Child ; China ; Community-Acquired Infections ; microbiology ; Drug Resistance, Bacterial ; genetics ; Haemophilus influenzae type b ; drug effects ; genetics ; isolation & purification ; Humans ; Microbial Sensitivity Tests ; Pneumonia ; microbiology

<b>INTRODUCTIONb>In recent years, acellular pertussis combination vaccines have facilitated compliance with and coverage of the national immunisation programme in Singapore. This phase-II study (Rota-007) evaluated the immunogenicity, reactogenicity and safety of a DTPa-IPV/Hib combined vaccine when co-administered with a rotavirus vaccine.

<b>MATERIALS AND METHODSb>A total of 2464 children aged 3 months were vaccinated with DTPa-IPV/Hib together with a randomised 1:3 ratio of either placebo (n=653) or 1 of 3 different formulations of a rotavirus vaccine. Blood samples were collected for immunogenicity analysis 1 month after the third DTPa-IPV/Hib vaccine dose in a subset of subjects (n = 640). Local and general reactogenicity and unsolicited adverse events were recorded during the follow-up after each vaccination.

<b>RESULTSb>Serological analysis showed >95% response for all antigens in the co-administered DTPa-IPV/Hib vaccine, with no difference between the rotavirus vaccine and placebo groups. No differences in adverse events and reactogenicity were reported in the rotavirus vaccine and placebo groups. Only 0.2% of the subjects reported Grade 3 adverse events. Three subjects (from the vaccine groups) died during the study, which were assessed by the investigators as unrelated to vaccination. No deaths were reported in the placebo group.

<b>CONCLUSIONb>The combined DTPa- IPV/Hib vaccine is safe, well tolerated and highly immunogenic when given alone or coadministered with the rotavirus vaccine for infants in Singapore.

Child ; Child Welfare ; Child, Preschool ; Double-Blind Method ; Female ; Haemophilus Infections ; immunology ; prevention & control ; Haemophilus influenzae type b ; isolation & purification ; Humans ; Infant ; Infant, Newborn ; Male ; Patient Compliance ; Poliomyelitis ; prevention & control ; Rotavirus Vaccines ; Singapore ; Vaccines, Combined ; Vaccines, Conjugate ; adverse effects ; immunology

No abstract available.
Acute Disease ; Adolescent ; Alkaline Phosphatase/*blood ; Anti-Bacterial Agents/*therapeutic use ; Arthritis, Infectious/*drug therapy/*enzymology/microbiology ; *Bacterial Infections/drug therapy/enzymology/microbiology ; Child ; Child, Preschool ; Haemophilus influenzae type b/isolation & purification ; Humans ; Infant ; Osteomyelitis/*drug therapy/*enzymology/microbiology ; Staphylococcus aureus/isolation & purification ; Streptococcus pneumoniae/isolation & purification ; Streptococcus pyogenes/isolation & purification