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.

Abstract

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 degrees C or higher following vaccination with HEXAVAC or concomitant PENTACOQ and HBVAXPRO.

STUDY DESIGN:

This was an open, randomized, pragmatic, post-licensure multicenter 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 centers. During the combined three-day periods following the primary series injections, the incidence of fever of 40.0 degrees C or higher with HEXAVAC was not greater than with [PENTACOQ and HBVAXPRO]. The incidence of fever at thresholds of 38.0 degrees C, 38.5 degrees C, 39.0 degrees C and 39.5 degrees C was significantly lower in the HEXAVAC group. The vaccine attributable risk for fever of 40.0 degrees C following the booster injection with HEXAVAC was statistically acceptable.

CONCLUSION:

The incidence of fever of 40.0 degrees C or higher in this study was very low and similar in both groups (HEXAVAC or [PENTACOQ + HBVAXPRO] as a three-dose primary series). Fever > or =38.0 degrees C and < or =39.5 degrees C was significantly less frequent following administration of HEXAVAC. The incidence of fever of 40.0 degrees C or higher following a HEXAVAC booster dose was low in all infants studied.

• Authors: Philippe Reinert, Anne Fiquet, Stéphane Thomas, Anne Schuyleman, Michael Watson, HEXALIS Study Group
• Journal: Human vaccines (Hum Vaccin) 2006 Sep-Oct Vol. 2 Issue 5 Pg. 215-21 ISSN: 1554-8600 [Print] United States
• PMID: 17035735 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Biomarkers
• Diphtheria-Tetanus-Pertussis Vaccine
• Hepatitis B Vaccines
• Hexavac
• Poliovirus Vaccine, Inactivated
• Vaccines, Combined

Topics

• Biomarkers
• Diphtheria-Tetanus-Pertussis Vaccine
• Female
• Fever (etiology)
• Hepatitis B Vaccines
• Humans
• Infant
• Male
• Poliovirus Vaccine, Inactivated
• Vaccines, Combined (adverse effects)