NCT00819013

Brief Summary

This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered. Subjects will be randomized according to a randomization scheme.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
3 years until next milestone

Results Posted

Study results publicly available

January 16, 2012

Completed
Last Updated

January 19, 2012

Status Verified

January 1, 2012

Enrollment Period

1.5 years

First QC Date

October 10, 2008

Results QC Date

November 1, 2011

Last Update Submit

January 16, 2012

Conditions

Influenza

Outcome Measures

Primary Outcomes (5)

  • Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.

    Day 0 through Day 60 post-vaccination

  • Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

    Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.

    Day 0 through Day 7 post-vaccination

  • Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

    Day 0 through Day 60 post-vaccination 1

  • Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine

    Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)

    Day 15 through Month 10 Post-vaccination 1

  • Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.

    Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)

    Day 15 through Month 10 Post-vaccination 1

Secondary Outcomes (6)

  • Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

    Month 4 through Month 10 post-vaccination 1

  • Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

    Day 0 and Day 60 Post-vaccination 1

  • Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

    Day 0 and Day 60 Post-vaccination 1

  • Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

    Day 0 and Day 60 Post-vaccination 1

  • Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

    Day 0 and Day 15 through Month 10 post-vaccination 1

  • +1 more secondary outcomes

Study Arms (4)

Study Group 1

EXPERIMENTAL

ACAM-FLU-A low dose + Adjuvant 1

Biological: Influenza A Vaccine: ACAM FLU-A

Study Group 2

EXPERIMENTAL

ACAM-FLU-A low dose + Adjuvant 2

Biological: Influenza A Vaccine: ACAM FLU-A

Study Group 3

EXPERIMENTAL

ACAM-FLU-A low dose

Biological: Influenza A Vaccine: ACAM FLU-A

Study Group 4

PLACEBO COMPARATOR

Saline placebo

Biological: Saline placebo

Interventions

Influenza A Vaccine: ACAM FLU-ABIOLOGICAL

0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular

Also known as: ACAM FLU-A
Study Group 1
Saline placeboBIOLOGICAL

0.5 mL, Intramuscular

Also known as: USP Saline
Study Group 4

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult males or females 18 - 40 years of age in good general health

You may not qualify if:

  • Known allergies or severe reactions to any of the vaccine components including those to adjuvants
  • History of severe allergic reactions, including angioedema;
  • History of asthma or recurrent wheezing; (current or within past 2 years);
  • History of neurological symptoms or signs following administration of any vaccine;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Miami Research Associates

Miami, Florida, 33143, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

Northwest Kinetics

Tacoma, Washington, 98418, United States

Location

Related Publications (1)

  • Ibanez LI, Roose K, De Filette M, Schotsaert M, De Sloovere J, Roels S, Pollard C, Schepens B, Grooten J, Fiers W, Saelens X. M2e-displaying virus-like particles with associated RNA promote T helper 1 type adaptive immunity against influenza A. PLoS One. 2013;8(3):e59081. doi: 10.1371/journal.pone.0059081. Epub 2013 Mar 18.

    PMID: 23527091DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Medical Director
Organization
Sanofi Pasteur Inc.
RegistryContactUs@sanofipasteur.com

Study Officials

  • Medical Director

    Sanofi Pasteur Inc

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2008

First Posted

January 8, 2009

Study Start

July 1, 2007

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

January 19, 2012

Results First Posted

January 16, 2012

Record last verified: 2012-01

Locations

US(3)