INTRODUCTIONMeasles, mumps and rubella (MMR) are viral infections causing significant mortality and morbidity for which effective and safe vaccines are available. The safety, reactogenicity and immunogenicity of a combined MMR vaccine when administered to healthy Singaporean children were evaluated in this study.

MATERIALS AND METHODSA total of 150 children aged 12 to 18 months were vaccinated in this open, single-group, single-centre study [209762/147]. Solicited local and general symptoms reported within 4 days of vaccination and fever, parotid/salivary gland swelling and signs of meningism in the 43 days following vaccination were recorded using diary cards. Serious adverse events occurring during the study period were monitored. Immunogenicity was assessed at 42 days post-vaccination.

RESULTSRedness (8.7%) and pain (7.2%) at injection site were the most commonly reported solicited local symptoms during the 4-day follow-up period after vaccination. Percentage of subjects reporting drowsiness, irritability and loss of appetite during the 4-day follow-up after vaccination was 7.2%, 8% and 7.2%, respectively. None of the solicited symptoms reported during the 4-day follow-up period was of grade "3" intensity. Fever (42.8%) was the most commonly reported solicited general symptom, with 5.1% of the children reporting fever >39.0 degrees C (axillary). No serious adverse events considered to be related to vaccination were reported. Seroconversion rates were 100% for measles and rubella antibodies and 98.1% for mumps antibodies.

CONCLUSIONSGlaxoSmithKline Biologicals' MMR vaccine was shown to be well tolerated and highly immunogenic when used in Singaporean children 12 to 18 months of age.

Female ; Health Status ; Humans ; Infant ; Infant Welfare ; Male ; Measles ; prevention & control ; Measles-Mumps-Rubella Vaccine ; adverse effects ; immunology ; Mumps ; prevention & control ; Mumps virus ; Prospective Studies ; Rubella ; prevention & control ; Singapore

INTRODUCTIONChildren in Singapore receive vaccination against hepatitis B virus (HBV) at 0, 1 and 5 or 6 months of age, and vaccination against pertussis, diphtheria, tetanus, and polio at 3, 4 and 5 months of age. Parents often choose to vaccinate with the combined acellular-pertussis-inactivated polio-Hib vaccine (DTPa-IPV/Hib). We investigated whether a combined hexavalent vaccine, DTPa-HBV-IPV/Hib, could replace the separate administration of DTPa-IPV/Hib and HBV for the final vaccination at 5 months of age (Trial DTPa-HBV-IPV-075).

MATERIALS AND METHODSIn an open study, 150 children were randomised to complete their vaccination schedule with DTPa-IPV/Hib + HBV or DTPa-HBV-IPV/Hib.

RESULTSOne month after the final vaccination, there was no difference between groups in seroprotection rates or antibody concentrations against HBV. Seroprotection rates against diphtheria, tetanus, Hib and polio, as well as vaccine response rates to pertussis antigens were also similar between groups. Local and general symptoms occurred at a similar rate after the third dose of either vaccine.

CONCLUSIONThe immunogenicity and reactogenicity of the hexavalent vaccine DTPa-HBV-IPV/Hib (Infanrix hexa, GSK) group is comparable to that of separately administered DTPa-IPV/Hib and HBV vaccines. Combined hexavalent vaccine, DTPa-HBV-IPV/Hib, could replace the separate administration of DTPa-IPV/Hib and HBV for vaccination at 5 months of age, thereby reducing the number of injections required.

Diphtheria ; immunology ; Diphtheria-Tetanus-Pertussis Vaccine ; Female ; Haemophilus Vaccines ; Haemophilus influenzae ; immunology ; Hepatitis B ; prevention & control ; Hepatitis B Antibodies ; blood ; Hepatitis B Vaccines ; administration & dosage ; Humans ; Immunization Schedule ; Infant ; Infant, Newborn ; Male ; Poliovirus Vaccine, Inactivated ; Singapore ; Tetanus ; immunology ; Vaccination ; Vaccines, Combined ; administration & dosage ; Vaccines, Inactivated

INTRODUCTIONThe world's first rotavirus vaccine, Rotashield or RRV-TV, was registered in the US in 1998, but withdrawn within a year because of an observed association with intussusception (IS). Surveillance for IS has consequently become important in safety monitoring of new-generation rotavirus vaccines during development. Post-marketing surveillance is also important, and requires the availability of local baseline epidemiology data on IS.

MATERIALS AND METHODSAn eight-year study of IS in children under 2 years of age in Singapore was performed by retrospective review of admissions to KK Women's and Children's Hospital, the main paediatric hospital, from 1997 to 2001, followed by prospective surveillance of all hospitals from 2001 to 2004, using the case definition of the Brighton Collaboration Intussusception Working Group.

RESULTSThe average IS incidence was 60 per 100,000 in under-ones, and 32 per 100,000 in under-twos, with a downward trend between 1999 and 2004. Ninety-two per cent of subjects were aged below one year, with 51% aged 6 months to 11 months. The mean age at which IS occurred increased from 6.4 months to 12.5 months over the study period. The male-to-female ratio was 1.3:1. No trend in IS numbers was observed over different months of the year.

CONCLUSIONIS in Singapore shows no seasonality, but has demonstrated a trend of decreasing incidence in recent years. While highest in the first year of life, the risk of IS is increasing in the second year of life. Males have a slightly higher risk.

Child, Preschool ; Female ; Humans ; Immunization Programs ; Incidence ; Infant ; Infant, Newborn ; Intussusception ; chemically induced ; epidemiology ; Male ; Prospective Studies ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Rotavirus ; immunology ; Rotavirus Infections ; prevention & control ; Rotavirus Vaccines ; adverse effects ; Singapore ; epidemiology ; Vaccination ; adverse effects

INTRODUCTIONIn 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.

MATERIALS AND METHODSA 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.

RESULTSSerological 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.

CONCLUSIONThe 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

INTRODUCTIONThis was the first study conducted to evaluate the efficacy of 2 oral doses of the human rotavirus vaccine, RIX4414 in Singaporean infants during the first 3 years of life.

MATERIALS AND METHODSHealthy infants, 11 to 17 weeks of age were enrolled in this randomised (1:1), double-blinded, placebo-controlled study to receive 2 oral doses of RIX4414 vaccine/placebo following a 0-, 1-month schedule. Vaccine efficacy against severe rotavirus (RV) gastroenteritis (Vesikari score ≥11) caused by wild-type RV strains from a period starting from 2 weeks post-Dose 2 until 2 and 3 years of age was calculated with 95% confidence interval (CI). Immunogenicity and safety of the vaccine were also assessed.

RESULTSOf 6542 infants enrolled, 6466 were included in the efficacy analysis and a subset of 100 infants was included in the immunogenicity analysis. Fewer severe RV gastroenteritis episodes were reported in the RIX4414 group when compared to placebo at both 2 and 3 year follow-up periods. Vaccine efficacy against severe RV gastroenteritis at the respective time points were 93.8% (95% CI, 59.9 to 99.9) and 95.2% (95% CI, 70.5 to 99.9). One to 2 months post-Dose 2 of RIX4414, 97.5% (95% CI, 86.8 to 99.9) of infants seroconverted for anti-RV IgA antibodies. The number of serious adverse events recorded from Dose 1 until 3 years of age was similar in both groups.

CONCLUSIONTwo oral doses of RIX4414 vaccine was immunogenic and provided high level of protection against severe RV gastroenteritis in Singaporean children, during the first 3 years of life when the disease burden is highest.

Antibodies, Viral ; immunology ; Double-Blind Method ; Female ; Gastroenteritis ; prevention & control ; virology ; Humans ; Immunogenicity, Vaccine ; Immunoglobulin A ; immunology ; Infant ; Male ; Rotavirus ; immunology ; Rotavirus Infections ; prevention & control ; Rotavirus Vaccines ; immunology ; therapeutic use ; Singapore ; Treatment Outcome ; Vaccines, Attenuated ; immunology ; therapeutic use

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.
Human ; Male ; Female ; Infant ; MEASLES-MUMPS-RUBELLA VACCINE ; ENZYME-LINKED IMMUNOSORBENT ASSAY