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.

Examine the non-inferiority and safety of papilloma virus vaccine (bi-valency, by Noyan Pajouhan Biopharma) in comparison with Cervarix® (Bivalency, by GlaxoSmithKline)

Phase III, randomized, two arm, double blind, parallel, active controlled in 218 female subjects

Study will be conducted in Arash Women’s hospital in Tehran. Study is double blinded (nurse, investigator and the volunteers), Information of investigational vaccine in a sealed envelope with continue number will be given to them.

Inclusion criteria: Female subject of 15-25 years Being Healthy Subjects that have an intact uterus and cervix obtaining written informed consent 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. History of immunosuppressive or immunodeficient condition Known chronic diseases. Administration of immunoglobulin and/or any blood products within the 90 days before first dose of vaccine. Positive β-HCG test.

This study has two arm in which one arm will receive the HPV vaccine 16,18 (Noyan Pajouhan Biopharma) and other arm will receive the Cervarix® (GlaxoSmithKline) at a dose of 0.5 ml intramuscularly in 0,1,6 month schedule.

Primary outcome: Antibody titer against papillomavirus 16,18 with GMT comparision after 7 months. Secondary outcome: Proportion of local and systemic solicited and unsolicited events Proportion of serous adverse events Number of females with seroconversin against HPV 16,18 at the end of study.

Randomization sequences will be made by R-CRAN software. This randomization sequence is consist of quadruple permuted balanced blocks to achieve the target sample size of 202 volunteers ( made of 51 blocks that are only 202 sequences out of 204 sequences chain). Each of these sequences will be converted to untitled codes of alphabet and number. Centrally, master sheet of randomization will be kept with data manager team, therefor, after approval of eligibility of each volunteer, through phone call will be given to the site of study. Series of untitled codes and initial alphabets of volunteer’s name and family name will make the identity number of volunteers for using in Case Report Form and made the information bank.

All the healthy volunteers will be vaccinated by an experienced nurse in the site of study and based on availability of vaccine in the stock and adhering the trial sticker on the vaccine and administration by nurse the nurse, investigator and the volunteers won’t be aware of brand of administered vaccine, since in ICF aim of study has been mentioned, volunteers know that they will be randomly assigned in one of study vaccine groups and neither involved persons in the study nor volunteers are aware of type of administered vaccine. Randomization won’t be disclosed to people who conduct the trial and the information in a sealed envelope with continue number will be given to them.