Trial Outcomes & Findings for Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis (NCT NCT00573651)

NCT ID: NCT00573651

Last Updated: 2024-07-05

Results Overview

dichotomized as negative or positive

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: 7 months
• Results posted on: 2024-07-05

Participant Flow

Patients were recruited from pediatric rheumatology clinics at UHCleveland Medical Center, Cleveland Clinic, the MetroHealth System, and the University of Chicago. Recruitment began in October of 2007 (IRB approval 10/22/2007) and finished in October of 2014.

This is open label vaccine on top of current therapy.

Participant milestones

Measure	JIA Except SJIA Active Systemic Symptoms Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to the clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody.
Overall Study STARTED	43
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	JIA Except SJIA Active Systemic Symptoms Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to the clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody.
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis

Baseline characteristics by cohort

Measure	Aggregate of All Three Arms. n=43 Participants All girls enrolled in the study 9-26 data were analyzed together as the original 72 subjects planned was not large enough to have statistically significant results once it became apparent that outcomes would need to be not only analyzed by subgroup but also by age 9-15 and 16-26.
Age, Categorical <=18 years	39 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 months

Population: 3 samples were lost in transport to lab

dichotomized as negative or positive

Outcome measures

Measure

JIA Except SJIA With Active Systemic Symptoms n=35 Participants Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody. Blood Draws for Serum Titers: All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Positive Serum GMTs at 7 Months (HPV06)

34 participants

PRIMARY outcome

Timeframe: 7 months

Population: 3 samples were lost in transport to lab

dichotomized as negative or positive

Outcome measures

Measure

JIA Except SJIA With Active Systemic Symptoms n=35 Participants Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody. Blood Draws for Serum Titers: All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Positive Serum GMTs at 7 Months (HPV11)

35 participants

PRIMARY outcome

Timeframe: 7 months

Population: 3 samples were lost in transport to lab

dichotomized as negative or positive

Outcome measures

Measure

JIA Except SJIA With Active Systemic Symptoms n=35 Participants Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody. Blood Draws for Serum Titers: All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Positive Serum GMTs at 7 Months (HPV16)

35 participants

PRIMARY outcome

Timeframe: 7 months

Population: 3 samples were lost in transport to lab

dichotomized as negative or positive

Outcome measures

Measure

JIA Except SJIA With Active Systemic Symptoms n=35 Participants Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody. Blood Draws for Serum Titers: All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Positive Serum GMTs at 7 Months (HPV18)

35 participants

SECONDARY outcome

Timeframe: 2 years

increased arthritis requiring addition of steroids, intensification of NSAIDs or new DMARD or biological DMARD

Outcome measures

Measure

JIA Except SJIA With Active Systemic Symptoms n=42 Participants Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody. Blood Draws for Serum Titers: All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Disease Flare

27 participants

SECONDARY outcome

Timeframe: 2 years

worsening of >30% from the prior visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Not all participants agreed to blood draw, 2 missed visits and 2 drop outs.

dichotomized as negative or positive

Outcome measures

Measure

JIA Except SJIA With Active Systemic Symptoms n=27 Participants Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody. Blood Draws for Serum Titers: All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Positive Serum GMT (HVP06)

27 participants

SECONDARY outcome

Timeframe: 12 months

Population: Not all participants agreed to blood draw, 2 missed visits and 2 drop outs.

dichotomized as negative or positive

Outcome measures

Measure

JIA Except SJIA With Active Systemic Symptoms n=27 Participants Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody. Blood Draws for Serum Titers: All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Positive Serum GMT (HVP11)

26 participants

SECONDARY outcome

Timeframe: 12 months

Population: Not all participants agreed to blood draw, 2 missed visits and 2 drop outs.

dichotomized as negative or positive

Outcome measures

Measure

JIA Except SJIA With Active Systemic Symptoms n=27 Participants Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody. Blood Draws for Serum Titers: All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Positive Serum GMT (HVP16)

27 participants

SECONDARY outcome

Timeframe: 12 months

Population: Not all participants agreed to blood draw, 2 missed visits and 2 drop outs.

dichotomized as negative or positive

Outcome measures

Measure

JIA Except SJIA With Active Systemic Symptoms n=27 Participants Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody. Blood Draws for Serum Titers: All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Positive Serum GMT (HVP18)

27 participants

SECONDARY outcome

Timeframe: 24 months

Population: Not all participants agreed blood draw, and subject withdraw.

Outcome measures

Measure

JIA Except SJIA With Active Systemic Symptoms n=12 Participants Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody. Blood Draws for Serum Titers: All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Positive Serum GMT (HPV06)

11 participants

SECONDARY outcome

Timeframe: 24 months

Population: Not all participants agreed blood draw, and subject withdraw.

Outcome measures

Measure

JIA Except SJIA With Active Systemic Symptoms n=12 Participants Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody. Blood Draws for Serum Titers: All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Positive Serum GMT (HPV11)

9 participants

SECONDARY outcome

Timeframe: 24 months

Population: Not all participants agreed blood draw, and subject withdraw.

Outcome measures

Measure

JIA Except SJIA With Active Systemic Symptoms n=12 Participants Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody. Blood Draws for Serum Titers: All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Positive Serum GMT (HPV16)

11 participants

SECONDARY outcome

Timeframe: 24 months

Population: Not all participants agreed blood draw, and subject withdraw.

Outcome measures

Measure

JIA Except SJIA With Active Systemic Symptoms n=12 Participants Females age 9-26 with JIA of all types that have had arthritis and do not have active systemic symptoms. All study subjects are receiving the Gardasil vaccine as part of their clinical care. The study observes outcomes related to this clinical care. Study intervention consists of some Blood Draws for serum titers taken to measure antibody. Blood Draws for Serum Titers: All study subjects are receiving the Gardasil vaccine as part of their clinical care. The Gardasil vaccine is not given because of study participation. The study observes outcomes related to this clinical care. Study intervention consists of some blood samples taken to measure antibody and RNA titers. Other study specific procedures performed include Questionnaires and observational data.

Positive Serum GMT (HPV18)

8 participants

Adverse Events

Aggregate of All Three Arms.

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure

Aggregate of All Three Arms. n=43 participants at risk All girls enrolled in the study 9-26 data were analyzed together as the original 72 subjects planned was not large enough to have statistically significant results once it became apparent that outcomes would need to be not only analyzed by subgroup but also by age 9-15 and 16-26.

Pregnancy, puerperium and perinatal conditions pregnancy

2.3% 1/43 • Number of events 1 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.

Other adverse events

Measure	Aggregate of All Three Arms. n=43 participants at risk All girls enrolled in the study 9-26 data were analyzed together as the original 72 subjects planned was not large enough to have statistically significant results once it became apparent that outcomes would need to be not only analyzed by subgroup but also by age 9-15 and 16-26.
Respiratory, thoracic and mediastinal disorders upper respiratory infection	23.3% 10/43 • Number of events 11 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Infections and infestations Achiness	7.0% 3/43 • Number of events 3 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Gastrointestinal disorders nausea or diarrhea	18.6% 8/43 • Number of events 8 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Musculoskeletal and connective tissue disorders arthralgia	9.3% 4/43 • Number of events 4 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Vascular disorders lightheadedness	11.6% 5/43 • Number of events 5 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Infections and infestations fever	7.0% 3/43 • Number of events 3 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Skin and subcutaneous tissue disorders rash	2.3% 1/43 • Number of events 2 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Musculoskeletal and connective tissue disorders bruise	4.7% 2/43 • Number of events 3 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Respiratory, thoracic and mediastinal disorders shortness of breath	4.7% 2/43 • Number of events 2 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Infections and infestations strep throat	4.7% 2/43 • Number of events 2 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Vascular disorders syncope vaso-vagal	2.3% 1/43 • Number of events 1 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Musculoskeletal and connective tissue disorders flare	4.7% 2/43 • Number of events 2 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Injury, poisoning and procedural complications dry socket following extraction	2.3% 1/43 • Number of events 1 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Ear and labyrinth disorders otalgia	2.3% 1/43 • Number of events 1 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Infections and infestations Herpes zoster	2.3% 1/43 • Number of events 1 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Injury, poisoning and procedural complications Injection site pain	2.3% 1/43 • Number of events 1 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
General disorders insomnia	2.3% 1/43 • Number of events 1 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Injury, poisoning and procedural complications musculoskeletal pain due to MVA injury	2.3% 1/43 • Number of events 1 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Infections and infestations warts, plantar	2.3% 1/43 • Number of events 1 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Infections and infestations thrush	2.3% 1/43 • Number of events 1 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.
Gastrointestinal disorders vomiting	4.7% 2/43 • Number of events 2 • Data was collected for up to completion of the 24 month visit for patients that completed the study or the last known study visit. In the initial protocol pregnancy after immunization was not excluded as an SAE. The label for Gardasil vaccine however does not say that patients need to avoid pregnancy following the immunization series. We had one pregnancy during the follow up period. The IRB protocol was amended to exclude pregnancy as an SAE once all vaccines are complete during the follow up period.

Additional Information

Nora G Singer

The MetroHealth System

Phone: 216-778-2138

Email: nsinger@metrohealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place