Immunogenicity, Reactogenicity and Safety of a Combined DTPa-IPV Vaccine Compared with Separate DTPa and IPV Vaccines in Healthy Korean Infants

Abstract

∫∫ , Wavre, BelgiumPurpose : To compare immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (DTPa-IPV, Infanrix TM IPV, GlaxoSmithKline Biologicals) with co-administration of commercially available DTPa and IPV vaccines at separate injection sites (DTPa+IPV). Methods : A total of 458 infants aged 8-12 weeks were randomized to receive three-dose primary vaccination at 2, 4 and 6 months with DTPa-IPV or DTPa+IPV. Blood samples were collected pre and post vaccination for measurement of immune responses. Reactogenicity was assessed following each dose using diary cards. Results : One month post-dose 3, seroprotection rates for anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3 were 99.5% and vaccine response rates to pertussis antigens were at least 98.6% in both DTPa-IPV and DTPa + IPV ≥ groups. Non-inferiority between the groups was demonstrated based on pre-defined statistical criteria. Incidences of both local and systemic symptoms were within the same range across both groups with grade 3 symptoms reported following no more than 4.3% of DTPa-IPV doses and 4.5% of DTPa + IPV doses. Two serious adverse events (both pyrexia) after DTPa-IPV administration were considered vaccine-related. Both infants recovered fully. Conclusion : Combined DTPa-IPV vaccine was immunogenic and well tolerated when used as a three-dose primary vaccination course in Korean infants. DTPa-IPV could be incorporated into the Korean vaccination schedule, reducing the number of injections required to complete primary immunization. (Korean J Pediatr Infect Dis 2010;17:156-168)

Post-marketing surveillance to assess the safety and tolerability of a combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP-IPV) in Korean children

“…The most common expected AE was fever, occurring in 11.9% of subjects, and which accounted for 14.8% of all AEs and 48.4% of all ADRs. This rate is similar to that reported in the pre-licensure RCT investigating immunogenicity and safety in Korean infants (fever ≥37.5°C reported in 11.6% of children 8 ) but slightly higher than data from RCTs in non-Korean populations (US, Europe, Australia) that reported rates of fever ranging from 6.1% to 9.6%. 6,14 Local injectionsite reactions were relatively uncommon, with 20 such AEs occurring in 16 subjects (2.5%), most of which were of mild intensity.…”

“…6,14 Local injectionsite reactions were relatively uncommon, with 20 such AEs occurring in 16 subjects (2.5%), most of which were of mild intensity. This is substantially lower than that reported in previous studies in Korean infants (where the proportion of infants with reactions ranged from 17.4% to 32.4%) 8 and is lower than that reported in previous studies in non-Korean populations. 6,14 The majority of all AEs reported (59.6%) were considered as unexpected AEs, representing signs/symptoms not described in the Korean PI.…”

“…7 Data from a randomized controlled trial (RCT) conducted in Korean infants indicate that DTaP-IPV has comparable immunogenicity and safety to that seen with separate DTaP and IPV vaccinations when given as a three-dose primary vaccination schedule. 8 Studies conducted in other populations (including the United States [US], Europe, and Australia) also indicate comparable immunogenicity and safety to separate DTaP and IPV vaccinations when given a booster-dose. In addition, they show DTaP-IPV can be safely co-administered with other childhood vaccinations, [9][10][11][12][13][14][15] and post-licensure surveillance data from the US indicate no safety concerns.…”

Comparison of the Immunogenicity and Safety of Three Enhanced Inactivated Poliovirus Vaccines from Different Manufacturers in Healthy Korean Infants: A Prospective Multicenter Study

“…In 2000, the WHO Western Pacific Region, including Korea, was declared free of indigenous poliovirus. This certifies the absence of poliovirus for at least 3 years and the presence of a well-established surveillance system that effectively detects and reports all cases of acute paralytic polio associated with vaccination [12]. Korea introduced a vaccine-associated paralytic polio reporting system in 1988, and a single case of vaccine-associated paralytic polio has been confirmed to date [11].…”

“…With advances in cell culture techniques, vaccine viruses can be produced in large quantity, and eIPV with enhanced immunogenicity was developed through greater antigenic content. Some European nations have used eIPV as their primary vaccination since the 1980s, and the US has been using eIPV only since 2000 [11,12].…”