A Phase 1 interventional study of Placebo among 18-45 yrs and Placebo among 9-17 yrs in Penile Cancer, Anal Cancer and PIN-1, sponsored by Shanghai Bovax Biotechnology Co., Ltd.. Completed at 1 site in China. Open to male participants aged 9 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Shanghai Bovax Biotechnology Co., Ltd. · Phase 1, Interventional, and Prevention
To evaluate the safety and tolerability of the 9vHPV vaccine in Chinese healthy male aged 9 to 45 years.
99 studies on the registry are indexed under Penile Neoplasms; 28 are open to participants now.
This study's enrollment of 90 is above the median of 37 across 81 interventional studies indexed under Penile Neoplasms.
Browse Penile Neoplasms studies →Shanghai Bovax Biotechnology Co., Ltd. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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 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.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule (0.5mL/each dose).
Biological: Placebo among 18-45 yrs
Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule (0.5mL/each dose).
Biological: Placebo among 9-17 yrs
Subjects received 3 doses of placebo according to a 0, 2, 6-month schedule (0.5mL/each dose).
Subjects received 3 doses of placebo according to a 0, 2, 6-month schedule (0.5mL/each dose).
Number of subjects with Adverse Events (AEs)
Subjects with solicited and unsolicited AEs
Time frame: From Day 0 to Month 7
Number of subjects with Severe adverse events (SAE)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: From Day 0 to Month 12
Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by Geometric mean titer (GMT)
Immunogenicity were assessed by the GMT of anti HPV6/11/16/18/33/45/52/58 neutralizing antibodies after day 31 post last dose, among the subjects who were aged 9-45
Time frame: day 31 post last dose
Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by seroconversion rate
Immunogenicity were assessed by the seroconversion rate of anti HPV6/11/16/18/33/45/52/58 neutralizing antibodies after day 31 post last dose, among the subjects who were aged 9-45 and seronegative before vaccination
Time frame: day 31 post last dose
Number of subjects receiving the 3-doses scheduled vaccination with antibody responses as assessed by IgG antibody GMT and seroconversion rate
Immunogenicity were assessed by the seroconversion rate and GMT of anti HPV6/11/16/18/33/45/52/58 IgG antibodies after day 31 post last dose, among the subjects who were aged 9-45 and seronegative before vaccination
Time frame: day 31 post last dose
The immunogenicity of subjects receiving 3 doses of vaccination was assessed by IgG antibodies and neutralizing antibodies
Immunogenicity were assessed by the seroconversion rate and GMT (4-fold increase rate) of anti HPV6/11/16/18/33/45/52/58 IgG and neutralizing antibodies after day 31 post last dose, among the subjects who were aged 9-45 and seropositive before vaccination
Time frame: day 31 post last dose
Ran from Sep 2022 to primary completion in Nov 2023, 13 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Shanghai Bovax Biotechnology Co., Ltd.