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Safety, immunogenicity and persistence of immune response to the combined diphtheria, tetanus, acellular pertussis, poliovirus and Haemophilus influenzae type 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.

SUBMITTER: Li Y

PROVIDER: S-EPMC5360111 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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

Li Yanping Y Li Rong Cheng RC Ye Qiang Q Li Changgui C Liu You Ping YP Ma Xiao X Li Yanan Y Zhao Hong H Chen Xiaoling X Assudani Deepak D Karkada Naveen N Han Htay Htay HH Van Der Meeren Olivier O Mesaros Narcisa N

Human vaccines & immunotherapeutics 20161021 3

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 a ...[more]

PMID: 27768515

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Project description:IntroductionTETRAXIM™ (Sanofi), a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccine, has been licensed in South Korea since 2009. In accordance with the Ministry of Food and Drug Safety regulations, this post-marketing surveillance (PMS) study evaluated the safety of the DTaP-IPV vaccine in real-world clinical practice in infants and children who received it as either a part of the three-dose primary series dose at 2, 4, and 6 months or school entry booster between 4 and 6 years of age.MethodsThis multicenter, observational, PMS study was conducted in real-world practice in South Korea for 6 years (2009-2015) in participants aged between 2 months and 6 years. The study outcomes included solicited reactions, unsolicited adverse events (AEs)/adverse drug reactions (ADRs), unexpected AEs/ADRs, and serious AEs (SAEs)/ADRs.ResultsData from 647 participants was included in the safety analysis. Overall, 268 AEs were reported by 181 (28%) participants: 47 (17.5%) solicited reactions, 220 (82.1%) unsolicited AEs, and 1 (0.4%) unsolicited ADR. A total of 48 AEs (including 47 solicited reactions) were reported to have a causal relationship with the DTaP-IPV vaccine and were reported by 36 (5.6%) participants. A total of 212 unexpected AEs were reported by 152 (23.5%) participants, none of which had a causal relationship with the DTaP-IPV vaccine. Neither immediate AEs nor SAEs were reported during the study. Among the participants who reported AEs, 220 (34%) were on concomitant medications. Most AEs were of mild intensity, and all participants recovered.ConclusionNo safety concerns related to the DTaP-IPV vaccine in a real-world setting were raised in participants aged 2-6 months for the primary series and 4-6 years for the school-entry booster dose in the Korean population. The DTaP-IPV vaccine was well tolerated and can be continued as part of routine immunization programs in infants and children.Trial registrationNCT01437423.

Dataset Information

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

Publications

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

Similar Datasets

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