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Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recu...
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| Zeitschriftentitel: | BMJ Open |
|---|---|
| Personen und Körperschaften: | , , , |
| In: | BMJ Open, 9, 2019, 5, S. e026953 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
BMJ
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| Schlagwörter: |
| author_facet |
Zafack, Joseline Guetsop Bureau, Alexandre Skowronski, Danuta M De Serres, Gaston Zafack, Joseline Guetsop Bureau, Alexandre Skowronski, Danuta M De Serres, Gaston |
|---|---|
| author |
Zafack, Joseline Guetsop Bureau, Alexandre Skowronski, Danuta M De Serres, Gaston |
| spellingShingle |
Zafack, Joseline Guetsop Bureau, Alexandre Skowronski, Danuta M De Serres, Gaston BMJ Open Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials General Medicine |
| author_sort |
zafack, joseline guetsop |
| spelling |
Zafack, Joseline Guetsop Bureau, Alexandre Skowronski, Danuta M De Serres, Gaston 2044-6055 2044-6055 BMJ General Medicine http://dx.doi.org/10.1136/bmjopen-2018-026953 <jats:sec><jats:title>Objectives</jats:title><jats:p>(1) To assess if co-administration of four-component meningococcal serogroup B vaccine (4CMenB) and other routine vaccines caused an interaction increasing the risk and/or severity of adverse events following immunisation (AEFI) compared with administration at separate visits and (2) to estimate the risk of AEFI recurrence.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Risk-interval design</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>Three randomised controlled trials conducted in Europe.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>A total of 5026 healthy 2-month-old to 15-month-old infants.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>4CMenB and routine vaccines (hexavalent combined diphtheria-tetanus-acellular pertussis-inactivated polio-Haemophilus influenzae type b-hepatitis B vaccine+seven-valent pneumococcal conjugate vaccine or measles-mumps-rubella-varicella vaccine) administered concomitantly or separately 1 month apart, in regular (2, 4, 6 and 12 months), accelerated (2, 3, 4 and 12 months) or delayed (two doses of 4CMenB at ≥12 months of age) schedules.</jats:p></jats:sec><jats:sec><jats:title>Outcome measures</jats:title><jats:p>Primary: Fever (≥38°C) during the first 48 hours post immunisation. Secondary: crying, change in eating habits, diarrhoea, irritability and tenderness at the 4CMenB injection site.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Compared with separate administration, concomitant administration decreased the overall incidence of fever (≥38°C), 86% versus 75%, and other systemic AEFIs but increased the incidence of 4CMenB injection site tenderness, 55% versus 66%, moderate/severe fevers (≥39°C), 13% versus 18%, and long-lasting (>1 day) fevers, 23% versus 33%. Co-administration reduced AEFI risk by 4%–49% with the greatest impact among infants with prior AEFI(s). Fever recurrence risk was proportional to the number of prior fever events: 79% at dose 2 with one prior episode; 44% and 74% at dose 3 with one and two prior episodes, respectively; and 29%, 45% and 60% at dose 4 with one, two and three prior episodes, respectively. Severity was not increased at recurrence and a similar pattern of recurrence risk proportional to the number of prior events was observed for other AEFIs.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>The cumulative risk of AEFI is reduced with concomitant versus separate administration of 4CMenB and routine infant vaccines. Infants with a prior AEFI are at higher risk of the same AEFI at subsequent immunisations, but severity with recurrence is usually not increased.</jats:p></jats:sec><jats:sec><jats:title>Trials registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT00657709" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT00657709</jats:ext-link>,<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT00847145" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT00847145</jats:ext-link>,<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT00721396" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT00721396</jats:ext-link>and<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT02712177" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT02712177</jats:ext-link>; Pre-results.</jats:p></jats:sec> Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials BMJ Open |
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10.1136/bmjopen-2018-026953 |
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| title |
Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials |
| title_unstemmed |
Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials |
| title_full |
Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials |
| title_fullStr |
Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials |
| title_full_unstemmed |
Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials |
| title_short |
Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials |
| title_sort |
adverse events following immunisation with four-component meningococcal serogroup b vaccine (4cmenb): interaction with co-administration of routine infant vaccines and risk of recurrence in european randomised controlled trials |
| topic |
General Medicine |
| url |
http://dx.doi.org/10.1136/bmjopen-2018-026953 |
| publishDate |
2019 |
| physical |
e026953 |
| description |
<jats:sec><jats:title>Objectives</jats:title><jats:p>(1) To assess if co-administration of four-component meningococcal serogroup B vaccine (4CMenB) and other routine vaccines caused an interaction increasing the risk and/or severity of adverse events following immunisation (AEFI) compared with administration at separate visits and (2) to estimate the risk of AEFI recurrence.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Risk-interval design</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>Three randomised controlled trials conducted in Europe.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>A total of 5026 healthy 2-month-old to 15-month-old infants.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>4CMenB and routine vaccines (hexavalent combined diphtheria-tetanus-acellular pertussis-inactivated polio-Haemophilus influenzae type b-hepatitis B vaccine+seven-valent pneumococcal conjugate vaccine or measles-mumps-rubella-varicella vaccine) administered concomitantly or separately 1 month apart, in regular (2, 4, 6 and 12 months), accelerated (2, 3, 4 and 12 months) or delayed (two doses of 4CMenB at ≥12 months of age) schedules.</jats:p></jats:sec><jats:sec><jats:title>Outcome measures</jats:title><jats:p>Primary: Fever (≥38°C) during the first 48 hours post immunisation. Secondary: crying, change in eating habits, diarrhoea, irritability and tenderness at the 4CMenB injection site.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Compared with separate administration, concomitant administration decreased the overall incidence of fever (≥38°C), 86% versus 75%, and other systemic AEFIs but increased the incidence of 4CMenB injection site tenderness, 55% versus 66%, moderate/severe fevers (≥39°C), 13% versus 18%, and long-lasting (>1 day) fevers, 23% versus 33%. Co-administration reduced AEFI risk by 4%–49% with the greatest impact among infants with prior AEFI(s). Fever recurrence risk was proportional to the number of prior fever events: 79% at dose 2 with one prior episode; 44% and 74% at dose 3 with one and two prior episodes, respectively; and 29%, 45% and 60% at dose 4 with one, two and three prior episodes, respectively. Severity was not increased at recurrence and a similar pattern of recurrence risk proportional to the number of prior events was observed for other AEFIs.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>The cumulative risk of AEFI is reduced with concomitant versus separate administration of 4CMenB and routine infant vaccines. Infants with a prior AEFI are at higher risk of the same AEFI at subsequent immunisations, but severity with recurrence is usually not increased.</jats:p></jats:sec><jats:sec><jats:title>Trials registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT00657709" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT00657709</jats:ext-link>,<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT00847145" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT00847145</jats:ext-link>,<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT00721396" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT00721396</jats:ext-link>and<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT02712177" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT02712177</jats:ext-link>; Pre-results.</jats:p></jats:sec> |
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| description | <jats:sec><jats:title>Objectives</jats:title><jats:p>(1) To assess if co-administration of four-component meningococcal serogroup B vaccine (4CMenB) and other routine vaccines caused an interaction increasing the risk and/or severity of adverse events following immunisation (AEFI) compared with administration at separate visits and (2) to estimate the risk of AEFI recurrence.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Risk-interval design</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>Three randomised controlled trials conducted in Europe.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>A total of 5026 healthy 2-month-old to 15-month-old infants.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>4CMenB and routine vaccines (hexavalent combined diphtheria-tetanus-acellular pertussis-inactivated polio-Haemophilus influenzae type b-hepatitis B vaccine+seven-valent pneumococcal conjugate vaccine or measles-mumps-rubella-varicella vaccine) administered concomitantly or separately 1 month apart, in regular (2, 4, 6 and 12 months), accelerated (2, 3, 4 and 12 months) or delayed (two doses of 4CMenB at ≥12 months of age) schedules.</jats:p></jats:sec><jats:sec><jats:title>Outcome measures</jats:title><jats:p>Primary: Fever (≥38°C) during the first 48 hours post immunisation. Secondary: crying, change in eating habits, diarrhoea, irritability and tenderness at the 4CMenB injection site.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Compared with separate administration, concomitant administration decreased the overall incidence of fever (≥38°C), 86% versus 75%, and other systemic AEFIs but increased the incidence of 4CMenB injection site tenderness, 55% versus 66%, moderate/severe fevers (≥39°C), 13% versus 18%, and long-lasting (>1 day) fevers, 23% versus 33%. Co-administration reduced AEFI risk by 4%–49% with the greatest impact among infants with prior AEFI(s). Fever recurrence risk was proportional to the number of prior fever events: 79% at dose 2 with one prior episode; 44% and 74% at dose 3 with one and two prior episodes, respectively; and 29%, 45% and 60% at dose 4 with one, two and three prior episodes, respectively. Severity was not increased at recurrence and a similar pattern of recurrence risk proportional to the number of prior events was observed for other AEFIs.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>The cumulative risk of AEFI is reduced with concomitant versus separate administration of 4CMenB and routine infant vaccines. Infants with a prior AEFI are at higher risk of the same AEFI at subsequent immunisations, but severity with recurrence is usually not increased.</jats:p></jats:sec><jats:sec><jats:title>Trials registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT00657709" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT00657709</jats:ext-link>,<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT00847145" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT00847145</jats:ext-link>,<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT00721396" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT00721396</jats:ext-link>and<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT02712177" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT02712177</jats:ext-link>; Pre-results.</jats:p></jats:sec> |
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| spelling | Zafack, Joseline Guetsop Bureau, Alexandre Skowronski, Danuta M De Serres, Gaston 2044-6055 2044-6055 BMJ General Medicine http://dx.doi.org/10.1136/bmjopen-2018-026953 <jats:sec><jats:title>Objectives</jats:title><jats:p>(1) To assess if co-administration of four-component meningococcal serogroup B vaccine (4CMenB) and other routine vaccines caused an interaction increasing the risk and/or severity of adverse events following immunisation (AEFI) compared with administration at separate visits and (2) to estimate the risk of AEFI recurrence.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Risk-interval design</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>Three randomised controlled trials conducted in Europe.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>A total of 5026 healthy 2-month-old to 15-month-old infants.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>4CMenB and routine vaccines (hexavalent combined diphtheria-tetanus-acellular pertussis-inactivated polio-Haemophilus influenzae type b-hepatitis B vaccine+seven-valent pneumococcal conjugate vaccine or measles-mumps-rubella-varicella vaccine) administered concomitantly or separately 1 month apart, in regular (2, 4, 6 and 12 months), accelerated (2, 3, 4 and 12 months) or delayed (two doses of 4CMenB at ≥12 months of age) schedules.</jats:p></jats:sec><jats:sec><jats:title>Outcome measures</jats:title><jats:p>Primary: Fever (≥38°C) during the first 48 hours post immunisation. Secondary: crying, change in eating habits, diarrhoea, irritability and tenderness at the 4CMenB injection site.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Compared with separate administration, concomitant administration decreased the overall incidence of fever (≥38°C), 86% versus 75%, and other systemic AEFIs but increased the incidence of 4CMenB injection site tenderness, 55% versus 66%, moderate/severe fevers (≥39°C), 13% versus 18%, and long-lasting (>1 day) fevers, 23% versus 33%. Co-administration reduced AEFI risk by 4%–49% with the greatest impact among infants with prior AEFI(s). Fever recurrence risk was proportional to the number of prior fever events: 79% at dose 2 with one prior episode; 44% and 74% at dose 3 with one and two prior episodes, respectively; and 29%, 45% and 60% at dose 4 with one, two and three prior episodes, respectively. Severity was not increased at recurrence and a similar pattern of recurrence risk proportional to the number of prior events was observed for other AEFIs.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>The cumulative risk of AEFI is reduced with concomitant versus separate administration of 4CMenB and routine infant vaccines. Infants with a prior AEFI are at higher risk of the same AEFI at subsequent immunisations, but severity with recurrence is usually not increased.</jats:p></jats:sec><jats:sec><jats:title>Trials registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT00657709" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT00657709</jats:ext-link>,<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT00847145" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT00847145</jats:ext-link>,<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT00721396" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT00721396</jats:ext-link>and<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT02712177" ext-link-type="clintrialgov" specific-use="clinicaltrial pre-results">NCT02712177</jats:ext-link>; Pre-results.</jats:p></jats:sec> Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials BMJ Open |
| spellingShingle | Zafack, Joseline Guetsop, Bureau, Alexandre, Skowronski, Danuta M, De Serres, Gaston, BMJ Open, Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials, General Medicine |
| title | Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials |
| title_full | Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials |
| title_fullStr | Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials |
| title_full_unstemmed | Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials |
| title_short | Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials |
| title_sort | adverse events following immunisation with four-component meningococcal serogroup b vaccine (4cmenb): interaction with co-administration of routine infant vaccines and risk of recurrence in european randomised controlled trials |
| title_unstemmed | Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials |
| topic | General Medicine |
| url | http://dx.doi.org/10.1136/bmjopen-2018-026953 |