Immunogenicity And Safety Of The Acellular Pertussis, Diphtheria, Tetanus, Inactivated Poliomyelitis, Haemophilus Influenza Type B Conjugate Vaccine (DTaP-IPV/Hib Combined Vaccine): A Meta-analysis

Background： Acellular pertussis, diphtheria, tetanus, inactivatedpoliomyelitis, haemophilus influenza type b were highly contagious andacute infectious diseases in children. The acellular pertussis, diphtheria,tetanus, inactivated poliomyelitis, haemophilus influenza type b diseasesepidemic were characterized by that severe cases were reduced while lightcases were increased. Prevalence of latent infections were prevalent, thelocal outbreak was still distributed. Acellular pertussis, diphtheria, tetanus,inactivated poliomyelitis, haemophilus influenza type b vaccines couldefficiently increase the people’s antibody level and reduce morbidity. Withthe extensive use of combination vaccines, vaccine types for choice therewere many different views. Base on ensure the immune effect, could wetake combined vaccines to reduce the vaccination number, cost and vaccinemanagement difficulty, thereby increase the immunization dependence, there was no formed conclusion.Objective： To evaluate the immunogenicity and safety ofDTaP-IPV/Hib combined vaccine in comparison with commerciallyavailable DTaP (diphtheria, tetanus and pertussis), haemophilus influenzaetype b (Hib), tetanus conjugate and IPV monovalent vaccine.Methods：Randomized controlled trial literaturs on DTaP-IPV/Hibcompared with DTaP, IPV, Hib vaccine of immunogenicity effect andsafety were retrieved by searching international and national databases.Retrieval words were：acellular Pertussis, diphtheria, tetanus, inactivatedpoliomyelitis, Haemophilus influenza type b vaccine, DTaP/IPV-Hib, andconnecting with the conjunction "AND" and "OR". Inclusion criterias:①Research methods were randomized controlled trial, regardless ofwhether the "blind" were included;②The test group’ objects wereinoculated with DTaP-IPV/Hib combined vaccine, the control group wereinoculated with DTaP, IPV, Hib vaccine;③Literature uses the followingevaluation indicators: immunogenicity indicators were seroprotection/seroconversion rates and anti-bodytiter; safety indicators are theincidences of swelling, tenderness, swelling and so on;④The objects ofstudy were <2years old healthy children, before inoculation temperaturewas normal, not limited to sex, nationality and race. Exclusion criterias:①Research methods were not randomized controlled trial;②The controlgroup subjects were not inoculated with DTaP, Hib, IPV vaccine; ③Missing datas;④The animal experiments;⑤Statistical indicators couldnot be performed data extraction, and faile to contact the author. Thequalities of included studies were evaluated according to the modifiedJadad score. Jadad standard was included random sequence, random hidden,blind method, withdrawal. Quality assessment of the literature wasdivided into high quality and low quality,4~7was regarded as a highquality literature,1~3was as low quality literature.The pooled meandifference and relative risk and95%CI were assessed by Meta analysiswith RevMan5.0software. The main indicators were the seroprotection/seroconversion rates, anti-bodytiter and the incidence of adverse reactions.Heterogeneity was evaluated using by I2value. The Egger ’and Macaskill’stest were used to evaluate the publication bias.Results：Totally6studies were included for the final analysis. Theseroconversion rate of the Anti-PT (RR=0.26,95%CI:0.14~0.48) incombination vaccine was higher than DTaP vaccine, other indicators wereshowed no statistical significances. The antibody titer of Anti-PT(MD=21.11,95%CI:9.36~32.86), Anti-polio type1(MD=59.15,95%CI:2.81~115.48), Anti-polio type3(MD=169.82,95%CI:75.33~264.30) wereelevated respectively in the combination vaccine. But the antibody titer ofAnti-PRP (MD=-3.58,95%CI:-5.52~-1.64) in the combination vaccinegroup was lower. Redness (RR=0.82,95%CI:0.72~0.93) and Tenderness(RR=0.45,95%CI:0.30~0.65) were lower in the combination vaccine. Swelling (RR=2.03,95%CI:1.02~4.01) was more common in the patientsgiven the combination vaccine.Conclusions： This study supports the conclusion that theDTaP-IPV/Hib combination vaccine was equivalent to the separateinjections based on similar antibody responses to the vaccine antigens,immunogenicity and safety after primary doses.