To evaluate the safety of Needle free injection system and immunogenecity of available Cervavac HPV vaccine in healthy young girls
- Registration Number
- CTRI/2024/01/061632
- Lead Sponsor
- IntegriMedical Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1 Healthy young girls of 9 years to 12 years of age on the day of inclusion
2 Informed Consent Form (ICF) signed by the parent(s) or any other Legally Acceptable Representative (LAR)
3 Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
4 Confirmed through medical history to have been born to a mother who tested negative for hepatitis B surface antigen (HBsAg)
5 Young girls with intact uterus and not pregnant.
6 Subject’s willingness and ability to comply with the requirements of the protocol as judged by the investigator
1 Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
2 Subject has a known history of prior vaccination with HPV vaccine.
3 Subject concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical/genital specimens
4 Subject with a current diagnosis or prior history of genital warts or treatment of genital warts
5 Female subject with current diagnosis or history of treatment for cervical pre-malignancies or malignancy
6 Subject has a history of any allergic diseases or severe allergic reaction to any agent
7 Subject has had an acute illness and/or fever at the time of vaccination or during the 7 days prior to the vaccination
8 Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired Human Immunodeficiency Virus infection.
9 Coagulation disorder that would contraindicate IM injections
10 Subject has history of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia or any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
11 Subject has history of any cancer, organ transplant or any other immune system disease
12 Subject has had chronic administration of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins immunosuppressants or other immune-modifying drugs in last 3 months or planned at any time during the study
13 Subject has received any oral or injectable antibiotics and/or antiviral from five days before screening through to enrolment
14 Subject has history of receiving a blood transfusion or other blood products in three months prior to screening
15 Subject has history of administration of any non-study vaccine within 30 days prior to administration of study vaccine or planned during the course of 7-month study period.
16 History of any surgical procedure for the removal of the uterus or hysterectomy.
17 Any medically diagnosed or suspected immunodeficient condition (other than HIV for HIV seropositive subjects), based on medical history, physical examination and/or laboratory tests results
18 Subjects with a history of convulsions epilepsy other central nervous system diseases severe disease of haematopoietic system decompensated heart disease or impaired renal function
19 A history of serious chronic illness major congenital defects immunosuppression (immunosuppressive illness or therapy)
20 Subjects with any other clinically significant concurrent illness affecting immune response after vaccination
21 Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
22 Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
23 Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)To evaluate the Safety of Needle Free Injection System (NFIS) <br/ ><br> <br/ ><br>(Note safety in terms of Pain redness swelling itching observed at the injection site and any other adverse events or serious adverse events due to NFIS) <br/ ><br>2) To evaluate the number of participants reporting solicited injection site reactions solicited &/or unsolicited systemic reactions after administration of Cervavac HPV vaccineTimepoint: (Pre-Vaccination)Day 1 to Day 28(Post Vaccination)
- Secondary Outcome Measures
Name Time Method 1) Evaluate the levels of antibodies concentration to the vaccine antigens following single dose of Cervavac HPV vaccineTimepoint: (Pre Vaccination)Day 1 to Day 28 (Post Vaccination)