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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
Statement of
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.
RMID: 0020040009
DOI: 10.1086/381184
Appears in Collections:Paediatrics publications

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