A safety study to compare, over a 7 day period, the fever rates following one dose of either Influenza Virus Vaccine or placebo administered outside the influenza season to healthy children and adolescents aged 6 to less than 18 years.
This was a prospective, randomized, double-blind, placebo-controlled, study. Subjects were randomized to receive either CAIV-T or Placebo. All subjects were healthy children and adolescents aged at least 6 years of age and less than 18 years of age at the time of enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
240
The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 ml into each nostril). Each dose of CAIV-T used in this study contained approximately 10\^7+/-0.5 fluorescent focus units (FFU) (equivalent to 10\^7+/-0.5 TCID50) of each of the following three influenza virus strains: Influenza Cold Adapted Virus Type H1N1, strain A/New Caledonia/20/99; Influenza Cold Adapted Virus Type H3N2, strain A/ Panama/2007/99; Influenza Cold Adapted Virus Type B, strain B/Hong Kong/ 330/01.
The placebo consisted of physiologic normal saline.
Catholic University Leuven
Leuven, Belgium
Zamenhoflaan 12
Schoten, Belgium
Universiteit Antwerpen
Wilrijk, Belgium
Oddzial Dzieciecy Szpitala Powiatowete im
Trzebnica, Poland
Number of subjects with fever greater than or equal to 39.1C oral
Time frame: Days 0-7
Number of subjects with any reactogenicity
Following vaccination the following reactions were reported daily: runny nose/nasal congestion, sore throat, cough, vomiting, decreased activity level, decreased appetite, irritability, abdominal pain together with oral temperature were referred to as prompted systemic reactions.
Time frame: Day 0-7
Number of subjects with any adverse events
Adverse events were defined as any untoward, undesired or unexpected clinical event in the form of signs, symptoms, disease or laboratory or physiological observations that occurred in a temporal relationship to the use of a WVR product, regardless of causal relationship.
Time frame: Days 0-7
Number of subjects with any serious adverse events
A Serious AE was an AE that occurred after any dose that: resulted in death, regardless of cause; was life-threatening; required in-patient hospitalization or prolonged an existing hospitalization; resulted in a persistent or significant disability or incapacity; resulted in cancer; resulted in a congenital anomaly or birth defect (in the offspring of a vaccine recipient, where applicable).
Time frame: Days 0-21
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The Gables Medicentre
Coventry, United Kingdom
Townhead Surgery
Irvine, Ayshire, United Kingdom