@article{a4d731c749094f179c214b8242269779,
title = "Phase 2 Evaluation of Parainfluenza Type 3 Cold Passage Mutant 45 Live Attenuated Vaccine in Healthy Children 6-18 Months Old",
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.",
author = "Belshe, {Robert B.} and Newman, {Frances K.} and Tsai, {Theodore F.} and Karron, {Ruth A.} and Keith Reisinger and Don Roberton and Helen Marshall and Richard Schwartz and James King and Henderson, {Frederick W.} and William Rodriguez and Severs, {Joseph M.} and Wright, {Peter F.} and Harry Keyserling and Weinberg, {Geoffrey A.} and Kenneth Bromberg and Richard Loh and Peter Sly and Peter McIntyre and Ziegler, {John B.} and Jill Hackell and Anne Deatly and Alice Georgiu and Maribel Paschalis and Wu, {Shin Lu} and Tatem, {Joanne M.} and Brian Murphy and Edwin Anderson",
note = "Funding Information: a Present affiliations: Office of Counterterrorism and Pediatric Drug Initiatives, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland (W.R.); US Army Medical Research Institute of Infectious Diseases, Medical Division, Ft. Detrick, Maryland (E.A.). Funding Information: Financial support: Cooperative Research and Development Agreement (AI-0099) between the National Institute of Allergy and Infectious Diseases and Wyeth Vaccines.",
year = "2004",
month = feb,
day = "1",
doi = "10.1086/381184",
language = "English (US)",
volume = "189",
pages = "462--470",
journal = "Journal of Infectious Diseases",
issn = "0022-1899",
publisher = "Oxford University Press",
number = "3",
}