Status:
WITHDRAWN
Safety and Immunogenicity Study of Influenza Vaccines in HIV-infected and HIV-uninfected Pregnant Women in Western Kenya
Lead Sponsor:
Centers for Disease Control and Prevention
Conditions:
Influenza, Human
HIV
Eligibility:
FEMALE
13-49 years
Phase:
PHASE2
PHASE3
Brief Summary
In 2012, the WHO Strategic Advisory Group of Experts (SAGE) concluded that pregnant women are the most important risk group for season influenza vaccination based upon "compelling evidence of substant...
Detailed Description
Recent investments in influenza surveillance in many African countries confirm results from other countries that young children, pregnant women, and those with chronic medical conditions are at increa...
Eligibility Criteria
Inclusion
- Resident of HDSS village
- Singleton pregnancy
- Second or third trimester (after quickening) but before 33 weeks of gestation by fundal height
- Does not plan to relocate out of the HDSS area or population-based surveillance site in the next 12 months and agrees to all follow-up visits/contact by phone
- Is not currently enrolled in another intervention study
- Provides informed consent by signature or thumb print
- Consents to HIV testing and counseling as required
- Willing to deliver in the labor ward of the study hospital
- No history of chronic illness requiring multiple hospitalizations or prolonged medical therapy (except HIV on ART)
Exclusion
- History of allergic reaction to any component of the study vaccines
- Residence outside the study area or planning to relocate out in the 9 months following enrollment
- Received immunoglobulin or blood products within 45 days of study entry
- Used immunosuppressive medication within 45 days of study entry (inhaled and topical corticosteroids permitted)
- High risk pregnancy including any pre-existing condition likely to cause complications of pregnancy (hypertension, diabetes, current asthma, eclampsia or pre-eclampsia, epilepsy, heart disease, renal disease, liver disease, fistula repair, leg or spine deformity)
- Unable to give informed consent (for example due to mental disability)
- Previous enrollment in a study with similar interventions
- Gestational age \>32 weeks by last menstrual period or fundal height
- Acutely ill with temperature ≥37.5°C on the day of randomization/vaccination
- Hemoglobin \<7.0 g/dL
- Influenza vaccination in previous 12 months
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01810731
Start Date
April 1 2014
End Date
April 1 2014
Last Update
April 10 2014
Active Locations (1)
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1
Siaya District Hospital
Siaya, Kenya