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Protective Efficacy of Combined Live Intranasal and Inactivated Influenza A Virus Vaccines in the Elderly

John J. Treanor, MD; H. Reid Mattison, MD; Ghinwa Dumyati, MD; Amos Yinnon, MD; Shirley Erb, RN; Diane O'Brien, RN; Raphael Dolin, MD; and Robert F. Betts, MD
[+] Article, Author, and Disclosure Information

Use of human volunteers for research purposes followed guidelines of the Clinical Research Subpanel of the National Institute of Allergy and Infectious Diseases, and study protocols were reviewed and approved by the Research Subjects Review Boards of the University of Rochester and the participating institutions.

Grant Support: By contract N01-AI-05049 from the National Institute of Allergy and Infectious Disease.

Requests for Reprints: John J. Treanor, MD, Infectious Disease Unit, University of Rochester, Box 689, 601 Elmwood Avenue, Rochester, NY 14642.

Current Author Addresses: Drs. Treanor, Mattison, Dumyati, Yinnon, Dolin, and Betts and Ms. Erb and Ms. O'Brien: University of Rochester, 601 Elmwood Avenue, Rochester, NY 14642.

©1992 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1992;117(8):625-633. doi:10.7326/0003-4819-117-8-625
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Objective: To evaluate the efficacy of adding intranasal live attenuated cold-adapted influenza A vaccine to inactivated influenza vaccine to prevent influenza A in elderly residents of long-term-care institutions.

Design: Randomized, double-blind, placebo-controlled study conducted over 3 years.

Setting: Three large nursing homes.

Participants: A total of 523 residents of nursing homes (mean age, 84.2 years).

Interventions: All participants received trivalent inactivated influenza vaccine parenterally and were randomly assigned to receive either live attenuated influenza A (H3N2) virus vaccine or placebo intranasally.

Measurements: Laboratory-documented influenza A was defined as a respiratory illness plus isolation of influenza A virus from nasal secretions, significant serologic response, or both. Participants were considered to have been exposed to influenza A if they resided in an institution in which cases of influenza A were documented. Outbreak-associated illnesses were defined as those occurring between the first and last isolation of influenza virus from within the institution, ± 3 days.

Results: Participants who received intranasal vaccine and were subsequently exposed to influenza A had significantly lower rates of laboratory-documented influenza A (9 of 162 vaccine recipients compared with 24 of 169 placebo recipients; vaccine protective efficacy, 60.6%; 95% Cl, 18% to 82%), outbreak-associated respiratory illnesses (13 of 162 vaccine recipients compared with 34 of 169 placebo recipients; vaccine protective efficacy, 56.8%; Cl 23% to 76%), and outbreakassociated influenza-like illnesses (6 of 162 vaccine recipients compared with 18 of 169 placebo recipients; vaccine protective efficacy, 65.0%; Cl 17% to 86%).

Conclusions: Intranasal immunization with live attenuated influenza A virus vaccine provided additional protection against influenza A when added to parenteral trivalent inactivated influenza vaccine among elderly nursing home residents.





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