Phase 3
Completed N=607
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05
Source: ClinicalTrials.gov NCT02255409 ↗Enrolled (actual)
607
Serious AEs
1.8%
Results posted
Mar 2023
Primary outcomePrimary: Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs. — 7; 4; 0; 0 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 This can indicate results are unpublished — a known publication-bias signal.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
Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial V118\_05
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs. |
7; 4; 0; 0; 13; 7 | — |
| PRIMARY Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22) |
57.9; 56.4; 50.7; 56.6; 73.5; 57.2 | — |
| PRIMARY Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22). |
100.0; 99.6; 99.7; 100.0; 95.7; 81.3 | — |
| SECONDARY Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature |
0; 0; 0; 0 | — |
| SECONDARY Safety Endpoint: Number of Subjects With Any Unsolicited AEs |
85; 60 | — |
| SECONDARY Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) |
202; 148; 173; 112; 127; 80 | — |
| SECONDARY Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181) |
27.7; 21.9; 30.1; 27.9; 24.6; 12.7 | — |
| SECONDARY Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 181) |
99.7; 94.8; 99.7; 94.0; 73.0; 39.8 | — |
| SECONDARY Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181) |
320.27; 165.23; 1036.27; 700.78; 424.00; 282.31 | — |
| SECONDARY Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains |
5.82; 3.93; 2.40; 1.60; 5.41; 4.03 | — |
| SECONDARY Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181) |
36.1; 30.4; 27.7; 13.2 | — |
| SECONDARY Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Heterologous Influenza Strains (Day 181) |
96.8; 80.4; 83.9; 37.5 | — |
| SECONDARY Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181) |
126.35; 48.02; 630.62; 402.54; 304.10; 179.12 | — |
| SECONDARY Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains |
7.80; 4.98; 3.72; 2.19; 9.29; 4.21 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subject who has completed their Day 181 clinic visit for non-naïve subjects or their Day 209 clinic visit for naïve subjects in parent study.
- Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up
Exclusion Criteria
- Individuals recently vaccinated against influenza.
- Subjects with contraindications to receive influenza vaccine.
- Please contact the site for additional eligibility criteria.
Data sourced from ClinicalTrials.gov (NCT02255409). 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.