Phase 4
Completed N=90
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2020-2021 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
Influenza Immunization · Healthy Volunteers
Source: ClinicalTrials.gov NCT04551677 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2 — 29; 31; 15; 30 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 This can indicate results are unpublished — a known publication-bias signal.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
Primary Objective:
To provide serum samples (collected from participants before vaccination [Blood Sample 1] and after final vaccination [Blood Sample 2]) to Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines. In addition, serum samples from adult participants may be further analyzed by the Sponsor to assess breadth of immune response induced by the study vaccines.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2 |
29; 31; 15; 30; 14; 1 | — |
| PRIMARY Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3 |
30; 30 | — |
Eligibility Criteria
Inclusion criteria
- Aged 6 months to =65 years of age on the day of first study vaccination (study product administration).
- For participants 6 to =37 weeks) and with a birth weight >=5.5 pound (lbs) (2.5 kilograms [kg]).
- Informed consent form (ICF) was signed and dated by participants >=65 years of age.
- Assent form was signed and dated by participants 7 to =100.4 degree [°] Fahrenheit [38.0° Celsius]). A prospective participant 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 or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) or in-laws of the Investigator or employee with direct involvement in the proposed study.
- 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 (NCT04551677). 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.