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Clinical Trials/EUCTR2007-006297-28-DE
EUCTR2007-006297-28-DE
Active, not recruiting
Not Applicable

An open-label Phase II study to evaluate immunogenicity and safety of a single IMVAMUNE® booster vaccination two years after the last IMVAMUNE® vaccination in former POX-MVA-005 vaccinees

Bavarian Nordic A/S0 sitesMay 30, 2008
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Bavarian Nordic A/S
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 30, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Groups 1 and 2 (first 75 consenting subjects in each group to be vaccinated):
  • •1\. Male and female subjects having participated in Group 1 or 2 of the study POX MVA\-005 who completed the trial according to protocol.
  • •2\. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours prior to vaccination.
  • •3\. Women of childbearing potential must have used an acceptable method of contraception for 30 days prior to the vaccination, must agree to use an acceptable method of contraception during the study, and must not become pregnant for at least 28 days after the vaccination. A woman is considered of childbearing potential unless post\-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products.)
  • •4\. Read, signed and dated informed consent document after being advised of the risks and benefits of the study in a language understood by the subject signed, and prior to performance of any study specific procedure.
  • •5\. Troponin I within normal institutional limits.
  • •6\. White blood cells \= 2,500/mm3 and \= 11,000/mm3\.
  • •7\. Absolute neutrophil count within normal limits.
  • •8\. Negative urine glucose by dipstick or urinalysis.
  • •9\. Hemoglobin within the laboratory reference ranges (unless the investigator considers the deviation to be not clinically significant).

Exclusion Criteria

  • •Groups 1 and 2 (first 75 consenting subjects in each group to be vaccinated:
  • •1\. Participation in another study with a smallpox vaccine after the POX\-MVA\-005 study.
  • •2\. Pregnant or breast\-feeding women.
  • •3\. Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
  • •4\. History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject.
  • •5\. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
  • •6\. Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
  • •7\. History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous site of cancer.
  • •8\. History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders.
  • •9\. Clinically significant mental disorder not adequately controlled by medical treatment.

Outcomes

Primary Outcomes

Not specified

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