Phase 4
Completed N=240
Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations
Source: ClinicalTrials.gov NCT03617523 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions — 15; 3; 4; 2 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objectives of this study were:
* To describe the immunogenicity of the 2018-2019 formulation of Fluzone® Quadrivalent vaccine in children 6 to less than ( =) 65 years of age.
* To describe the safety of the 2018-2019 formulation of Fluzone Quadrivalent vaccine in children 6 to =65 years of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions |
15; 3; 4; 2; 3; 4 | — |
| PRIMARY Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions |
9; 27; 22; 24; 5; 1 | — |
| PRIMARY Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine |
229; 1008; 239; 1109; 160; 688 | — |
| PRIMARY Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine |
525; 708; 266; 379; 644; 359 | — |
| PRIMARY Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine |
9.06; 4.47; 3.94; 6.40; 8.11; 13.3 | — |
| PRIMARY Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine |
2.93; 6.34; 3.07; 3.55; 8.19; 3.69 | — |
| PRIMARY Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2 |
84.6; 96.6; 80.8; 96.6; 80.8; 100 | — |
| PRIMARY Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 |
100; 100; 93.3; 98.4; 100; 98.3 | — |
| PRIMARY Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2 |
80.0; 42.9; 56.0; 64.3; 80.0; 92.9 | — |
| PRIMARY Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5 |
32.8; 51.7; 46.7; 44.3; 70.7; 50.0 | — |
Eligibility Criteria
Inclusion criteria
- Aged 6 months to =18 years on the day of first study vaccination (study product administration).
- For participants 6 to =37 weeks) and with a birth weight >=2.5 kilograms (kg) (5.5 pounds [lbs.]).
- Informed consent form (ICF) had been signed and dated by participants >=18 years of age.
- Assent form had been signed and dated by participants 7 to =100.4 degree Fahrenheit [38.0 degree Celsius]). A prospective participant was not included in the study until the condition had resolved or the febrile event had subsided.
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study (participants >=18 years of age) or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study (all participants).
- History of serious adverse reaction to any influenza vaccine.
- Personal history of Guillain-Barré syndrome.
- Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
- Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.
- Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT03617523). 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.