Phase 3
Completed N=5,723
Efficacy Study With QIVc in Pediatric Subjects
Influenza, Human
Source: ClinicalTrials.gov NCT03932682 ↗
Enrolled (actual)
5,723
Serious AEs
2.6%
Results posted
Mar 2025
Primary outcomePrimary: Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match — 104; 173 Cases
◆ Published Evidence
Not yet cited
0citations
Efficacy, immunogenicity, and safety of a cell culture-derived quadrivalent influenza vaccine compared with a non-influenza vaccine in infants and children across five influenza seasons: a phase 3, multinational, observer-blind, randomised controlled trial.
Summary
This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of laboratory confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.
Linked Publications
-
Efficacy, immunogenicity, and safety of a cell culture-derived quadrivalent influenza vaccine compared with a non-influenza vaccine in infants and children across five influenza seasons: a phase 3, multinational, observer-blind, randomised controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match |
104; 173 | — |
| PRIMARY Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza, Due to Influenza Type A and/or B Virus Antigenically Matched by Ferret Antigenicity Testing to the Strains Selected for the Seasonal Influenza Vaccine |
44; 82 | — |
| SECONDARY Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Caused by Influenza Virus Strains Antigenically Dissimilar to the Influenza Strains Selected for the Seasonal Influenza Vaccine |
20; 43 | — |
| SECONDARY Efficacy Endpoint: First Occurrence of Culture Confirmed Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine |
61; 121 | — |
| SECONDARY Efficacy Endpoint: First Occurrence of RT-PCR Confirmed Moderate-to-severe Influenza Due to Any Influenza Type A and/or Type B Virus Regardless of Antigenic Match to the Influenza Strains Selected for the Seasonal Influenza Vaccine |
0; 9 | — |
| SECONDARY Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay) |
40.06; 44.28; 22.99; 27.50; 10.15; 8.72 | — |
| SECONDARY Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay) |
45.54; 12.04; 57.01; 3.60; 68.47; 2.68 | — |
| SECONDARY Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay) |
3.36; 1.53; 3.71; 0.67; 6.28; 0.70 | — |
| SECONDARY Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay) |
22.06; 31.10; 57.54; 55.89; 61.40; 43.43 | — |
| SECONDARY Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay) |
73.21; 2.78; 74.77; 4.50; 87.39; 4.46 | — |
| SECONDARY Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay) |
16.16; 1.70; 8.12; 1.15; 17.55; 0.81 | — |
| SECONDARY Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs) |
55.8; 60.8; 32.3; 40.4; 40.9; 42.5 | — |
| SECONDARY Safety Endpoint: Percentage of Subjects With Unsolicited AEs |
42.5; 45.4; 4.2; 3.6 | — |
| SECONDARY Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination |
2.2; 3.0; 0; 0.04; 0.7; 0.4 | — |
| SECONDARY Safety Endpoint: Percentage of Subjects With Medically-attended AEs |
28.9; 32.6 | — |
Eligibility Criteria
Inclusion Criteria
In order to participate in this study, all subjects must meet all of the inclusion criteria described.
- 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.
- Individuals in generally good health as per the Investigator's medical judgement.
If applicable, prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet the criteria of the original inclusion criteria listed above, they should not receive additional vaccinations.
Exclusion Criteria
- Acute (severe) febrile illness. Enrollment could be considered if the fever is absent for 72 hours.
- 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.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination.
- A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
- Abnormal function of the immune system resulting from a clinical condition
- Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
- Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism.
Additional eligibility criteria are provided in the study protocol.
Data sourced from ClinicalTrials.gov (NCT03932682) 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.