HPV Infections
Conditions
Brief summary
The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females
Interventions
BIOLOGICALQuadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
V501; Gardasil, 0.5 ml injection in 3 dosing regimen
BIOLOGICALComparator: Placebo (unspecified)
Placebo 0.5 ml injection in 3 dosing regimen
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Virginal Female Subject Aged 9 To 17 Years
Exclusion criteria
* Male Subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series | At one month after completed vaccination series (Month 7) | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) by vaccine group. The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 7.0. |
| Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series | At one month after completed vaccination series (Month 7) | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 8.0. |
| Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series | At one month after completed vaccination series (Month 7) | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 11.0. |
| Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series | At one month after completed vaccination series (Month 7) | Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 10.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series | 24 month after completed vaccination series (Month 30) | Month 30 HPV cLIA Geometric Mean Titers by vaccine group. |
Participant flow
Recruitment details
Study was conducted at 8 sites in Japan from 2006 to 2009.
Participants by arm
| Arm | Count |
|---|---|
| V501 V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501) | 82 |
| Placebo Placebo vaccination 0.5 ml injection in 3 dosing regimen. | 25 |
| Total | 107 |
Baseline characteristics
| Characteristic | V501 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 12.8 years STANDARD_DEVIATION 2.4 | 12.6 years STANDARD_DEVIATION 2.6 | 12.7 years STANDARD_DEVIATION 2.4 |
| Body Weight | 45.5 Kilogram STANDARD_DEVIATION 10.8 | 45.2 Kilogram STANDARD_DEVIATION 9.6 | 45.4 Kilogram STANDARD_DEVIATION 10.5 |
| Sex: Female, Male Female | 82 Participants | 25 Participants | 107 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 77 / 82 | 23 / 25 |
| serious Total, serious adverse events | 2 / 82 | 0 / 25 |
Outcome results
Primary
Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 8.0.
Time frame: At one month after completed vaccination series (Month 7)
Population: The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V501 | Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series | 944.5 Geometric Mean Titers (mMU/mL) |
| Placebo | Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series | 8.0 Geometric Mean Titers (mMU/mL) |
p-value: <0.001Wilcoxon (Mann-Whitney)
Primary
Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 11.0.
Time frame: At one month after completed vaccination series (Month 7)
Population: The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V501 | Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series | 4275.4 Geometric Mean Titers (mMU/mL) |
| Placebo | Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series | 11.0 Geometric Mean Titers (mMU/mL) |
p-value: <0.001Wilcoxon (Mann-Whitney)
Primary
Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 10.0.
Time frame: At one month after completed vaccination series (Month 7)
Population: The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V501 | Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series | 829.2 Geometric Mean Titers (mMU/mL) |
| Placebo | Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series | 10.0 Geometric Mean Titers (mMU/mL) |
p-value: <0.001Wilcoxon (Mann-Whitney)
Primary
Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series
Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) by vaccine group. The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as 7.0.
Time frame: At one month after completed vaccination series (Month 7)
Population: The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V501 | Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series | 674.5 Geometric Mean Titers (mMU/mL) |
| Placebo | Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series | 7.0 Geometric Mean Titers (mMU/mL) |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series
Month 30 HPV cLIA Geometric Mean Titers by vaccine group.
Time frame: 24 month after completed vaccination series (Month 30)
Population: The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 30 serum sample collected within an acceptable time range.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V501 | HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series | 155.2 Geometric Mean Titers (mMU/mL) |
| Placebo | HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series | 198.2 Geometric Mean Titers (mMU/mL) |
| V501-HPV 16 | HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series | 617.1 Geometric Mean Titers (mMU/mL) |
| V501-HPV 18 | HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series | 90.0 Geometric Mean Titers (mMU/mL) |
95% CI: [126.2, 190.9]
95% CI: [160.9, 244.2]
95% CI: [491.7, 774.5]
95% CI: [68.8, 117.8]