Immunogenicity and Safety of Trivalent Influenza Vaccine in Non-pregnant HIV-infected Women
NCT ID: NCT01812980
Last Updated: 2013-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
105 participants
INTERVENTIONAL
2013-05-31
2013-07-31
Brief Summary
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Detailed Description
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Visit 1 (enrollment) Informed Consent Form (ICF) signed Inclusion/ exclusion/ Withdrawal criteria Medical history Targeted physical exam Blood draw TIV administered Diary card dispensed
Local/ systematic reactions
Visit 2: 1 month post enrolment (28-35 days) Inclusion/ exclusion/ Withdrawal criteria Medical history Targeted physical exam Blood draw Diary card collected Local/ systematic reactions reviewed
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Trivalent Inactivated Influenza Vaccine
Single dose, intramuscular injection from a pre-filled syringe
WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains:
* an A/California/7/2009 (H1N1)pdm09-like virus;
* an A/Victoria/361/2011 (H3N2)-like virus; - a B/Wisconsin/1/2010-like virus.
Trivalent Inactivated Influenza Vaccine
WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains:
* an A/California/7/2009 (H1N1)pdm09-like virus;
* an A/Victoria/361/2011 (H3N2)-like virus; - a B/Wisconsin/1/2010-like virus.
Interventions
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Trivalent Inactivated Influenza Vaccine
WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains:
* an A/California/7/2009 (H1N1)pdm09-like virus;
* an A/Victoria/361/2011 (H3N2)-like virus; - a B/Wisconsin/1/2010-like virus.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to understand and comply with planned study procedures.
* Provides written informed consent prior to initiation of study.
* Not pregnant at time of enrolment (confirmed by urine testing). If pregnant in past year, participant must be at least 6 months post delivery at time of enrolment.
* Women age ≥ 18 years to \< 39 years.
Exclusion Criteria
* Receipt of any live licensed vaccine ≤ 28 days or any other vaccine (except for tetanus toxoid vaccine) ≤ 14 days prior to study-vaccine.
* Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) ≤ 28 days prior to vaccination in this study, unless study approval is obtained.
* Any significant (in the opinion of the site investigator) acute illness and/or oral temperature greater than or equal to 38 degrees C ≤ 24 hours prior to study entry.
* Use of anti-cancer systemic chemotherapy or radiation therapy ≤ 48 weeks of study enrollment, or has immunosuppression as a result of an underlying illness or treatment.
* Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) ≤ 12 weeks of study entry, or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) ≤ 12 weeks before study entry (nasal and topical steroids are allowed).
* Receipt of immunoglobulin or other blood products (with exception of Rho D immune globulin) ≤ 12 weeks prior to enrollment in this study or is scheduled to receive immunoglobulin or other blood products.
* Receipt of Interleukin 2, IFN, GMCSF or other immune mediators ≤ 12 weeks before enrollment.
* Uncontrolled major psychiatric disorder.
* History of a severe adverse reaction to previous TIV.
* Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
18 Years
39 Years
FEMALE
No
Sponsors
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Bill and Melinda Gates Foundation
OTHER
University of Witwatersrand, South Africa
OTHER
Responsible Party
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Michelle Groome
Investigator
Principal Investigators
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Shabir A Madhi, PHD
Role: PRINCIPAL_INVESTIGATOR
University of Witwatersrand, South Africa
Locations
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Nrf/Dst Vpd Rmpru
Soweto, Gauteng, South Africa
Countries
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Other Identifiers
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MatFlu_HIVpos_nonpregnant
Identifier Type: -
Identifier Source: org_study_id