Related Experiment Videos
Defining the key parameters for comparing reactions among acellular and whole-cell pertussis vaccines
M E Pichichero1, C Christy, M D Decker
1Department of Pediatrics, University of Rochester School of Medicine, NY, USA.
Insights
A minimum data set including fever, fussiness, and injection site reactions through the second evening is sufficient to compare acellular (DTaP) and whole-cell (DTP) pertussis vaccines. Other reactions like vomiting or drowsiness do not help differentiate vaccine responses.
Area of Science:
- Immunology
- Vaccinology
- Pediatric Medicine
Background:
- Acellular pertussis vaccines (DTaP) and whole-cell pertussis vaccines (DTP) are combined with diphtheria and tetanus toxoids.
- Accurate and comparable data on vaccine reactions are crucial for post-marketing surveillance and vaccine safety assessments.
Purpose of the Study:
- To identify the minimum dataset for accurately describing and comparing common reactions following DTaP and DTP vaccination in infants.
- To streamline data collection for future vaccine safety studies.
Main Methods:
- A multicenter trial involving 2342 infants receiving primary DTaP or DTP vaccination series.
- Evaluation of local (redness, swelling, pain) and systemic (fever, fussiness, antipyretic use, drowsiness, appetite, vomiting) reactions.
- Reactions were assessed at multiple time points up to 14 days post-immunization.
Main Results:
- Condensing reaction data to five key indicators (fever > 100°F, moderate/severe fussiness, local redness/swelling, moderate/severe pain) effectively discriminated between vaccines.
- Reaction data collected beyond the second evening post-immunization did not significantly differentiate vaccine responses.
- Information on antipyretic use, appetite, drowsiness, or vomiting was not useful for distinguishing between DTaP and DTP vaccines.
Conclusions:
- A minimum dataset focusing on fever, fussiness, and injection site reactions within the first two days is sufficient for comparing DTaP and DTP vaccines.
- This simplified data collection approach enhances efficiency without compromising the ability to detect significant differences in common adverse reactions.
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 degrees 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 degrees 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.