Phase 4
Completed N=166
Immunologic Response to Influenza Vaccination in Children and Adolescents
Influenza, Human · Immune Response
Source: ClinicalTrials.gov NCT03614975 ↗
Enrolled (actual)
166
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination — 20; 14; 9; 11 Participants — p=0.28
◆ Published Evidence
Established
▲ Trending
20citations · ~3 / year
A randomized controlled trial of antibody response to 2018-19 cell-based vs. egg-based quadrivalent inactivated influenza vaccine in children.
Summary
The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-20 years of age. This is a randomized controlled trial (RCT), that will assess immune response in 120 participants (60 per vaccine arm) pre- and post-vaccination to Flucelvax (egg-free inactivated flu shot) and Fluzone (egg-based inactivated flu shot).
Linked Publications
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A randomized controlled trial of antibody response to 2018-19 cell-based vs. egg-based quadrivalent inactivated influenza vaccine in children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination |
20; 14; 9; 11; 22; 24 | 0.28 |
| SECONDARY Determining Seroprotection Level at Each Time Point |
45; 39; 66; 58; 51; 45 | 0.42 |
| SECONDARY Determining Geometric Mean Titers (GMTs) at Each Time Point |
6.63; 6.42; 8.08; 7.76; 7.42; 6.94 | 0.49 |
Eligibility Criteria
Inclusion Criteria
- aged 4-20 years;
- has prior vaccination history available (which can be determined based either on medical record review or through state registry review;
- plans to receive the current seasonal influenza vaccination at one of the recruiting sites
Exclusion Criteria
- unable or unwilling to completed required study activities, including informed consent, randomization to vaccine, and bloodwork;
- has already received influenza vaccine for the current season;
- has a known immunocompromising condition or is on an immunosuppressing medication (e.g., high dose steroids >10 days);
- is known to be pregnant;
- has a history of severe allergy to eggs or to influenza vaccine or any of its components
Data sourced from ClinicalTrials.gov (NCT03614975) 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.