Safety, immunogenicity and persistence of immune response to the combined diphtheria, tetanus, acellular pertussis, poliovirus andHaemophilus influenzaetype b conjugate vaccine (DTPa-IPV/Hib) administered in Chinese infants

Abstract

We conducted 3 phase III, randomized, open-label, clinical trials assessing the safety, reactogenicity (all studies), immunogenicity (Primary vaccination study) and persistence of immune responses (Booster study) to the combined diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b vaccine (DTPa-IPV/Hib) in Chinese infants and toddlers.In the Pilot study (NCT00964028), 50 infants (randomized 1:1) received 3 doses of DTPa-IPV/Hib at 2–3–4 (Group A) or 3–4–5 months of age (Group B). In the Primary study (NCT01086423), 984 healthy infants (randomized 1:1:1) received 3 doses of DTPa-IPV/Hib at 2–3–4 (Group A) or 3–4–5 (Group B) months of age, or concomitant DTPa/Hib and poliomyelitis (IPV) vaccination at 2–3–4 months of age (Control group); 825 infants received a booster dose of DTPa/Hib and IPV at 18–24 months of age (Booster study; NCT01449812).In the Pilot study, unsolicited symptoms were more frequent in Group A (16 versus 1 infant; mostly upper respiratory tract infection and pyrexia); this observation was attributed to an epidemic outbreak of viral infections. Non-inferiority of 3-dose primary vaccination with DTPa-IPV/Hib over separately administered DTPa/Hib and IPV was demonstrated for Group A (primary objective). Similar antibody concentrations were observed in all groups, except for anti-polyribosyl-ribitol phosphate and anti-poliovirus types 1–3 which were higher in DTPa-IPV/Hib recipients. Protective antibody levels against all vaccine antigens remained high until booster vaccination. Three-dose vaccination with DTPa-IPV/Hib had a clinically acceptable safety profile.

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

“…6,7 Injection site redness and swelling were the most commonly reported local symptoms and irritability the most common general symptom, which are consistent with the results of previous studies assessing the reactogenicity of DTPa-IPV/Hib, 9,34 but differs from a study conducted in China, where pain and fever were the most common solicited symptoms after primary and booster vaccinations. 35 Consistent with previous reports, no SAEs that occurred during the study were considered to be related to the study vaccines by the study investigators. 6,9,35 Strengths of the trial include high completion rate where nearly all vaccinated children completed the study.…”

“…35 Consistent with previous reports, no SAEs that occurred during the study were considered to be related to the study vaccines by the study investigators. 6,9,35 Strengths of the trial include high completion rate where nearly all vaccinated children completed the study. A potential limitation of the study was its open design, which is unlikely to have influenced the immunogenicity assessments, but may have biased the safety assessment.…”

Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course and a booster dose in healthy children in Russia: a phase III, non-randomized, open-label study

“…This is in line with data from previous studies conducted in healthy children in Asia and Europe. 15 , 29 , 30 When infants received DTPa-IPV and Hib vaccines, administered separately or combined as a single injection, according to a 2-4-6-months primary schedule followed by a booster dose at 16–19 months of age, seroprotection rates for diphtheria and tetanus were 100% one month after the primary series, and declined in time, but returned to 100% one month after the booster dose. 13 In another study evaluating the immune responses of DTPa-IPV/Hib co-administered with a rotavirus vaccine, 97.3% of participants were seroprotected against diphtheria and 100% against tetanus after three vaccine doses administered at 3, 4 and 5 months of age.…”

Situação Vacinal Contra Hepatite B e Tétano de Estudantes de Medicina do Estado do Rio de Janeiro

“…As vacinas pentavalentes (DTP-HB-Hib), tetravalentes (DTP-Hib) e a (DTP) isolada, possuem reatogenicidades semelhantes, e podem provocar eventos adversos, sendo o componente pertússis seu principal responsável. Entretanto, os riscos de reações graves relacionados às vacinas são muito menores do que os das doenças contra as quais essas protegem (BRASIL, 2014;LEE;LI, 2017;SATO, 2018).…”