Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
9vHPV Vaccine · 9 trials · 10 indications
cLIA GMT to each of 9 vaccine types of 9vHPV vaccine. The GMT for each HPV type will be reported in mMU/mL.
cLIA GMT to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The GMT for each HPV type will be reported in mMU/mL.
cLIA seropositivity to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The percentage of participants who are seropositive for each HPV type will be summarized.
cLIA GMT to each of 9 vaccine types of 9vHPV vaccine at one month post last dose. The GMT for each HPV type will be reported in mMU/mL.
cLIA GMT to each of 9 vaccine types of 9vHPV vaccine at up to 60 months post last dose. The GMT for each HPV type will be reported in mMU/mL.
cLIA seropositivity to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized.
Antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured using a competitive Luminex immunoassay (cLIA). Per protocol, antibody titers were expressed as milli Merck units/milliliter (mMU/mL). Geometric Mean Titers (GMTs) are reported for both arms for all randomized participants included in the per-protocol immunogenicity (PPI) population. The PPI population is HPV-type specific.
The geometric mean concentration (GMC) of serum-derived antibodies to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike protein was determined using an electrochemiluminescence (ECL) assay. GMCs are reported for both arms for all randomized participants included in the mRNA-1273 per-protocol (mRNA-1273-PP) population.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited AEs are predefined local AEs (at the injection site) for which the participant was specifically questioned, and noted by the participant in their vaccine report card (VRC). Per protocol, the percentage of participants with ≥1 solicited injection site AE has been reported separately based on injection site for participants in the Concomitant Group (Day 1 mRNA-1273 Dose 1 right arm; Day 1 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Group (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting for Concomitant Group Day 1 Dose 1 separated by injection site is specific to this outcome only and does not apply to other safety outcomes.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited AEs are predefined systemic events for which the participant is specifically questioned, and which are noted by the participant in their VRC. Per protocol the percentage of participants who experienced ≥1 solicited systemic (affecting the whole body) AE are reported here for participants in the Concomitant (Day 1 mRNA-1273 Dose 1 right arm + 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Groups (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group they have been combined below.
A serious adverse event (SAE) was defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. Per protocol the percentage of participants who experienced ≥1 SAE are reported here for participants in the Concomitant (Day 1 mRNA-1273 Dose 1 right arm + 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Groups (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group they have been combined below.
A SAE was defined as one that results in death, is life threatening, or requires hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect, or other important medical event that may require medical intervention. An SAE judged by the investigator to be related to the study vaccine is a vaccine-related SAE. Per protocol the percentage of participants who experienced ≥1 vaccine-related SAE are reported here for participants in Concomitant (Day 1 mRNA-1273 Dose 1 right arm + 9vHPV Dose 1 left arm; Month 1 mRNA-1273 Dose 2 right arm; Month 6 9vHPV Dose 2 left arm) and Non-Concomitant Groups (Day 1 mRNA-1273 Dose 1 right arm; Month 1 mRNA-1273 Dose 2 right arm; Month 2 9vHPV Dose 1 left arm; Month 8 9vHPV Dose 2 left arm). Per protocol, reporting is based on time of injection; as 9vHPV Dose 1 AND mRNA-1273 Dose 1 were both given on Day 1 of the Concomitant Group they have been combined below.
This endpoint is defined as having occurred if a participant is positive for the same HPV type by the HPV PCR assay in the penile, scrotum, perineal, perianal and intra-anal swabs, biopsy, or excised samples obtained in 3 or more consecutive visits over a period of at least 12 months.
This endpoint is defined as having occurred if on a single biopsy or excised tissue from a participant, there is: (a) a pathology panel consensus diagnosis of genital warts, PIN of any grade, or penile/perianal/perineal cancer; and (b) detection of at least 1 of HPV types 6, 11, 16, 18, 31, 33, 45, 52 or 58 by Thinsection PCR in an adjacent section from the same tissue block.
The percentage of seropositive participants is reported. Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined using competitive Luminex Immunoassay (cLIA). Seroconversion was defined as changing serostatus from seronegative at Day 1 to seropositive at 4 weeks post last vaccination.
The number of participants with injection-site AEs (erythema/redness, pain and swelling) is reported. An AE any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
The number of participants with a systemic AE is reported. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
The number of participants with an SAE is reported. An SAE is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention.
Serum antibody titers for human papilloma virus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using competitive luminex immunoassay (cLIA). The geometric mean titer (GMT) for each HPV type will be reported in milli Merck units/mL (mMU/mL).
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with injection-site AEs (erythema/redness, pain and swelling) will be assessed.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with a systemic AE will be assessed.
A serious adverse event (SAE) is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. An SAE that is judged by the investigator to be related to the study vaccine is defined as a vaccine-related SAE.
A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same HPV type by the HPV polymerase chain reaction (PCR) assay to at least 1 common gene in Oral Rinse and Gargle (ORG) samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart.
Seroconversion was defined as a participant who was anti-HPV seronegative at Day 1 and became seropositive at 4 weeks postdose 3 (Month 7). Anti-HPV antibodies were measured using a Competitive Luminex Immunoassay.
Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.
Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.
| Arm | Type | Description |
|---|---|---|
| 9 to 14 Years Old: Day 1 and Month 6 | EXPERIMENTAL | Chinese females 9 to 14 years old will receive a 0.5 mL intramuscular (IM) injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 6 |
| 9 to 14 Years Old: Day 1 and Month 12 | EXPERIMENTAL | Chinese females 9 to 14 years old will receive a 0.5 mL iIM injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 12 |
| 20 to 26 Years Old: Day 1, Month 2 and Month 6 | EXPERIMENTAL | Chinese females 20 to 26 years old will receive a 0.5 mL IM injection of 9-valent HPV (9vHPV) vaccine on Day 1, Month 2 and Month 6 |
| 9 to 19 Years Old: Day 1, Months 2 and 6 | EXPERIMENTAL | Chinese males 9 to 19 years old will receive a 0.5 mL intramuscular (IM) injection of 9-valent HPV (9vHPV) vaccine on Day 1, Month 2 and Month 6 |
| 9 to 14 Years Old: Day 1, and Month 6 | EXPERIMENTAL | Chinese males 9 to 14 years old will receive a 0.5 mL IM injection of 9vHPV vaccine on Day 1 and Month 6 |
| Concomitant Group | EXPERIMENTAL | Participants will receive Dose 1 of 9-valent human papillomavirus \[Types 6, 11, 16, 18, 31, 33, 45, 52, 58\] (9vHPV) vaccine administered into the left arm as an intramuscular (IM) injection, AND Dose 1 of the messenger ribonucleic acid (mRNA)-1273 vaccine administered into the right arm as an IM injection on Day 1; participants will then receive Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 6. |
| Non-concomitant Group | EXPERIMENTAL | Participants will receive Dose 1 of the mRNA-1273 vaccine administered into the right arm as an IM injection on Day 1 and Dose 2 of the mRNA-1273 vaccine administered into the right arm as an IM injection at Month 1. Participants will then receive Dose 1 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 2 and Dose 2 of the 9vHPV vaccine administered into the left arm as an IM injection at Month 8. |
| V503 | EXPERIMENTAL | Participants will receive a single 0.5 mL intramuscular (IM) injection of V503 at Day 1, Month 2, and Month 6. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single 0.5 mL IM injection of placebo at Day 1, Month 2, and Month 6. |
| 3-dose in 9 to 15 year old boys | EXPERIMENTAL | 9 to 15 year old boys will receive a 3-dose regimen of 9vHPV vaccine (Day 1, Month 2 and Month 6). |
| 2-dose in 9 to 14 year old boys | EXPERIMENTAL | 9 to 14 year old boys receive a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6). |
| 2-dose in 9 to 14 year old girls | EXPERIMENTAL | 9 to 14 year old girls receive a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6). |
| Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients) | EXPERIMENTAL | 10 to 15 year old girls and boys (who previously received 1 dose of 9vHPV vaccine) receive a second dose of 9vHPV vaccine at Day 1. |
| Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months Apart | EXPERIMENTAL | 9 to 14 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 12. |
| Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months Apart | EXPERIMENTAL | 9 to 13 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Months 24. |
| Cohort 3: 2 Doses of 9vHPV Vaccine Given 36 Months Apart | EXPERIMENTAL | 9 to 12 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 36. |
| Cohort 4: 2 Doses of 9vHPV Vaccine Given 60 Months Apart | EXPERIMENTAL | 9 to 10 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 60. |
| Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month Period | ACTIVE_COMPARATOR | 16 to 26 year old young women receive 3 dose regimen of 9vHPV vaccine at Day 1, Month 2 and Month 6. |
| 9vHPV vaccine | EXPERIMENTAL | Single 0.5-mL intramuscular injection at Day 1, Month 2, and Month 6 |
| Females | ACTIVE_COMPARATOR | Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 |
| Heterosexual Males | EXPERIMENTAL | Healthy heterosexual males 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 |
| Men who have Sex with Men | EXPERIMENTAL | Healthy MSM 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6 |
| Name | Type | Description |
|---|---|---|
| 9vHPV vaccine | BIOLOGICAL | A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection. |
| mRNA-1273 Vaccine | BIOLOGICAL | mRNA-1273 50 mcg dose administered as a 0.25-mL IM injection |
| Placebo | OTHER | Sterile saline solution administered as a 0.5 mL IM injection |
| Placebo (Saline for Injection) | OTHER | 0.9% sodium chloride given as a 0.5-mL intramuscular injection |
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Is a healthy Chinese female. * Is not a woman of childbearing potential (WOCBP); or is a WOCBP who has not had sex with males or has had sex with males and used effective contraception dur...
9vHPV Vaccine is a 9-valent human papillomavirus vaccine being developed for the prevention of genital warts and papillomavirus infections. It is currently in Phase 3 clinical trials, with studies evaluating its efficacy and safety in both men and women across various age groups.
9vHPV Vaccine is developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The vaccine is currently in Phase 3 clinical development for the prevention of genital warts and papillomavirus infections.
9vHPV Vaccine is in Phase 3 clinical development. It is an investigational vaccine, not yet approved by regulatory authorities. Multiple Phase 3 trials are ongoing or completed, evaluating its immunogenicity, efficacy, and safety in diverse populations, including men and women of various ages.
9vHPV Vaccine is being studied in several Phase 3 trials, including NCT01651949 in men and women aged 16-26, NCT04199689 in men aged 20-45, NCT05314023 in Chinese males aged 9-19, and NCT05450705 in Chinese girls aged 9-14. These trials assess efficacy against genital warts and papillomavirus infections.
9vHPV Vaccine is a 9-valent human papillomavirus vaccine developed by Merck. While it is commonly known by its brand name Gardasil 9, the clinical trials referenced here use the investigational name 9vHPV Vaccine. The vaccine targets nine HPV types to prevent related infections and diseases.