Trial Outcomes & Findings for Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031) (NCT NCT01078220)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

189629 participants

Primary outcome timeframe

On day of each vaccination

Results posted on

2017-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Any Dose Safety Population Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
Overall Study STARTED	189629
Overall Study COMPLETED	189629
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Any Dose Safety Population n=189629 Participants Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
Age, Customized <9 years	45 Participants n=93 Participants
Age, Customized Between 9 and 15 years	96839 Participants n=93 Participants
Age, Customized Between 16 and 26 years	91066 Participants n=93 Participants
Age, Customized >26 years	1679 Participants n=93 Participants
Sex: Female, Male Female	189629 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Any Dose Safety Population n=189629 Participants Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.	3-Dose Safety Population n=44001 Participants Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
Incidence Rate of Syncope	24.21 Rate per 1000 person years	13.84 Rate per 1000 person years

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Any Dose Safety Population n=189629 Participants Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.	3-Dose Safety Population n=44001 Participants Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
Incidence Rate of Cellulitis Days 1-14 after vaccination	3.53 Rate per 1000 person years	2.17 Rate per 1000 person years
Incidence Rate of Cellulitis Days 1-60 after vaccination	2.25 Rate per 1000 person years	1.66 Rate per 1000 person years

SECONDARY outcome

Timeframe: First dose of Gardasil in pregnancy up to 6 months after birth

Population: Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records.

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

Outcome measures

Outcome measures
Measure	Any Dose Safety Population n=1740 Participants Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.	3-Dose Safety Population Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy Number (No.) of potential congenital anomalies	170 Number of congenital anomalies	—
Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy No. that underwent medical record review	170 Number of congenital anomalies	—
Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy No. of confirmed congenital anomalies	44 Number of congenital anomalies	—
Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy No. associated with Gardasil by safety committee	0 Number of congenital anomalies	—

SECONDARY outcome

Timeframe: First dose of Gardasil in pregnancy up to pregnancy resolution

Population: Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records.

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

Outcome measures

Outcome measures
Measure	Any Dose Safety Population n=1740 Participants Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.	3-Dose Safety Population Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
Number of Miscarriages Among Females Who Received Gardasil During Pregnancy No. of potential miscarriages indentified	633 Number of miscarriages	—
Number of Miscarriages Among Females Who Received Gardasil During Pregnancy No. that underwent medical record review	100 Number of miscarriages	—
Number of Miscarriages Among Females Who Received Gardasil During Pregnancy No. of confirmed miscarriages	9 Number of miscarriages	—
Number of Miscarriages Among Females Who Received Gardasil During Pregnancy No. associated with Gardasil by safety committee	0 Number of miscarriages	—

SECONDARY outcome

Timeframe: within 6 months immediately after each vaccination

Population: Number of females with at least 12 months' membership at a MCO prior to Gardasil.

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.

Outcome measures

Outcome measures
Measure	Any Dose Safety Population n=149306 Participants Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.	3-Dose Safety Population Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil No. of potential autoimmune cases	719 Number of autoimmune cases	—
Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil No. that underwent medical record review	318 Number of autoimmune cases	—
Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil No. of confirmed new onset cases within 6 months	124 Number of autoimmune cases	—
Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil No. associated with Gardasil by safety committee	0 Number of autoimmune cases	—

Adverse Events

Any Dose Safety Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

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. Sponsor review can be expedited to meet publication guidelines.
Publication restrictions are in place

Restriction type: OTHER