Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Given at 6, 7.5 and...
MalariaMalaria VaccinesThe purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and yellow fever vaccines to children aged 6 months at the first vaccination.
Immunogenicity of Co-administration of Measles and Japanese Encephalitis Vaccines
MeaslesRubella1 moreJapanese encephalitis (JE) is the leading cause of viral neurological disease and disability in Asia. A live attenuated vaccine (LJEV) manufactured in China has several advantages over other JE vaccines such as one dose schedule, using for infants, and the cheaper cost. Because the LJEV has been prequalified by the World Health Organization (WHO) in 2013, it will likely be used in other countries, and possibly co-administered with the first dose of measles-containing vaccine (MCV) to ensure early protection and reduce additional vaccination visits. The evidence for immunogenicity and safety of co-administration of LJEV with MCV is limited. Only one study conducted in the Philippines examining the co-administration of MCV with LJEV among 9 months infants, the results showed the proportion of achieved sero-protection against measles following MCV (96%) was slightly lower than in the MCV-only group (100%), and the measles antibody titres were also slightly lower in the co-administration group. Due to limited evidence available, the WHO position paper of measles vaccines has encouraged further investigation on the possible impact of co-administration of LJEV on measles vaccine effectiveness. In China, Measles-Rubella combined vaccine (MR) and LJEV is given at 8 months of age nationally. Considering China is reaching towards the goal of measles elimination, it will be important to conduct a study to compare the immunogenicity of MR administered alone or with LJEV, and also evaluate the safety and tolerability of LJEV administered with MR among 8 months infants. This study is a prospective, randomized, open-label, multi-center study enrolling infants aged 8 months. Basic demographic information of the infant will be taken and blood samples will be collected at enrollment (baseline) and at 6weeks following administration of MR, the measles antibodies will be measured, and compare seroconversion rates to assess for non-inferiority. All infants will be monitored for adverse events after MR.
Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)...
VaricellaMeasles8 morePrimary Objective: To demonstrate that ProQuad® can be administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the antibody response rates to measles, mumps, rubella, varicella, hepatitis B and Haemophilus influenzae type b; or to the 3 pertussis antibody titres measured at 42 days following vaccination. Secondary Objectives: To describe the antibody titres and the antibody response rates to measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b as measured at 42 days following vaccination by an Infanrix® hexa primary series schedule and all data are pooled. To evaluate the safety profile of ProQuad® when administered concomitantly with a booster dose of Infanrix® hexa by an Infanrix® hexa primary series schedule and all data are pooled.
Safety Study of ProQuad® rHA in Infants (V221-037)
MeaslesMumps2 morePrimary objective: To describe the safety profile of a second dose of ProQuad® manufactured with recombinant human albumin (rHA) when administered to children in their second year of life. Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured with rHA when administered to children in their second year of life.
Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to...
RubellaMumps1 moreTo evaluate the safety and immunogenicity of GSK Biologicals' live attenuated MMR vaccine (Priorix) in a local population in Singapore. The vaccine was administered as a single dose to healthy children (12-18 months of age) and blood samples were collected at two time points (before vaccination and after vaccination).
Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety...
Hepatitis AMeasles3 moreTwo doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety data will be collected following each vaccination.
Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox...
MeaslesRubella2 moreThis is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.
V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)
MeaslesMumps2 moreThe study is being conducted to demonstrate that V221 may be administered concomitantly with pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles, mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.
Clinical Trial of Measles, Mumps and Rubella Combined Vaccine, Live
ImmunotoxicityVaccineTo evaluate the immunogenicity, lot-to-lot consistency and safety of three consecutive batches of Measles, Mumps and Rubella Combined Vaccine, Live.
Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric...
Pneumococcal ImmunisationDiphtheria Immunisation9 morePrimary objectives: To assess the safety profile of each SP0202 formulation and Prevnar 13 in toddlers and infants (after each and any injection). To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4) To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in infants (Groups 5-8) To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in infants (Groups 5-8) Secondary objectives: To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4) To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in a subset of infants (Groups 5-8) To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in a subset of infants (Groups 5-8) In toddlers: to describe the Ab responses against Pentacel antigens before and 1 month following injection of Pentacel In infants: to describe the Ab responses against antigens of the routine pediatric vaccines (Pentacel, RotaTeq, ENGERIX-B, M-M-RII, and VARIVAX) when administered concomitantly with either SP0202 or Prevnar 13 (at pre-Dose 1 (as applicable) for RotaTeq, Diphteria, Tetanus and Pertussis antigens; at PD3 for ENGERIX-B, RotaTeq, and Pentacel; at PD4 for M-M-RII and VARIVAX])