15 Dec Flu: Vaccine For Prevention in Children

MedicalResearch.com Interview with:
Ghassan Dbaibo, M.D., FAAP
Professor and Vice-Chair for Research and Faculty Development
Department of Pediatrics and Adolescent Medicine
Head, Division of Pediatric Infectious Diseases
Director, Center for Infectious Diseases Research
Professor, Department of Biochemistry and Molecular Genetics
American University of Beirut Beirut, Lebanon

MedicalResearch.com: What are the main findings of the study?

Dr. Dbaibo:

• 55% efficacy (95% CI 39–67%) for prevention of all influenza
• These results are comparable with other estimates of efficacy and effectiveness for trivalent inactivated flu vaccines in this age group
•  73% efficacy (97.5% CI 47–86%) for prevention of moderate-to-severe influenza
• By preventing moderate-to-severe influenza, vaccination prevented the most clinically consequential outcomes of infection, reducing hospitalisations by 75% and medical visits by 69%.
• Seroprotection rates of more than 95% for each of the four influenza strains in the vaccine
• An acceptable safety and reactogenicity profile
  MedicalResearch.com: Were any of the findings unexpected?

Dr. Dbaibo:

This the first large randomised controlled study of the efficacy of a quadrivalent inactivated vaccine against both influenza A and B. The results were in complete alignment with the immunogenicity and safety data from the Phase II clinical trials. They also include a novel endpoint ‘moderate-to-severe influenza’,  chosen because parents are most likely to seek medical help for children who have high fever, earache, or lower respiratory symptoms.  The results have confirmed the efficacy of the vaccine against influenza, and particularly against moderate-to-severe influenza.  They also showed an 80% reduction in lower respiratory tract infections – the most common serious outcome of influenza.  Therefore, vaccination of children in this age group can help to reduce the significant burden placed on parents, doctors and hospitals every flu season.

MedicalResearch.com: What should clinicians and patients take away from your report?

Dr. Dbaibo:

The results confirm the efficacy of the QIV vaccine against influenza, and particularly against moderate-to-severe influenza.  They also showed an 80% reduction in lower respiratory tract infections – the most common serious outcome of influenza.  Therefore, vaccination of children in this age group can help to reduce the significant burden placed on parents, doctors and hospitals every flu season.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Dr. Dbaibo:

We are keen to see efficacy results for other quadrivalent influenza vaccines, and other studies that use the endpoint of ‘moderate-to-severe influenza’, since this measures clinically consequential disease.

Citation:

Vaccine for Prevention of Mild and Moderate-to-Severe Influenza in Children

Varsha K. Jain, M.D., M.P.H., Luis Rivera, M.D., Khalequ Zaman, M.B., B.S., Ph.D., Roberto A. Espos, Jr., M.D., M.H.S.A., Chukiat Sirivichayakul, M.D., Beatriz P. Quiambao, M.D., Doris M. Rivera-Medina, M.D., Pirunghul Kerdpanich, M.D., Mehmet Ceyhan, M.D., Ener C. Dinleyici, M.D., Alejandro Cravioto, M.D., Ph.D., Mohammed Yunus, M.B., B.S., Pornthep Chanthavanich, M.D., Kriengsak Limkittikul, M.D., Zafer Kurugol, M.D., Ph.D., Emre Alhan, M.D., Adrian Caplanusi, M.D., Ph.D., Serge Durviaux, B.A., Philippe Boutet, D.V.M., Ph.D., Opokua Ofori-Anyinam, Ph.D., Vijayalakshmi Chandrasekaran, M.Sc., Ghassan Dbaibo, M.D., and Bruce L. Innis, M.D.

NEJM: December 11, 2013DOI: 10.1056/NEJMoa1215817

Last Updated on December 15, 2013 by Marie Benz MD FAAD