Efficacy, Immunogenicity and Safety of a Human Rotavirus Vaccine RIX4414 in Singaporean Infants.

Introduction: This 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 Methods: Healthy 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).

Acute hepatic failure among hospitalized Thai children.

We conducted a hospital-based study from June 2002 to December 2006 of Thai children aged 1-15 years with acute hepatic failure (AHF) to determine the causes and outcomes. Eleven children were included in the study. Hepatitis B virus was the cause of AHF in one child, infection-associated hemophagocytic syndrome was the cause in 1 child, Wilson's disease was the cause in 1 child and dengue fever was suspected to be the cause in 2 children.

Etiology, incidence and outcomes of acute hepatic failure in 0-18 year old Filipino children.

Data on the epidemiology of acute hepatic failure (AHF) among pediatric Filipinos is limited. This study investigated the etiology, outcomes and incidence of AHF among 0-18 year old Filipino children. A hospital-based retrospective and prospective surveillance study was conducted at Philippine General Hospital between January 2000 and December 2006.

Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Taiwan.

Background/purpose: The immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae (H. Influenzae) protein D conjugate vaccine (PHiD-CV), co-administered with routine childhood vaccines, were assessed in Taiwanese infants.

Methods: In this open study, 230 healthy infants were primed with three doses of PHiD-CV (Synflorix) and diphtheria, tetanus, acellular pertussis, hepatitis B (HBV), inactivated poliomyelitis and Haemophilus influenzae type b (Hib) conjugate vaccine (DTPa-HBV-IPV/Hib vaccine) at 1.

Rotavirus vaccine RIX4414 efficacy sustained during the third year of life: a randomized clinical trial in an Asian population.

RIX4414 (Rotarix™), has shown high efficacy during the first 2-years of life. A 2-year randomized, double-blind, placebo-controlled trial in Singapore, Hong Kong, and Taiwan was extended for another year. Infants (6-17 weeks) received 2-doses (1-2 months apart) of RIX4414 (n=5359) or placebo (n=5349).

Immunogenicity and safety of an AS03(A)-adjuvanted H5N1 influenza vaccine in a Taiwanese population.

Background/purpose: A multicenter study (NCT00449670) conducted across Taiwan, Singapore, Hong Kong and Thailand evaluated the safety and manufacturing consistency of four formulations of an AS03(A)-adjuvanted H5N1 vaccine in terms of immune response against the vaccine-homologous strain (A/Vietnam/1194/2004). This manuscript presents data from the Taiwanese population.

Methods: A total of 400 individuals, aged 18-60 years, were randomized into six groups (2:2:2:2:1:1 ratio) to receive two doses (21 days apart) of one of the four adjuvanted formulations (H5N1-AS03(A)-groups) or one of the two nonadjuvanted formulations (H5N1-DIL-groups).

Cross-clade immunogenicity and antigen-sparing with an AS03(A)-adjuvanted prepandemic influenza vaccine in a Thai population.

Objective: The present study (NCT00449670) in Asian subjects (18-60 years) evaluated the manufacturing consistency of four formulations of 3.75 mg AS03(A)-adjuvanted H5N1 influenza vaccine, in terms of post-immunization Hemagglutination Inhibition (HI) titers against the A/Vietnam/1194/2004 and A/Indonesia/05/2005 strains. The immunogenicity and safety of the vaccine in the Thai population are reported herein.

Human papillomavirus 16/18 AS04-adjuvanted cervical cancer vaccine: immunogenicity and safety in 15-25 years old healthy Korean women.

Objective: The study assessed the immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Korean women aged 15-25 years.

Methods: Phase IIIB, double-blind, randomised (2:1), multi-centre trial was conducted in Korea from June 2007 to March 2008. The study enrolled 225 women in the HPV (N=149) and placebo (N=76) groups who received three doses of HPV-16/18 AS04-adjuvanted vaccine or placebo (aluminium hydroxide) administered intramuscularly at 0, 1, and 6 months and were followed until one month post-dose 3.

Immunogenicity and reactogenicity of DTPa-IPV/Hib vaccine co-administered with hepatitis B vaccine for primary and booster vaccination of Taiwanese infants.

Immunogenicity and reactogenicity of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (Hib) conjugate vaccine (DTPa-IPV/Hib, Infanrix™-IPV + Hib) was assessed when co-administered with hepatitis B (HBV) vaccine. Seventy healthy infants received DTPa-IPV/Hib at 1.5, 3.

Immunogenicity and reactogenicity of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus and Haemophilus influenzae type B.

Immunogenicity and reactogenicity of primary vaccination with combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus (DTPa-HBV-IPV) vaccine when co-administered with Haemophilus influenzae (Hib) conjugate vaccine were assessed in 60 healthy infants. Infants received HBV vaccine at birth, then DTPa-HBV-IPV and Hib vaccines at age 1.5 months, 3.

Safety and reactogenicity of DTPa-HBV-IPV/Hib and DTPa-IPV/I-Hib vaccines in a post-marketing surveillance setting.

Combination vaccines have been shown to improve the timeliness of vaccination and vaccine coverage. Safety and reactogenicity of combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus and Haemophilus influenzae type b vaccine (DTPa-IPV/Hib, Infanrix IPV+Hib, GlaxoSmithKline Biologicals) was assessed in two clinical studies. In Study A, 2,590 subjects received DTPa-IPV/Hib at 3, 4 and 5 months of age with a booster at 18 months.

Immunogenicity of a human rotavirus vaccine (RIX4414) after storage at 37 °C for seven days.

Aim: The lyophilized formulation of the human rotavirus vaccine, RIX4414 (RotarixTM), is recommended to be stored at 2°C-8°C for optimal immunogenicity. In some settings with inadequate infrastructure for vaccine storage, unforeseen circumstances may cause cold chain breakage, resulting in the vaccine to be left at ambient temperatures. This study evaluated the heat stability of lyophilized RIX4414 vaccine in terms of immunogenicity when stored at tropical room temperature (37 °C) for 7 days before reconstitution.

Immunogenicity of HBV vaccine during stated shelf-life.

Thiomersal has been used as preservative in multi-dose vials of hepatitis B vaccine (Engerix-B). Due to safety concerns, thiomersal was replaced with 2-phenoxyethanol (2PE) as preservative in multi-dose vials. The potency of 2PE preserved hepatitis B vaccine multiple use vials was measured over the shelf-life in terms of immunogenicity, reactogenicity and safety.

Vaccination with a human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in Korean girls aged 10-14 years.

The human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine has been demonstrated to be highly efficacious and immunogenic with a favorable safety profile. This study assessed the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Korean girls aged 10-14 yr. This multi-center, observer-blind trial randomly assigned 321 healthy girls to receive three doses (0, 1, 6-month schedule) of HPV-16/18 AS04-adjuvanted vaccine or hepatitis A vaccine.

Immunogenicity, reactogenicity and safety of three-dose primary and booster vaccination with combined diphtheria-tetanus-whole-cell pertussis-hepatitis B-reduced antigen content Haemophilus influenzae type b vaccine in Filipino children.

Objectives: To evaluate the immunogenicity, reactogenicity and safety of primary and booster vaccination with DTPw-HBVLT/Hib2.5 vaccine containing low thiomersal and reduced quantities of Hib polysaccharide (PRP).

Background: Combined DTP vaccines have high global coverage.

Human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine: immunogenicity and safety in healthy Chinese women from Hong Kong.

Objective: To assess the immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine in Chinese women aged 18 to 35 years enrolled from Hong Kong.

Design: Double-blind, randomised controlled trial with vaccine and placebo groups.

Setting: Single-centre study in Hong Kong.

Immunogenicity of a live-attenuated human rotavirus RIX4414 vaccine with or without buffering agent.

Aim: The lyophilized form of the human rotavirus RIX4414 vaccine (Rotarix()) is usually reconstituted with a liquid calcium carbonate (CaCO(3)) buffer and administered orally. However, errors in the reconstitution could occur (e.g.

Booster vaccination against pertussis in Chinese children at six years of age using reduced antigen content diphtheria-tetanus-acellular pertussis vaccine (Boostrix()).

Pertussis continues to circulate in Chinese communities and older children, adolescents and adults are sources of infection for unprotected infants. Two studies conducted in Jiangsu Province in the People's Republic of China assessed the immunogenicity, reactogenicity and safety of Boostrix(), a combined reduced antigen content diphtheria-tetanus-acellular pertussis vaccine (dTpa) when administered as a booster dose to children 6 to 8 years of age. Immunogenicity was assessed before and one month after vaccination in a subset.

Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Indian women.

Aim: India has the highest number of annual incident cases and mortality rates for cervical cancer worldwide. This study was conducted to assess the immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine in healthy Indian women aged 18-35 years old.

Methods: This double-blind, randomized (1:1), controlled and multicenter trial with two parallel groups, the Vaccine and Placebo groups, included 354 subjects in four centers across India.

Antibody persistence six years after two doses of combined hepatitis A and B vaccine.

Persistent immunity to hepatitis A and hepatitis B antibodies six years after vaccination of adolescents (aged 12-15 years) with a combined hepatitis A and B (HAB) vaccine following a 0, 6 month or a 0, 12 month schedule was assessed. Yearly (Year-2-6) serum samples were tested for anti-HAV and anti-HBs using EIA. Subjects with anti-HBs concentrations <10 mIU/mL (14/23) at Year-5 or Year-6, received an additional HBV vaccine dose approximately 12 months after Year-6.

Retrospective surveillance for intussusception in children aged less than five years in a South Indian tertiary-care hospital.

To facilitate the assessment of the safety profile of rotavirus vaccines effectively, baseline data on intussusception are important for comparison with intussusception rates following the introduction of vaccine. The aim of the study was to describe epidemiological and clinical features of intussusception in children aged less than five years in an Indian medical facility. Hospital data on intussusception for children discharged during 1 January 2001-30 June 2004 from the Christian Medical College Hospital, Vellore, India, were reviewed.

Persistence of antibodies and immune memory to hepatitis B vaccine 20 years after infant vaccination in Thailand.

Booster vaccination against hepatitis B (HBV) is not currently recommended, although debate continues on the duration of protection after priming. We assessed antibody persistence and immune memory to hepatitis B 20 years after priming with a recombinant HBV-vaccine during infancy. Infants were vaccinated at birth, 1, 2 and 12 months of age.

Priorities and challenges for hepatitis B control in the Philippines and the importance of a vaccine dose at birth.

The Philippines annual birth cohort of over 2 million is the second largest in the Western Pacific Region; 44% of births occur outside health facilities. With third dose infant hepatitis B (HB) vaccine coverage of 43% in 2006, erratic vaccine supply, and lack of policies or processes for universal HB vaccine birth dose delivery, a substantial burden of preventable chronic HB infection continues to occur. Funding, policy, technical and immunization delivery developments now make substantial progress in HB control in the Philippines possible.

Community-based cross-sectional seroprevalence study of hepatitis A in Bangladesh.

Aim: To elucidate the age-distribution of anti-hepatitis A virus (HAV) seroprevalence across different socioeconomic status (SES) categories in Bangladesh which, despite scarce data, is generally deemed to have high endemicity.

Methods: Blood samples of 818 subjects from a stratified sample of schools and hospitals, comprising different age categories and SES were collected. They were assayed for total anti-HAV antibodies.

An update of paediatric intussusception incidence in Singapore: 1997-2007, 11 years of intussusception surveillance.

Introduction: Understanding baseline epidemiology of intussusception (IS) in different geographical settings is important for the safety assessment of rotavirus vaccines. This paper presents IS surveillance data from Singapore between 1997 and 2007, including the period between November 2005 and December 2007 when rotavirus vaccines (primarily Rotarix) were available to newborns in Singapore.

Materials And Methods: Case ascertainment, collection, analyses and presentation of IS data was done as per recommendations of the Brighton Collaboration Working Group.