Antibody persistence at 18–20months of age and safety and immunogenicity of a booster dose of a combined DTaP–IPV//PRP∼T vaccine compared to separate vaccines (DTaP, PRP∼T and IPV) following primary vaccination of healthy infants in the People's Republic of China

Li, Rong Cheng; Li, Feng Xiang; Li, Yan Ping; Hou, Qi Ming; Li, Chang Gui; Li, Ya Nan; Chen, Fu Sheng; Hu, Xue; Su, Wen Bin; Zhang, Shu Min; Fang, Han Hua; Q, Ye; Zeng, Tian De; Liu, Tao Xuan; Li, Xiu Bi; Huang, Yun Neng; Deng, Man Ling; Zhang, Yan Ping; Ortiz, Esteban

doi:10.1016/j.vaccine.2011.09.131

Cited by 8 publications

(5 citation statements)

References 30 publications

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“…In a separate study assessing IPV's immune persistence in China, the SPRs for serotypes 1-3 in the conventional IPV group were 98.3%, 94.7%, and 94.9% at 18-24 months, marginally lower than our findings [22]. Another study on the immune persistence of DTaP-IPV//PRP∼T at 18-20 months reported SPRs for types 1-3 Salk-strain poliovirus antibodies at 94%, 88.4%, and 87.6%, which were also lower than those observed in this study [23].…”

Section: Discussioncontrasting

confidence: 91%

Immune Persistence following Primary Immunization and the Immunogenicity and Safety of a Booster Dose of a Multidose Sabin Strain-Based Inactivated Polio Vaccine in Infants Aged 18 Months

Feng,

Shao,

Wang

et al. 2024

Vaccines

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Background: The multidose Sabin-strain inactivated poliovirus vaccine (sIPV) has the potential to significantly aid in the eradication of poliomyelitis, particularly in low- and middle-income countries. As part of a phase III clinical trial in which infants were given three doses of primary immunization at 2, 3, and 4 months of age, this study aimed to evaluate immune persistence following primary immunization, as well as the safety and immunogenicity of a booster of the 5-dose sIPV in infants aged 18 months. Methods: Infants aged 18 months were given one booster dose of 5-dose sIPV in stage one, which was open-label. Unblinding was performed for stage two after completing primary immunization, which was randomized, blinded, and controlled; infants aged 18 months in the test group I–III, IPV group, and single-dose sIPV group were given one booster dose of 5-dose sIPV, conventional IPV, and single-dose sIPV, respectively, in stage two. Results: This study included 1438 infants in the immune persistence and safety set and 1387 infants in the booster per-protocol set. Fourteen months after primary immunization, the seropositivity rates (≥1:8) for types 1–3 were 100%, 99.88%, and 99.53% in the 5-dose sIPV groups; 100%, 98.97%, and 97.23% in the IPV group; and 99.66%, 100%, and 99.66% in the single-dose sIPV group. A total of 30 days after booster immunization, the seropositivity rates (≥1:8) of 3 serotypes in all the groups reached 100%. The geometric mean titers of neutralizing antibodies for types 1–3 in the 5-dose sIPV group were 9962.89, 10273, and 7870.21, with geometric mean increases of 15.76, 33.15, and 24.5, compared to the pre-booster level. The overall incidence of adverse reactions was 8.97%, with fever being the most common, observed at rates of 7.1%, 5.52%, and 7.96% in the 5-dose sIPV, IPV, and single-dose groups, respectively (p = 0.4845). Conclusions: The 5-dose sIPV has shown promising immune persistence and robust immune response following a booster immunization, coupled with an acceptable safety profile.

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Section: Discussioncontrasting

confidence: 91%

Immune Persistence following Primary Immunization and the Immunogenicity and Safety of a Booster Dose of a Multidose Sabin Strain-Based Inactivated Polio Vaccine in Infants Aged 18 Months

Feng,

Shao,

Wang

et al. 2024

Vaccines

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“…The booster dose of the study vaccine has been evaluated in multiple countries. The booster dose was well tolerated in children aged 18–19 months from India [ 27 ], was highly immunogenic and well tolerated in children aged 18–19 months from South Africa who were previously primed with the same vaccine [ 28 ], demonstrated a strong response to each antigen in the second year of life in children aged 18–20 months from China [ 29 ], was well tolerated and highly immunogenic following primary vaccination with a hexavalent vaccine in children aged 18–24 months from Thailand [ 20 ] and children aged 18 months from Argentina [ 30 ], elicited good antibody titers in the Philippines with the 0, 6, and 14-week schedule [ 10 ], and demonstrated good antibody persistence in 5–6-year-olds from France who were given the booster at 12–16 months of age [ 31 ]. These data support the use of DTaP-IPV//Hib as a toddler booster vaccine following various types and schedules of the primary series of vaccination.…”

Section: Discussionmentioning

confidence: 99%

Post-Marketing Safety Surveillance of a Childhood Pentavalent Diphtheria–Tetanus–Acellular Pertussis–Polio and Haemophilus influenzae Type B (DTaP-IPV//Hib) Vaccine in South Korea

et al. 2022

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Introduction PENTAXIM™ (Sanofi), DTaP-IPV//Hib, a pentavalent combination vaccine for protection against diphtheria, tetanus, pertussis, poliomyelitis, and invasive infections caused by Haemophilus influenzae type b, has been licensed in South Korea by the Ministry of Food and Drug Safety (MFDS) on May 9, 2016, and is currently used in routine vaccination. The aim of this phase IV study, conducted as a post-licensure commitment in South Korea, was to evaluate the safety of the DTaP-IPV//Hib vaccine when administered in infants at 2, 4, and 6 months of age in the real-world clinical practice. Methods This multicenter, observational, post-marketing surveillance (PMS) study was conducted in real-world practice in South Korea. Infants aged 2 months or older were enrolled across seven centers from July 31, 2018 to February 11, 2020. The study outcomes included occurrence, time to onset, duration, intensity, and causality assessment (for unsolicited adverse events [AEs] only) for several pre-listed solicited injection-site and systemic reactions, unsolicited AEs, and serious adverse events (SAEs). Results Data from 619 participants were included in the safety analysis. Overall, 618 AEs were reported by 273 (44.1%) participants consisting of 121 solicited injection-site reactions (15.4%), 344 solicited systemic reactions (24.6%), and 153 unsolicited AEs (15.7%) of which, 124 were unexpected AEs (12.9%) (regardless of intensity). None of the unsolicited AEs were reported to have a causal relationship with the study vaccine. One SAE of pyrexia (solicited reaction) was reported. Most AEs were of mild intensity, and all participants recovered. Conclusion This PMS study of the DTaP-IPV//Hib vaccine confirmed its safety profile in a real-life setting in South Korea and justified that the vaccine is well tolerated when used in infants aged 2 months or older for the primary series.

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“…Included studies are described in Table 1 and Supplemental Digital Content 3, http://links.lww.com/INF/B614. [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34] The 20 trials were conducted in 15 countries in Africa, Asia, Europe and North and South America. Sixteen trials used PRP-T, 3 used PRP-OMP and 2 used PRP-HbOC.…”

Section: Resultsmentioning

confidence: 99%

“…Programmatic considerations are also likely to influence the choice of Hib vaccine schedule. Costs of vaccine administration are likely to be lower and vaccine coverage higher if vaccine administration PRP-T Canada1 [17] Canada2 [18] Chile2 [21] China1 [22] Europe [24] France [25] Combined risk difference 0.00 (95%CI -0.01, 0.01)…”

confidence: 99%

Comparing Haemophilus influenzae Type b Conjugate Vaccine Schedules

Low

Redmond

Rutjes³

et al. 2013

Pediatric Infectious Disease Journal

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Antibody persistence at 18–20months of age and safety and immunogenicity of a booster dose of a combined DTaP–IPV//PRP∼T vaccine compared to separate vaccines (DTaP, PRP∼T and IPV) following primary vaccination of healthy infants in the People's Republic of China

Cited by 8 publications

References 30 publications

Immune Persistence following Primary Immunization and the Immunogenicity and Safety of a Booster Dose of a Multidose Sabin Strain-Based Inactivated Polio Vaccine in Infants Aged 18 Months

Immune Persistence following Primary Immunization and the Immunogenicity and Safety of a Booster Dose of a Multidose Sabin Strain-Based Inactivated Polio Vaccine in Infants Aged 18 Months

Post-Marketing Safety Surveillance of a Childhood Pentavalent Diphtheria–Tetanus–Acellular Pertussis–Polio and Haemophilus influenzae Type B (DTaP-IPV//Hib) Vaccine in South Korea

Comparing Haemophilus influenzae Type b Conjugate Vaccine Schedules

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