NCT01078220

Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)

Completed Results posted Last updated 11 July 2017

What this trial tests

trial in Human Papillomavirus Infection in 189,629 participants. Completed in 13 December 2010.

Timeline

6 February 2007

Primary endpoint
13 December 2010

13 December 2010

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Status	Completed
Study type	OBSERVATIONAL
Enrollment	189,629
Start date	6 February 2007
Primary completion	13 December 2010
Estimated completion	13 December 2010

Conditions studied

• Human Papillomavirus Infection — all drugs for Human Papillomavirus Infection →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

9 and older, female only, with Human Papillomavirus Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence Rate of Syncope Primary · On day of each vaccination

Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.

Group	Value	95% CI
Any Dose Safety Population	24.21
3-Dose Safety Population	13.84

Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy Secondary · First dose of Gardasil in pregnancy up to 6 months after birth

Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.

Number (No.) of potential congenital anomalies

Group	Value	95% CI
Pregnancy Safety Population	170

No. that underwent medical record review

Group	Value	95% CI
Pregnancy Safety Population	170

No. of confirmed congenital anomalies

Group	Value	95% CI
Pregnancy Safety Population	44

No. associated with Gardasil by safety committee

Group	Value	95% CI
Pregnancy Safety Population	0

Number of Miscarriages Among Females Who Received Gardasil During Pregnancy Secondary · First dose of Gardasil in pregnancy up to pregnancy resolution

Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.

No. of potential miscarriages indentified

Group	Value	95% CI
Pregnancy Safety Population	633

No. that underwent medical record review

Group	Value	95% CI
Pregnancy Safety Population	100

No. of confirmed miscarriages

Group	Value	95% CI
Pregnancy Safety Population	9

No. associated with Gardasil by safety committee

Group	Value	95% CI
Pregnancy Safety Population	0

Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil Secondary · within 6 months immediately after each vaccination

Autoimmune cases were defined as newly diagnosed cases within 6 months after any dose of Gardasil, as confirmed by medical record review by panels of physicians specializing in the 16 autoimmune conditions of interest.

No. of potential autoimmune cases

Group	Value	95% CI
Autoimmune Safety Population	719

No. that underwent medical record review

Group	Value	95% CI
Autoimmune Safety Population	318

No. of confirmed new onset cases within 6 months

Group	Value	95% CI
Autoimmune Safety Population	124

No. associated with Gardasil by safety committee

Group	Value	95% CI
Autoimmune Safety Population	0

Incidence Rate of Cellulitis Primary · Within 14 days and within 60 days immediately after each vaccination

Cellulitis was defined as the presence of a cellulitis or abscess diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.

Days 1-14 after vaccination

Group	Value	95% CI
Any Dose Safety Population	3.53
3-Dose Safety Population	2.17

Days 1-60 after vaccination

Group	Value	95% CI
Any Dose Safety Population	2.25
3-Dose Safety Population	1.66

Sponsor's own description

This is a post-licensure safety surveillance program to detect potential safety signals in subjects, from the managed care organizations database, who have used GARDASIL™.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Postlicensure safety surveillance of congenital anomaly and miscarriage among pregnancies exposed to quadrivalent human papillomavirus vaccine.
   Sy LS, Meyer KI, Klein NP, Chao C, et al · · 2018 · cited 10× · PMID 29140750 · DOI 10.1080/21645515.2017.1403702