Phase 4
N=465
Immunologic Response to FluMist vs. Flucelvax
Influenza, Human · Immune Response
Bottom Line
View on ClinicalTrials.gov: NCT03982069 ↗Enrolled (actual)
465
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Number of Participants With Seroconversion Response In 2019 — 5; 33; 11; 44 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- FluMist live attenuated influenza vaccine (Biological); Flucelvax inactivated influenza vaccine (Biological)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Richard Zimmerman MD
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Seroconversion Response In 2019 |
5; 33; 11; 44; 8; 47 | <0.001 sig |
| PRIMARY Number of Participants With Seroconversion Response In 2020 |
8; 59; 10; 58; 2; 38 | <0.001 sig |
| SECONDARY Number of Participants With Seroprotection Response in 2019 |
54; 61; 58; 93; 34; 41 | <0.001 sig |
| SECONDARY Geometric Mean Titers (GMTs) at Each Time Point 2019 |
94; 90; 108; 269; 75; 78 | 0.79 |
| SECONDARY Number of Participants With Seroprotection Response in 2020 |
25; 25; 33; 79; 59; 54 | 0.83 |
| SECONDARY Geometric Mean Titers (GMTs) at Each Time Point 2020 |
42; 34; 51; 171; 97; 84 | 0.22 |
Summary
The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-21 years of age. This is a randomized controlled trial (RCT), that will assess immune response in about 440 participants (about 220 per vaccine arm) pre- and post-vaccination to FluMist (live attenuated influenza vaccine given by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine).
Eligibility Criteria
Inclusion Criteria
- aged 4-21 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 (NCT03982069). 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.