Phase 3
Completed N=1,601
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)
Source: ClinicalTrials.gov NCT02583256 ↗Enrolled (actual)
1,601
Serious AEs
2.3%
Results posted
Apr 2019
Primary outcomePrimary: Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis — 1219.00; 1020.89; 2355.52; 2529.83 titer
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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. Subjects will receive either the Same or Alternate Type of Vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis |
1219.00; 1020.89; 2355.52; 2529.83; 276.23; 232.82 | — |
| PRIMARY Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis |
1218.91; 1023.37; 2345.71; 2521.60; 274.75; 230.51 | — |
| SECONDARY Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison) |
1206.20; 866.51; 2369.95; 2229.48; 221.54; 156.01 | — |
| SECONDARY Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) |
489.45; 411.72; 429.06; 307.36; 1423.38; 1438.40 | — |
| SECONDARY Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) |
62.7; 60.9; 72.04; 62.37; 68.9; 68.0 | — |
| SECONDARY Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains |
7.69; 6.44; 7.61; 5.47; 3.11; 2.61 | — |
| SECONDARY Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains |
100; 100; 100; 99.7; 100; 99.2 | — |
| SECONDARY Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains |
100.0; 100.0; 99.7; 97.7; 100.0; 100.0 | — |
| SECONDARY Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains |
97.7; 156.6; 40.9; 91.6; 2436.1; 2415.2 | — |
| SECONDARY Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains |
14.67; 14.55; 13.40; 12.63; 5.31; 5.42 | — |
| SECONDARY Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains |
78.3; 73.7; 83.1; 69.0; 100; 100 | — |
| SECONDARY Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains |
264.36; 198.13; 104.28; 140.38; 2253.81; 2295.46 | — |
| SECONDARY Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains |
11.85; 12.07; 15.73; 8.11; 3.67; 3.66 | — |
| SECONDARY Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains |
1174.69; 1209.21; 230.09; 182.80; 3403.72; 3161.01 | — |
| SECONDARY Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains |
5.40; 5.02; 5.70; 3.83; 3.95; 2.63 | — |
| SECONDARY Safety Endpoint: Percentage of Subjects With Solicited AEs |
64.76; 50.12; 53.48; 40.71; 44.67; 37.97 | — |
| SECONDARY Safety Endpoint: Percentage of Subjects With Unsolicited AEs |
54.09; 55.33; 55.97; 52.16; 6.20; 3.97 | — |
| SECONDARY Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE. |
2.48; 2.73; 1.74; 2.04; 0; 0 | — |
| SECONDARY Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature |
0.25; 0.74; 0.25; 0.76 | — |
| SECONDARY Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness |
3.23; 3.47; 3.73; 2.80; 1.49; 1.49 | — |
| SECONDARY Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains |
100.00; 100.00; 100.00; 100.00; 98.31; 100.00 | — |
| SECONDARY Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains |
100.00; 100.00; 100.00; 100.00; 100.00; 100.00 | — |
Eligibility Criteria
Inclusion Criteria
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
- Subject's parent/legal guardian has voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Male or female subject who has completed their Visit 13 (Study Day 366 for non-naïve subjects) or clinic Visit 15 (Day 390 for naïve subjects) in parent trial V118\_05.
- For naïve subjects in parent trial V118\_05 to have received two doses of the same study vaccine (i.e. 2 doses of aQIV or 2 doses of QIV).
Exclusion Criteria
- Previous immunization with any influenza vaccine (licensed or investigational) within 6 months prior to enrollment.
- Subjects with a clinical condition representing a contraindication to intramuscular vaccination or blood draws.
- Unwillingness of the parent(s)/ legal guardian(s) of the subject to refuse to participate in another clinical trial while enrolled in V118-05E3.
Additional eligibility criteria may be discussed by contacting the site.
Data sourced from ClinicalTrials.gov (NCT02583256). 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.