Primary vaccination with a new heptavalent DTPw-HBV/Hib-Neisseria meningitidis serogroups A and C combined vaccine is well tolerated.

Abstract

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.

CONCLUSION:

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.

• Authors: Angkool Kerdpanich, Boonyarat Warachit, Pensri Kosuwon, Salvacion R Gatchalian, Veerachai Watanaveeradej, Thitiporn Borkird, Pope Kosalaraksa, Htay-Htay Han, Yanee Hutagalung, Dominique Boutriau, Kurt Dobbelaere
• Journal: International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases (Int J Infect Dis) Vol. 12 Issue 1 Pg. 88-97 (Jan 2008) ISSN: 1201-9712 [Print] Canada
• PMID: 17716936 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Diphtheria-Tetanus-Pertussis Vaccine
• Hepatitis B Vaccines
• Meningococcal Vaccines
• Tritanrix-HepB vaccine
• Vaccines, Combined

Topics

• Diphtheria-Tetanus-Pertussis Vaccine (administration & dosage, adverse effects)
• Female
• Fever (etiology, immunology)
• Hepatitis B Vaccines (administration & dosage, adverse effects)
• Humans
• Immunization Schedule
• Immunization, Secondary
• Infant
• Male
• Meningococcal Vaccines (administration & dosage, adverse effects)
• Philippines
• Seizures, Febrile (etiology, immunology)
• Thailand
• Vaccines, Combined (administration & dosage, adverse effects)