Modification of the vaccine manufacturing process improves the pyrogenicity profile of inactivated influenza vaccines in young children.
Vaccine
; 37(18): 2447-2454, 2019 04 24.
Article
em En
| MEDLINE
| ID: mdl-30935743
ABSTRACT
BACKGROUND:
There were increased reports of fevers and febrile reactions in young children (particularly children aged <5â¯years) receiving the Seqirus/CSL Southern Hemisphere 2010 trivalent inactivated influenza vaccine (IIV3). Modifying the vaccine manufacturing process by increasing the minimum concentration of splitting agent (sodium taurodeoxycholate [TDOC]) from 0.5% w/v to 1.5% w/v for all strains resolved this issue. The current analysis compared fever rates in three pediatric studies of Seqirus IIV3 (S-IIV3) or quadrivalent inactivated influenza vaccine (S-IIV4), prepared using the modified manufacturing process, with fever rates in three pediatric studies of historical (pre-2010) IIV3 formulations. The historical IIV3 formulations, S-IIV3, and S-IIV4 had 0/3, 2/3, and 4/4 vaccine strains split at 1.5% TDOC, respectively.METHODS:
For each study, fever rates (any grade and severe) were determined for the following age subgroups (as applicable), using the fever intensity grading system used in the S-IIV3/S-IIV4 studies 6â¯months to <3â¯years; 3 to <5â¯years; 5 to <9â¯years; and 9 to <18â¯years.RESULTS:
For each age subgroup, the any grade and severe fever rates were lower in the S-IIV3/S-IIV4 studies than in the historical IIV3 formulation studies, with the greatest differences in fever rates observed in the youngest age groups. In the 6â¯months to <3â¯years group, the any grade fever rate was 7.0% (severe fever 2.5%) in one S-IIV4 study compared with 38.7% to 40.0% (severe fever 9.6% to 17.8%) in the historical IIV3 formulation studies. In the 3 to <5â¯years subgroup, the any grade fever rate was 4.9% (severe fever 1.2%) in one S-IIV4 study compared with 34.1% to 36.0% (severe fever 6.3% to 16.5%) in the historical IIV3 formulation studies.CONCLUSION:
This analysis provides clinical evidence that the modified manufacturing process improved the fever profile across all pediatric age groups, in particular, in children aged <5â¯years.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vacinas contra Influenza
/
Febre
Limite:
Adolescent
/
Child
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Child, preschool
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Humans
/
Infant
Idioma:
En
Revista:
Vaccine
Ano de publicação:
2019
Tipo de documento:
Article