NCT01709019

RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly

A Phase I Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum Adjuvant, and Co-administered With a Licensed Inactivated Influenza Vaccine, in Healthy Subjects ≥ 60 Years of Age.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

Up to 220 eligible subjects will be enrolled into one of five treatment groups. It is anticipated that some of the randomized study subjects may not complete the study; subjects who withdraw or are discontinued, will not be replaced. Randomization will be stratified by age (60 to \<75 years and ≥ 75 years) in order to distribute the proportion of such persons in each age group equally across treatment groups. Treatments will comprise a single IM dose of a placebo or RSV-F protein nanoparticle vaccine on Day 0, with concurrent IM immunization with a licensed inactivated influenza vaccine. A rescue dose of the licensed TIV will be provided to subjects in all groups except the placebo group on Day 28, the placebo group will receive saline. For each subject, study follow-up will span approximately one year from the first immunization (on Day 0) for all subjects.

Conditions

• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
BIOLOGICAL	Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)	0.5mL IM injections
BIOLOGICAL	Low dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & day 28)	0.5mL IM injections
BIOLOGICAL	High dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)	0.5mL IM injections
BIOLOGICAL	High dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)	0.5mL IM injections
BIOLOGICAL	Placebo (Day 0 & Day 28); Seasonal TIV (Day 0)	0.5mL IM Injections

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-07-01
• Completion: 2014-03-01
• First posted: 2012-10-17
• Last updated: 2014-03-05

Locations

4 sites across 1 country: United States