Reactogenicity and Safety of DTPa Vaccine and Haemophilus influenzae Type b Conjugate Vaccine (Hib) in a Single Injection vs DTPw ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2001-01

AUTHORS

J. Arístegui, Pilar García-Corbeira, J. de la Flor, R. Dal-Ré, J. Marés, F. Moraga, M. Campins

ABSTRACT

To compare the reactogenicity and safety of the administration of diphtheria-tetanus-acellular pertussis (DTPa) and Haemophilus influenzae type b conjugate (Hib) vaccines in one injection with those of the simultaneous administration of diphtheria-tetanus-whole cell pertussis (DTPw) and Hib vaccines in opposite limbs as booster doses to 18-month-old children previously primed with three doses of DTPw and Hib vaccines as a primary vaccination course. Nonblind, prospective, randomised, multicentre comparative study set in Spain. 216 children (17.2 ± 0.99 months old). Children were randomised to receive DTPa/Hib (group 1; n = 111) or DTPw + Hib (group 2; n = 105) and were followed for up to 30 days post-vaccination. All children received oral polio vaccine concomitantly. Local and general symptoms were recorded by parents on diary cards. The incidences of any solicited local reaction and any solicited general symptom ‘probably related’ or ‘suspected to be related’ to vaccination were statistically significantly higher (p < 0.0001) in group 2 than in group 1. Pain at the injection site was the most commonly reported local reaction, both in terms of any pain (40% in group 1; 89% at the DTPw site in group 2; p < 0.0001) and in pain that caused the child to cry when the limb was moved (1% and 42%; p < 0.0001). Any redness or swelling were significantly more common (p < 0.0001) at the DTPw injection site (71% and 60%, respectively) than at the DTPa/Hib site (34% and 27%). Fever (rectal temperature ≥38°C) was recorded for 10% and 56% of participants in groups 1 and 2, respectively (p < 0.0001). Only one case in group 1 and three cases in group 2 had fever >39.5°C. Fussiness (group 1: 28%; group 2: 71%), loss of appetite (15% and 37%, respectively), and restlessness (16% and 34%, respectively) were also statistically significantly more frequent (at least p < 0.003) in DTPw + Hib recipients. Analgesics/antipyretics were prescribed as prophylactic treatment in only <8% of cases; however, antipyretics were significantly more often prescribed (p < 0.0001) after vaccination in group 2 children (46%) than in group 1 children (6%). Unsolicited symptoms were recorded for 33 participants, including 22 cases [group 1: one case; group 2 (DTPw limb): 21 cases] of lameness that resolved within 1 to 5 days (median 1 day). Administration of DTPa/Hib in one injection leads to better reactogenicity and safety profiles than the administration of DTPw + Hib as two injections as booster doses to 18-month-old children primed with DTPw and Hib vaccines. More... »

PAGES

9-16

Identifiers

URI

http://scigraph.springernature.com/pub.10.2165/00044011-200121010-00002

DOI

http://dx.doi.org/10.2165/00044011-200121010-00002

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1052288774


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