Primary vaccination with a new heptavalent DTPw-HBV/Hib-Neisseria meningitidis serogroups A and C combined vaccine is well tolerated.
OBJECTIVE
Safety and reactogenicity of a new heptavalent DTPw-HBV/Hib-MenAC (diphtheria, tetanus, whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C) vaccine was compared with a widely used pentavalent DTPw-HBV/Hib vaccine.


METHODS
Three phase III randomized studies comparable in design and methodology, in which healthy infants received DTPw-HBV/Hib-MenAC (N=1334) or DTPw-HBV/Hib (N=446) at 2, 4, and 6 months, were pooled for analysis. Solicited symptoms were recorded for 4 days, and unsolicited adverse events for 31 days after each dose. Serious adverse events (SAEs) were recorded throughout the studies.


RESULTS
There were no significant differences between the two groups in the proportion of subjects with fever >39.5 degrees C or >40.0 degrees C (p<0.005). Compared to group DTPw-HBV/Hib, a significantly higher percentage of subjects in group DTPw-HBV/Hib-MenAC reported fever >39 degrees C (21.2% vs. 14.8%, p=0.004). Fever subsided quickly, did not lead to differences in attendance to medical services and did not increase from dose to dose. Sixty-seven SAEs were reported, 56/1334 (4.2%) in group DTPw-HBV/Hib-MenAC and 11/446 (2.5%) in the DTPw-HBV/Hib group.


CONCLUSIONS
Overall, the heptavalent and pentavalent vaccines had similar safety profiles. The difference observed in percentage of subjects with fever >39 degrees C did not lead to differences in medically attended visits for fever.
Kerdpanich
Angkool
A
Infectious Disease Unit, Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand.
Warachit
Boonyarat
B
Kosuwon
Pensri
P
Gatchalian
Salvacion R
SR
Watanaveeradej
Veerachai
V
Borkird
Thitiporn
T
Kosalaraksa
Pope
P
Han
Htay-Htay
HH
Hutagalung
Yanee
Y
Boutriau
Dominique
D
Dobbelaere
Kurt
K
D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005334:Fever / Q000209:etiology / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D010679:Philippines; D003294:Seizures, Febrile / Q000209:etiology / Q000276:immunology; D013785:Thailand; D017778:Vaccines, Combined / Q000008:administration & dosage* / Q000009:adverse effects
D015721:Diphtheria-Tetanus-Pertussis Vaccine; D017325:Hepatitis B Vaccines; D022401:Meningococcal Vaccines; C524362:Tritanrix-HepB vaccine; D017778:Vaccines, Combined