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

Details

• Alternative Title:
  JAMA Pediatr
• Personal Author:
  Stockwell, Melissa S. ; Broder, Karen ; LaRussa, Philip ; Lewis, Paige ; Fernandez, Nadira ; Sharma, Devindra ; Barrett, Angela ; Sosa, Jose ; Vellozzi, Claudia
• Description:
  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:
  
  
• Subjects:
  Article Female Fever Humans Infant Influenza, Human Influenza Vaccines Male New York City Pneumococcal Vaccines Prospective Studies Reaction Time Risk Factors Text Messaging Treatment Outcome

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• Source:
  JAMA Pediatr. 168(3):211-219
• Pubmed ID:
  24395025
• Pubmed Central ID:
  PMC6693332
• Document Type:
  Journal Article
• Funding:
  CC999999/ImCDC/Intramural CDC HHS/United States ; 200-2002-00732/PHS HHS/United States
• Volume:
  168
• Issue:
  3
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:516a9a13a2928327087439690ab375be5130fee702ff053ecb34cdd60dbee843
• Download URL:
  https://stacks.cdc.gov/view/cdc/80730/cdc_80730_DS1.pdf
• File Type:
  [PDF - 780.02 KB ]