A Phase 4 single arm multicentric study to assess the safety of SIIPL qHPVvaccine CERVAVAC when administered in a two dose schedule to girls andboys aged 9 to 14 years and in a three dose schedule to women and men aged 15 to 26 years - NI

Serum Institute of India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

试验速览

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•1. Female and male subjects aged 9-26 years.
•2. Subjects who are eligible for receiving CERVAVAC vaccine according to the approved local prescribing information and as per the Investigator’s opinion.
•3.Subject’s or their parent’s willingness and ability to comply with the requirements of the protocol.
•4.Subject willing to sign a written informed consent.
•5. Either of the parent is willing to sign written informed consent form for subject less than years of age and subject is willing to sign written assent form.

•1.Subject who has a known history of prior vaccination with HPV vaccine.
•2. Subject who was previously enrolled in HPV vaccine surveillance and had received a similar active agent.
•3.Subject who had received any investigational product within 30-days prior to their first visit.
•4.Hypersensitivity to the active substances or to any of the excipients of the vaccine including severe allergic reactions to yeast, a vaccine component.
•5.Pregnant females or females planning to become pregnant during the study duration.
•6.Any condition which in the opinion of the Investigator might interfere with the evaluation of the study objectives.

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