NCT01072799

Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine

A Phase 2 Study to Assess the Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4,560 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of three dose levels (5µg, 15µg and 45µg HA) of the novel A (H1N1) influenza VLP vaccine as compared with a placebo in healthy adults (18 to 64 years of age).

Detailed description

The study will be conducted in two parts (A \& B) at a single center in Mexico. The purpose of Part A is to evaluate the safety of the H1N1 VLP vaccine and to evaluate immunogenicity and select a dose for Part B. In Part A, 1,000 subjects will be enrolled and randomized to a 1:1:1:1 schedule (5µg, 15µg and 45µg doses of H1N1 VLP vaccine or placebo. Subjects will receive two intramuscular (IM) injections (0.5mL/dose) of the H1N1 VLP vaccine or placebo 21 days apart. Blood for HAI assays will be collected at 3 time points (baseline, Day 14 and Day 36). Subjects will be followed for all adverse events (AEs) from the first day of the study through 21 days after the second dose (Day 36). Subjects will be followed for serious AEs and significant new medical conditions (SNMCs) to the end of the study 6 months post-dose 2 (Day 194). Once the first 500 subjects are enrolled into Part A, enrollment will be halted until 3 days of safety follow-up data are reviewed by the study Data and Safety Monitoring Board (DSMB). A second data review will occur following Day 14 visit for Part A to select the dose to be administered in Part B. Part B of the study will be conducted to evaluate safety and accumulate enough safety data to potentially move forward with broader use of the vaccine assuming favorable results. In Part B, a total of 3,250 - 3,750 subjects will be randomized to receive the selected dose of H1N1 VLP vaccine or placebo. A total of 3,000 H1N1 VLP vaccine recipients at the selected dose or higher, and 1,250 placebo recipients will be enrolled in Parts A and B. Following completion of Day 36 in Part A, data may be reviewed to assess 1 injection vs. 2 injections in Part B.

Conditions

• Seasonal Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	Two doses (Day 1 and Day 22); 0.5mL
BIOLOGICAL	A/H1N1 2009 Influenza VLP Vaccine	Two doses (Day 1 \& Day 22); 0.5mL

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-02-22
• Last updated: 2012-04-25

Locations

1 site across 1 country: Mexico