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Large scale safety study of a liquid hexavalent vaccine (D-T-acP-IPV-PRP--T-HBs) administered at 2, 4, 6 and 12-14
J G Liese1, S Stojanov, F Berut
1Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital, Ludwig-Maximilians-Universität, Lindwurmstr. 4, D-80337 München, Germany.
Insights
The new liquid hexavalent vaccine (Hexavac) demonstrated good safety in 1783 children. Most reactions were mild, with few serious adverse events considered vaccine-related.
Area of Science:
- Pediatric Vaccinology
- Immunology
- Public Health
Background:
- The introduction of new vaccines requires rigorous safety assessments.
- Hexavalent vaccines offer combined protection against multiple diseases, simplifying immunization schedules.
Purpose of the Study:
- To evaluate the safety and tolerability of a novel liquid hexavalent vaccine (Hexavac) in a large pediatric cohort.
- To monitor immediate, local, systemic reactions, and serious adverse events (SAEs) following vaccination.
Main Methods:
- A prospective safety study involving 1783 children vaccinated with Hexavac at 2, 4, 6, and 12-14 months of age.
- Systematic monitoring of local reactions (redness, swelling), systemic events (fever, irritability), and SAEs.
Main Results:
- Common local reactions included redness and swelling, with higher frequencies after the booster dose.
- Frequent systemic events were irritability and fever, with higher incidence of fever post-booster.
- Serious adverse events were rare, with only 3 considered vaccine-related and resolving without sequelae.
Conclusions:
- The liquid hexavalent vaccine (Hexavac) is generally well-tolerated in children.
- The vaccine's safety profile supports its use in routine pediatric immunization schedules.
- Monitoring confirmed a favorable safety outcome for this new combination vaccine.
Abstract:
A study was conducted to assess the safety of a new, liquid hexavalent vaccine (Hexavac, Aventis Pasteur MSD, Lyon, France) in a large population of 1783 children in Germany vaccinated at 2, 4, 6 and 12-14 months of age. Immediate reactions, local and systemic reactions, and serious adverse events (SAEs) were monitored. The frequencies of redness > or = 2 cm and swelling > or = 2 cm were 6.7 and 7.1% after all doses of the primary series combined and 13.4 and 12.0% following the booster dose, respectively. Transient swelling of the entire thigh was reported in seven infants after all doses of the primary series (0.1%) and in four children after the booster dose (0.2%). The most frequent systemic adverse events within 3 days after vaccination were irritability (19.3% after primary series and 13.2% after booster) and fever > or = 38.0 degrees C (15.4% after primary series and 28.5% after booster). Fever above 40.0 degrees C was reported in 0.1% of the infants post-primary series and in 0.9% of the children after the booster immunization. Only 3 of 144 SAE were considered to be vaccine related and were seen to resolve spontaneously and without sequelae. The liquid hexavalent vaccine was generally well tolerated when given to children as a primary immunization series at 2, 4 and 6 months and as a booster dose at 12-14 months.
