IRCT20090526001952N9CompletedPhase 3
A Phase III, Randomized,Two armed, Parallel, Double blinded, Active controlled Non-inferiority to evaluate the efficacy of Protection and safety of Papillomavirus vaccine (Bivalent, manufactured by Noyan Pajouhan Biopharma) in comparison with Cervarix® (Bivalent, manufactured by GlaxoSmithKline) in immunogenicity and GMT (Geometric Mean Titer) ratio in healthy female volunteers of 15 to 25 years of age.
oyan Pajouhan biopharma0 sites218 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 218
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 15 years to 25 years (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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