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Randomized, double-blind, phase III, pivotal field trial of the comparative immunogenicity, safety, and tolerability of two yellow fever 17D vaccines (Arilvax and YF-VAX) in healthy infants and children in Peru.
Am J Trop Med Hyg. 2005 Feb; 72(2):189-97.AJ

Abstract

We conducted a randomized, double-blind, phase III yellow fever (YF) vaccine trial among 1,107 healthy children in Sullana in northern Peru. The safety and efficacy (by measurement of geometric mean neutralizing antibody titer responses) were determined for two YF vaccines, ARILVAX (n = 738) and YF-VAX(R) (n = 369). Serocon-version rates were higher (94.9%) in ARILVAX than in YF-VAX (90.6%) recipients. The two-sided 95% confidence interval (YF-VAX-ARILVAX) was (-12.8% to -2.5%), indicating that the higher seroconversion rate for Arilvax was significant. Post-vaccination (30-day) mean log(10) neutralization indices were found to be similar for both products: 1.32 for ARILVAX and 1.26 for YF-VAX (P = 0.1404, by analysis of variance). A similar number of subjects in each group reported at least one adverse event (AE); 441 (59.8%) for ARILVAX versus 211 (59.9%) for YF-VAX. Most (591; 96.7%) of these were of a mild nature and resolved without treatment. There were no treatment-related serious AEs. This is the first randomized, double-blind comparison of two YF vaccines in a pediatric population; both vaccines were shown to be highly immunogenic and well-tolerated.

Authors+Show Affiliations

U.S. Naval Medical Research Center Detachment, Lima, Peru. worn@nmrcd.med.navy.mil <worn@nmrcd.med.navy.mil>No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

15741556

Citation

Belmusto-Worn, Vivian E., et al. "Randomized, Double-blind, Phase III, Pivotal Field Trial of the Comparative Immunogenicity, Safety, and Tolerability of Two Yellow Fever 17D Vaccines (Arilvax and YF-VAX) in Healthy Infants and Children in Peru." The American Journal of Tropical Medicine and Hygiene, vol. 72, no. 2, 2005, pp. 189-97.
Belmusto-Worn VE, Sanchez JL, McCarthy K, et al. Randomized, double-blind, phase III, pivotal field trial of the comparative immunogenicity, safety, and tolerability of two yellow fever 17D vaccines (Arilvax and YF-VAX) in healthy infants and children in Peru. Am J Trop Med Hyg. 2005;72(2):189-97.
Belmusto-Worn, V. E., Sanchez, J. L., McCarthy, K., Nichols, R., Bautista, C. T., Magill, A. J., Pastor-Cauna, G., Echevarria, C., Laguna-Torres, V. A., Samame, B. K., Baldeon, M. E., Burans, J. P., Olson, J. G., Bedford, P., Kitchener, S., & Monath, T. P. (2005). Randomized, double-blind, phase III, pivotal field trial of the comparative immunogenicity, safety, and tolerability of two yellow fever 17D vaccines (Arilvax and YF-VAX) in healthy infants and children in Peru. The American Journal of Tropical Medicine and Hygiene, 72(2), 189-97.
Belmusto-Worn VE, et al. Randomized, Double-blind, Phase III, Pivotal Field Trial of the Comparative Immunogenicity, Safety, and Tolerability of Two Yellow Fever 17D Vaccines (Arilvax and YF-VAX) in Healthy Infants and Children in Peru. Am J Trop Med Hyg. 2005;72(2):189-97. PubMed PMID: 15741556.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, double-blind, phase III, pivotal field trial of the comparative immunogenicity, safety, and tolerability of two yellow fever 17D vaccines (Arilvax and YF-VAX) in healthy infants and children in Peru. AU - Belmusto-Worn,Vivian E, AU - Sanchez,Jose L, AU - McCarthy,Karen, AU - Nichols,Richard, AU - Bautista,Christian T, AU - Magill,Alan J, AU - Pastor-Cauna,Giovanna, AU - Echevarria,Carlos, AU - Laguna-Torres,Victor A, AU - Samame,Billey K, AU - Baldeon,Maria E, AU - Burans,James P, AU - Olson,James G, AU - Bedford,Philip, AU - Kitchener,Scott, AU - Monath,Thomas P, PY - 2005/3/3/pubmed PY - 2005/4/9/medline PY - 2005/3/3/entrez SP - 189 EP - 97 JF - The American journal of tropical medicine and hygiene JO - Am J Trop Med Hyg VL - 72 IS - 2 N2 - We conducted a randomized, double-blind, phase III yellow fever (YF) vaccine trial among 1,107 healthy children in Sullana in northern Peru. The safety and efficacy (by measurement of geometric mean neutralizing antibody titer responses) were determined for two YF vaccines, ARILVAX (n = 738) and YF-VAX(R) (n = 369). Serocon-version rates were higher (94.9%) in ARILVAX than in YF-VAX (90.6%) recipients. The two-sided 95% confidence interval (YF-VAX-ARILVAX) was (-12.8% to -2.5%), indicating that the higher seroconversion rate for Arilvax was significant. Post-vaccination (30-day) mean log(10) neutralization indices were found to be similar for both products: 1.32 for ARILVAX and 1.26 for YF-VAX (P = 0.1404, by analysis of variance). A similar number of subjects in each group reported at least one adverse event (AE); 441 (59.8%) for ARILVAX versus 211 (59.9%) for YF-VAX. Most (591; 96.7%) of these were of a mild nature and resolved without treatment. There were no treatment-related serious AEs. This is the first randomized, double-blind comparison of two YF vaccines in a pediatric population; both vaccines were shown to be highly immunogenic and well-tolerated. SN - 0002-9637 UR - https://www.unboundmedicine.com/medline/citation/15741556/Randomized_double_blind_phase_III_pivotal_field_trial_of_the_comparative_immunogenicity_safety_and_tolerability_of_two_yellow_fever_17D_vaccines__Arilvax_and_YF_VAX__in_healthy_infants_and_children_in_Peru_ L2 - https://ClinicalTrials.gov/search/term=15741556 [PUBMED-IDS] DB - PRIME DP - Unbound Medicine ER -