Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/7512
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Type: | Journal article |
Title: | Phase 2 evaluation of parainfluenza type 3 cold passage mutant 45 live attenuated vaccine in healthy children 6-18 months old |
Author: | Belshe, R. Newman, F. Tsai, T. Karron, R. Reisinger, K. Roberton, D. Marshall, H. Schwartz, R. King, J. Henderson, F. Rodriguez, W. Severs, J. Wright, P. Keyserling, H. Weinberg, G. Bromberg, K. Loh, R. Sly, P. McIntyre, P. Ziegler, J. et al. |
Citation: | Journal of Infectious Diseases, 2004; 189(3):462-470 |
Publisher: | Univ Chicago Press |
Issue Date: | 2004 |
ISSN: | 0022-1899 1537-6613 |
Statement of Responsibility: | Robert B. Belshe, Frances K. Newman, Theodore F. Tsai, Ruth A. Karron, Keith Reisinger, Don Roberton, Helen Marshall, Richard Schwartz, James King, Frederick W. Henderson, William Rodriguez, Joseph M. Severs, Peter F. Wright, Harry Keyserling, Geoffrey A. Weinberg, Kenneth Bromberg, Richard Loh, Peter Sly, Peter McIntyre, John B. Ziegler, Jill Hackell, Anne Deatly, Alice Georgiu, Maribel Paschalis, Shin-Lu Wu, Joanne M. Tatem, Brian Murphy and Edwin Anderson |
Abstract: | A phase 2 evaluation of live attenuated parainfluenza type 3 (PIV3)–cold passage mutant 45 (cp45) vaccine was conducted in 380 children 6–18 months old; 226 children (59%) were seronegative for PIV3. Of the 226 seronegative children, 114 received PIV3-cp45 vaccine, and 112 received placebo. No significant difference in the occurrence of adverse events (i.e., runny nose, cough, or temperature 38°C) was noted during the 14 days after vaccination. There was no difference between groups in the occurrence of acute otitis media or serous otitis media. Paired serum samples were available for 109 of the seronegative vaccine recipients and for 110 of the seronegative placebo recipients; 84% of seronegative vaccine recipients developed a 4-fold increase in antibody titers. The geometric mean antibody titer after vaccination was 1:25 in the vaccine group and <1:4 in the placebo group. PIV3-cp45 vaccine was safe and immunogenic in seronegative children and should be evaluated for efficacy in a phase 3 field trial. |
Keywords: | Humans Parainfluenza Virus 3, Human Respiratory Tract Infections Respirovirus Infections Rhinitis Cough Otitis Media Acute Disease Fever Vaccines, Attenuated Viral Vaccines Hemagglutinins, Viral Antibodies, Viral Vaccination Serial Passage Administration, Intranasal Double-Blind Method Mutation Infant United States Australia Cold Temperature |
Description: | © 2004 by the Infectious Diseases Society of America. All rights reserved. |
DOI: | 10.1086/381184 |
Published version: | http://dx.doi.org/10.1086/381184 |
Appears in Collections: | Aurora harvest Paediatrics publications |
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