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Research Paper
Fever as a Marker of Reactogenicity of an Acellular Pertussis-Containing Hexavalent Vaccine (HEXAVAC®) in a Large-Scale, Open, Randomized Safety Study in Healthy French Infants
Philippe Reinert, Michael Watson, Anne Fiquet, Stéphane Thomas, Anne Schuyleman (on behalf of the HEXALIS Study Group)
volume 2 | issue 5
september/october 2006Pages: 215 - 221
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Objective: New multivalent vaccines simplify childhood immunisation schedules and can increase vaccination coverage. However, they must have a reactogenicity profile which is acceptable and comparable with that of previously available vaccines. The objective of this trial was to assess the incidence of fever of 40.0°C or higher following vaccination with HEXAVAC® or concomitant PENTACOQ® and HBVAXPRO™.
Study design: This was an open, randomised, pragmatic, post-licensure multicentre trial performed in France. Infants were randomly assigned to receive either a single injection of a hexavalent, aP-containing vaccine (HEXAVAC®) or separate injections of a pentavalent, wP-containing vaccine (PENTACOQ®) and Hepatitis B vaccine (HBVAXPRO™) at 2, 3 and 4 months of age. Both groups received a HEXAVAC® booster at 12-18 months of age.
Results and discussion: 7151 infants were enrolled in 389 centres. During the combined 3-day periods following the primary series injections, the incidence of fever of 40.0°C or higher with HEXAVAC® was not greater than with [PENTACOQ® and HBVAXPRO™]. The incidence of fever at thresholds of 38.0°C, 38.5°C, 39.0°C and 39.5°C was significantly lower in the HEXAVAC group. The vaccine attributable risk for fever of 40.0°C following the booster injection with HEXAVAC® was statistically acceptable.
Conclusion: The incidence of fever of 40.0°C higher in this study was very low and similar in both groups (HEXAVAC® or [PENTACOQ® + HBVAXPRO™] as a 3-dose primary series). Fever ≥ 38.0°C and ≤ 39.5°C was significantly less frequent following administration of HEXAVAC®. The incidence of fever of 40.0°C or higher following a HEXAVAC® booster dose was low in all infants studied.
We now provide open access to journal articles published online for one year or more. This article may be downloaded at the following link:
Download PDF If the document does not open, please right-click on the link (control-click on a Macintosh) and select the option to save the file to disk.