Multicentric study to assess the safety of qHPV vaccine

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067838

Enrollment

2000

Registered

2024-05-24

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z23- Encounter for immunization

Interventions

Intervention1: SIIPL’S qHPV VACCINE (CERVAVAC®): Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Vaccine (Recombinant). The 0.5 mLof the vaccine will be administered intramuscularly in the

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Not ApplicableTimepoint: Not Applicable	—

Countries

India

Contacts

Public ContactDr Hitt Sharma

Serum Institute of India Pvt Ltd

drhjs@seruminstitute.com02026602451

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026