safety,
Tolerability and IMMUNOGENICITY OF A combined DTPHib (Diphtheria,tetanus, wpertussis, haemophilus
influenzae type b-crm197 conjugate full liquid) VACCINE
Asensi-Botet F1,
Viviani S2, Veronese A2, Otero M-C1, Perez
Tamarit M-D1, Ridaura S1, Nacci P2, Calvo
M-A1, Lopez-Hontangas J-L1, Comes Castellano A-M2,
Podda A2
1 Departamento
de Enfermedades Infecciosas, Hospital Infantil ¨C Hospital Universitario La
F¨¦, Valencia, Spain
2
Clinical Research & Medical Affairs, Chiron S.p.A, Siena, Italy
Objective: To compare separate administration of Chiron DTwP
vaccine and Chiron Hib-crm197 conjugate vaccine to a combined full liquid
Chiron DTwPHib vaccine.
Methods: A total of 370 infants were
enrolled at Hospital ¡°La F¨¦¡± in Valencia, Spain, and randomised in a 1:1
ratio to receive at 2, 3 and 4 months of age either separate administration
of DTwP and Hib vaccines or the combined DtwPHib vaccine.
Results: Local and systemic reactions
were mild and similar in both vaccine groups. No related serious adverse events
were reported. In both vaccine groups >95% of subjects had anti-PRP
antibodies ¡Ý0.15 mg/mL. A higher proportion of
subjects who received the combined DTwPHib vaccine were protected in the
long term (anti-PRP ¡Ý1 mg/mL) as compared to subjects
who received separate vaccines (89% vs 78%). Similarly, Geometric Mean
Titres (GMTs) were significantly higher in recipients of the DTwPHib
vaccine than in recipients of separate vaccines (6.65 mg/mL vs 3.57 mg/mL). The proportion of
subjects who seroconverted to Agg2 and 3 was higher in recipients of
separate vaccines than in recipients of the combined DTwPHib vaccine
(82%vs73%). All subjects were protected against diphtheria and tetanus.
Conclusions:The combined DTwPHib full liquid vaccine was safe and immunogenic
as a primary vaccination in infants. The DTwPHib full liquid formulation
opens the prospect for additional antigens combinations.