TY - JOUR
T1 - Design of a group-randomized Streptococcus pneumoniae vaccine trial
AU - Moulton, Lawrence H.
AU - O'Brien, Katherine L.
AU - Kohberger, Robert
AU - Chang, Ih
AU - Reid, Raymond
AU - Weatherholtz, Robert
AU - Hackell, Jill G.
AU - Siber, George R.
AU - Santosham, Mathuram
N1 - Funding Information:
This work was supported in part by grants from Wyeth Lederle Vaccines, USAID (HRN-A-00-96-9006), WHO, and CDC. The opinions of the authors are not necessarily those of the Indian Health Service. We thank the Health Boards of the White Mountain Apache Tribe; the Health Boards of Chinle (Arizona), Fort Defiance (Arizona), Gallup (New Mexico), and Shiprock (New Mexico) of the Navajo Nation; the Navajo Nation Health Research Review Board; the Phoenix Area Indian Health Service Institutional Review Board; the National Indian Health Service Institutional Review Board; and the Johns Hopkins University Joint Committee on Clinical Investigation for review and approval of the study. We are indebted to Larry Rodgers for his invaluable assistance in defining the randomization units and producing maps.
PY - 2001
Y1 - 2001
N2 - A group-randomized, double-masked, phase III trial of a Streptococcus pneumoniae conjugate vaccine is being conducted in American Indian populations in the southwestern United States. Approximately 9000 infants will be enrolled in the primary efficacy cohort with vaccine allocation determined by community of residence. The trial is designed to continue until 48 cases of invasive pneumococcal disease due to vaccine serotypes have accumulated. Thirty-eight geographically and socially distinct areas were randomized within blocks formed by population size and geographic location. This design affords the opportunity to capture the effects of herd immunity (indirect effects) by estimating the impact of the vaccine intervention on nonimmunized infants. Group-randomized trials have challenging design and analysis features, many of which are discussed here in the context of the first such trial designed to lead to licensure of a drug or biologic in the United States.
AB - A group-randomized, double-masked, phase III trial of a Streptococcus pneumoniae conjugate vaccine is being conducted in American Indian populations in the southwestern United States. Approximately 9000 infants will be enrolled in the primary efficacy cohort with vaccine allocation determined by community of residence. The trial is designed to continue until 48 cases of invasive pneumococcal disease due to vaccine serotypes have accumulated. Thirty-eight geographically and socially distinct areas were randomized within blocks formed by population size and geographic location. This design affords the opportunity to capture the effects of herd immunity (indirect effects) by estimating the impact of the vaccine intervention on nonimmunized infants. Group-randomized trials have challenging design and analysis features, many of which are discussed here in the context of the first such trial designed to lead to licensure of a drug or biologic in the United States.
KW - Group-randomized trial
KW - Streptococcus pneumoniae
KW - Vaccine
UR - http://www.scopus.com/inward/record.url?scp=0034886473&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0034886473&partnerID=8YFLogxK
U2 - 10.1016/S0197-2456(01)00132-5
DO - 10.1016/S0197-2456(01)00132-5
M3 - Article
C2 - 11514043
AN - SCOPUS:0034886473
SN - 0197-2456
VL - 22
SP - 438
EP - 452
JO - Controlled Clinical Trials
JF - Controlled Clinical Trials
IS - 4
ER -