None listed
Conditions
Interventions
Intervention1: IntegriMedical Needle-Free Injection System (IM-N-FIS) with intramuscular 0.5 mL suspension of qHPV vaccine: Participants will receive two or three doses of 0.5 ml of qHPV vaccine as pe
Sponsors
Mr Sarvesh Mutha
Eligibility
Inclusion criteria
Inclusion criteria: Participants will be enrolled in the study if they meet all the following criteria: 1. Healthy female and male participants of age 9-26 years (both inclusive) at the time of the screening 2. Clinically healthy, as established by medical history and physical examination before entering the study 3. Female participants with childbearing potential, not pregnant at the time of vaccination 4. Sexually active participants to be using an effective method of contraception (i.e. intrauterine device or hormonal contraception or condom, diaphragm, cervical cap) 30 days prior to the enrollment and throughout the study period 5. Able to provide informed consent and assent (whichever applicable) 6. Able to comply with the study requirements
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they meet any of the following criteria: 1. Previous vaccination against HPV 2. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days prior to study enrollment, or planned use during the study period 3. Administration of any other vaccine within 30 days prior to study enrollment, or within 30 days of each study vaccination visits except for routine vaccines like rabies vaccine or tetanus containing vaccine 4. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the study enrollment, or planned use during the study period 5. Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination 6. History of allergic disease, suspected allergy, or reactions likely to be exacerbated by any component of vaccine, including yeast 7. History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, autoimmune disease. Participants with medically stable, well controlled autoimmune disease may be permitted 8. Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection 9. Received immunoglobulins and/or blood product within 90 days preceding enrollment, or planned use during the study period 10. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature 37.5 degree Celsius 11. Any condition that may interfere with ability to comply with trial procedures, as assessed by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of immediate adverse events 30 minutes after each vaccination Incidence, severity, and relationship of local and systemic solicited adverse events during 7-day follow-up period after each vaccination Incidence, severity, and relationship of unsolicited adverse events throughout the study period Incidence, severity and relationship of serious adverse events throughout the study period Pain assessment using Visual Analog Scale (VAS) at the time of vaccinationTimepoint: Incidence of immediate adverse events 30 minutes after each vaccination Incidence, severity, and relationship of local and systemic solicited adverse events during 7-day follow-up period after each vaccination Incidence, severity, and relationship of unsolicited adverse events throughout the study period Incidence, severity and relationship of serious adverse events throughout the study period Pain assessment using Visual Analog Scale (VAS) at the time of vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric Mean Titre of antibodies to HPV types 6, 11, 16, and 18 among participants receiving vaccination either with IM-N-FIS or CHN, 30 days after last dose of vaccination i.e. on Day 210. Percentage of participants with seroconversion to HPV types 6, 11, 16, and 18, 30 days after last dose of vaccination with either IM-N-FIS or CHN i.e. on Day 210. Fold rise of antibodies to HPV types 6, 11, 16, and 18 among participants receiving vaccination either with IM-N-FIS or CHN, 30 days after last dose of vaccination i.e. on Day 210. Timepoint: Immunogenicity samples would be collected at Pre dose visit 1 and at EOS visit | — |
Countries
India
Contacts
Public ContactDr Neeraj Prasad
IntegriMedical Private Limited
Outcome results
None listed