Additional 6-Month Safety Follow-up After Completion of Precursor Study 880801

Ology Bioservices

Status and phase: Completed; Phase 3

Conditions: Prophylaxis of Ross River Virus Infection

Treatments: Biological: Ross River Virus (RRV) Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01604746

881201

Details and patient eligibility

About

The purpose of this study is to verify the long-term safety of a 2.5 µg, adjuvanted (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine.

Enrollment: 1,146 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Subjects who participated in precursor Study 880801 and meet all of the following criteria:

• Subject received 3 RRV vaccinations in Study 880801
• Subject has completed Visit 6 in Study 880801
• Subject and, if applicable, subject´s parent(s)/legal guardian(s), understand the nature of the study and its procedures, agree to its provisions and provide written informed consent prior to study entry
• Subject provides written assent according to his/her age, if applicable

Exclusion criteria

• Subject has participated in another clinical study other than Study 880801 involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,146 participants in 1 patient group

Safety assessment

No Intervention group

Description:

Vaccine safety will be assessed in the period between 6 and 12 months after the 3rd vaccination in precursor Study 880801 based on diaries distributed to all subjects for documentation of SAEs or AESI. Females who became pregnant after the 3rd vaccination in Study 880801 will be followed until end of pregnancy.

Treatment:

Biological: Ross River Virus (RRV) Vaccine