Phase 3
Completed N=2,414
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
Influenza · Human · Virus Diseases
Source: ClinicalTrials.gov NCT04074928 ↗
Enrolled (actual)
2,414
Serious AEs
0.9%
Results posted
Jan 2022
Primary outcomePrimary: Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HAI) Assay Using Cell-derived Target Viruses — 78.0; 57.3; 35.6; 26.0 Titer
◆ Published Evidence
Emerging
15citations · ~4 / year
Safety and Immunogenicity of Cell-Based Quadrivalent Influenza Vaccine: A Randomized Trial.
Summary
This phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47 months of age. The purpose of this study is to demonstrate that vaccination with QIVc elicits an immune response that is noninferior to that of a US-licensed comparator QIV containing the same virus strains, in children 6 months through 47 months of age.
Linked Publications
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Safety and Immunogenicity of Cell-Based Quadrivalent Influenza Vaccine: A Randomized Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HAI) Assay Using Cell-derived Target Viruses |
78.0; 57.3; 35.6; 26.0; 22.4; 19.6 | — |
| PRIMARY Immunogenicity Endpoint: Seroconversion Rates (SCR) and Differences in SCR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived Target Viruses |
58.24; 46.78; 46.52; 31.65; 30.31; 24.35 | — |
| PRIMARY Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses |
23.1; 23.9 | — |
| PRIMARY Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses |
27.64; 30.77 | — |
| SECONDARY Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses |
14.0; 13.9; 92.2; 82.9; 6.7; 6.7 | — |
| SECONDARY Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H1N1, B/Victoria and B/ Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses |
58.52; 56.00; 38.64; 38.61; 19.69; 20.87 | — |
| SECONDARY Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses |
12.9; 12.6; 43.4; 44.7 | — |
| SECONDARY Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses |
37.44; 39.34 | — |
| SECONDARY Immunogenicity Endpoint: Geometric Mean Ratio (GMR) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived and Egg-derived Target Viruses |
5.34; 3.97; 4.12; 3.03; 2.65; 2.31 | — |
| SECONDARY Immunogenicity Endpoint: GMR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived and Egg-derived Target Viruses |
5.74; 4.29; 3.14; 2.86; 1.88; 1.63 | — |
| SECONDARY Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and Egg-derived Target Viruses |
2.11; 2.19; 3.13; 3.22 | — |
| SECONDARY Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs) |
940; 491; 656; 350; 681; 358 | — |
| SECONDARY Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs |
418; 207; 308; 164; 98; 41 | — |
| SECONDARY Safety Endpoint: Percentage of Subjects With Any Serious Adverse Events (SAEs), New Onset of Chronic Disease (NOCD) or AEs Leading to Withdrawal During the Entire Study Period |
15; 7; 0; 0; 3; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Individuals of 6 through 47 months of age on the day of informed consent.
- Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Individuals who can comply with study procedures including follow-up
- Individual is in generally good health as per the Investigator's medical judgement
Exclusion Criteria
- Acute (severe) febrile illness
- History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study
- A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis
- Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
- Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
Data sourced from ClinicalTrials.gov (NCT04074928) and the linked publication. 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.