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Longitudinal study of adverse reactions following diphtheria-tetanus-pertussis vaccine in infancy
S S Long1, A Deforest, D G Smith
1Department of Pediatrics, St Christopher's Hospital for Children, Philadelphia, PA 19133.
Insights
The diphtheria and tetanus toxoids and whole cell pertussis vaccine (DTP) is safe and effective in children. Most adverse events were mild and transient, with no serious complications observed.
Area of Science:
- Pediatrics
- Immunology
- Vaccinology
Background:
- The diphtheria and tetanus toxoids and whole cell pertussis vaccine (DTP) is a critical component of childhood immunization schedules.
- Understanding the immunogenicity and adverse effects of DTP is essential for public health.
- Previous studies have indicated potential adverse reactions, necessitating further investigation.
Purpose of the Study:
- To evaluate the immunogenicity and adverse effects of the DTP vaccine in a prospective study.
- To compare a standard four-dose immunization schedule with a three-dose schedule.
- To identify factors influencing vaccine reactions and antibody response.
Main Methods:
- A prospective study involving 538 children aged 2 to 20 months.
- Randomization to either a standard four-dose DTP schedule or a three-dose schedule with a saline placebo.
- Longitudinal observation and data collection on immunogenicity and adverse events for 48 hours post-injection.
Main Results:
- The three-dose schedule was not recommended due to serologic data.
- 96% of DTP doses and 36% of placebo injections were associated with adverse effects like fever or local reactions.
- Age influenced the type and rate of adverse events, more so than vaccine dose number.
- No serious adverse events such as convulsions or encephalopathy were reported.
- Neither reactions nor acetaminophen use impacted antibody response.
Conclusions:
- The DTP vaccine is generally safe, with most adverse events being mild and transient.
- The standard four-dose schedule appears more effective than the three-dose schedule.
- Age is a significant factor in DTP vaccine's adverse event profile.
- Further research may explore optimizing DTP vaccination schedules and understanding reaction predictors.
Abstract:
A prospective study of immunogenicity and adverse effects of 1553 doses of diphtheria and tetanus toxoids and whole cell pertussis vaccine (DTP) was performed in 538 children observed longitudinally from 2 months to 20 months of age. Subjects were randomized to the standard four-dose immunization schedule or to a three-dose schedule (with a saline injection substituted for DTP at 6 months of age). The three-dose schedule could not be recommended on the basis of serologic data. Compliance for completing a clinical observation form in the 48 hours following injections was greater than 99%. Fever, local reactions, or adverse behavioral effects were described in association with 96% of DTP doses and 36% of placebo injections. Contraindications to DTP immunization developed in 3% of study children. No convulsion, hypotonic hyporesponsive episode, encephalopathy, or temperature greater than 40.5 degrees C occurred. Behavioral and local inflammatory effects occurred maximally in the first 6 hours following vaccine but fever peaked later. There was no interrelationship between occurrence of local reaction and fever. Data suggest that age has more effect on the type and rate of adverse clinical events than does vaccine dose number. Existing antibody levels to vaccine components, lot of vaccine, breast-feeding, or gestational age did not affect rate or type of clinical reactions. Neither occurrence of reactions nor the use of acetaminophen affected antibody response to vaccine.