Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults

NCT03026348 Phase 2 COMPLETED

This is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300 eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions of subjects in various strata will not be pre-specified and the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the treatment groups. Serology measures consistent with the study outcomes will be reported.

Details

Lead sponsor	Novavax
Phase	Phase 2
Status	COMPLETED
Enrolment	300
Start date	2017-01
Completion	2018-05-18

Conditions

• Respiratory Syncytial Viruses

Interventions

• RSV F Vaccine with Aluminum Phosphate Adjuvant
• RSV F Vaccine
• Matrix-M1 Adjuvant
• Phosphate Buffer

Primary outcomes

• Neutralizing antibody titers to at least one RSV/A strain — Day 0, 21, 28
• Subjects with solicited local and systemic AEs occurring within the 7-day period following dosings on Day 0 and Day 21 and all adverse events, solicited and unsolicited, occurring within the 56-day period of Day 0. — Day 0 - Day 6, Day 21 - Day 27; Day 0 - Day 56

Countries

Australia