Papillomavirus Infections
Conditions
Brief summary
This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is well tolerated and causes a non-inferior immune response when compared to administration of REPEVAX™ one month following the first dose of V503.
Interventions
BIOLOGICALV503 Vaccine
V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
BIOLOGICALREPEVAX™ (Concomitant)
REPEVAX™ given as a single 0.5 mL intramuscular injection at Day 1
BIOLOGICALREPEVAX™ (Non-concomitant)
REPEVAX™ given as a single 0.5 mL intramuscular injection at Month 1
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant is in good health * Participant's parent/legal guardian can read, understand, and complete the vaccination report card * Participant is not sexually active and does not plan on becoming sexually active during the study * Participant has received a documented full primary immunization series against diphtheria, tetanus, pertussis, and poliovirus (inactivated and/or oral poliovirus), but not in the last 5 years. There must be a 5-year interval from a prior vaccination containing any one of these vaccine antigens.
Exclusion criteria
* Participant has a known allergy to any vaccine component of V503 or REPEVAX™ * Participant has had a severe reaction affecting the brain (e.g., evolving encephalopathy) within 7 days after a previous dose of a pertussis-containing vaccine * Participant has had a progressive severe illness affecting the brain after a previous dose of tetanus, diphtheria, poliovirus or a component pertussis combination (acellular and whole cell) vaccine * Participant ever had Guillain-Barré syndrome or brachial neuritis following a previous dose of a tetanus-containing vaccine * Participant has a condition that is a contraindication to vaccination as indicated in the most up to date package inserts of REPEVAX™ * Participant has a history of severe allergic reaction that required medical intervention * Participant has hemophilia, thrombocytopenia, is receiving anticoagulation therapy and/or has any coagulation disorder that would contraindicate intramuscular injections * Participant is concurrently enrolled in clinical studies of investigational agents * Female participant is pregnant * Participant has donated blood within 1 week prior to first study vaccination, or intends to donate during the study * Participant is immunocompromised, immunodeficient, or has an autoimmune condition * Participant has had a splenectomy * Participant has received immunosuppressive therapies in the prior year * Participant has received immune globulin product or blood-derived product in the last 3 months * Participant has received inactivated vaccine(s) within 14 days or live vaccine(s) within 21 days of first study vaccination * Participant has received a marketed HPV vaccine or has participated in an HPV vaccine trial * Participant has received a tetanus, diphtheria, pertussis, or poliovirus (inactivated and/or oral poliovirus) vaccination within the last 5 years * Participant has a fever ≥100°F within 24 hours of vaccination * Participant has any history or current condition, therapy, lab abnormality, or other circumstance such that it is not in the best interest of the participant to participate * Participant and parent/legal guardian are unable to give assent/consent * Participant is unlikely to adhere to the study procedures or is planning to relocate during the study * Participant has recent history of illicit drug or alcohol abuse * Participant has a history of HPV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody | 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination | For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to poliovirus type 1, 2, and 3 were measured using a microneutralization assay. Serial dilutions of sera were incubated with type-specific standard poliovirus and sensitive cells. Neutralization of the virus was measured by cell staining. Acceptable titers were defined as neutralization at \>=1:8 dilution of serum. |
| Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | 4 weeks following Month 6 vaccination | Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL. |
| Percentage of Participants With a V503 Injection-site Adverse Experience | Day 1 through Day 5 following Day 1 vaccination | 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 vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint. |
| Percentage of Participants With a Repevax™ Injection-site Adverse Experience | Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination | For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 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 vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received Repevax™ vaccination were reported for this endpoint. |
| Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent) | Up to 5 days following the Day 1 and Month 1 vaccination / visit | For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination. |
| Percentage of Participants With a Systemic Adverse Experience | Up to 15 days following the Day 1 and Month 1 vaccination / visit | For the Concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an adverse experience. A systemic AE was an AE that was not associated with the injection site. |
| Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody | 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination | For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limits of quantitation of the assays was 0.01 International Units (IU)/mL and 0.04 IU/mL, respectively. Acceptable titers refer to the World Health Organization-defined protective titer of \>=0.1 IU/mL. |
| Geometric Mean Titers of Pertussis Antibody Responses | 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination | For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. Titers are expressed as enzyme-linked immunoassay units/mL (ELU/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Seroconvert for Each of the HPV Types | Month 7 | Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: \>=30, HPV Type 11: \>=16; HPV Type 16: \>=20, HPV Type 18: \>=24, HPV Type 31: \>=10, HPV Type 33: \>=8, HPV Type 45: \>=8, HPV Type 52: \>=8, and HPV Type 58: \>=8. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Concomitant Vaccination V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1 | 526 |
| Non-concomitant Vaccination V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1 | 528 |
| Total | 1,054 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 10 |
Baseline characteristics
| Characteristic | Concomitant Vaccination | Non-concomitant Vaccination | Total |
|---|---|---|---|
| Age, Continuous | 12.4 Years STANDARD_DEVIATION 1.2 | 12.4 Years STANDARD_DEVIATION 1.2 | 12.4 Years STANDARD_DEVIATION 1.2 |
| Sex: Female, Male Female | 264 Participants | 264 Participants | 528 Participants |
| Sex: Female, Male Male | 262 Participants | 264 Participants | 526 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 509 / 525 | 505 / 527 |
| serious Total, serious adverse events | 9 / 525 | 7 / 527 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503
Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.
Time frame: 4 weeks following Month 6 vaccination
Population: The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV18: n=486, 475 | 1854.1 milli Merck Units/mL |
| Concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 6: n=477, 461 | 1637.9 milli Merck Units/mL |
| Concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 11: n=479, 462 | 1170.3 milli Merck Units/mL |
| Concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 16: n=489, 479 | 6529.4 milli Merck Units/mL |
| Concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 31: n=485, 473 | 1646.2 milli Merck Units/mL |
| Concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 33: n=487, 478 | 823.8 milli Merck Units/mL |
| Concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 45: n=489, 478 | 658.2 milli Merck Units/mL |
| Concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 52: n=490, 479 | 965.4 milli Merck Units/mL |
| Concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 58: n=484, 469 | 1188.8 milli Merck Units/mL |
| Non-concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 52: n=490, 479 | 1015.3 milli Merck Units/mL |
| Non-concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 45: n=489, 478 | 675.6 milli Merck Units/mL |
| Non-concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 31: n=485, 473 | 1750.6 milli Merck Units/mL |
| Non-concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 6: n=477, 461 | 1725.0 milli Merck Units/mL |
| Non-concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 58: n=484, 469 | 1334.8 milli Merck Units/mL |
| Non-concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 11: n=479, 462 | 1212.6 milli Merck Units/mL |
| Non-concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 33: n=487, 478 | 915.5 milli Merck Units/mL |
| Non-concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV 16: n=489, 479 | 6940.6 milli Merck Units/mL |
| Non-concomitant Vaccination | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Anti-HPV18: n=486, 475 | 1954.8 milli Merck Units/mL |
Comparison: Anti-HPV 6p-value: <0.00195% CI: [0.86, 1.05]ANOVA
Comparison: Anti-HPV 11p-value: <0.00195% CI: [0.87, 1.07]ANOVA
Comparison: Anti-HPV 16p-value: <0.00195% CI: [0.85, 1.04]ANOVA
Comparison: Anti-HPV 18p-value: <0.00195% CI: [0.84, 1.07]ANOVA
Comparison: Anti-HPV 31p-value: <0.00195% CI: [0.84, 1.06]ANOVA
Comparison: Anti-HPV 33p-value: <0.00195% CI: [0.81, 1]ANOVA
Comparison: Anti-HPV 45p-value: <0.00195% CI: [0.86, 1.11]ANOVA
Comparison: Anti-HPV 52p-value: <0.00195% CI: [0.85, 1.06]ANOVA
Comparison: Anti-HPV 58p-value: <0.00195% CI: [0.8, 0.99]ANOVA
Primary
Geometric Mean Titers of Pertussis Antibody Responses
For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. Titers are expressed as enzyme-linked immunoassay units/mL (ELU/mL).
Time frame: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
Population: The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Concomitant Vaccination | Geometric Mean Titers of Pertussis Antibody Responses | Anti-PT: n=505, 473 | 41.5 ELU/mL |
| Concomitant Vaccination | Geometric Mean Titers of Pertussis Antibody Responses | Anti-FIM 2/3: n=505, 474 | 378.2 ELU/mL |
| Concomitant Vaccination | Geometric Mean Titers of Pertussis Antibody Responses | Anti-FHA: n=505, 474 | 188.1 ELU/mL |
| Concomitant Vaccination | Geometric Mean Titers of Pertussis Antibody Responses | Anti-PRN: n=505, 474 | 372.9 ELU/mL |
| Non-concomitant Vaccination | Geometric Mean Titers of Pertussis Antibody Responses | Anti-PRN: n=505, 474 | 398.2 ELU/mL |
| Non-concomitant Vaccination | Geometric Mean Titers of Pertussis Antibody Responses | Anti-FHA: n=505, 474 | 190.6 ELU/mL |
| Non-concomitant Vaccination | Geometric Mean Titers of Pertussis Antibody Responses | Anti-FIM 2/3: n=505, 474 | 423.6 ELU/mL |
| Non-concomitant Vaccination | Geometric Mean Titers of Pertussis Antibody Responses | Anti-PT: n=505, 473 | 43.8 ELU/mL |
Comparison: Anti-PTp-value: <0.00195% CI: [0.85, 1.06]ANOVA
Comparison: Anti-FHAp-value: <0.00195% CI: [0.9, 1.08]ANOVA
Comparison: Anti-PRNp-value: <0.00195% CI: [0.8, 1.09]ANOVA
Comparison: Anti-FIM 2/3p-value: 0.00595% CI: [0.72, 1.11]ANOVA
Primary
Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody
For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limits of quantitation of the assays was 0.01 International Units (IU)/mL and 0.04 IU/mL, respectively. Acceptable titers refer to the World Health Organization-defined protective titer of \>=0.1 IU/mL.
Time frame: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
Population: The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Vaccination | Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody | Anti-diphtheria titer >=0.1 IU/mL: n=505, 474 | 99.8 Percentage of participants |
| Concomitant Vaccination | Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody | Anti-tetanus titer >=0.1 IU/mL: n=504, 472 | 99.6 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody | Anti-tetanus titer >=0.1 IU/mL: n=504, 472 | 99.6 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody | Anti-diphtheria titer >=0.1 IU/mL: n=505, 474 | 99.6 Percentage of participants |
Comparison: Anti-diphtheria titer \>=0.1 IU/mLp-value: <0.00195% CI: [-0.7, 1.4]Miettinen and Nurminen
Comparison: Anti-tetanus titer \>=0.1 IU/mLp-value: <0.00195% CI: [-1.1, 1.2]Miettinen and Nurminen
Primary
Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody
For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to poliovirus type 1, 2, and 3 were measured using a microneutralization assay. Serial dilutions of sera were incubated with type-specific standard poliovirus and sensitive cells. Neutralization of the virus was measured by cell staining. Acceptable titers were defined as neutralization at \>=1:8 dilution of serum.
Time frame: 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
Population: The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Vaccination | Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody | Poliovirus type 1: n=505, 474 | 99.6 Percentage of participants |
| Concomitant Vaccination | Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody | Poliovirus type 2: n=505, 474 | 99.6 Percentage of participants |
| Concomitant Vaccination | Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody | Poliovirus type 3: n=505, 474 | 100 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody | Poliovirus type 2: n=505, 474 | 99.8 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody | Poliovirus type 1: n=505, 474 | 99.8 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody | Poliovirus type 3: n=505, 474 | 100 Percentage of participants |
Comparison: Poliovirus type 1p-value: <0.00195% CI: [-1.2, 0.8]Miettinen and Nurminen
Comparison: Poliovirus type 2p-value: <0.00195% CI: [-1.2, 0.8]Miettinen and Nurminen
Comparison: Poliovirus type 3p-value: <0.00195% CI: [-0.8, 0.8]Miettinen and Nurminen
Primary
Percentage of Participants With a Repevax™ Injection-site Adverse Experience
For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 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 vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received Repevax™ vaccination were reported for this endpoint.
Time frame: Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination
Population: The population analyzed included all vaccinated participants with follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Vaccination | Percentage of Participants With a Repevax™ Injection-site Adverse Experience | 88.0 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants With a Repevax™ Injection-site Adverse Experience | 84.6 Percentage of participants |
Primary
Percentage of Participants With a Systemic Adverse Experience
For the Concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an adverse experience. A systemic AE was an AE that was not associated with the injection site.
Time frame: Up to 15 days following the Day 1 and Month 1 vaccination / visit
Population: The population analyzed included all vaccinated participants with follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Vaccination | Percentage of Participants With a Systemic Adverse Experience | 48.6 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants With a Systemic Adverse Experience | 48.6 Percentage of participants |
Primary
Percentage of Participants With a V503 Injection-site Adverse Experience
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 vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint.
Time frame: Day 1 through Day 5 following Day 1 vaccination
Population: The population analyzed included all vaccinated participants with follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Vaccination | Percentage of Participants With a V503 Injection-site Adverse Experience | 63.4 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants With a V503 Injection-site Adverse Experience | 62.8 Percentage of participants |
Primary
Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)
For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination.
Time frame: Up to 5 days following the Day 1 and Month 1 vaccination / visit
Population: The population analyzed included all vaccinated participants with follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Concomitant Vaccination | Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent) | 8.8 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent) | 8.4 Percentage of participants |
Secondary
Percentage of Participants Who Seroconvert for Each of the HPV Types
Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: \>=30, HPV Type 11: \>=16; HPV Type 16: \>=20, HPV Type 18: \>=24, HPV Type 31: \>=10, HPV Type 33: \>=8, HPV Type 45: \>=8, HPV Type 52: \>=8, and HPV Type 58: \>=8.
Time frame: Month 7
Population: The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 31: n=485, 473 | 100.0 Percentage of participants |
| Concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 18: n=486, 475 | 100.0 Percentage of participants |
| Concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 33: n=487, 478 | 100.0 Percentage of participants |
| Concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 11: n=479, 462 | 100.0 Percentage of participants |
| Concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 45: n=489, 478 | 100.0 Percentage of participants |
| Concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 52: n=490, 479 | 100.0 Percentage of participants |
| Concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 16: n=489, 479 | 100.0 Percentage of participants |
| Concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 58: n=484, 469 | 100.0 Percentage of participants |
| Concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 6: n=477, 461 | 99.8 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 58: n=484, 469 | 100.0 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 6: n=477, 461 | 100.0 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 18: n=486, 475 | 100.0 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 45: n=489, 478 | 100.0 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 11: n=479, 462 | 100.0 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 16: n=489, 479 | 100.0 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 31: n=485, 473 | 100.0 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 33: n=487, 478 | 100.0 Percentage of participants |
| Non-concomitant Vaccination | Percentage of Participants Who Seroconvert for Each of the HPV Types | Anti-HPV 52: n=490, 479 | 100.0 Percentage of participants |