MMR trivalent vaccine based on safety, reactogenicity and immunogenicity observed in 12-24 month-old healthy Filipino children: Evaluation of lot-to-lot consistency of a live-attenuated measles-mumps-rubella

In this double-blind, randomized single-dose study, 194 healthy Filipino children aged 12-24 months were randomized into three groups (1:1:1) to receive one of the three lots of live-attenuated measles-mumps-rubella (MMR) vaccine to assess lot-to-lot consistency in safety and immunogenicity. Adverse events were recorded during 43-day post-vaccination follow-up period. Antibody levels were measured using ELISA pre-vaccination and on Day-60. No statistically significant differences were observed across groups for overall incidences of local and general symptoms (p>0.05) or immune response rates against the three antigens (p=0.835, 0.458 and 0.222 for anti-measles, anti-mumps and anti-rubella, respectively). The three lots demonstrated consistency in their reactogenicity and immunogenicity profile.

Four is better than nine. a combined diphtheria-tetanus-pertussis-hepatitis B-Haemophilus influenzae type b vaccine for routine immunization in Malaysia.

Malaysian infants would have to receive nine injections during the first few months of life in order to be protected against disease caused by hepatitis B (HBV), diphtheria, tetanus, pertussis and Haemophilus influenzae type b (Hib) if single HBV and Hib vaccines were used. We evaluated a combined DTPw-HBV/Hib vaccine administered at 1.5, 3 and 5 months after a birth dose of hepatitis B vaccine (HBV). One month after completion of the primary vaccination, 99% of subjects had seroprotective anti-HBV antibody levels, and at least 98% had seroprotective antibodies against diphtheria, tetanus, and Hib, and were seropositive for pertussis antibodies. The immune response to the combined vaccine was comparable to that induced by separate injections with DTPw, HBV and Hib vaccines. Overall, the DTPw-HBV/Hib vaccine was as well tolerated as separate administration of DTPw, HBV and Hib vaccines. The combined DTPw-HBV/Hib vaccine induces protection against five diseases as recommended in the Malaysian routine vaccination schedule. Use of the combined DTPw-HBV/Hib vaccine can reduce the required number of injections from nine to four in the first few months of life.

Comparative study of the reactogenicity of a three-component acellular pertussis vaccine and whole-cell pertussis vaccine administered to healthy Singaporean infants.

The objective of this study was to assess and compare the reactogenicity of GlaxoSmithKline (GSK) Biologicals' diphtheria-tetanus-tricomponent acellular pertussis vaccine (DTPa) and the locally used combined diphtheria-tetanus-whole-cell pertussis vaccine (DTPw) as a primary vaccination course in healthy infants at the age of 3, 4 and 5 months. A phase IV, single-blinded, randomized comparative clinical study involved one hundred and eighty healthy infants with two study groups in a 2:1 ratio to receive either DTPa or DTPw vaccine which were administered intramuscularly at the right anterior-lateral aspect of the thigh. The incidence and intensity of local solicited symptoms such as pain, redness and swelling at injection site and general solicited symptoms such as fever and fussiness were evaluated. Serious adverse events were followed for one month after each vaccination. The overall incidence of local and general symptoms was significantly higher in the group receiving locally used DTPw vaccine as compared to the group receiving GSK DTPa vaccine. Solicited local symptoms, pain (47.4% vs 15.1%), redness (95.9% vs 84.9%) and swelling (46.2% vs 18.5%), were reported more frequently in the group receiving DTPw vaccine than in the group receiving DTPa vaccine. Fever (> or = 37.5 degrees C) (52% vs 14.6%) and fussiness (60.8% vs 33.6%) were also more commonly reported in the DTPw group. There were six serious adverse events reported (4 with DTPw and 2 with DTPa). None of them related to the study vaccines, as considered by the investigators. Thus it was found that GSK Biologicals' DTPa vaccine was significantly less reactogenic as compared to the locally used DTPw vaccine manufactured by Commonwealth Serum Laboratories when administered as a 3-dose primary vaccination course to healthy infants at the age of 3, 4 and 5 months in Singapore.