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

Stockwell, Melissa S.; Broder, Karen R.; LaRussa, Philip; Lewis, Paige; Fernandez, Nadira; Sharma, Devindra; Barrett, A. H.; Sosa, José Carlos Erdozaín; Vellozzi, Claudia

doi:10.1001/jamapediatrics.2013.4469

Cited by 53 publications

(50 citation statements)

References 21 publications

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“…A subsequent study of the 2011/12 US influenza season confirmed elevated fever after concurrent TIV and PCV13 on Day 0 to 1 and listed fever rates after TIV alone similar to our findings at 7.5% in children aged six to 23 months [68].…”

Section: Discussionsupporting

confidence: 88%

Systematic review of fever, febrile convulsions and serious adverse events following administration of inactivated trivalent influenza vaccines in children

et al. 2015

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In 2010, increased febrile convulsions (FC) occurred after administration of inactivated trivalent influenza vaccine (TIV) in Australia. We systematically reviewed the rates of fever, FC and serious adverse events (SAEs) after TIV, focussing on published and unpublished clinical trial data from 2005 to 2012, and performed meta-analysis of fever rates. From 4,372 records in electronic databases, 18 randomised controlled trials (RCTs), 14 non-randomised clinical trials, six observational studies and 12 registered trials (five RCTs and seven non-randomised) were identified. In published RCTs, fever ≥ 38 °C rates after first dose of non-adjuvanted TIV were 6.7% and 6.9% for children aged 6-35 months and ≥ 3 years, respectively. Analysis of RCTs by vaccine manufacturer showed pooled fever estimates up to 5.1% with Sanofi or GlaxoSmithKline vaccines; bioCSL vaccines were used in two non-randomised clinical trials and one unpublished RCT and were associated with fever in 22.5-37.1% for children aged 6-35 months. In RCTs, FCs occurred at a rate of 1.1 per 1,000 vaccinated children. While most TIVs induced acceptably low fever rates, bioCSL influenza vaccines were associated with much higher rates of fever in young children. Future standardised study methodology and access to individual level data would be illuminating.

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Section: Discussionsupporting

confidence: 88%

Systematic review of fever, febrile convulsions and serious adverse events following administration of inactivated trivalent influenza vaccines in children

et al. 2015

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“…Increasing evidence suggests that co-administration and type of vaccine co-administered could play a role in the occurrence of an event such as convulsions following PCV. Overall, the results of our study are coherent with available literature data [19][20][21][22].…”

Section: Discussionsupporting

confidence: 92%

“…This study showed a risk of febrile seizure when TIV was co-administered with PCV13 that was higher than after single administration of TIV or PCV13 [21]. These findings were validated by an observational study conducted in the US which used prospective data collection and showed a higher risk of fever when TIV and PCV13 were co-administered than when either of these vaccines was administered without the other [22]. Increasing evidence suggests that co-administration and type of vaccine co-administered could play a role in the occurrence of an event such as convulsions following PCV.…”

Section: Discussionsupporting

confidence: 66%

Comparative safety evaluation of 7-valent and 13-valent pneumococcal vaccines in routine paediatric vaccinations in four Italian regions, 2009 to 2011

et al. 2015

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This study was aimed at estimating the risk of all types of adverse events following immunisation (AEFI), neurological events and convulsions following the co-administration of 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13) with hexavalent vaccine. Paediatric spontaneous reports and exposure to vaccinations in four Italian regions were available. The estimated incidence rate ratio (IRR) for AEFI following co-administration of hexavalent vaccine with either PCV13 or PCV7 was 1.08 (95% confidence interval (CI): 0.91-1.28); the IRR for, respectively, neurological events and convulsion following co-administration of PCV13 with hexavalent vaccine were 1.27 (95% CI: 0.85-1.89) and 1.43 (95% CI: 0.70-2.91). Co-administration of PCV13 with hexavalent vaccine had a protective effect against AEFI (IRR = 0.59; 95% CI: 0.49-0.72). This protective effect was not observed for neurological events or convulsions following coadministration of PCV13 with hexavalent vaccine compared with single administration (IRR = 1.44; 95% CI: 0.77-2.67 and IRR = 1.46; 95% CI: 0.50-4.25, respectively). We observed a trend of increased risk of neurological events or convulsions following PCV13 used in routine practice. Analysis of spontaneously reported data is a quick method to estimate associations between vaccines and less common adverse events. Given methodological limitations these findings cannot be conclusive and require further investigations.

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“…In Australia, SMS technology has also been used to study vaccine reactions among healthcare workers and pregnant women [13,14]. One study in the United States also used SMS follow-up of parents, detecting increased fever rates in children who had concomitantly received trivalent influenza vaccine and 13-valent pneumococcal vaccine compared with those who received each vaccine alone [15]. Similarly, we reported an increased (although low) rate of fever when influenza vaccine was administered together with other vaccines.…”

Section: Discussionsupporting

confidence: 58%

Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015

et al. 2015

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

Abstract: clinicaltrials.gov Identifier: NCT01467934.

Cited by 53 publications

References 21 publications

Systematic review of fever, febrile convulsions and serious adverse events following administration of inactivated trivalent influenza vaccines in children

Systematic review of fever, febrile convulsions and serious adverse events following administration of inactivated trivalent influenza vaccines in children

Comparative safety evaluation of 7-valent and 13-valent pneumococcal vaccines in routine paediatric vaccinations in four Italian regions, 2009 to 2011

Real-time safety surveillance of seasonal influenza vaccines in children, Australia, 2015

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