Papillomavirus Infections
Conditions
Brief summary
Researchers want to learn if V503 (also called the 9-valent human papillomavirus \[9vHPV\] vaccine, recombinant) can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Chinese females who previously received the bivalent HPV (2vHPV) vaccine. The 9vHPV vaccine protects against diseases caused by 9 types of HPV (6, 11, 16, 18, 31, 33, 45, 52, and 58) and the 2vHPV vaccine protects against diseases caused by 2 types of HPV (16 and 18). The goals of the trial are to learn: * If the 9vHPV vaccine can induce an immune response to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in participants who received the 2vHPV vaccine * About the safety of the 9vHPV vaccine in prior 2vHPV vaccine recipients
Interventions
BIOLOGICALV503
V503 (9-vHPV vaccine \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\]) administered as a 0.5-mL intramuscular (IM) injection on Day 1, Month 2, and Month 6
BIOLOGICALPlacebo
Saline administered as a 0.5-mL IM injection on Day 1, Month 2, and Month 6
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * For participants to be enrolled in prior 2vHPV (bivalent human papillomavirus \[HPV\] vaccine) vaccine groups: has received at least one dose of any one of the three currently marketed 2vHPV vaccines, with the last dose administered at least one year prior to Day 1. * For participants to be enrolled in HPV vaccine naïve groups: has never received any HPV vaccine.
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experience at Least 1 Solicited Systemic AE | Up to approximately Day 8 post any vaccination | 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. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants who experience 1 or more systemic AE will be reported. |
| Percentage of Participants Who Are Seropositive by Competitive Luminex Immunoassay (cLIA) to HPV Types 6, 11, 31, 33, 45, 52, and 58 (Month 7) | Up to approximately 1 month post vaccination 3 (Up to approximately Month 7) | The percentage of participants who are seropositive for HPV types 6, 11, 31, 33, 45, 52, and 58 in the Prior 2vHPV Vaccine Recipients Receiving V503 group will be determined using cLIA. Seropositivity is defined as having a titer at or above the prespecified seropositivity cutoff for a given HPV type. |
| Percentage of Participants Who Experience at Least 1 Solicited Injection-site Adverse Event (AE) | Up to approximately Day 8 post any vaccination | 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. AEs such as redness/erythema, swelling, pain, and induration at the injection site are recorded. The percentage of participants who experience 1 or more injection-site AE will be reported. |
| Percentage of Participants Who Experience at Least 1 Serious AE (SAE) | Up to approximately Month 12 | 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. An SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The percentage of participants who experience 1 or more SAEs will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Percentage of Participants Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Between Prior 2vHPV Vaccine Recipients and HPV Vaccine-Naïve Participants | Up to approximately 1 month post vaccination (Up to approximately 7 months) | The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be determined using cLIA. Seropositivity is defined as having a titer at or above the prespecified seropositivity cutoff for a given HPV type. The difference in seropositivity percentages between participants who previously received a 2vHPV vaccine and subsequently receive V503 and participants who were HPV vaccine-naïve and receive V503 will be evaluated. |
| Percentage of Participants Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Up to approximately 1 month post vaccination (Up to approximately 7 months) | The percentage of participants who are seropositive for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be determined using cLIA. Seropositivity is defined as having a titer at or above the prespecified seropositivity cutoff for a given HPV type. |
| cLIA Geometric Mean Titers (GMTs) for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | Up to approximately 1 month post vaccination (Up to approximately 7 months) | Antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 will be measured using a cLIA. Antibody titers will be expressed as milli Merck Units/milliliter (mMU/mL). |
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed