Clinical trial of safety (reactogenicity) and immunogenicity of needle-free jet injection of reduced-dose, intradermal, Influenza vaccine (INF) administered to more than or equal to six month- to less than 24 month-old infants and toddlers in the Dominican Republic
- Conditions
- InfluenzaInfections and InfestationsInfluenza and pneumonia
- Registration Number
- ISRCTN64287576
- Lead Sponsor
- Centers for Disease Control and Prevention
- Brief Summary
2008 Interim results of phase I, presented at the 11th Annual Conference on Vaccine Research, May 2008. Abstract P-25 available on nominal page 80 (81 of 106) in the abstract book: http://www.nfid.org/pdf/conferences/vaccine08abstracts.pdf
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 450
1. Age from six or older to less than 24 months
2. Born after a full-term pregnancy of gestational age of more than or equal to 37 weeks, and a birth weight of more than or equal to 2.5 kg
3. History of prior or first attendance as a patient, or as a sibling of a patient, seeking routine immunisation or other clinical care at the Hospital Infantil Robert Reid Cabral (HIRRC)
4. Up-to-date for routine doses of vaccines officially recommended for the participants age in the Dominican Republic
5. In good health
1. Have fever (by parental report or by rectal temperature greater than or equal to 38.5°C or axillary greater than or equal to 38.0°C) currently or within the past three days, or who are currently suffering from an acute or chronic infectious disease
2. Have had an acute or chronic infection requiring systemic antimicrobial therapy (antibiotic or antiviral) or other prescribed treatment within the past 21 days
3. Are malnourished, defined by weight less than two standard deviations below the median weight for their age
4. Are allergic to eggs, or have a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations, or have allergy or hypersensitivity to any component of the study vaccine
5. Have ever received previously any influenza vaccine
6. Have received within the prior 28 days, or for whom there is the indication to receive in the next 56 days, any non-study vaccination or investigational agent outside of the study
7. Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
8. Have currently any serious confirmed or suspected disease, such as metabolic, cardiac, or autoimmune disease, or diabetes
9. Have a history of epilepsy or a seizure disorder, or neurodevelopmental disorders such as autism
10. Have any condition which, in the opinion of the investigator, may interfere in the evaluation of the objectives of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Immunogenicity