Phase 3 Completed N=2,055 Randomized Single-blind Prevention

Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

Influenza · Fever

Source: ClinicalTrials.gov NCT01857206 ↗

Enrolled (actual)

2,055

Serious AEs

2.0%

Results posted

Nov 2014

Primary outcomePrimary: Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. — 422; 202; 370; 160 Subjects

Summary

Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.	422; 202; 370; 160; 109; 43	—
PRIMARY Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.	277; 139; 158; 88; 50; 26	—
PRIMARY Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.	17; 7; 7; 9; 0; 0	—

Eligibility Criteria

Inclusion Criteria

Healthy subjects 4-17 years of age

Exclusion Criteria

Subjects who are not healthy,
Subjects who are pregnant or breast feeding,
Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01857206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.