DPT-IPV-Hib vaccine(Biken Techno Corp.)

Rotavirus infections have been reported to account for 40-50% of all hospitalized acute gastroenteritis cases in young children (<5 years) in Japan. Since 2011, Rotarix containing the live attenuated human rotavirus RIX4414 strain (HRV) has been licensed in Japan for infants. Vaccination against rotavirus is optional in Japan whereas administration of diphtheria, pertussis, tetanus, and inactivated poliovirus (DPT-IPV) vaccine is part of the national routine immunization program. In this open-label, randomized, controlled, multicenter study, we evaluated the immunogenicity and safety of the DPT-IPV vaccine (Squarekids) administered concomitantly or staggered with the liquid HRV (Rotarix) vaccine in healthy Japanese infants. A total of 292 infants aged 6-12 weeks were randomly assigned to receive DPT-IPV vaccine and HRV vaccine co-administered (n = 147) or staggered (n = 145). Immune responses to DPT-IPV vaccine were evaluated by measuring the post-vaccination serum antibody titers/concentrations to each antigen at one month following the third dose of DPT-IPV vaccine. Seroprotection/seropositivity against each of the diphtheria, pertussis (pertussis toxin and filamentous hemagglutinin), tetanus, and poliovirus type 1, 2 and 3 antigens was 92.8% or higher in both groups. In terms of immunogenicity, DPT-IPV vaccine co-administered with HRV vaccine was shown to be non-inferior to DPT-IPV vaccine with a staggered administration. The safety profile was comparable in the two vaccine groups with no vaccine-related serious adverse events, no deaths and no cases of intussusception. These results support co-administration of HRV vaccine with DPT-IPV vaccine in Japan. ClinicalTrials.gov NCT02907216.

Epidemiologic evidence for an association between vaccinations and atopy development is inconsistent. We evaluated the influence of Haemophilus influenzae type b (Hib) combination vaccines in 6-month-old infants on the prevalence of atopic disorders in 18-month-old children.

We used multistage, stratified systematic sampling to recruit 24,200 mother-newborn pairs from the Taiwan national birth registration in 2005. Vaccination status was ascertained through official vaccine cards, while risk factors for atopic disorders were gathered by questionnaires at 6 months of age. Information about development of atopic dermatitis (AD) and recurrent wheezing was collected at 18 months of age. The relationship between atopic disorders and Hib combination vaccines, diphtheria-pertussis-tetanus-Hib and oral poliomyelitis vaccines (DPT-Hib&OPV) and DPT-Hib-inactivated poliomyelitis vaccines (DPT-Hib-IPV), were estimated by multiple logistic regression.

A total of 19,968 children completed the follow-up and participated in the study. AD was noted in 1584 (7.9%) infants while recurrent wheezing was found in 1220 (6.1%) infants. The adjusted odds ratios (ORs) (95% CI) for the development of AD in the DPT-Hib&OPV and DPT-Hib-IPV vaccination groups were given as 1.38 (1.15-1.65) and 1.49 (1.29-1.72), compared to those without Hib vaccination (DTP&OPV vaccination). However, the association between DPT-Hib&OPV and DPT-Hib-IPV vaccinations and recurrent wheezing failed to reach statistical significance.

There is a potential risk for AD after receiving Hib combination vaccines. Hib vaccination is important to the public health, and therefore the observation requires further investigations.