Post-marketing evaluation of the short term safety of COMVAX®

Robert Davis, Steven Black, Henry Shinefield, Lisa Mahoney, Ann Zavitkovsky, Edwin Lewis, Alex Nikas, Harry Guess, Paul Coplan

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

We report an evaluation of the short-term safety of a pediatric bivalent combination vaccine containing RECOMBIVAXHB® and Liquid PedvaxHIB®, COMVAX®. Safety was assessed through identification of medical utilization; potential adverse events were identified through computerized clinical databases for deaths, hospitalizations, emergency room visits, and outpatient clinic visits. We calculated relative risks whenever there was at least one diagnosis-specific event in the risk period following vaccination and compared the rates in specific time windows following vaccination with rates at 31-60 days following vaccination and also with rates in a historical cohort of children. A total of 27,802 doses of COMVAX® were administered, with 127 separate adverse event codes with statistically significant elevated risks, and 66 codes with significantly decreased risks. Most potentially serious diagnoses appeared in four major categories: "Respiratory Events" "Gastroenteritis" "Adverse Effect of Medicinal and iological Substance, NOS" and "Fever". There was no consistent pattern to indicate increased risks for serious respiratory or gastrointestinal illness. For fever, most of the findings appeared to be explained by changes in data collection or by concomitant vaccination with M-M-R-II®. There was an increased risk for fever hospitalizations following shot 1. The total number of children hospitalized with fever was seven out of 12,468 children; all recovered fully. In this study population of 27,802 vaccine recipients, COMVAX appeared to have a favorable safety profile.

Original languageEnglish (US)
Pages (from-to)536-543
Number of pages8
JournalVaccine
Volume22
Issue number3-4
DOIs
StatePublished - Jan 2 2004

Fingerprint

Marketing
fever
marketing
vaccination
Safety
Vaccination
Fever
vaccines
risk reduction
gastroenteritis
Hospitalization
relative risk
Combined Vaccines
Hospitalized Child
adverse effects
Gastroenteritis
Ambulatory Care
death
Ambulatory Care Facilities
liquids

All Science Journal Classification (ASJC) codes

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

Davis, R., Black, S., Shinefield, H., Mahoney, L., Zavitkovsky, A., Lewis, E., ... Coplan, P. (2004). Post-marketing evaluation of the short term safety of COMVAX®. Vaccine, 22(3-4), 536-543. https://doi.org/10.1016/j.vaccine.2003.06.001

Post-marketing evaluation of the short term safety of COMVAX®. / Davis, Robert; Black, Steven; Shinefield, Henry; Mahoney, Lisa; Zavitkovsky, Ann; Lewis, Edwin; Nikas, Alex; Guess, Harry; Coplan, Paul.

In: Vaccine, Vol. 22, No. 3-4, 02.01.2004, p. 536-543.

Research output: Contribution to journalArticle

Davis, R, Black, S, Shinefield, H, Mahoney, L, Zavitkovsky, A, Lewis, E, Nikas, A, Guess, H & Coplan, P 2004, 'Post-marketing evaluation of the short term safety of COMVAX®', Vaccine, vol. 22, no. 3-4, pp. 536-543. https://doi.org/10.1016/j.vaccine.2003.06.001
Davis R, Black S, Shinefield H, Mahoney L, Zavitkovsky A, Lewis E et al. Post-marketing evaluation of the short term safety of COMVAX®. Vaccine. 2004 Jan 2;22(3-4):536-543. https://doi.org/10.1016/j.vaccine.2003.06.001
Davis, Robert ; Black, Steven ; Shinefield, Henry ; Mahoney, Lisa ; Zavitkovsky, Ann ; Lewis, Edwin ; Nikas, Alex ; Guess, Harry ; Coplan, Paul. / Post-marketing evaluation of the short term safety of COMVAX®. In: Vaccine. 2004 ; Vol. 22, No. 3-4. pp. 536-543.
@article{94e7215e72234144af15aba4de8cfc86,
title = "Post-marketing evaluation of the short term safety of COMVAX{\circledR}",
abstract = "We report an evaluation of the short-term safety of a pediatric bivalent combination vaccine containing RECOMBIVAXHB{\circledR} and Liquid PedvaxHIB{\circledR}, COMVAX{\circledR}. Safety was assessed through identification of medical utilization; potential adverse events were identified through computerized clinical databases for deaths, hospitalizations, emergency room visits, and outpatient clinic visits. We calculated relative risks whenever there was at least one diagnosis-specific event in the risk period following vaccination and compared the rates in specific time windows following vaccination with rates at 31-60 days following vaccination and also with rates in a historical cohort of children. A total of 27,802 doses of COMVAX{\circledR} were administered, with 127 separate adverse event codes with statistically significant elevated risks, and 66 codes with significantly decreased risks. Most potentially serious diagnoses appeared in four major categories: {"}Respiratory Events{"} {"}Gastroenteritis{"} {"}Adverse Effect of Medicinal and iological Substance, NOS{"} and {"}Fever{"}. There was no consistent pattern to indicate increased risks for serious respiratory or gastrointestinal illness. For fever, most of the findings appeared to be explained by changes in data collection or by concomitant vaccination with M-M-R-II{\circledR}. There was an increased risk for fever hospitalizations following shot 1. The total number of children hospitalized with fever was seven out of 12,468 children; all recovered fully. In this study population of 27,802 vaccine recipients, COMVAX appeared to have a favorable safety profile.",
author = "Robert Davis and Steven Black and Henry Shinefield and Lisa Mahoney and Ann Zavitkovsky and Edwin Lewis and Alex Nikas and Harry Guess and Paul Coplan",
year = "2004",
month = "1",
day = "2",
doi = "10.1016/j.vaccine.2003.06.001",
language = "English (US)",
volume = "22",
pages = "536--543",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "3-4",

}

TY - JOUR

T1 - Post-marketing evaluation of the short term safety of COMVAX®

AU - Davis, Robert

AU - Black, Steven

AU - Shinefield, Henry

AU - Mahoney, Lisa

AU - Zavitkovsky, Ann

AU - Lewis, Edwin

AU - Nikas, Alex

AU - Guess, Harry

AU - Coplan, Paul

PY - 2004/1/2

Y1 - 2004/1/2

N2 - We report an evaluation of the short-term safety of a pediatric bivalent combination vaccine containing RECOMBIVAXHB® and Liquid PedvaxHIB®, COMVAX®. Safety was assessed through identification of medical utilization; potential adverse events were identified through computerized clinical databases for deaths, hospitalizations, emergency room visits, and outpatient clinic visits. We calculated relative risks whenever there was at least one diagnosis-specific event in the risk period following vaccination and compared the rates in specific time windows following vaccination with rates at 31-60 days following vaccination and also with rates in a historical cohort of children. A total of 27,802 doses of COMVAX® were administered, with 127 separate adverse event codes with statistically significant elevated risks, and 66 codes with significantly decreased risks. Most potentially serious diagnoses appeared in four major categories: "Respiratory Events" "Gastroenteritis" "Adverse Effect of Medicinal and iological Substance, NOS" and "Fever". There was no consistent pattern to indicate increased risks for serious respiratory or gastrointestinal illness. For fever, most of the findings appeared to be explained by changes in data collection or by concomitant vaccination with M-M-R-II®. There was an increased risk for fever hospitalizations following shot 1. The total number of children hospitalized with fever was seven out of 12,468 children; all recovered fully. In this study population of 27,802 vaccine recipients, COMVAX appeared to have a favorable safety profile.

AB - We report an evaluation of the short-term safety of a pediatric bivalent combination vaccine containing RECOMBIVAXHB® and Liquid PedvaxHIB®, COMVAX®. Safety was assessed through identification of medical utilization; potential adverse events were identified through computerized clinical databases for deaths, hospitalizations, emergency room visits, and outpatient clinic visits. We calculated relative risks whenever there was at least one diagnosis-specific event in the risk period following vaccination and compared the rates in specific time windows following vaccination with rates at 31-60 days following vaccination and also with rates in a historical cohort of children. A total of 27,802 doses of COMVAX® were administered, with 127 separate adverse event codes with statistically significant elevated risks, and 66 codes with significantly decreased risks. Most potentially serious diagnoses appeared in four major categories: "Respiratory Events" "Gastroenteritis" "Adverse Effect of Medicinal and iological Substance, NOS" and "Fever". There was no consistent pattern to indicate increased risks for serious respiratory or gastrointestinal illness. For fever, most of the findings appeared to be explained by changes in data collection or by concomitant vaccination with M-M-R-II®. There was an increased risk for fever hospitalizations following shot 1. The total number of children hospitalized with fever was seven out of 12,468 children; all recovered fully. In this study population of 27,802 vaccine recipients, COMVAX appeared to have a favorable safety profile.

UR - http://www.scopus.com/inward/record.url?scp=0345528126&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0345528126&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2003.06.001

DO - 10.1016/j.vaccine.2003.06.001

M3 - Article

VL - 22

SP - 536

EP - 543

JO - Vaccine

JF - Vaccine

SN - 0264-410X

IS - 3-4

ER -