Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6-35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres.
| Τίτλος | Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6-35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres. |
| Publication Type | Journal Article |
| Year of Publication | 2019 |
| Authors | Pepin, S., Dupuy M., Borja-Tabora C. Fay Corazo, Montellano M., Bravo L., Santos J., de Castro J-A., Rivera-Medina D. Maribel, Cutland C., Ariza M., Diez-Domingo J., Gonzalez C. Diaz, Martinón-Torres F., Papadopoulou-Alataki E., Theodoriadou M., Kazek-Duret M. Pierre, Gurunathan S., & De Bruijn I. |
| Corporate Authors | GQM05 Study Group |
| Journal | Vaccine |
| Volume | 37 |
| Issue | 13 |
| Pagination | 1876-1884 |
| Date Published | 2019 03 22 |
| ISSN | 1873-2518 |
| Λέξεις κλειδιά | Africa, Americas, Antibodies, Viral, Asia, Child, Preschool, Double-Blind Method, Europe, Female, Humans, Immunogenicity, Vaccine, Infant, Influenza A Virus, H1N1 Subtype, Influenza A Virus, H3N2 Subtype, Influenza B virus, Influenza Vaccines, Influenza, Human, Internationality, Male, Seasons, Vaccines, Inactivated |
| Abstract | BACKGROUND: A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetra™, Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata) was approved in Europe in 2016 for individuals aged ≥ 3 years. This study examined the efficacy and safety of IIV4 in children aged 6-35 months.METHODS: This was a phase III randomised controlled trial conducted in Latin America, Asia, Africa, and Europe during the Northern Hemisphere 2014/2015 and 2015/2016 and Southern Hemisphere 2014 and 2015 influenza seasons. Healthy children aged 6-35 months not previously vaccinated against influenza were randomised to receive two full doses 28 days apart of IIV4, placebo, the licensed trivalent split-virion inactivated vaccine (IIV3), an investigational IIV3 containing a B strain from the alternate lineage. The primary objective was to demonstrate efficacy against influenza illness caused by any strain or vaccine-similar strains.RESULTS: The study enrolled 5806 participants. Efficacy, assessed in 4980 participants completing the study according to protocol, was demonstrated for IIV4. Vaccine efficacy was 50.98% (97% CI, 37.36-61.86%) against influenza caused by any A or B type and 68.40% (97% CI, 47.07-81.92%) against influenza caused by vaccine-like strains. Safety profiles were similar for IIV4, placebo, and the IIV3s, although injection-site reactions were slightly more frequent for IIV4 than placebo.CONCLUSIONS: IIV4 was safe and effective for protecting children aged 6-35 months against influenza illness caused by vaccine-similar or any circulating strains.CLINICAL TRIAL REGISTRATION: EudraCT no. 2013-001231-51. |
| DOI | 10.1016/j.vaccine.2018.11.074 |
| Alternate Journal | Vaccine |
| PubMed ID | 30558818 |
