but not limited to known or suspected HIV infection or HIV-related disease, a history of or an active autoimmune disorder (as per the judgment of the Investigator)
•b. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent.
•c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
•d. Receipt of immunosuppressive therapy within 90 days prior to informed consent
•4. Received immunoglobulins or any blood products within 180 days prior to informed consent.
•5. Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
•6. Study personnel as an immediate family or household member.
•7. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
•8. Individuals who received any other vaccines within 14 days for inactivated vaccines or 28 days for live vaccines prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccination. Exception - an inactivated influenza vaccine may be administered up to 7 days prior to study vaccination or 7 days after study vaccination.
•9. Individuals who anticipate becoming pregnant prior to the end of the study, Day 181 Visit.10. Individuals who are nursing (breastfeeding).
•11. Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens that was not part of V98_06 study.
•12. Individuals with a fever (oral temperature = 38°C) within 3 days prior to day 1 or use of antipyretics and/or analgesic medications within 24 hours prior to day 1.
•13. Individuals with acute or chronic infection(s) that require systemic antibiotic treatment or antiviral therapy, within 7 days prior to day 1.
•14. Individuals with a history of severe allergic reactions after previous vaccinations or medications, such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component or medical equipment including latex used in this study.
•15. Individuals with any progressive or severe neurologic disorder, seizure disorder, epilepsy or Guillain-Barré syndrome.
•16. Individuals with history of substance or alcohol abuse within the past 2 years.

研究者

发起方

GlaxoSmithKline Biologicals S.A.

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