Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Human Papilloma Virus Vaccine: 0.5 ml intramuscular in the deltoid region of the upper arm
Control Intervention1: Not applicable: Nil
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult male aged between 18-26 years and female subjects aged between 18-45 years and normal Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight. 2. Healthy subjects as established by personal medical history, physical examination, laboratory investigation during screening and as per the clinical judgment of the Investigator. 3. Sexually active participants to be using an effective method of contraception (i.e. intrauterine device or hormonal contraception or condom, diaphragm, cervical cap). 4. Subjectâ??s willingness and ability to comply with the requirements of the protocol. 5. Subject willing to sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of HPV vaccination or HPV infection 2. Female participant who is pregnant or breast-feeding, or wanting to fall pregnant during trial participation. 3. History of abnormal cervical cancer tests in females or history of genital warts in females and males. 4. History of any surgical procedure for the removal of the uterus or hysterectomy. 5. History of major congenital defects or illness. 6. Investigator site personnel directly affiliated with this study. 7. Acute illness and/or fever at the time of vaccination or during the past 7 days. 8. Administration of corticosteroids, cytotoxic agents or radiotherapy or other immune-modifying drugs in last 3 months. 9. Receipt of any oral or injectable antibiotics and/or antiviral from 5 days before screening through to enrollment. 10. History of receipt a blood transfusion or other blood products. 11. Use of any investigational or non-registered drug. 12. History of administration of any vaccine in past 30 days or during the study. 13. History of any major illness. 16. History of anaphylactic shock 17. Participant having any allergies to medications and food. 18. History or presence of significant alcoholism, drug abuse in the past one year. 19. History or presence of significant smoking. 20. Reactive serology for HIV, hepatitis B and hepatitis C viruses 21. Abnormal ECG and chest X-ray 22. Participation in a drug research study within past 3 months or planned participation during the study. 23. Participant has any plans to relocate from the area prior to the completion of the study. 24. Any other condition which in the opinion of the investigator will jeopardize the safety of the subject due to participation in the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Occurrence of unsolicited adverse events, including serious adverse events within 30 days after vaccination.Timepoint: Blood and urine samples for safety assessment to be drawn at screening, day 7 and day 30. | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Occurrence of immediate adverse events after single dose. 2. Occurrence of solicited adverse reactions within 7-day postvaccination follow-up period. 3.Occurrence of solicited adverse events within 30 days after vaccination.Timepoint: Blood and urine samples for safety assessment to be drawn at screening, day 7 and day 30. | — |
Countries
India
Contacts
Public ContactDr Hitt Sharma
Serum Institute Of India Pvt Ltd
Outcome results
None listed