Zepp Fred, Knuf Markus, Habermehl Pirmin, Mannhardt-Laakmann Wilma, Howe Barbara, Friedland Leonard R
Children's Hospital, Johannes Gutenberg University, Mainz, Germany.
J Pediatr. 2006 Nov;149(5):603-610. doi: 10.1016/j.jpeds.2006.06.016.
The safety of a booster dose of a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine was evaluated in adolescents previously vaccinated with five doses of acellular pertussis-containing vaccine.
Adolescents (n = 319) previously vaccinated with either 5 doses of diphtheria-tetanus-acellular pertussis (DTaP) (n = 193) or 4 doses of DTaP plus another acellular pertussis-containing vaccine received one dose each of Tdap and hepatitis A vaccine in a double-blinded, randomized, crossover trial. Rates of adverse events (AEs) after vaccination with Tdap versus hepatitis A and rates of local AEs among adolescents vaccinated with Tdap (sixth acellular pertussis-containing vaccine dose) versus rates in these same individuals after vaccination with their fifth DTaP dose were assessed.
After Tdap, pain (63.6%), redness (51.7%), and swelling (41.4%) were the most frequently reported AEs. Large injection site swelling (swelling > 100 mm, arm circumference increase > 50 mm or diffuse swelling interfering with daily activities) occurred in three adolescents and resolved without sequelae. After the sixth dose of acellular pertussis-containing vaccine, adolescents reported more pain and less redness and swelling compared with incidences of these AEs reported when these same individuals received their fifth DTaP dose.
These results suggest that Tdap is well tolerated as a sixth consecutive dose of acellular pertussis-containing vaccine.
在先前已接种五剂含无细胞百日咳疫苗的青少年中，评估一剂抗原含量降低的破伤风-白喉-无细胞百日咳（Tdap）疫苗加强针的安全性。
在一项双盲、随机、交叉试验中，319名先前接种过5剂白喉-破伤风-无细胞百日咳（DTaP）（n = 193）或4剂DTaP加另一剂含无细胞百日咳疫苗的青少年，分别接种一剂Tdap和甲型肝炎疫苗。评估接种Tdap与甲型肝炎疫苗后的不良事件（AE）发生率，以及接种Tdap（第六剂含无细胞百日咳疫苗）的青少年局部AE发生率与这些个体接种第五剂DTaP后的发生率。
接种Tdap后，疼痛（63.6%）、发红（51.7%）和肿胀（41.4%）是最常报告的AE。三名青少年出现大的注射部位肿胀（肿胀>100 mm，上臂周长增加>50 mm或弥漫性肿胀影响日常活动），且无后遗症地消退。与这些个体接种第五剂DTaP时报告的这些AE发生率相比，接种第六剂含无细胞百日咳疫苗后，青少年报告的疼痛更多，发红和肿胀更少。
这些结果表明，Tdap作为连续第六剂含无细胞百日咳疫苗耐受性良好。
