Trial Outcomes & Findings for V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110) (NCT NCT01544478)

NCT ID: NCT01544478

Last Updated: 2018-11-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 1030 participants
• Primary outcome timeframe: Up to Month 48
• Results posted on: 2018-11-28

Participant Flow

A total of 1036 participants were screened and 1030 were enrolled in the study.

Participant milestones

Measure	V501 Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
Overall Study STARTED	1030
Overall Study Vaccination 1	1030
Overall Study Vaccination 2	1026
Overall Study Vaccination 3	1019
Overall Study COMPLETED	912
Overall Study NOT COMPLETED	118

Reasons for withdrawal

Measure	V501 Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
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

V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)

Baseline characteristics by cohort

Measure	V501 n=1030 Participants Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
Age, Continuous	22.9 Years STANDARD_DEVIATION 2.2 • n=5 Participants
Sex: Female, Male Female	1030 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1030 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	V501 n=3035 Person-years at risk Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
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 Interval 0.0 to 0.1

Adverse Events

V501

Serious events: 8 serious events

Other events: 169 other events

Deaths: 0 deaths

Serious adverse events

Measure	V501 n=1029 participants at risk Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
Infections and infestations Peritonsillitis	0.10% 1/1029 • Number of events 1 • Up to Month 48 Participants at risk included all who received at least 1 vaccination and had safety follow-up. One participant received vaccination but did not have safety follow-up.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.10% 1/1029 • Number of events 1 • Up to Month 48 Participants at risk included all who received at least 1 vaccination and had safety follow-up. One participant received vaccination but did not have safety follow-up.
Surgical and medical procedures Abortion induced	0.39% 4/1029 • Number of events 4 • Up to Month 48 Participants at risk included all who received at least 1 vaccination and had safety follow-up. One participant received vaccination but did not have safety follow-up.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.10% 1/1029 • Number of events 1 • Up to Month 48 Participants at risk included all who received at least 1 vaccination and had safety follow-up. One participant received vaccination but did not have safety follow-up.
Pregnancy, puerperium and perinatal conditions Foetal malpresentation	0.10% 1/1029 • Number of events 1 • Up to Month 48 Participants at risk included all who received at least 1 vaccination and had safety follow-up. One participant received vaccination but did not have safety follow-up.

Other adverse events

Measure	V501 n=1029 participants at risk Participants received a 0.5-mL vaccination of V501 by intramuscular injection on Day 1, Month 2, and Month 6
Infections and infestations Nasopharyngitis	5.9% 61/1029 • Number of events 67 • Up to Month 48 Participants at risk included all who received at least 1 vaccination and had safety follow-up. One participant received vaccination but did not have safety follow-up.
General disorders Injection site pain	11.5% 118/1029 • Number of events 168 • Up to Month 48 Participants at risk included all who received at least 1 vaccination and had safety follow-up. One participant received vaccination but did not have safety follow-up.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
• Publication restrictions are in place

Restriction type: OTHER