弁護士谷直樹/医療事件のみを取り扱う法律事務所のブログ

2014年 01月 16日 ( 1 )

インフルエンザワクチンと肺炎球菌ワクチンの同時接種で1日目までの発熱リスク増大

米コロンビア大学医学部のMelissa S. Stockwell氏らは、生後6~23カ月の乳幼児530人の親に体温計を渡し、7日間にわたって子供の体温を測ってもらった結果、同時接種した子供が接種当日から翌日(1日目)までに38度以上の熱を出した割合は37.6%で、インフルエンザワクチンのみ(7.5%)や肺炎球菌ワクチンのみ(9.5%)の場合に比べて高かった、と報告しています.
ただし、2~7日目の発熱率については接種方法による差はなかった、とのことです.

健康百科「インフルと肺炎球菌のワクチン、同時接種で発熱の恐れ」(2014年1月15日)参照

Risk of Fever After Pediatric Trivalent Inactivated Influenza Vaccine and 13-Valent Pneumococcal Conjugate Vaccine.」

「IMPORTANCE An observational study found an increased risk of febrile seizure on the day of or 1 day after vaccination (days 0-1) with trivalent inactivated influenza vaccine (TIV) in the 2010-2011 season; risk was highest with simultaneous vaccination with TIV and 13-valent pneumococcal vaccine (PCV13) in children who were 6 to 23 months old.

Text messaging is a novel method for surveillance of adverse events after immunization that has not been used for hypothesis-driven vaccine safety research. OBJECTIVE To prospectively evaluate whether children receiving TIV and PCV13 simultaneously had higher rates of fever on days 0 to 1 than those receiving either product without the other. DESIGN, SETTING, AND PARTICIPANTS Prospective observational cohort study of parents of children 6 to 23 months old recruited from 3 medical center-affiliated clinics in New York City from November 1, 2011, through April 5, 2012. A total of 530 of 614 eligible participants (86.3%) were enrolled. Parents were texted on the night of vaccination (day 0) and the 7 subsequent nights (days 1-7) to report their child's temperature. We used log-binomial regression to calculate adjusted relative risks (aRRs) and excess risk for fever on days 0 to 1, adjusted for age group, past influenza vaccination and simultaneous receipt of selected inactivated vaccines.

EXPOSURES Receipt of TIV and/or PCV13. MAIN OUTCOME(S) AND MEASURE(S) Temperature of 38°C or higher on days 0 to 1 after vaccination.
RESULTS On days 0 to 1, children receiving TIV and PCV13 simultaneously had higher rates (37.6%) of fever (temperature ≥38°C) than those receiving TIV (7.5%; aRR, 2.69; 95% CI, 1.30-5.60) or PCV13 (9.5%; aRR, 2.67; 95% CI, 1.25-5.66).

The excess risk of fever after TIV and PCV13 was 20 and 23 per 100 vaccinations compared with TIV without PCV13 and PCV13 without TIV, respectively.
Fever rates for days 2 to 7 were similar across groups. For days 0 to 1, 74.8% of the text messages were confirmed delivered; for another 9.0%, delivery status was unknown.

Response rates were 95.1% and 90.9% for days 0 and 1 for confirmed delivered messages, respectively.
CONCLUSIONS AND RELEVANCE Simultaneous TIV and PCV13 administration was associated with higher transient increased fever risk than administration of either vaccine without the other product.

Text messaging to prospectively assess a specific vaccine adverse event has potential for enhancing prelicensure and postlicensure monitoring of adverse events after immunization and deserves further study. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01467934.」

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by medical-law | 2014-01-16 08:34 | 医療