Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00928577
First received: June 25, 2009
Last updated: April 21, 2014
Last verified: April 2014

June 25, 2009
April 21, 2014
December 2008
December 2014   (final data collection date for primary outcome measure)
The percentage and rate per 1,000 of participants with subclinical, suspected, probable, or confirmed myopericarditis following vaccination with either ACAM2000® Smallpox vaccine or other vaccinia vaccine. [ Time Frame: Day 10 post-vaccination ] [ Designated as safety issue: No ]
To compare the safety profile of ACAM2000® Smallpox vaccine compared to other vaccinia vaccine. [ Time Frame: 1 to 5 years of post-vaccination ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00928577 on ClinicalTrials.gov Archive Site
Number of participants reporting dermatologic adverse events of rash following vaccination with either ACAM2000 or other vaccinia vaccine [ Time Frame: Day 10 post-vaccination ] [ Designated as safety issue: No ]

Dermatologic adverse events of rash are those that meet the following criteria:

  • Serious rashes persisting more than 48 hours that are distant from the vaccination site and
  • associated with systemic symptoms, or
  • involving mucous membranes.
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Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)
A Phase IV Prospective Safety Surveillance Cohort Study Of ACAM2000® In Deploying Military Personnel

Primary Objectives:

  • To compare the rates of myopericarditis (subclinical, suspected, probable, or confirmed) in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts.
  • To identify cases of subclinical myopericarditis in deploying military subjects who received ACAM2000 vaccine.

Secondary Objectives:

  • To compare the rates of severe and serious dermatologic adverse events observed in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts.
  • To compare the rates of severe and serious neurological adverse events observed in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts.
  • To compare the rates of adverse events observed in subjects approximately 10 days following their ACAM2000® vaccination to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts.
  • To evaluate potential risk factors associated with the development of confirmed, probable, and/or suspected ACAM2000-associated myopericarditis.

This is a prospective safety surveillance study in a US military Department of Defense (DoD) population. Military subjects either naive to smallpox immunization and have received ACAM2000® vaccine or who have previously been immunized with a vaccinia vaccine, usually Dryvax®, will be enrolled into the study.

No vaccine will be administered as part of this study.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Participants in Cohort 1 are vaccinia vaccine naive and had received ACAM2000® vaccine as part of their Service Member readiness.

Participants in Cohort 2 did not receive ACAM2000® vaccine as part of their Service Member readiness process because they are still protected by previous vaccinia vaccination or are ineligible for current ACAM2000 vaccination either because of recency of prior vaccinia vaccination or for reasons solely attributable to conditions or characteristics of their contacts (such as a healthy soldier who is married to someone with a contraindicated condition).

Smallpox
Not Provided
  • ACAM2000 Smallpox Vaccine Group
    Participants are vaccinia vaccine-naive and have received ACAM2000 Smallpox vaccine as part of their Service Member readiness process.
  • Other vaccinia vaccine Group
    Participants did not receive ACAM2000 Smallpox vaccine as part of their Service Member readiness process because they are still protected by previous vaccinia vaccination or are ineligible for current ACAM2000 vaccination either because of recency of prior vaccinia vaccination or for reasons solely attributable to conditions or characteristics of their contacts (such as a healthy soldier who is married to someone with a contraindicated condition).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20000
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria :

  • Written informed consent obtained prior to the conduct of any study-related procedures.
  • Male and Female military personnel positioned for active deployment.
  • Participant naïve to previous smallpox vaccination and received the ACAM2000 vaccine (Cohort 1), OR, Participant has not received ACAM2000 vaccine within the prior 3 years, AND is ineligible for current ACAM2000 vaccination either because of recency of prior vaccinia vaccination or for reasons solely attributable to conditions or characteristics of their contacts (such as a healthy soldier who is married to someone with a contraindicated condition) (Cohort 2).

Exclusion Criteria :

  • Subjects judged by the investigator as unlikely to understand the scope of the study and/or unlikely to be able to be compliant with the study procedures and visits.
  • Participation in any other studies involving investigational or marketed products within 30 days prior to Visit 1.
Both
17 Years and older
Yes
Contact: Public Registry Sanofi Pasteur RegistryContactUs@sanofipasteur.com
United States
 
NCT00928577
H-406-004
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc
Sanofi
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP