Safety and immunogenicity of three different formulations of a liquid hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine at 2, 4, 6 and 12-14 months of age.

[Guest guest]

Vaccine. 2010 Dec 3. [Epub ahead of print]

Safety and immunogenicity of three different formulations of a liquid hexavalent

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus

influenzae b conjugate-hepatitis B vaccine at 2, 4, 6 and 12-14 months of age.

-Mitoma F, Halperin SA, Tapiero B, Hoffenbach A, Zappacosta PS, Radley D,

Bradshaw S, JC, Boslego JW, Hesley TM, Bhuyan PK, Silber JL.

Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.

Abstract

The current recommended infant vaccination schedules require many injections at

multiple sites, which increase stress for infants and parents and may create

challenges to vaccination compliance. Therefore, combination vaccines, which

reduce the number of injections at each medical visit, can be an essential

method to improve compliance. The objective of this study was to assess the

safety and immunogenicity of an investigational, liquid, hexavalent, pediatric

vaccine at 2, 4, 6, and 12-14 months of age. In this multicenter, open-label

controlled study, 756 infants were randomized in approximately equal numbers to

receive 0.5mL intramuscular dose of

diptheria-tetanus-pertussis-polio-Haemophilus influenzae type b+hepatitis B

vaccine, or 1 of 3 double-blind investigational formulations. All formulations

included a hepatitis B surface antigen (HBsAg) concentration of 10ìg/0.5mL. The

three hexavalent vaccine formulations used in this study contained either Hib

polyribosylribitol phosphate (PRP) conjugate component (tetanus toxoid [PRP-T,

12ìg] or Neisseria meningitidis outer membrane protein complex [PRP-OPMC, 3ìg or

6ìg]): a minimum acceptable postdose 3 antibody response rate for each antigen

was defined by the lower limit of a 95% confidence interval exceeding a

prespecified target. Rates of adverse events (AEs) were similar among groups,

with a trend for increased solicited vaccine-related injection-site reactions

(pain, erythema, swelling) with increasing PRP-OMPC dose. No serious

vaccine-related AEs were reported in the investigational groups. Both PRP-OMPC

formulations met prespecified acceptability criteria for all antigens: PRP,

HBsAg, pertussis, diphtheria, tetanus and poliovirus. The PRP-T formulation met

the acceptability criterion for antibody responses to all antigens other than

PRP at postdose 3. Postdose 4 responses were adequate for all antigens in all

formulations. All vaccine formulations were well-tolerated. Both PRP-OMPC

formulations met prespecified immunogenicity criteria of PRP-OMPC evaluation.

. Published by Elsevier Ltd.

PMID: 21134456 [PubMed - as supplied by publisher]