Safety and reactogenicity of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzaetype b (DTPa-IPV/Hib) vaccine in healthy Vietnamese toddlers: An open-label, phase III study

Abstract

The introduction of combination vaccines plays a significant role in increasing vaccine acceptance and widening vaccine coverage. Primary vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenza type b (Hib) diseases has been implemented in Vietnam. In this study we evaluated the safety and reactogenicity of combined diphtheria-tetanus-pertussis-inactivated polio (DTPa-IPV)/Hib vaccine when administered as a booster dose in 300 healthy Vietnamese children <2 years of age (mean age: 15.8 months). During the 4-day follow-up period, pain (31.7%) and redness (27.3%) were the most frequent solicited local symptoms. Pain (2%) was also the most frequent grade 3 local symptom. One subject reported 2 serious adverse events that were not causally related to the study vaccine. DTPa-IPV/Hib conjugate vaccine was well tolerated as a booster dose in healthy Vietnamese children aged <2 years.

Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course in healthy Korean infants: phase III, randomized study

“…3 The vaccine administered as a primary and/or booster vaccination has been shown to be well tolerated and immunogenic in infants in previous studies. [4][5][6][7][8][9] Since population-based immune response differences might be observed, [10][11][12][13][14] further studies may be needed to include multivalent vaccines in the National Immunization Programs of different countries. In Korea, three-dose primary vaccination of infants against diphtheria, tetanus, pertussis, poliomyelitis and Hib is recommended by the Korean Pediatric Society at 2, 4 and 6 months of age.…”

Co-administration of vaccines: a focus on tetravalent Measles-Mumps-Rubella-Varicella (MMRV) and meningococcal C conjugate vaccines

“…38 Some international studies demonstrated the advantages of vaccinations administered in the same visit, such as an increase in vaccination coverage, an increase in compliance with the entire vaccination course and the respect of the correct timing. 9,11,25,26 Kurosky et al 73 show how the combination of vaccines has considerably increased adherence to the complete vaccination course compared to what happens with the administration of monovalent vaccines. For example, as regards MMR vaccination, compliance with the timing of the vaccination course in those who received the combined vaccine was significantly higher (81.4%) compared to those who received the single vaccines (63.4%).…”

“…There are concerns about the possibility that too many vaccines overload the immune system, that the combined vaccines may be less effective and can cause a greater number of adverse reactions compared to the vaccines administered separately. 10,11 Combined products reduce the number of injections and pain compared to repeated injections; on the other hand, they also reduce cumulative exposure to preservatives and stabilizers that are erroneously linked by hesitant parents to the onset of adverse reactions. 12,13 Furthermore, co-administration reduces the number of visits and, therefore, decreases stress and discomfort for children and parents.…”

“…2,5 Public health impact of co-administration Combined and co-administered vaccines optimize vaccination coverage thanks to the simplification of vaccination programs. 11,25,26 These elements guarantee a significant impact in terms of public health, specifically with the increase in vaccination coverage and the more efficient management of services. 9 Considering the higher spending on the purchase of more expensive vaccines that could initially discourage their use, the combination of vaccination saves economic resources thanks to the more profitable management of vaccination services, which will benefit from an easier management of appointments and potentially reduce registration errors.…”

“…There are concerns about the possibility that too many vaccines overload the immune system, that the combined vaccines may be less effective and can cause a greater number of adverse reactions compared to the vaccines administered separately. 10 , 11 …”