Defining the key parameters for comparing reactions among acellular and whole-cell pertussis vaccines

M. E. Pichichero, C. Christy, M. D. Decker, M. C. Steinhoff, K. M. Edwards, M. B. Rennels, E. L. Anderson, J. A. Englund

Research output: Contribution to journalArticle

Abstract

Objective. To facilitate future vaccine reaction data collection and analysis, we sought to determine the minimum data set required to describe accurately and to compare common reactions after the administration of acellular (DTaP) or whole-cell (DTP) pertussis vaccine with diphtheria and tetanus toxoids combined. Methods. Thirteen DTaP and 2 DTP vaccines were studied in a multicenter trial involving 2342 infants who received a primary series of vaccinations at 2, 4, and 6 months of age. Temperature, fussiness, redness, swelling and pain at the injection site, antipyretic use, drowsiness, loss of appetite, and vomiting were evaluated. Reactions were assessed at 3 hours and (if not immunized in the evening) 6 hours after immunization, at bedtime each evening for 7 evenings, and on the 14th evening after immunization. Results. Two reaction assessment approaches were compared: (1) analysis of all reactions, regardless of the degree of severity; and (2) a condensation of the data to five key reactions (fever >100°F, moderate or more fussiness, any local redness, any local swelling, and moderate or more local pain). We found that the onset of reactions was infrequent beyond the second evening, and that collection and analysis of reaction data beyond that time did not further discriminate among the vaccines. Information regarding antipyretic use, loss of appetite, drowsiness, or vomiting did not assist in differentiating among these vaccines. Conclusion. Monitoring the occurrence of fever greater than 100°F, moderate or severe fussiness, injection site redness or swelling, and moderate or severe injection site pain occurring through the second evening after immunization will provide the minimum data set needed to discriminate among DTaP and DTP vaccines with respect to the common adverse reactions.

Original languageEnglish (US)
Pages (from-to)588-592
Number of pages5
JournalPediatrics
Volume96
Issue number3 II SUPPL.
StatePublished - 1995
Externally publishedYes

Fingerprint

Diphtheria-Tetanus-Pertussis Vaccine
Pertussis Vaccine
Immunization
Antipyretics
Vaccines
Sleep Stages
Appetite
Pain
Injections
Vomiting
Fever
Diphtheria-Tetanus-acellular Pertussis Vaccines
Diphtheria Toxoid
Tetanus Toxoid
Multicenter Studies
Vaccination
Temperature
Datasets

Keywords

  • acellular
  • adverse reactions
  • diphtheria-tetanus-pertussis vaccine
  • pertussis vaccine
  • whole-cell
  • whooping cough

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Pichichero, M. E., Christy, C., Decker, M. D., Steinhoff, M. C., Edwards, K. M., Rennels, M. B., ... Englund, J. A. (1995). Defining the key parameters for comparing reactions among acellular and whole-cell pertussis vaccines. Pediatrics, 96(3 II SUPPL.), 588-592.

Defining the key parameters for comparing reactions among acellular and whole-cell pertussis vaccines. / Pichichero, M. E.; Christy, C.; Decker, M. D.; Steinhoff, M. C.; Edwards, K. M.; Rennels, M. B.; Anderson, E. L.; Englund, J. A.

In: Pediatrics, Vol. 96, No. 3 II SUPPL., 1995, p. 588-592.

Research output: Contribution to journalArticle

Pichichero, ME, Christy, C, Decker, MD, Steinhoff, MC, Edwards, KM, Rennels, MB, Anderson, EL & Englund, JA 1995, 'Defining the key parameters for comparing reactions among acellular and whole-cell pertussis vaccines', Pediatrics, vol. 96, no. 3 II SUPPL., pp. 588-592.
Pichichero ME, Christy C, Decker MD, Steinhoff MC, Edwards KM, Rennels MB et al. Defining the key parameters for comparing reactions among acellular and whole-cell pertussis vaccines. Pediatrics. 1995;96(3 II SUPPL.):588-592.
Pichichero, M. E. ; Christy, C. ; Decker, M. D. ; Steinhoff, M. C. ; Edwards, K. M. ; Rennels, M. B. ; Anderson, E. L. ; Englund, J. A. / Defining the key parameters for comparing reactions among acellular and whole-cell pertussis vaccines. In: Pediatrics. 1995 ; Vol. 96, No. 3 II SUPPL. pp. 588-592.
@article{15d8f05f86204e779f88e27acb66eec4,
title = "Defining the key parameters for comparing reactions among acellular and whole-cell pertussis vaccines",
abstract = "Objective. To facilitate future vaccine reaction data collection and analysis, we sought to determine the minimum data set required to describe accurately and to compare common reactions after the administration of acellular (DTaP) or whole-cell (DTP) pertussis vaccine with diphtheria and tetanus toxoids combined. Methods. Thirteen DTaP and 2 DTP vaccines were studied in a multicenter trial involving 2342 infants who received a primary series of vaccinations at 2, 4, and 6 months of age. Temperature, fussiness, redness, swelling and pain at the injection site, antipyretic use, drowsiness, loss of appetite, and vomiting were evaluated. Reactions were assessed at 3 hours and (if not immunized in the evening) 6 hours after immunization, at bedtime each evening for 7 evenings, and on the 14th evening after immunization. Results. Two reaction assessment approaches were compared: (1) analysis of all reactions, regardless of the degree of severity; and (2) a condensation of the data to five key reactions (fever >100°F, moderate or more fussiness, any local redness, any local swelling, and moderate or more local pain). We found that the onset of reactions was infrequent beyond the second evening, and that collection and analysis of reaction data beyond that time did not further discriminate among the vaccines. Information regarding antipyretic use, loss of appetite, drowsiness, or vomiting did not assist in differentiating among these vaccines. Conclusion. Monitoring the occurrence of fever greater than 100°F, moderate or severe fussiness, injection site redness or swelling, and moderate or severe injection site pain occurring through the second evening after immunization will provide the minimum data set needed to discriminate among DTaP and DTP vaccines with respect to the common adverse reactions.",
keywords = "acellular, adverse reactions, diphtheria-tetanus-pertussis vaccine, pertussis vaccine, whole-cell, whooping cough",
author = "Pichichero, {M. E.} and C. Christy and Decker, {M. D.} and Steinhoff, {M. C.} and Edwards, {K. M.} and Rennels, {M. B.} and Anderson, {E. L.} and Englund, {J. A.}",
year = "1995",
language = "English (US)",
volume = "96",
pages = "588--592",
journal = "Pediatrics",
issn = "0031-4005",
publisher = "American Academy of Pediatrics",
number = "3 II SUPPL.",

}

TY - JOUR

T1 - Defining the key parameters for comparing reactions among acellular and whole-cell pertussis vaccines

AU - Pichichero, M. E.

AU - Christy, C.

AU - Decker, M. D.

AU - Steinhoff, M. C.

AU - Edwards, K. M.

AU - Rennels, M. B.

AU - Anderson, E. L.

AU - Englund, J. A.

PY - 1995

Y1 - 1995

N2 - Objective. To facilitate future vaccine reaction data collection and analysis, we sought to determine the minimum data set required to describe accurately and to compare common reactions after the administration of acellular (DTaP) or whole-cell (DTP) pertussis vaccine with diphtheria and tetanus toxoids combined. Methods. Thirteen DTaP and 2 DTP vaccines were studied in a multicenter trial involving 2342 infants who received a primary series of vaccinations at 2, 4, and 6 months of age. Temperature, fussiness, redness, swelling and pain at the injection site, antipyretic use, drowsiness, loss of appetite, and vomiting were evaluated. Reactions were assessed at 3 hours and (if not immunized in the evening) 6 hours after immunization, at bedtime each evening for 7 evenings, and on the 14th evening after immunization. Results. Two reaction assessment approaches were compared: (1) analysis of all reactions, regardless of the degree of severity; and (2) a condensation of the data to five key reactions (fever >100°F, moderate or more fussiness, any local redness, any local swelling, and moderate or more local pain). We found that the onset of reactions was infrequent beyond the second evening, and that collection and analysis of reaction data beyond that time did not further discriminate among the vaccines. Information regarding antipyretic use, loss of appetite, drowsiness, or vomiting did not assist in differentiating among these vaccines. Conclusion. Monitoring the occurrence of fever greater than 100°F, moderate or severe fussiness, injection site redness or swelling, and moderate or severe injection site pain occurring through the second evening after immunization will provide the minimum data set needed to discriminate among DTaP and DTP vaccines with respect to the common adverse reactions.

AB - Objective. To facilitate future vaccine reaction data collection and analysis, we sought to determine the minimum data set required to describe accurately and to compare common reactions after the administration of acellular (DTaP) or whole-cell (DTP) pertussis vaccine with diphtheria and tetanus toxoids combined. Methods. Thirteen DTaP and 2 DTP vaccines were studied in a multicenter trial involving 2342 infants who received a primary series of vaccinations at 2, 4, and 6 months of age. Temperature, fussiness, redness, swelling and pain at the injection site, antipyretic use, drowsiness, loss of appetite, and vomiting were evaluated. Reactions were assessed at 3 hours and (if not immunized in the evening) 6 hours after immunization, at bedtime each evening for 7 evenings, and on the 14th evening after immunization. Results. Two reaction assessment approaches were compared: (1) analysis of all reactions, regardless of the degree of severity; and (2) a condensation of the data to five key reactions (fever >100°F, moderate or more fussiness, any local redness, any local swelling, and moderate or more local pain). We found that the onset of reactions was infrequent beyond the second evening, and that collection and analysis of reaction data beyond that time did not further discriminate among the vaccines. Information regarding antipyretic use, loss of appetite, drowsiness, or vomiting did not assist in differentiating among these vaccines. Conclusion. Monitoring the occurrence of fever greater than 100°F, moderate or severe fussiness, injection site redness or swelling, and moderate or severe injection site pain occurring through the second evening after immunization will provide the minimum data set needed to discriminate among DTaP and DTP vaccines with respect to the common adverse reactions.

KW - acellular

KW - adverse reactions

KW - diphtheria-tetanus-pertussis vaccine

KW - pertussis vaccine

KW - whole-cell

KW - whooping cough

UR - http://www.scopus.com/inward/record.url?scp=0029147131&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0029147131&partnerID=8YFLogxK

M3 - Article

VL - 96

SP - 588

EP - 592

JO - Pediatrics

JF - Pediatrics

SN - 0031-4005

IS - 3 II SUPPL.

ER -