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document
Safety and tolerability of cold-adapted influenza vaccine , trivalent , in infants younger than 6 months of age . OBJECTIVE Young children are at high risk for influenza-related complications . Vaccination of close household contacts is recommended to provide indirect protection to children < 6 months of age . Studies have shown that live , cold-adapted influenza vaccine , trivalent , is efficacious in children . To assess the risks associated with inadvertent exposure of infants to vaccine viruses from vaccinated contacts , this study was designed to evaluate the safety and tolerability of cold-adapted influenza vaccine , trivalent , administered intranasally to healthy children 6 to < 24 weeks of age . METHODS Healthy infants aged 6 to < 16 weeks and 16 to < 24 weeks , respectively , were randomly assigned to receive 2 doses of influenza vaccine , or placebo intranasally 35 +/- 7 days apart . Reactogenicity events were monitored for 11 days after each dose . Other adverse events were monitored through 28 to 35 days after dose 2 . RESULTS Of the infants aged 6 to < 16 weeks , 31 received influenza vaccine and 28 received placebo , and of those aged 16 to < 24 weeks , 30 received influenza vaccine and 31 received placebo . In the 6- to < 16-week cohort , more influenza vaccine , recipients experienced irritability ( 66.7 % vs 35.7 % ) and runny nose or nasal congestion ( 63.3 % vs 33.3 % ) after dose 1 but not dose 2 . There were no significant increases in any other reactogenicity events or adverse events in the vaccine recipients compared with the placebo group . CONCLUSIONS Although there was an increase in mild reactogenicity events in children 6 to < 16 weeks of age , cold-adapted influenza vaccine , trivalent , was generally well tolerated in infants 6 to < 24 weeks of age . These findings support further evaluation of cold-adapted influenza vaccine , trivalent , in infants < 6 months of age .
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Intervention_Pharmacological
influenza vaccine , trivalent
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Intervention_Pharmacological
influenza vaccine
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Intervention_Pharmacological
influenza vaccine
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Intervention_Pharmacological
2 doses of influenza vaccine
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Intervention_Control
placebo
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Intervention_Pharmacological
influenza vaccine
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Intervention_Control
placebo
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Intervention_Pharmacological
influenza vaccine
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Intervention_Control
placebo .
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Intervention_Control
placebo
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Intervention_Pharmacological
influenza vaccine
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Intervention_Pharmacological
influenza vaccine
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Outcome_Other
Safety and tolerability
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Outcome_Other
safety and tolerability
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Outcome_Adverse-effects
irritability
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Outcome_Adverse-effects
runny nose or nasal congestion
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Outcome_Adverse-effects
reactogenicity events or adverse events
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Outcome_Adverse-effects
mild reactogenicity events
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Participant_Age
infants younger than 6 months of age
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Participant_Age
Young children
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Participant_Age
children < 6 months of age
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Participant_Condition
healthy
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Participant_Age
children 6 to < 24 weeks of age
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Participant_Condition
Healthy
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Participant_Age
infants aged 6 to < 16 weeks and 16 to < 24 weeks
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Participant_Age
6 to < 16 weeks
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Participant_Age
16 to < 24 weeks
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Participant_Age
6 to < 16 weeks
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Participant_Age
6 to < 24 weeks
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Participant_Age
6 months