Adenocarcinoma in Situ, Cervical Cancer, Cervical Intraepithelial Neoplasia
Conditions
Brief summary
This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.
Interventions
BIOLOGICALV501
HPV types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Japanese females * Not pregnant at Screening and agree to use effective contraception through Month 7 of the study * Lifetime history of 0 to 4 male or female sexual partners * No oral temperature ≥37.5 centigrade within 24 hours prior to injection
Exclusion criteria
* Received a marketed HPV vaccine * Prior abnormal Papanicolaou smear (PAP) or biopsy showing CIN * Known history of positive test for HPV * Known history of genital warts * Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study * History of splenectomy, known immune disorders, or receiving immunosuppressives * Immunocompromised or diagnosed as having human immunodeficiency virus (HIV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 | Up to Month 48 | The endpoint included pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, and HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block. The point estimates and exact 95% confidence intervals for incidence rate were based on the Poisson distribution. |
Participant flow
Recruitment details
A total of 1036 participants were screened and 1030 were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| V501 Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6 | 1,030 |
| Total | 1,030 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 48 |
| Overall Study | Physician Decision | 15 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Withdrawal by Subject | 52 |
Baseline characteristics
| Characteristic | V501 |
|---|---|
| Age, Continuous | 22.9 Years STANDARD_DEVIATION 2.2 |
| Race/Ethnicity, Customized Asian | 1030 Participants |
| Sex: Female, Male Female | 1030 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 169 / 1,029 |
| serious Total, serious adverse events | 8 / 1,029 |
Outcome results
Primary
Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18
The endpoint included pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, and HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block. The point estimates and exact 95% confidence intervals for incidence rate were based on the Poisson distribution.
Time frame: Up to Month 48
Population: The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for the relevant HPV type.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V501 | Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18 | 0.0 Cases per 100 person-years at risk |