Safety evaluation of PRP-D Haemophilus influenzae type b conjugate vaccine in children immunized at 18 months of age and older: follow-up study of 30,000 children.
We evaluated the safety of the PRP-D conjugate Hib vaccine (ProHIBit, Connaught) in 29,309 children vaccinated at 18-60 months of age in the Southern California Kaiser Permanente medical clinics during the period April 1, 1988, to July 31, 1989. Surveillance for potential reactions involved postcard questionnaires, telephone surveys, reports of Kaiser staff and review of hospitalizations and covered two periods following immunization: (1) the first 48 hours and (2) days 2 through 30. Surveillance for invasive Hib disease involved the above methods in addition to systematic reviews of laboratory and hospital records through January 31, 1990. Rates of local and systemic reactions within 48 hours of vaccination with PRP-D alone were low (less than or equal to 2% for fever greater than 102 degrees F, local redness or swelling) and similar to those previously reported after vaccination with PRP. Hospitalization and seizures (0.15% and 0.09% of vaccinated children, respectively) occurring within 1 month of immunization appeared to be unrelated to vaccination. One 29-month-old child had onset of a fatal episode of Hib sepsis/meningitis within 48 hours of vaccination. Also, a 30-month-old child developed Hib meningitis 10 months after PRP-D vaccination. We conclude that PRP-D is safe when given alone or in combination with other childhood vaccines between 18 and 60 months of age.
Vadheim
C M
CM
UCLA Center for Vaccine Research, Harbor-UCLA Medical Center, Torrance 90502.
Greenberg
D P
DP
Marcy
S M
SM
Froeschle
J
J
Ward
J I
JI
D001428:Bacterial Vaccines / Q000009:adverse effects*; D002140:California / Q000453:epidemiology; D002675:Child, Preschool; D004168:Diphtheria Toxoid / Q000009:adverse effects*; D004341:Drug Evaluation; D005500:Follow-Up Studies; D006192:Haemophilus Infections / Q000517:prevention & control*; D018073:Haemophilus Vaccines; D006193:Haemophilus influenzae / Q000276:immunology*; D006760:Hospitalization; D006801:Humans; D007223:Infant; D008583:Meningitis, Haemophilus / Q000209:etiology; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires
D001428:Bacterial Vaccines; D004168:Diphtheria Toxoid; D018073:Haemophilus Vaccines; C052180:Haemophilus influenzae type b-polysaccharide vaccine-diphtheria toxoid conjugate