Immunogenicity and reactogenicity of a reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine in healthy Taiwanese children and adolescents

Huang, Li Min; Chang, Luan‐Yin; Tang, Haïwen; Bock, Hans L.; Lu, Chun Yi; Huang, Fu Yuan; Lin, Tzou Yien; Lee, Chin‐Yun

doi:10.1016/j.jadohealth.2005.08.009

Cited by 21 publications

(15 citation statements)

References 34 publications

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“…23 The very low reactogenicity observed in our study as well as that by Huang et al and Kosuwon et al is consistent with the observation that the incidence of systemic adverse events following acellular pertussis booster vaccines is low, particularly when compared to the incidence following vaccination with DTPw. 25,26 Reactogenicity Reactogenicity (solicited local and general symptoms) was actively assessed using diary cards for 15-days (day 0-14) after each vaccination.…”

Section: Discussionsupporting

confidence: 93%

“…The combined reduced-antigen-content diphtheria, tetanus and acellular pertussis vaccine offers the opportunity to boost older children against recommended antigens, with the potential benefit of reduced reactogenicity compared to full-antigen content vaccines. [17][18][19][20][21][22][23][24] Protection against poliomyelitis has been afforded through administration of live attenuated OPV and IPV. IPV is increasingly preferred over OPV for the fact that it cannot, by its nature, induce vaccine associated paralytic poliomyelitis and that it can be combined with other injectable vaccines into a single vaccine formulation.…”

Section: Discussionmentioning

confidence: 99%

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Booster vaccination at 6-8 years of age with a reduced antigen content dTpa-IPV vaccine is immunogenic and safe after priming with whole-cell pertussis vaccine

et al. 2008

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Pertussis vaccines containing reduced amounts of antigen have been considered primarily for use in adolescents and adults to date. We evaluated a reduced antigen content combined diphtheria tetanus acellular pertussis and inactivated polio vaccine (dTpa-IPV) in 6-8 year-old children in Taiwan, who had received four doses of DTPw (combined diphtheria, tetanus, whole cell pertussis vaccine) and OPV (oral polio vaccine). One month after the booster dose, seroprotection rates and vaccine response rates to all antigens were at least 98.8%, and significant increases in antibody concentrations were observed. Booster vaccination was associated with minor local reactions and systemic symptoms. Symptoms of severe intensity did not occur, with the exception of local pain. The dTpa-IPV vaccine was immunogenic and well tolerated in 6-8 year-old children and offers an alternative to the current use of tetanus and diphtheria vaccine and OPV in Taiwan, addressing the established need for repeated booster vaccinations against pertussis at the same time.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Booster vaccination at 6-8 years of age with a reduced antigen content dTpa-IPV vaccine is immunogenic and safe after priming with whole-cell pertussis vaccine

et al. 2008

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“…dTpa administered using the new dTpa syringe presentation was also well tolerated and the incidence and nature of adverse events were similar irrespective of the syringe presentation and comparable with previous studies. 4,11,12,15 Large swelling reactions, which can be associated with repeated booster doses of dTpa vaccines, 6,14 were not observed in either study group.…”

Section: Introductionmentioning

confidence: 84%

“…4,5 Boostrix TM , which was first licensed in 1999, is currently available in over 70 countries and has a well-established immunogenicity and tolerability profile in populations ranging from school age to the elderly. [6][7][8][9][10][11][12][13][14][15][16][17][18][19] Traditionally, Boostrix TM has been available as a single-dose vial or a prefilled disposable syringe where the tip-cap and plunger stopper contained methylester W1883. However, following the discontinuation of W1883 production by the manufacturer (West), the syringe presentation has recently been replaced using prefilled syringes from a different manufacturer, wherein the tip-cap component contains FM27 (a latex-free non-cytotoxic rubber compound) and the plunger stopper component contains FM457 (an ultra-low extractable bromobutyl compound).…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents - A single blind randomized trial

Pavía-Ruz

Abarca

Lepetic³

et al. 2015

Human Vaccines & Immunotherapeutics

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Reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix TM , is indicated for booster vaccination of children, adolescents and adults. The original prefilled disposable dTpa syringe presentation was recently replaced by another prefilled-syringe presentation with latex-free tip-caps and plunger-stoppers. 671 healthy adolescents aged 10-15 years who had previously received 5 or 6 previous DT(P)/dT(pa) vaccine doses, were randomized (1:1) to receive dTpa booster, injected using the new (dTpa-new) or previous syringe (dTpa-previous) presentations. Immunogenicity was assessed before and 1-month post-booster vaccination; safety/reactogenicity were assessed during 31-days post-vaccination. Non-inferiority of dTpa-new versus dTpa-previous was demonstrated for all antigens (ULs 95% CIs for GMC ratios ranged between 1.03-1.13). 1-month post-booster, immune responses were in similar ranges for all antigens with both syringe presentations. dTpa delivered using either syringe presentation was well-tolerated. These clinical results complement the technical data and support the use of the new syringe presentation to deliver the dTpa vaccine.

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Parental reports of adverse events following simultaneously given dT-IPV and MMR vaccines in healthy 9-year-old children

2010

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In the Netherlands, children at 9 years of age receive a booster dT-IPV together with their second measles, mumps, and rubella (MMR) vaccination within the national immunization program. Safety is monitored continuously by enhanced passive surveillance. This population-based study was conducted to obtain more information on adverse events after vaccination at 9 years of age. Questionnaires on local and systemic reactions were distributed 1 and 3 weeks after vaccination, respectively, to parents of 1,250 healthy children who received their MMR and diphtheria, tetanus, and inactivated poliovirus injection (dT-IPV) vaccination as scheduled. Response to the questionnaires was 57.0% and 46.5%, respectively. Local reactions occurred in 86.5% of the children within 7 days after vaccination, more often at the dT-IPV (83.4%) than at the MMR site (32.7%). Pain was the most reported symptom (80.8% at the dT-IPV site; 29.1% at the MMR site). Systemic events occurred in 33.4% children within 7 days after vaccination, with headache as the most frequently reported (20.8%). Systemic events occurred in 20.8% children 8-21 days after vaccination. Children with local reactions at only the dT-IPV site had significantly more systemic events (19.3%) than those without local reactions (3.4%, p < 0.01). Such difference was not found for the MMR site. No serious adverse events were reported. Medical intervention was applied to 133 children (130 used analgesics and for three children the GP was consulted by phone). In conclusion, the frequency of reported local reactions is high, especially at the dT-IPV site, but all symptoms were transient. However, the use of reduced antigen content vaccines in association with the occurrence of adverse events is meaningful to explore. Furthermore, the overall rates are useful for monitoring variations in adverse events rates in the general population.

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Immunogenicity and reactogenicity of a reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine in healthy Taiwanese children and adolescents

Cited by 21 publications

References 34 publications

Booster vaccination at 6-8 years of age with a reduced antigen content dTpa-IPV vaccine is immunogenic and safe after priming with whole-cell pertussis vaccine

Booster vaccination at 6-8 years of age with a reduced antigen content dTpa-IPV vaccine is immunogenic and safe after priming with whole-cell pertussis vaccine

Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents - A single blind randomized trial

Parental reports of adverse events following simultaneously given dT-IPV and MMR vaccines in healthy 9-year-old children

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