WASHINGTON — Children who received a combined pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae type b vaccine experienced fever and injection site reactions at rates similar to, or less than, those seen in children who received the component vaccines, Arnd Herz, M.D., said in a poster presented at the annual meeting of the Pediatric Academic Societies.
Dr. Herz of the Kaiser Permanente Vaccine Study Center, Oakland, Calif., presented the combined results of three U.S. studies and one Canadian study at the meeting sponsored by the American Pediatric Society, the Society for Pediatric Research, Ambulatory Pediatric Association, and the American Academy of Pediatrics. These studies examined safety of the combined pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae (Hib) type b vaccine (Pentacel) in both the infant series and fourth dose of the toddler series, sponsored by Sanofi Pasteur Inc.
In the infant series, 4,198 infants received the combination vaccine, and 2,486 received control vaccines given separately. In the fourth dose studies, 5,033 children received the combination vaccine, and 1,157 received the control vaccines given separately.
All combination and control vaccines were given along with other recommended childhood vaccines.
The rate of fever was similar between groups in both series. In the infant series, fever occurred in 28% of the combination group and 31% of the control group. In the fourth dose studies, fever occurred in 11% of both groups.
Injection site reactions were similar among groups in both studies. In the infant series, 10% of the combination group experienced mild redness, 5% experienced swelling, and 60% experienced tenderness. Among the control group, 20% experienced redness, 10% experienced swelling, and 78% experienced tenderness. One infant in the combination group had an immediate reaction of urticaria.
In the fourth dose studies, redness occurred in 20% of both groups. Swelling occurred in 10% of both groups, and tenderness occurred in 50% of the combination group and 60% of the control group.
Crying and fussiness in the 3 days after vaccination were similar in all groups.
There were no serious vaccine-related adverse events in any of the studies.