Cervical Cancer, Genital Warts, Human Papilloma Virus, Vaginal Cancer, Vulvar Cancer
Conditions
Brief summary
This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s) of IMX for further studies of the octavalent HPV L1 VLP vaccine.
Detailed description
The study was performed in 2 staggered phases, Phase A and Phase B. In Phase A, participants were randomized to qHPV, Octavalent HPV with 15 mcg IMX/AAHS, or Octavalent HPV with 30 mcg IMX/AAHS. After the safety for Phase A was reviewed, Phase B was initiated. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.
Interventions
BIOLOGICALOctavalent HPV with 15 mcg IMX / AAHS
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
BIOLOGICALOctavalent HPV with 30 mcg IMX / AAHS
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
BIOLOGICALOctavalent HPV with 60 mcg IMX / AAHS
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
BIOLOGICALOctavalent HPV with 120 mcg IMX / AAHS
0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
BIOLOGICALComparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
0.5-mL intramuscular injection administered at 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
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant is in good physical health * Participant has had a lifetime history of 0 to 4 sexual partners * Females between 18-to-24 years
Exclusion criteria
* Participant has a history of abnormal Pap test * Participant has a history of positive test for HPV * Participant has a history of recent or ongoing alcohol or drug abuse * Participant is immunocompromised or has an autoimmune condition * Participant has received immunosuppressive therapy within a year of screening * Participant has previously received an HPV vaccine * Participant is pregnant * Participant has a history of external genital/vaginal warts * Participant is currently enrolled in a clinical trial * Participant has a history of a severe allergic reaction that required medical attention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | 4 weeks postdose 3 (Phase A) | The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent. |
| Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | 4 weeks postdose 3 (Phase B) | The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent. |
| Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | 4 weeks postdose 3 (Phase A) | A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively. |
| Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | 4 weeks postdose 3 (Phase B) | A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively. |
Participant flow
Recruitment details
158 participants were enrolled. Of the enrolled 158 participants, 8 were screening failures. 150 participants were randomized to the base study (up to 12 months), conducted in 2 phases, Phase A and Phase B. Some participants continued in a voluntary, long-term extension of the study (up to 36 months).
Pre-assignment details
In Phase A, participants were randomized to quadrivalent Human Papillomavirus (qHPV), Octavalent HPV with 15 mcg ISCOMATRIX™ (IMX) / Aluminum Hydroxyphosphate Sulfate (AAHS), or Octavalent HPV with 30 mcg IMX/AAHS. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.
Participants by arm
| Arm | Count |
|---|---|
| qHPV (GARDASIL™) - Phase A Control Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. | 15 |
| Octavalent HPV With 15 mcg IMX / AAHS Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate(AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. | 30 |
| Octavalent HPV With 30 mcg IMX / AAHS Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. | 30 |
| qHPV (GARDASIL™) - Phase B Control Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. | 15 |
| Octavalent HPV With 60 mcg IMX / AAHS Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. | 30 |
| Octavalent HPV With 120 mcg IMX / AAHS Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. | 30 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Base Study (Up to 12 Months) | Other | 0 | 0 | 0 | 0 | 0 | 1 |
| Base Study (Up to 12 Months) | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 |
| Extension Study (Up to 36 Months) | Lost to Follow-up | 4 | 2 | 4 | 1 | 2 | 0 |
| Extension Study (Up to 36 Months) | Moved | 0 | 2 | 1 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | qHPV (GARDASIL™) - Phase A Control | Octavalent HPV With 15 mcg IMX / AAHS | Octavalent HPV With 30 mcg IMX / AAHS | qHPV (GARDASIL™) - Phase B Control | Octavalent HPV With 60 mcg IMX / AAHS | Octavalent HPV With 120 mcg IMX / AAHS | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 20.3 years STANDARD_DEVIATION 1.6 | 20.8 years STANDARD_DEVIATION 1.8 | 20.2 years STANDARD_DEVIATION 1.5 | 19.9 years STANDARD_DEVIATION 1.6 | 20.5 years STANDARD_DEVIATION 1.8 | 20.8 years STANDARD_DEVIATION 2 | 20.5 years STANDARD_DEVIATION 1.7 |
| Region of Enrollment Australia | 15 participants | 30 participants | 30 participants | 15 participants | 30 participants | 30 participants | 150 participants |
| Sex: Female, Male Female | 15 Participants | 30 Participants | 30 Participants | 15 Participants | 30 Participants | 30 Participants | 150 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 30 / 30 | 30 / 30 | 30 / 30 | 30 / 30 | 30 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
Time frame: 4 weeks postdose 3 (Phase A)
Population: Per Protocol Immunogenicity (PPI) population: participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 for the relevant HPV type(s), had a valid Month 7 serology result collected in the appropriate day range.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 6 (N=11, N=21, N=22) | 1273.3 mMU/mL |
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 11 (N=11, N=21, N=22) | 1991.6 mMU/mL |
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 16 (N=11, N=23, N=24) | 2381.9 mMU/mL |
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 18 (N=11, N=24, N=24) | 568.7 mMU/mL |
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 31(N=11, N=24, N=23) | 24.3 mMU/mL |
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 45 (N=11, N=26, N=25) | 10.8 mMU/mL |
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 52 (N=9, N=23, N=25) | NA mMU/mL |
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 58 (N=10, N=24, N=22) | 17.7 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 16 (N=11, N=23, N=24) | 3961.8 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 52 (N=9, N=23, N=25) | 2531.1 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 18 (N=11, N=24, N=24) | 1375.7 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 31(N=11, N=24, N=23) | 2037.5 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 45 (N=11, N=26, N=25) | 1042.8 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 6 (N=11, N=21, N=22) | 2203.0 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 11 (N=11, N=21, N=22) | 2564.3 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 58 (N=10, N=24, N=22) | 1759.2 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 16 (N=11, N=23, N=24) | 7484.4 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 11 (N=11, N=21, N=22) | 3921.6 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 6 (N=11, N=21, N=22) | 4784.7 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 18 (N=11, N=24, N=24) | 2315.3 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 52 (N=9, N=23, N=25) | 4292.0 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 45 (N=11, N=26, N=25) | 2116.5 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 31(N=11, N=24, N=23) | 4782.3 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | Anti-HPV 58 (N=10, N=24, N=22) | 3146.4 mMU/mL |
Primary
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
Time frame: 4 weeks postdose 3 (Phase B)
Population: PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7~for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 6 (N=10, N=19, N=23) | 2350.9 mMU/mL |
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 11 (N=10, N=19, N=23) | 3762.2 mMU/mL |
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 16 (N=7, N=19, N=20) | 2783.6 mMU/mL |
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 18 (N=10, N=19, N=25) | 948.2 mMU/mL |
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 31 (N=11, N=22, N=24) | 36.9 mMU/mL |
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 45 (N=11, N=20, N=24) | 4.7 mMU/mL |
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 52 (N=10, N=20, N=23) | NA mMU/mL |
| qHPV (GARDASIL™) - Phase A Control | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 58 (N=9, N=21, N=24) | 9.6 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 16 (N=7, N=19, N=20) | 12947.5 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 52 (N=10, N=20, N=23) | 5714.9 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 18 (N=10, N=19, N=25) | 5090.0 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 31 (N=11, N=22, N=24) | 7779.0 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 45 (N=11, N=20, N=24) | 3974.8 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 6 (N=10, N=19, N=23) | 6006.0 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 11 (N=10, N=19, N=23) | 6514.2 mMU/mL |
| Octavalent HPV With 15 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 58 (N=9, N=21, N=24) | 4961.8 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 16 (N=7, N=19, N=20) | 10105.9 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 11 (N=10, N=19, N=23) | 6609.3 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 6 (N=10, N=19, N=23) | 4484.8 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 18 (N=10, N=19, N=25) | 4070.9 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 52 (N=10, N=20, N=23) | 6624.6 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 45 (N=11, N=20, N=24) | 4696.4 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 31 (N=11, N=22, N=24) | 5487.3 mMU/mL |
| Octavalent HPV With 30 mcg IMX / AAHS | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | Anti-HPV Type 58 (N=9, N=21, N=24) | 5191.2 mMU/mL |
Primary
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
Time frame: 4 weeks postdose 3 (Phase A)
Population: PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7~for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 6 (N=11, N=21, N=22) | 11 Participants |
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 11 (N=11, N=21, N=22) | 11 Participants |
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 16 (N=11, N=23, N=24) | 11 Participants |
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 18 (N=11, N=24, N=24) | 11 Participants |
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 31 (N=11, N=24, N=23) | 6 Participants |
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 45 (N=11, N=26, N=25) | 4 Participants |
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 52 (N=9, N=23, N=25) | 0 Participants |
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 58 (N=10, N=24, N=22) | 3 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 16 (N=11, N=23, N=24) | 23 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 52 (N=9, N=23, N=25) | 23 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 18 (N=11, N=24, N=24) | 24 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 31 (N=11, N=24, N=23) | 24 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 45 (N=11, N=26, N=25) | 26 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 6 (N=11, N=21, N=22) | 21 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 11 (N=11, N=21, N=22) | 21 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 58 (N=10, N=24, N=22) | 24 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 16 (N=11, N=23, N=24) | 24 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 11 (N=11, N=21, N=22) | 22 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 6 (N=11, N=21, N=22) | 22 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 18 (N=11, N=24, N=24) | 24 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 52 (N=9, N=23, N=25) | 25 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 45 (N=11, N=26, N=25) | 25 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 31 (N=11, N=24, N=23) | 23 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | Anti-HPV 58 (N=10, N=24, N=22) | 22 Participants |
Primary
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
Time frame: 4 weeks postdose 3 (Phase B)
Population: PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7~for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 6 (N=10, N=19, N=23) | 10 Participants |
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 11 (N=10, N=19, N=23) | 10 Participants |
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 16 (N=7, N=19, N=20) | 7 Participants |
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 18 (N=10, N=19, N=25) | 10 Participants |
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 31 (N=11, N=22, N=24) | 9 Participants |
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 45 (N=11, N=20, N=24) | 2 Participants |
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 52 (N=10, N=20, N=23) | 0 Participants |
| qHPV (GARDASIL™) - Phase A Control | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 58 (N=9, N=21, N=24) | 2 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 16 (N=7, N=19, N=20) | 19 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 52 (N=10, N=20, N=23) | 20 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 18 (N=10, N=19, N=25) | 19 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 31 (N=11, N=22, N=24) | 22 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 45 (N=11, N=20, N=24) | 20 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 6 (N=10, N=19, N=23) | 19 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 11 (N=10, N=19, N=23) | 19 Participants |
| Octavalent HPV With 15 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 58 (N=9, N=21, N=24) | 21 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 16 (N=7, N=19, N=20) | 20 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 11 (N=10, N=19, N=23) | 23 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 6 (N=10, N=19, N=23) | 23 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 18 (N=10, N=19, N=25) | 25 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 52 (N=10, N=20, N=23) | 23 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 45 (N=11, N=20, N=24) | 24 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 31 (N=11, N=22, N=24) | 24 Participants |
| Octavalent HPV With 30 mcg IMX / AAHS | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | Anti-HPV 58 (N=9, N=21, N=24) | 24 Participants |