Study of the Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in a Community-Based, Non-Randomized, Open-Label Trial in Children to Assess Safety and Herd Immunity for the Control of Epidemic Influenza
Influenza virus vaccine (CAIV-T)
Infections+4
+ Orthomyxoviridae Infections
+ Respiratory Tract Diseases
Prevention Study
Summary
This is a Phase III trial (an advanced study with a large number of patients). Your child will receive a single dose of flu vaccine, which is given by a nasal spray.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 Months to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Your child may be eligible for this study if he/she: Is between the ages of 18 months and 18 years, with consent of parent or guardian. Is a resident of the Temple-Belton, Texas area. Exclusion Criteria: Your child will not be eligible for this study if he/she: Has had a fever within 3 days before vaccination. Has symptoms of a weakened immune system. Has had a wheezing episode within the past 2 weeks. Has moderate to severe asthma. Is allergic to eggs. Needs to take aspirin on a regular basis. Has received another vaccine or study drug in the past month.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location