Multicentric study to assess the safety of qHPV vaccine

Phase 4

Conditions: Health Condition 1: Z23- Encounter for immunization

Registration Number: CTRI/2024/05/067838

Lead Sponsor: Serum Institute of India Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Incidence, severity, and relationship of local and systemic solicited adverse events (AE) up to 7 days following each vaccination. <br/ ><br> <br/ ><br>2) Incidence, severity, and relationship of unsolicited adverse events (AE) occurring up to end of study (EOS) visit (Day 210). <br/ ><br> <br/ ><br>3) Incidence, severity, and relationship of serious adverse events (SAE) occurring up to end of study (EOS) visit (Day 210). <br/ ><br>Timepoint: 1) Local and systemic AE up to 7 days. <br/ ><br> <br/ ><br>2) Unsolicited AE up to day 210. <br/ ><br> <br/ ><br>3) SAEs up to day 210.

Secondary Outcome Measures