A Phase 2 interventional study of Medium dose for 15-HPV vaccine and High dose for 15-HPV vaccine in HPV Infection, HPV-Related Carcinoma and HPV-Related Intraepithelial Neoplasia, sponsored by Shanghai Bovax Biotechnology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 9 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Shanghai Bovax Biotechnology Co., Ltd. · Phase 2, Interventional, and Prevention
To evaluate the safety and Immunogenicity of 15-valent HPV vaccine in 9-45year-old participants.
A Randomized, double-blind, placebo and positive controlled trial is planned in 330 healthy participants across two age groups (18-45 years and 9-17 years) to evaluate the safety and immunogenicity of the 15-valent HPV vaccine.
116 studies on the registry are indexed under Condylomata Acuminata; 11 are open to participants now.
This study's planned enrollment of 330 is above the median of 158 across 95 interventional studies indexed under Condylomata Acuminata.
Browse Condylomata Acuminata studies →Shanghai Bovax Biotechnology Co., Ltd. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Compared within Condylomata Acuminata, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Papillomavirus Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants aged 9-45 years were given 3 doses of medium dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
Biological: Medium dose for 15-HPV vaccine
Participants aged 9-45 years were given 3 doses of high dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
Biological: High dose for 15-HPV vaccine
Participants aged 9-45 years were given 3 doses of placebo intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
Biological: Placebo
Participants aged 18-45 years were given 3 doses of 9-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
Biological: 9-HPV vaccine
Participants aged 9-45 years were given 3 doses of medium dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
Participants aged 9-45 years were given 3 doses of high dose 15-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
Participants aged 9-45 years were given 3 doses of placebo intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
Participants aged 9-45 years were given 3 doses of 9-HPV vaccine intramuscular into the upper arm deltoid muscle according to 0, 2, and 6 months immunization schedule
Percentage of Participants With Adverse Events
AE of local and systemic reactions within 30 minutes after each dose
Time frame: Up to 30 minutes after any vaccination
Percentage of Participants With Solicited Adverse Events
The percentage of participants with one or more solicited AEs was assessed.
Time frame: Up to 14 days after any vaccination
Percentage of Participants With Unsolicited Adverse Events
Percentage of Participants With Unsolicited Adverse Events
Time frame: Up to 30 days after any vaccination
Percentage of Participants With Serious Adverse Events
The percentage of participants with one or more SAEs was assessed
Time frame: From Day 0 after the first dose of vaccination to 6 months after the thrid dose
Percentage of Female Participants With Pregnancy Events
The percentage of participants with Pregnancy Events was assessed
Time frame: From Day 0 after the first dose of vaccination to 6 months after the thrid dose
Immunogenicity after receiving 3 doses of 15-HPV vaccine
Geometric mean titer (GMT) of anti-vaccine containing corresponding type of neutralizing antibody in subjects aged 18-45 years on the 31-day after the third dose of immunization
Time frame: Up to 31 days after the third vaccination
Immunogenicity of 15-HPV vaccine
Seroconversion rate (SCR)of the anti-vaccine containing the corresponding type of neutralizing antibody on day 31 after total immunization in subjects aged 18-45 years
Time frame: Up to 31 days after the third vaccination
Immunogenicity after receiving 3 doses of 15-HPV vaccine among the participants
Geometric Mean Fold Increase (GMI) and 4-fold increase rates of anti-vaccine corresponding types of neutralizing antibodies in baseline seropositive subjects aged 18-45 years at day 31 after immunization
Time frame: Up to 31 days after the third vaccination
Plan to share: No
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Shanghai Bovax Biotechnology Co., Ltd.