A/H5N1in Adult - Aventis

Influenza Clinical Trial

Official title: A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adults

Status Completed

Clinical Trial Summary

The purpose of this research study is to compare how the body reacts to different strengths of the new H5N1 flu vaccine. The study will also look at how antibodies are made after a subject receives the H5N1 flu vaccine. The vaccine will be given as a shot in the arm. Participants will be randomly assigned to receive 1 of 4 different dosages of the vaccine or a placebo (dummy) dose of the vaccine. Study procedures will include a physical exam, a urine pregnancy test for women, and blood samples. Participants will be asked to complete a diary to record temperatures, medications taken, and side effects from the vaccine. Volunteers will be involved with study procedures for approximately 7 months. The study will enroll about 450-470 healthy participants, ages 18-64.

Clinical Trial Description

Approximately 450 healthy adults, 18 to 64 years old, inclusive, will be enrolled into this multicenter, randomized, double-blinded, placebo-controlled, dose-ranging clinical trial. The study will be conducted in 2 stages. During Stage I, 113 subjects who meet the entry criteria for the study will be randomized to receive saline placebo, or 7.5, 15, 45, or 90 mcg of the influenza A/H5N1 vaccine by intramuscular injection in an approximate 1:2:2:2:2 ratio (N=25/vaccine dose group and 13 in the placebo group). Subjects will receive 2 doses separated by approximately 28 days. Vaccine administration will be performed by an unblinded vaccine administrator, who will not be involved in subsequent assessments. Subjects will be observed in the clinic for 15 to 30 minutes after inoculation, and subjects will maintain a memory aid to record oral temperature and systemic and local AEs for 7 days after each immunization. Subjects will be contacted by telephone on Day 2 after each immunization to assess for the occurrence of AEs, and they will return on Day 7 for AE and concomitant medication assessment, a targeted physical examination (if indicated), and review of the memory aid. Serum for immunogenicity evaluations will be obtained prior to the first vaccination (ie, at screening for Stage I and Day 0 for Stage II), prior to the second vaccination, at Day 28, and on Days 56 and 208. All available 7-day safety data following the first dose of vaccine on the 113 subjects enrolled in Stage I will be reviewed by the Safety Monitoring Committee (SMC) prior to enrollment of the remaining subjects (Stage II), who will be followed according to the same protocol. All available 7-day safety data following the second dose of vaccine on the subjects enrolled in Stage I also will be reviewed by the SMC prior to administering the second dose of vaccine to the subjects in Stage II. This study is linked to DMID protocols 07-0022, 05-0006, 05-0090 and 08-0059. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

• NCT number: NCT00115986
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2005
• Completion date: February 2006