Trial Outcomes & Findings for HPV Vaccination in Special Risk Groups: 5 Year Follow-up (NCT NCT01896986)

NCT ID: NCT01896986

Last Updated: 2017-06-15

Results Overview

To evaluate the long term immunogenicity of the quadrivalent 4/6/11/18 HPV vaccine Gardasil® by following up a cohort of adolescent females aged 16-30 years with PRD or IBD, 5 years post HPV vaccination at the Royal Children's Hospital (RCH) Melbourne .

• Recruitment status: TERMINATED
• Target enrollment: 37 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2017-06-15

Participant Flow

Participant milestones

Measure	PRD Patrients Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus) Subgroups: 1. receiving immunosuppressant therapy 2. not on immunosuppressant therapy	IBD Patients Children/adolescent females 12-26 years diagnosed with IBD. Subgroups: 3\. receiving immunosuppressant therapy 4. not on immunosuppressant therapy
Overall Study STARTED	14	23
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	14	23

Reasons for withdrawal

Measure	PRD Patrients Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus) Subgroups: 1. receiving immunosuppressant therapy 2. not on immunosuppressant therapy	IBD Patients Children/adolescent females 12-26 years diagnosed with IBD. Subgroups: 3\. receiving immunosuppressant therapy 4. not on immunosuppressant therapy
Overall Study samples lost	14	23

Baseline Characteristics

HPV Vaccination in Special Risk Groups: 5 Year Follow-up

Baseline characteristics by cohort

Measure	PRD Patrients n=14 Participants Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus) Subgroups: 1. receiving immunosuppressant therapy 2. not on immunosuppressant therapy	IBD Patients n=23 Participants Children/adolescent females 12-26 years diagnosed with IBD. Subgroups: 3\. receiving immunosuppressant therapy 4. not on immunosuppressant therapy	Total n=37 Participants Total of all reporting groups
Age, Continuous	19 years n=5 Participants	23 years n=7 Participants	21 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	23 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Australia	14 participants n=5 Participants	23 participants n=7 Participants	37 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: No immunogenicity data collected as samples were lost.

To evaluate the long term immunogenicity of the quadrivalent 4/6/11/18 HPV vaccine Gardasil® by following up a cohort of adolescent females aged 16-30 years with PRD or IBD, 5 years post HPV vaccination at the Royal Children's Hospital (RCH) Melbourne .

Outcome measures

Measure	PRD Patrients Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus) Subgroups: 1. receiving immunosuppressant therapy 2. not on immunosuppressant therapy No samples analysed.	IBD Patients Children/adolescent females 12-26 years diagnosed with IBD. Subgroups: 3\. receiving immunosuppressant therapy 4. not on immunosuppressant therapy No samples analysed.
Immunogenicity to HPV Vaccine Gardasil	0	0

Adverse Events

PRD Patrients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IBD Patients

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

Dr. Nigel Crawford

MCRI

Phone: 9345 4772

Email: nigel.crawford@rch.org.au

Results disclosure agreements

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