Evaluate non-inferiority efficacy of protection and safety of noyan pajouhan Biopharma human papillomavirus vaccine type 16,18 in healthy female volunteers.
- Conditions
- cervical cancer.Malignant neoplasm of cervix uteri
- Registration Number
- IRCT20090526001952N9
- Lead Sponsor
- oyan Pajouhan biopharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 218
Female subjects between, and including, 15 to 25 years of age at the time of the first vaccination
Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study
Subjects that have an intact uterus and cervix
Written informed consent obtained from the subject prior to enrollment.
Subjects who can and will comply with the requirements of the protocol.
Previous vaccination against HPV
History of allergic reaction to vaccine administration
Chronic administration of immune-suppressants (more than 14 days) or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration of a vaccine not foreseen by the study protocol.
Any confirmed or suspected immunosuppressive or immunodeficient condition (based on medical history and physical examination).
Known chronic disease such as Cancer, hepatic or renal disease, neurologic disease, diabetes or autoimmune diseases
Administration of immunoglobulin and/or any blood products within the 90 days preceding the first dose of study vaccine
Positive ß-HCG test.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Antibody titre against papillomavirus 16,18 with GMT comparison after 7 months. Timepoint: After 7 months. Method of measurement: Geometric Mean Titre.
- Secondary Outcome Measures
Name Time Method Percentage of participants with seroconversion against HPV 16 and 18. Timepoint: Number of females with seroconversion after 6 months of first injection. Method of measurement: For seroconversion of type 16,18 Human papillomavirus measure the ratio of level of threshold of antibody against human papillomavirus 16,18 to total population in percentage.;Percentage of any adverse effects. Timepoint: Solicited adverse effects after one week of each injection; Unsolicited adverse effects after one month of each injection;. Method of measurement: Solicited, unsolicited and serious adverse event: ratio of events to total study population in percentage.