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Examining Immune Setpoints in Children and Adults Who Received Multivalent Hepatitis B Vaccines








Examining Immune Setpoints in Children and Adults Who Received Multivalent Hepatitis B Vaccines


Yun Zhang


J. Craig Venter Institute (JCVI)






22 January 2020


Vaccination is one of the greatest medical achievements in human history. However, the failure to develop highly effective vaccines for tuberculosis, HIV, malaria or cancers highlights our incomplete understanding of how the human immune system works. New technologies offer powerful approaches to help explain how vaccines work in the human body, but there are gaps in our knowledge that limit our ability to create effective vaccines that protect everyone. An ideal vaccine would provide significant protection for a long time (ideally lifelong) for everyone who receives it following only a single dose. Few licensed vaccines currently on the market achieve this ideal, and more research is needed to understand why some people respond to some vaccines while others don't have the same response. The HBV vaccine has one of the best-established and most easily-measurable immune correlates of protection of all vaccines. The amount of antibodies in a person's body that recognize the HBV antigen in the vaccine gives us a direct measurement to indicate protection. This antibody level makes it is easy to tell when someone has received the vaccine, and if they were protected after one, two, or three doses, with three doses being the standard recommended regimen for complete protection. Some people are protected after just one dose, while others require two or three doses to be fully protected, and still others do not achieve full protection even after receiving three doses. We use computational biology and mathematical approaches to combine data from a wide range of immunology tests to look at the connections between the immune system and vaccine responses and to understand why some people respond to the vaccine and some don't. In 2017, the Human Vaccines Project (HVP) network studied immune responses to a licensed HBV vaccine, Engerix-B, in 15 adult volunteers aged 40 to 80 years. The purpose of this study was to see if the immune responses varied between volunteers, to evaluate the kinetics of the response to HBV vaccine, and to establish which methods could be valuable in analyzing larger future immunology studies. Multiple biological measurements were collected, and the data sets were combined to allow researchers to measure the immune responses to the HBV vaccine. After combining the different types of data, we were able to develop models to predict who would respond well to the vaccine and be protected against HBV after one, two, or three doses. We observed that certain people were predisposed to have a specific immune response and level of protection, or what we call an “immune setpoint.” These setpoints may have implications that explain why some people are protected by a single dose of the HBV vaccine. If we can understand the underlying mechanisms for these immune setpoints we can accurately predict how different individuals will respond to the HBV vaccine. With this knowledge, we may be able to modulate the immune system prior to vaccination to produce a more protective immune response after only a single dose of vaccine. To confirm and strengthen the initial findings of the HBV vaccine study, the Human Vaccines Project would like to compare the immune responses to HBV in a larger number of people who received HBV vaccines. Additionally, we can apply the same technology to examine other vaccine types, which would extend our findings of immune setpoints and empower the field to design more effective vaccines that ideally would protect all populations with just one dose. The specific question examined in this study is whether most children and adults have a predisposition to high or low antibody responses to multiple vaccines, or to certain types of vaccines, and if there are any effects of age on immune responses. The answers to these questions will guide further research.



[{ "PostingID": 135, "Title": "GSK-110478", "Description": "Immunogenicity and reactogenicity study of a new formulation of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine administered as a booster dose to 18-23 months old children" },{ "PostingID": 136, "Title": "GSK-112157", "Description": "Immunogenicity and safety study of GlaxoSmithKline Biologicals’ GSK2202083A vaccine in healthy infants at 2, 3 and 4 months of age" },{ "PostingID": 137, "Title": "GSK-113978", "Description": "Immunogenicity and safety study of GlaxoSmithKline Biologicals’ GSK2202083A vaccine administered as a booster dose in 12-18 months old healthy children" },{ "PostingID": 141, "Title": "GSK-104977", "Description": "Non-inferiority of one formulation of GSK Biologicals' DTPw-HBV/Hib to 2 formulations of GSK Biologicals' DTPw-HBV/Hib with respect to the immune response to the PRP antigen, when administered to healthy infants at 6, 10, 14 weeks of age" },{ "PostingID": 142, "Title": "GSK-113264", "Description": "Immunogenicity and reactogenicity of a booster dose of GlaxoSmithKline Biologicals’ GSK2036874A vaccine in healthy toddlers" },{ "PostingID": 200, "Title": "GSK-113954", "Description": "Antibody persistence and immune memory against the hepatitis B antigen in 11-12 year old children, previously vaccinated with DTPa-HBV-IPV/Hib vaccine in study 217744/031" },{ "PostingID": 280, "Title": "GSK-111344", "Description": "Immunogenicity and reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine when given as a booster dose." },{ "PostingID": 333, "Title": "GSK-105910", "Description": "Compare immunogenicity & reactogenicity of 2 formulations of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (new vs current) given in healthy infants. The DTPa-HBV-IPV vaccine (new formulation) will also be assessed in a 3rd group of subjects" },{ "PostingID": 334, "Title": "GSK-217744/077 (DTPa-HBV-IPV-077)", "Description": "A phase III, double-blind, randomized, multicenter primary vaccination study to bridge the DTPa-HBV-IPV vaccine manufactured according to the large scale manufacturing process with the DTPa-HBV-IPV vaccine manufactured by the small scale manufacturing process when administered intramuscularly to infants at 2, 4 and 6 months of age, co-administered with Merck's Hib conjugate vaccine (Liquid PedvaxHIB®) in a separate injection at 2 and 4 months of age" },{ "PostingID": 335, "Title": "GSK-217744/084 (DTPa-Hep B-IPV-084)", "Description": "A phase III, open labeled, randomized, multicenter, clinical study of the safety of a primary series of GlaxoSmithKline Biologicals' (GSK Biologicals') DTaP-HepB-IPV combined candidate vaccine coadministered with HibTITER® and Prevnar® to healthy infants at 2, 4, and 6 months of age as compared to the separate administration of Infanrix® + Engerix-B®+ IPOL® + HibTITER + Prevnar" },{ "PostingID": 336, "Title": "GSK-217744/085 (DTPa-Hep B-IPV-085)", "Description": "A phase III, open labeled, randomized, multicenter, clinical study of the safety and immunogenicity of a primary series of GlaxoSmithKline Biologicals' (GSK Biologicals') DTaP-HepBIPV candidate vaccine coadministered with HibTITER® and Prevnar® to healthy infants at 2, 4, and 6 months of age as compared to the separate administration of Infanrix® + Engerix-B® + IPOL® + HibTITER + Prevnar and to GSK Biologicals' DTaP-HepB-IPV candidate vaccine coadministered with HibTITER" },{ "PostingID": 337, "Title": "GSK-217744/097 (DTPa-HBV-IPV-097)", "Description": "Study to assess immunogenicity and reactogenicity of three doses of GSK Bio’s combined Hib-MenC vaccine co-admind with GSK Bio’s DTPa-HBV-IPV vaccine and of two doses of Baxters meningococcal C conjugate vaccine co-admind with GSK Bio’s DTPa-HBV-IPV/Hib vaccine" },{ "PostingID": 339, "Title": "GSK-101518 (DTPa-HBV-IPV-103)", "Description": "A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix-hexa) given as a booster at 18-24 months of age to children who have received a three-dose primary immunisation course with the same vaccine in a previous study" },{ "PostingID": 340, "Title": "GSK-104005", "Description": "Phase IIIb, open, randomized, multicenter study to assess the immunogenicity & safety of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in Indian infants when given at 6-10-14 weeks of age or at 2-4-6 months of age" },{ "PostingID": 342, "Title": "GSK-106786", "Description": "A study to evaluate the immunogenicity and safety of a new formulation of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine as compared to the currently licensed Infanrix hexa in healthy infants (2,3,4 M)" },{ "PostingID": 343, "Title": "GSK-217744/076 (DTPa-HBV-IPV-076)", "Description": "An open, multicenter, phase IV clinical trial to assess the immunogenicity and reactogenicity of three doses of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in healthy infants at 2, 4 and 6 months of age, when co-administered with Wyeth-Lederle’s meningococcal group C conjugate vaccine." },{ "PostingID": 344, "Title": "GSK-217744/078 (DTPa-HBV-IPV-078)", "Description": "An open, multicentre, phase IV clinical trial to assess the immunogenicity and reactogenicity of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine, when co-administered at 3-4-5 Mth of age with Wyeth-Lederle's seven-valent pneumococcal conjugate vaccine at a different injection site during the same visit" },{ "PostingID": 345, "Title": "GSK-217744/081 (DTPa-HBV-IPV-081)", "Description": "An open, multicentre, phase IV booster vaccination study to assess the immunogenicity and reactogenicity of a 4th dose of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine, co-administered with Wyeth's seven-valent Pneumococcal conjugate vaccine at a different injection site during the same visit in healthy children" },{ "PostingID": 346, "Title": "GSK-217744/083 (DTPa-HBV-IPV-083)", "Description": "Study to assess immunogenicity and reactogenicity of GSK Bio’s combined DTPa-HBV-IPV/Hib vaccine in pre-term infants in comparison with term infants, administered as a booster dose to children who previously were primed with 3 doses of GSK Biologicals combined DTPa-HBV-IPV/Hib vaccine" },{ "PostingID": 347, "Title": "GSK-217744/086 (DTPa-HBV-IPV-086)", "Description": "Single-blind, multicentre, phase IV clinical trial to assess and compare the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) and Aventis Pasteur’s DTPa-HBV-IPV-Hib vaccine (Hexavac™) given as a primary vaccination course at 2, 4 and 6 months of age." },{ "PostingID": 348, "Title": "GSK-217744/090 (DTPa-HBV-IPV-090)", "Description": "A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa() given as a primary vaccination course at 2, 4 and 6 months of age to pre-term infants." },{ "PostingID": 349, "Title": "GSK-217744/094", "Description": "Study to assess and compare the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (INFANRIX™ HEXA) and Aventis Pasteur MSD’s DTPa-HBV-IPV-Hib vaccine (HEXAVAC™) given at 3, 5 and 11-12 months of age" },{ "PostingID": 464, "Title": "GSK-105539", "Description": "An open, randomized, phase IIIa study to evaluate the safety and immunogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine, when administered intramuscularly according to a 2-4-11 months vaccination schedule" },{ "PostingID": 1690, "Title": "GSK-811936/003", "Description": "A phase 3, open, randomized, controlled, multicentre study to evaluate the safety and reactogenicity profile of GSK Biologicals' Haemophilus influenzae type b–meningococcal serogroup C conjugate candidate vaccine given concomitantly with GSK Biologicals' diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio (DTPa-HBV-IPV) vaccine and to compare it with MenC-CRM197 conjugate vaccine co-administered with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine, when given as a 3-dose primary vaccination (at 2, 3, 4 months of age) to healthy infants." },{ "PostingID": 1794, "Title": "GSK-112688", "Description": "Long-term antibody persistence of hepatitis B antibodies and immune response to a hepatitis B vaccine (Engerix-B Kinder) challenge in children previously vaccinated with Infanrix hexa vaccine" },{ "PostingID": 2153, "Title": "GSK-103812", "Description": "Assess reactogenicity & safety of a booster of either Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hiberix™ given (single-blind) at 15-18 (Philippines)/15-24 mths (Thailand) & a dose of Mencevax™ ACWY at 24-30 mths (open label)" },{ "PostingID": 2154, "Title": "GSK-104171", "Description": "Assess reactogenicity & safety of a booster of either Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hiberix™ given (single-blind) at 15-18 (Philippines)/15-24 mths (Thailand) & a dose of Mencevax™ ACWY at 24-30 mths (open label)" },{ "PostingID": 2156, "Title": "GSK-104727", "Description": "Assess immunogenicity, safety & reactogenicity of a 4th dose of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC at 15-24 m & of a dose of Mencevax™ ACWY at 24-30 m in subjects primed with 3 doses of Tritanrix™-HepB/Hib-MenAC" },{ "PostingID": 2157, "Title": "GSK-104733", "Description": "Demonstrate lot-to-lot consistency of final production method of GSK Biologicals' Hib-MenAC vaccine mixed extemporaneously with Tritanrix™-HepB & demonstrate its non-inferiority vs Tritanrix™-HepB/Hiberix™ in healthy infants at 2, 4 and 6 months" },{ "PostingID": 2158, "Title": "GSK-104065", "Description": "Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib" },{ "PostingID": 2159, "Title": "GSK-104489", "Description": "Study to assess immunogenicity and safety of GlaxoSmithKline Biologicals' Kft’s DTPw-HBV/Hib vs DTPwCSL-HBV/Hib Kft and vs concomitant administration of CSL’s Triple Antigen and GlaxoSmithKline Biologicals’ Hiberix, to infants at 2, 4, 6 months of age, after a birth dose of hepatitis B" },{ "PostingID": 2160, "Title": "GSK-106602", "Description": "Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals’ DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals’ DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines." },{ "PostingID": 2753, "Title": "GSK-217744/099", "Description": "A phase II, randomized, partially blinded clinical trial to evaluate the immunogenicity and reactogenicity of an investigational vaccine regimen of GSK Biologicals as compared to GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix™ hexa) and to the concomitant administration of GSK Biologicals’ DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines, when given as a primary vaccination to healthy infants at 2, 3 and 4 months of age" },{ "PostingID": 2754, "Title": "GSK-759346/002", "Description": "Assess immune persistence & memory by giving plain PRP,PSA & PSC (10 mths age), & immunogenicity & safety of a Tritanrix™-HBV/Hib-MenAC/ Tritanrix™-HBV/Hib2.5 booster (15-18 mths age) in previously primed subjects" },{ "PostingID": 2755, "Title": "GSK-100480", "Description": "Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose" },{ "PostingID": 2756, "Title": "GSK-100791", "Description": "Study to assess immunogenicity and non-inferiority of investigational vaccination regimen as compared to Tritanrix-HepB/Hiberix and as compared to Meningitec when administered to healthy infants" },{ "PostingID": 2757, "Title": "GSK-101222", "Description": "Study to demonstrate the non-inferiority of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants." },{ "PostingID": 2758, "Title": "GSK-101223", "Description": "Study to assess the lot-to-lot consistency of the production method of GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine and to compare to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine, when administered as a primary vaccination course." },{ "PostingID": 2768, "Title": "GSK-113615", "Description": "Feasibility study of GlaxoSmithKline Biologicals’ GSK2202083A vaccine in healthy infants at 2, 4 and 12 months of age" },{ "PostingID": 2792, "Title": "GSK-104021", "Description": "A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine." },{ "PostingID": 3223, "Title": "GSK-217744/049 (DTPa-HBV-IPV-049)", "Description": "Immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV and Hib vaccines when administered concomitantly to healthy infants administered as a three-dose primary vaccination course at the age of 1.5, 3.5 and 6 months" },{ "PostingID": 3224, "Title": "GSK-217744/061 (DTPa-HBV-IPV-061)", "Description": "Phase II, single-blinded, randomized comparative study of the safety and immunogenicity of a booster dose of SB Bios' DTPa-HBV-IPV vaccine compared with Infanrix when both vaccines are co-administered with OmniHIB between 15 and 18 months of age after primary immunization at the age of 2, 4 and 6" },{ "PostingID": 3225, "Title": "GSK-347414/016", "Description": "A phase II, single-blind, randomised, controlled, multicentre study to evaluate the safety, reactogenicity and immunogenicity of two experimental formulations versus a licensed Haemophilus influenzae type b (Hib) conjugate vaccine (Hiberix™ or HibTiter™) administered as primary vaccination to infants in their thirth, fourth and fifth months of life, with concomitant administration of SmithKline Beecham Biologicals' DTPa-HBV-IPV vaccine" },{ "PostingID": 3226, "Title": "GSK-347414/028", "Description": "A randomized, controlled, open, phase-II clinical study to evaluate the safety and immunogenicity of an experimental formulation extemporaneously mixed with SmithKline Beecham Biologicals' Haemophilus influenzae type b (Hib) vaccine, administered as a booster dose with DTPa-HBV-IPV to healthy children 12 to 18 months old" },{ "PostingID": 3227, "Title": "GSK-217744/070 (DTPa-HBV-IPV-070)", "Description": "An open clinical study to assess the immunogenicity and safety of GSK Bio’s DTPa-HBV-IPV vaccine mixed in one syringe with Hib vaccine, as a primary vaccination course to pre-term infants(<37 weeks) at 2, 4 and 6 months of age in comparison with infants born after normal gestation period" },{ "PostingID": 3228, "Title": "GSK-217744/060", "Description": "Study to assess the immunogenicity and reactogenicity of DTPa-HBV-IPV mixed with Hib vaccine in healthy infants, followed by a dose of the same vaccine administered simultaneously with one dose of oral polio vaccine (OPV)" },{ "PostingID": 3229, "Title": "GSK-217744/063 (DTPa-HBV-IPV-063)", "Description": "Open, clinical study to assess the safety and reactogenicity of GSK Bios’ combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vac. admin. with GSK Bios’ Haemophilus influenzae type b, tetanus conjugate vac. in healthy infants, before a dose of the same vac and OPV" },{ "PostingID": 3230, "Title": "GSK-217744/066 (DTPa-HBV-IPV-066)", "Description": "Open, randomized, multicentre, phase III clinical trial to assess the reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine, co-administered during the same visit with GSK Biologicals’ HAV vaccine (Havrix(), in children in their second ..." },{ "PostingID": 3231, "Title": "GSK-217744/068", "Description": "Study to assess immunogenicity, safety and reactogenicity of GSK Bio’s DTPa-IPV/Hib and HBV vaccines compared to an investigational vaccination regimen in healthy infants born to hepatitis B surface antigen negative mothers and previously primed at birth with a dose of GSK Bio’s hepatitis B vaccine" },{ "PostingID": 3232, "Title": "GSK-217744/074 (DTPa-HBV-IPV-074)", "Description": "Open, randomized, multicenter, phase IIIb clinical trial to assess the incidence of high grade fever ((40.0°C) within 4 days following a booster dose in the second year of life of GSK Bios’ combined DTPa-HBV-IPV/Hib vaccine as compared to GSK Bios’ combined DTPa-IPV/Hib and HBV" },{ "PostingID": 3233, "Title": "GSK-217744/095 (DTPa-HBV-IPV-095)", "Description": "Study to assess immunogenicity and reactogenicity of GSK Bio’s DTPa-HBV-IPV/Hib vaccine when given as a booster dose to children previously primed at 2-4-6 months of age either with Aventis Pasteurs DTPa-HBV-IPV-Hib vaccine or GSK Bio’s DTPa-HBV-IPV/Hib vaccine in study DTPa-HBV-IPV-086" },{ "PostingID": 3234, "Title": "GSK-347414/020", "Description": "A Phase III, randomized, single blind study to assess the immune response induced by Prevenar™(Wyeth Lederle) when administered to healthy infants with DTPa-HBV-IPV/Hib, compared to an investigational vaccination regimen as a 3-dose primary vaccination course at a monthly interval starting at 8–16 Weeks of age" },{ "PostingID": 3235, "Title": "GSK-347414/026", "Description": "A Phase III, randomized single-blind clinical trial to assess the immune memory induced by an investigational vaccination regimen in comparison with Prevnar and the immune response to a fourth dose of the pneumococcal vaccine and the investigational vaccination regimen, when admininistered to healthy children (12-15 Months)" },{ "PostingID": 3236, "Title": "GSK-759348/001", "Description": "A randomised, controlled phase II study to evaluate the safety and immunogenicity of 7 different formulations of GSK Biologicals’ investigational vaccination regimen, when administered as a 3-dose primary immunisation schedule before 6 months of age, followed by a fourth dose during the second year of life" },{ "PostingID": 3237, "Title": "GSK-759348/003", "Description": "A randomized, controlled, phase II study to evaluate the safety and immunogenicity of four different formulations of GlaxoSmithKline (GSK) Biologicals’ investigational vaccination regimen, when administered as a 3-dose primary immunization schedule beginning before 6 months of age." },{ "PostingID": 3241, "Title": "GSK-347414/017", "Description": "A multinational, randomised, controlled, single-blind, phase-II study to evaluate the safety and immunogenicity of two investigational vaccination regimens versus a licensed Haemophilus influenzae type b (Hib) conjugate vaccine (Hiberix) given concomitantly with DTPw-HBV vaccine in a separate injection of DTPw-HBV to infants at 2, 4, and 6 months of age" },{ "PostingID": 3242, "Title": "GSK-763674/002", "Description": "A phase II open, randomized, controlled study to evaluate an investigational vaccination regimen administered as athree dose primary vaccination course at 2, 3 and 4 months of age." },{ "PostingID": 3243, "Title": "GSK-100478", "Description": "Study to show non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- hepatitis B vaccine at birth) versus Tritanrix™-HepB/Hiberix™ without hepatitis B vacc. at birth for antibody response to all vaccine antigens given in healthy infants" },{ "PostingID": 3244, "Title": "GSK-213501/016 (DTPw-HBV-Hib/016)", "Description": "A post-marketing surveillance study of GlaxoSmithKline (GSK) Biologicals Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B vaccine (TRITANRIX-HB) and Haemophilus influenzae type-b tetanus-conjugate (Hib) vaccine (HIBERIX)co-administered in the same syringe in 1,000 Filipino subjects." },{ "PostingID": 3245, "Title": "GSK-402764/004", "Description": "A phase III, open, randomized study to evaluate the immunogenicity and reactogenicity of investigational vaccination regimens" },{ "PostingID": 3246, "Title": "GSK-759346/001", "Description": "A phase II, open, randomized, controlled study to evaluate the immunogenicity of investigational vaccinationregimens administered as a three dose primary vaccination course at 6, 10 and 14 weeks of age." },{ "PostingID": 3248, "Title": "GSK-763674/001", "Description": "A phase II, open, randomized, controlled study to evaluate an investigational vaccination regimen administered as athree dose primary vaccination course at 2, 3 and 4 months of age." },{ "PostingID": 3249, "Title": "GSK-213501/018 (DTPw-HBV-Hib-018)", "Description": "Study to evaluate immunogenicity, safety and reactogenicity of two different immunization regimens against hepatitis B, diphtheria, tetanus, pertussis and Haemophilus influenzae type b (Hib)diseases in healthy infants primed with a birth dose of GSK Biologicals hepatitis B" },{ "PostingID": 3250, "Title": "GSK-213501/019 (DTPw-HBV-Hib-019)", "Description": "Study to assess immunogenicity and reactogenicity of GSK Bio’s quadrivalent diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus influenzae type b conjugate vaccines when mixed extemporaneously and given in a single injection to healthy infants" },{ "PostingID": 3289, "Title": "GSK-208127/091 (HAB-091)", "Description": "A phase IV, open, randomized, controlled, comparative, multicenter U.S. study of the safety of GSK Bios' combination hepatitis A and hepatitis B vaccine administered on a 0-1-6 mth schedule by intramuscular injection compared with concurrently administered monovalent vaccines in healthy adults" },{ "PostingID": 3290, "Title": "GSK-208127/097 (HAB-097)", "Description": "An open, randomized, monocentric study to evaluate the immunogenicity, reactogenicity and safety of GSK Bios' combined hepatitis A/hepatitis B vaccine compared to separate vaccinations with hepatitis A and hepatitis B vaccines of Chiron Behring/Aventis Pasteur in healthy adult volunteers." },{ "PostingID": 3297, "Title": "GSK-208127/129 (HAB-129)", "Description": "A phase III, double-blind, controlled, multicentric randomized study, to evaluate the immunogenicity and reactogenicity of the combined hepatitis A/hepatitis B preservative-free thimerosal-free vac as compared to the combined hepatitis A/hepatitis B vac with preservative, admin at 0-1-6 Mth" },{ "PostingID": 3640, "Title": "GSK-115375", "Description": "Antibody persistence in children previously vaccinated with three doses of Infanrix hexa™ or Infanrix-IPV/Hib™" },{ "PostingID": 3654, "Title": "GSK-208127/121", "Description": "An open, controlled, randomized, comparative, phase IIIb study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' combined hepatitis A and hepatitis B vaccine given on an accelerated schedule compared to separate vaccine with GSK Biologicals' monovalent hepatitis A vaccine in healthy adults" },{ "PostingID": 4289, "Title": "GSK-103488", "Description": "A randomized, controlled, phase II study to evaluate the safety and immunogenicity of different formulations of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3-dose primary immunization (2-3-4 month schedule) before 6 months of age" },{ "PostingID": 4632, "Title": "GSK-111157", "Description": "Immunogenicity and safety study of GlaxoSmithKline Biologicals’ Infanrix hexa™ vaccine in healthy infants in India" },{ "PostingID": 14519, "Title": "GSK-113681", "Description": "Immunogenicity of the hepatitis B antigen of the GSK Biologicals’ candidate malaria vaccine (257049)" },{ "PostingID": 14527, "Title": "GSK-759348/002", "Description": "A randomized, controlled, phase II study to evaluate the safety and immunogenicity of 7 different formulations of an investigational vaccination regimen, when administered as a 3-dose primary immunization schedule before 6 months of age, followed by a fourth dose during the second year of life" },{ "PostingID": 14528, "Title": "GSK-759348/007", "Description": "A randomized, controlled, phase II study to evaluate the safety and immunogenicity of five formulations of GlaxoSmithKline Biologicals’ investigational vaccination regimen, when administered intramuscularly as a 3-dose primary immunization schedule (2-3-4 month schedule) before 6 months of age." },{ "PostingID": 14529, "Title": "GSK-101853", "Description": "A randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ investigational vaccination regimen, when administered intramuscularly as a 3-dose primary immunization (2-3-4 month schedule) before 6 months of age." },{ "PostingID": 19621, "Title": "GSK-103506", "Description": "Immunogenicity and safety study of GlaxoSmithKline Biologicals’ Infanrix hexa vaccine in healthy infants" }]

Statistical Analysis Plan