Large scale safety study of a liquid hexavalent vaccine (D-T-acP-IPV-PRP--T-HBs) administered at 2, 4, 6 and 12-14 months of age.
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.
Liese
J G
JG
Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital, Ludwig-Maximilians-Universität, Lindwurmstr. 4, D-80337 München, Germany.
Stojanov
S
S
Berut
F
F
Minini
P
P
Harzer
E
E
Jow
S
S
Schödel
F
F
Boslego
J
J
Hoffenbach
A
A
Kronwitter
A
A
Belohradsky
B H
BH
D015721:Diphtheria-Tetanus-Pertussis Vaccine; D005260:Female; D017325:Hepatitis B Vaccines; D006801:Humans; D007223:Infant; D008297:Male; D011054:Poliovirus Vaccine, Inactivated; D012449:Safety; D013997:Time Factors; D014611:Vaccination; D017778:Vaccines, Combined / Q000009:adverse effects*
D015721:Diphtheria-Tetanus-Pertussis Vaccine; D017325:Hepatitis B Vaccines; C426944:Hexavac; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined