PubMed · 9270205
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G M Johnson. 1997. Immunizations.. https://pubmed.ncbi.nlm.nih.gov/9270205/
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BACKGROUND: The diphtheria-tetanus-whole-cell pertussis (DTPw) vaccine is being replaced in Western countries,and in several Spanish Autonomous Communities, by the diphtheria-tetanus-acellular pertussis (DTPa) vaccine. Although the administration of booster doses of DTPw or DTPa and Haemophilus influenzae type b conjugate (Hib) vaccines to toddlers is a current practice ina number of countries, there are few data comparing the reactogenicity profiles of their administration as a single injection. SUBJECTS AND METHOD: An open,prospective, randomised, multicentre trial was conducted to compare the reactogenicity profile of a single injection of DTPa and Hib vaccines (DTPa/Hib) with that of a single injection of DTPw and Hib vaccines (DTPw/Hib) as booster doses to toddlers--previously primed with DTPw and Hib vaccines. 200 children (15.1 +/-1.0 months-old) were randomised to receive DTPa/Hib (group 1;n = 101) or DTPw/Hib (group 2; n = 99) and followed up to 30 days post-vaccination. All subjects received the oral polio vaccine concomitantly. Local and general symptoms were recorded by parents on diary cards. RESULTS: Incidences of any local reaction and any general symptom < >/< >to vaccination were reported more frequently in group 2 than in group 1 (p < 0.0001). Pain at the injection site was reported by 29% and 66% of subjects in groups 1 and 2, respectively (p< 0.0001). Pain such that the child cried when limb was moved was also more frequently recorded in group 2 (15%) than in group 1 (1%) (p < 0.0001). Differences in prevalence of any swelling(16% in group 1, 30% in group 2) and swelling > 20 mm reached statistical significance (p (3/4) 0.012). Fever (rectal temperature>= 38 degrees C) was reported by 17% and 41 % in groups 1 and 2 subjects, respectively (p < 0.0001). Fussiness, loss of appetite and restlessness were also more frequently reported in DTPw/Hib subjects and reached statistical significance (at least p = 0.015).Analgesics/antipyretics were prescribed as a prophylactic treatment in only 14% of cases (9 and 19 subjects in groups 1 and 2, respectively;p = 0.0424). Antipyretic treatment after vaccination was significantly more prescribed in group 2 (27 cases) than in group 1 (8) (p <0.015). CONCLUSION: The administration of DTPa/Hib as a single injection leads to a better reactogenicity profile than the administration of DTPw/Hib, also as a single injection, as booster doses to toddlers primed with DTPw and Hib vaccines.
Based on the recommendations of the World Health Organization, India as a member-state is likely to implement universal immunization against hepatitis B through the existing Universal Immunization Programme (UIP). A pilot project is already under progress in two municipal zones of Delhi. This paper begins by reviewing epidemiological features of hepatitis B in India, some established aspects and other emerging trends. The gaps in the existing knowledge base are also given due consideration. The current recommendation is to deliver the vaccine at zero-day for infants in the absence of facilities for antenatal screening and immunoglobulin administration. The paper explores the potential pitfalls for integrating the proposed hepatitis B vaccination with the DPT (diphtheria/pertussis/tetanus) schedule. Based on the findings of the National Family Health Survey, the likely coverage for the states is estimated for both the schedules--zero-day and with DPT. The performance of the pilot phase is reviewed through the results of a coverage survey. The paper also estimates the resources that should be committed to launch the universal immunization of hepatitis B vaccination and the sustainability issues thereof. The paper finally concludes with the position that hepatitis B immunization will 'sink or sail' with the UIP. Further, this should act as an engine for recharging the infrastructure and functioning of the public health system and promote general preventive practices like universal precautions.
A study was conducted to assess the safety of a new, liquid hexavalent vaccine (Hexavac, Aventis Pasteur MSD, Lyon, France) in a large population of 1783 children in Germany vaccinated at 2, 4, 6 and 12-14 months of age. Immediate reactions, local and systemic reactions, and serious adverse events (SAEs) were monitored. The frequencies of redness > or = 2 cm and swelling > or = 2 cm were 6.7 and 7.1% after all doses of the primary series combined and 13.4 and 12.0% following the booster dose, respectively. Transient swelling of the entire thigh was reported in seven infants after all doses of the primary series (0.1%) and in four children after the booster dose (0.2%). The most frequent systemic adverse events within 3 days after vaccination were irritability (19.3% after primary series and 13.2% after booster) and fever > or = 38.0 degrees C (15.4% after primary series and 28.5% after booster). Fever above 40.0 degrees C was reported in 0.1% of the infants post-primary series and in 0.9% of the children after the booster immunization. Only 3 of 144 SAE were considered to be vaccine related and were seen to resolve spontaneously and without sequelae. The liquid hexavalent vaccine was generally well tolerated when given to children as a primary immunization series at 2, 4 and 6 months and as a booster dose at 12-14 months.