Phase 3
Completed N=430
A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications
Source: ClinicalTrials.gov NCT01998477 ↗Enrolled (actual)
430
Serious AEs
3.8%
Results posted
Apr 2017
Primary outcomePrimary: Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group — 149; 41; 89; 18 Subjects
◆ Published Evidence
Emerging
8citations · ~1 / year
Safety and tolerability of cell culture-derived and egg-derived trivalent influenza vaccines in 3 to <18-year-old children and adolescents at risk of influenza-related complications.
Summary
The study is designed to evaluate the safety of TIVc or TIV vaccine in children 3 to < 18 years of age who are at risk of complications of influenza disease due to underlying diseases.
Linked Publications
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Safety and tolerability of cell culture-derived and egg-derived trivalent influenza vaccines in 3 to <18-year-old children and adolescents at risk of influenza-related complications.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group |
149; 41; 89; 18; 25; 20 | — |
| PRIMARY Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata |
14; 19; 22; 12; 7; 7 | — |
| PRIMARY Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata |
213; 111; 77; 46; 90; 32 | — |
Eligibility Criteria
Inclusion Criteria
- Individuals 3 to <18 years of age with underlying medical conditions that indicate an increased risk of complications from influenza infection.
- Further eligibility criteria may be discussed by contacting the site(s)
Exclusion Criteria
- Individuals with any fatal prognosis of an underlying medical condition (<12 month life expectancy).
- Individuals hospitalized at the time of enrolment.
- Individuals with a history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any of the vaccine components.
- Further eligibility criteria may be discussed by contacting the site(s)
Data sourced from ClinicalTrials.gov (NCT01998477) and the linked publication. 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.