Assessing sex-differences and the effect of timing of vaccination on immunogenicity, reactogenicity and efficacy of vaccines in young children

Assessing sex-differences and the effect of timing of vaccination on immunogenicity, reactogenicity and efficacy of vaccines in young children

Funding is available from my NIHR Doctoral Research Fellowship (NIHR-2015-08-048) until September 2019.

AJP has previously conducted studies on behalf of Oxford University funded by vaccine manufacturers, but currently does not undertake industry funded clinical trials.

Males and females have different levels of risk for certain diseases. Men are more prone to suffer heart attacks and strokes than women. Women are more likely to develop multiple sclerosis than men. In young children, pneumonia and meningitis more often occur in boys than girls. In the same way that some infectious diseases are more common in males than females, difference can also occur in their immune responses to vaccination. The biological mechanisms by which males and females respond differently to vaccines is multifactorial and not well understood. Females have two X chromosomes which contain many genes related to immune mechanisms. Males and females also have different hormone levels which, additionally, change over time, further affecting a person's ability to respond to a vaccine or other source of immune challenge. Differences between males and females in response to vaccination have been mostly observed for viral vaccines and mostly in adults. Little information is available as to whether young boys and girls respond differently to their vaccinations even though the majority of all vaccines are received in these early years.

In this project we will assess sex-differences in response to vaccines administered to infants and toddlers.
In addition, we will assess the timing and spacing at which vaccines are administered as these can have important effects on the immune response to vaccine.

Data from randomised controlled trials of vaccines will be combined (meta-analysed) to assess the impact of key variables on antibody responses. Studies will include all randomised controlled trials assessing the immune response to vaccines in infants and healthy young children. The vaccines of interest include diphtheria, tetanus, pertussis, meningococcal, pneumococcal, measles, mumps, rubella, varicella and rotavirus vaccines.

The findings of this research will provide important insights into immune mechanisms and which will be important in planning of future clinical trials of vaccines and optimising vaccine schedules.

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GSK"},{"PostingID":254,"Title":"GSK-109509","Description":"Booster vaccination course with the pneumococcal vaccine GSK 1024850A, DTPw-HBV/Hib and OPV or IPV in children who completed the primary vaccination course in study 107007, Sponsor: GSK"},{"PostingID":256,"Title":"GSK-109661","Description":"Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A, Infanrix hexa and Rotarix, Sponsor: GSK"},{"PostingID":257,"Title":"GSK-110031","Description":"Phase II, observer-blind follow-up study to assess reacto-and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), when given as booster in primed children or as 2-dose catch-up in unprimed children., Sponsor: GSK"},{"PostingID":258,"Title":"GSK-110521","Description":"Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A co-administered with Zilbrix™ Hib and Polio Sabin™, Sponsor: GSK"},{"PostingID":259,"Title":"GSK-110808","Description":"Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A or Prevenar™ co-administered with Hiberix™, Sponsor: GSK"},{"PostingID":260,"Title":"GSK-111188","Description":"Primary vaccination course in healthy children receiving the pneumococcal vaccine GSK 1024850A co-administered with Tritanrix™-HepB/Hib at 6, 10 and 14 weeks of age, Sponsor: GSK"},{"PostingID":261,"Title":"GSK-111442","Description":"Evaluation of effectiveness of GSK Biologicals' pneumococcal conjugate vaccine 1024850A against invasive disease, Sponsor: GSK"},{"PostingID":262,"Title":"GSK-112801","Description":"Vaccination course in children primed and boosted with pneumococcal vaccine GSK 1024850A and in age-matched unprimed children, Sponsor: GSK"},{"PostingID":263,"Title":"GSK-112933","Description":"Booster vaccination with pneumococcal vaccine GSK1024850A or Prevenar™ co-administered with Hiberix™ in children primed with the same vaccines, Sponsor: GSK"},{"PostingID":264,"Title":"GSK-113166","Description":"Safety, reactogenicity and immunogenicity study of GSK Biologicals' pneumococcal vaccine GSK1024850A, given either as a booster dose or as a 2-dose catch-up immunization in healthy Malian children, Sponsor: GSK"},{"PostingID":265,"Title":"GSK-113199","Description":"Safety, reactogenicity and immunogenicity study of GSK Biologicals' pneumococcal vaccine GSK1024850A, given either as a booster dose or as a 2-dose catch-up immunization in healthy Nigerian children, Sponsor: GSK"},{"PostingID":266,"Title":"GSK-113266","Description":"Evaluation of immunological persistence following 3-dose priming with GSK Biologicals' 10-valent pneumococcal conjugate vaccine in study NCT00808444 and safety and immunogenicity following a booster dose of the same vaccine, Sponsor: GSK"},{"PostingID":272,"Title":"GSK-107625","Description":"Efficacy, safety, reactogenicity and immunogenicity study of the lyophilised formulation of Rotarix vaccine in healthy Japanese infants, Sponsor: GSK"},{"PostingID":273,"Title":"GSK-109216","Description":"Immunogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals' oral live attenuated human rotavirus (HRV) liquid vaccine (GSK 357941A) in healthy infants., Sponsor: GSK"},{"PostingID":274,"Title":"GSK-109861","Description":"Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A, Infanrix hexa and Rotarix, Sponsor: GSK"},{"PostingID":275,"Title":"GSK-111654","Description":"Non-inferiority of a commercial lot of the pneumococcal vaccine GSK1024850A compared to a clinical lot., Sponsor: GSK"},{"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, Sponsor: GSK"},{"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., Sponsor: GSK"},{"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., Sponsor: GSK"},{"PostingID":2759,"Title":"GSK-208136/039","Description":"Follow-up to evaluate the the immunogenicity & safety of GSK Biologicals' MMRV vaccine given as a two-dose schedule in the second year of life, as compared to separate administration of GSK Biologicals' Priorix® & Varilrix®., Sponsor: GSK"},{"PostingID":276,"Title":"GSK-112269","Description":"Immunogenicity, reactogenicity and safety study to evaluate two doses of the lyophilised formulation of the human rotavirus (HRV) vaccine when administered to healthy Korean infants previously uninfected with HRV, Sponsor: GSK"},{"PostingID":2760,"Title":"GSK-208136/040","Description":"Study to evaluate immunogenicity and safety of three production lots of GSK Biologicals' combined MeMuRu-OKA candidate vaccine given on a two-dose schedule to healthy children, as compared to separate administration of GSK Biologicals' Priorix® and Varilrix® vaccines, Sponsor: GSK"},{"PostingID":2761,"Title":"GSK-208136/041","Description":"Study to evaluate immunogenicity and safety of three production lots of GSK Biologicals' combined MeMuRu-OKA candidate vaccine given on a two-dose schedule to healthy children, as compared to separate administration of GSK Biologicals' Priorix® and Varilrix® vaccines, Sponsor: GSK"},{"PostingID":2762,"Title":"GSK-108760","Description":"Immunogenicity & safety study of GSK Biologicals' 208136 vaccine formulated with new measles and rubella working seeds, Sponsor: GSK"},{"PostingID":2763,"Title":"GSK-208136/038","Description":"Study to evaluate immunogenicity and safety of three production lots of GSK Biologicals' combined MeMuRu-OKA candidate vaccine given on a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' Priorix™ and Varilrix™ vaccines, Sponsor: GSK"},{"PostingID":2788,"Title":"GSK-208109/231","Description":"Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Co Varicella Vaccine (VARIVAX™) to Children 15 Months of Age, Sponsor: GSK"},{"PostingID":280,"Title":"GSK-111344","Description":"Immunogenicity and reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine when given as a booster dose., Sponsor: GSK"},{"PostingID":2806,"Title":"GSK-112036","Description":"Persistence of antibodies after GSK Biologicals' meningococcal vaccine GSK134612 in toddlers, Sponsor: GSK"},{"PostingID":2807,"Title":"GSK-112021","Description":"The long term antibody persistence study of GSK Biologicals' meningococcal vaccine GSK 134612 administered as 1 or 2 doses to healthy toddlers at 9-12 months of age and as a booster dose at 5 years post-primary vaccination, Sponsor: GSK"},{"PostingID":2809,"Title":"GSK-109563","Description":"COMPAS: A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media, Sponsor: GSK"},{"PostingID":2810,"Title":"GSK-111346","Description":"Assessment of long-term antibody persistence and immunological memory in children previously vaccinated with four pneumococcal conjugate vaccine doses and assessment of pneumococcal catch-up vaccination with GSK1024850A at 5 years of age, Sponsor: GSK"},{"PostingID":2811,"Title":"GSK-111347","Description":"Assessment of long-term antibody persistence and immunological memory in children previously vaccinated with four pneumococcal conjugate vaccine doses and assessment of pneumococcal catch-up vaccination with GSK1024850A at 5 years of age., Sponsor: GSK"},{"PostingID":2812,"Title":"GSK-112640","Description":"Immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' pneumococcal vaccine GSK1024850A following primary and booster vaccination of healthy Japanese children6, Sponsor: GSK"},{"PostingID":2813,"Title":"GSK-112909","Description":"Booster vaccination with pneumococcal vaccine GSK1024850A in primed children and catch-up vaccination in unprimed children, Sponsor: GSK"},{"PostingID":2830,"Title":"GSK-100388","Description":"Study in Healthy Children (, Sponsor: GSK"},{"PostingID":311,"Title":"GSK-110871","Description":"Immunogenicity and safety study of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in primed healthy toddlers., Sponsor: GSK"},{"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(, Sponsor: GSK"},{"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, Sponsor: GSK"},{"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, Sponsor: GSK"},{"PostingID":3247,"Title":"GSK-759346/007","Description":"Demonstrate non-inferiority of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ with respect to anti-HBs immune response, when given to healthy infants at 6,10 & 14 weeks age, after a birth dose of hepatitis B vaccine, Sponsor: GSK"},{"PostingID":3308,"Title":"GSK-444563/007 (rota-007)","Description":"Study to assess efficacy, immunogenicity, reactogenicity and safety of two doses of GSK Bio's oral live attenuated human rotavirus vaccine at different viral concentrations in healthy infants previously uninfected with human rotavirus and approximately 3 months of age, Sponsor: GSK"},{"PostingID":3324,"Title":"GSK-104420","Description":"A phase II study to evaluate the persistence of measles, mumps and rubella antibodies two years after the single dose primary vaccination in study 209762/151., Sponsor: GSK"},{"PostingID":3325,"Title":"GSK-209762/136 (MeMuRu-136)","Description":"A phase III, blinded, randomized, multicenter U.S. study evaluating the clinical consistency of three production lots of SmithKline Beecham Biologicals' MMR vaccine (PRIORIX) and comparability of PRIORIX with Merck's M-M-R IIvaccine, administered to healthy children 12 to 18 months of age, Sponsor: GSK"},{"PostingID":3326,"Title":"GSK-209762/147 (MeMuRu-147)","Description":"Phase IV open study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK)Biologicals live attenuated Measles-Mumps-Rubella (MMR) vaccine when given to healthy children at the age of 12 to 18months in Singapore., Sponsor: GSK"},{"PostingID":3327,"Title":"GSK-209762/148","Description":"Phase II, double blind, randomized sequential study to compare immunogenicity and reactogenicity of the current formulations of GSK Bios' measles-mumps-rubella vaccine and GSK Bios' varicella vaccine containing human serum albumin with the modified formulations which do not contain HSA, Sponsor: GSK"},{"PostingID":3329,"Title":"GSK-209762/150","Description":"Double blind, randomized sequential study to compare immunogenicity and reactogenicity of current formulations of GSK Bios' measles-mumps-rubella vaccine and GSK Bios' varicella vaccine to investigational vaccination regimens, Sponsor: GSK"},{"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, Sponsor: GSK"},{"PostingID":3330,"Title":"GSK-209762/151","Description":"Phase II study to evaluate immunogenicity, reactogenicity and safety of GSK Bios' investigational vaccination regimen compared to the currently licensed GSK Bios' Priorix™ and Merck and Co.'s M-M-R®II vaccines when administered as a primary vaccination to healthy children aged 12-24 months, Sponsor: GSK"},{"PostingID":3331,"Title":"GSK-404286/006","Description":"A phase II, open, randomized, controlled study to assess the immune memory induced by an investigational vaccination regimen and the safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen in toddlers primed in study 404286/001., Sponsor: GSK"},{"PostingID":3336,"Title":"GSK-711202/001","Description":"Evaluate immunogenicity, reactogenicity, safety of GSK Biologicals' MenC-TT vaccine (2 formulations) given with Infanrix hexa® + GSK Biologicals' Hib MenC-TT vaccine (2 formulations) given with Infanrix penta® to infants in mths 3,4,5 of life, Sponsor: GSK"},{"PostingID":3337,"Title":"GSK-711202/008","Description":"Evaluate the persistence and immune memory induced by a primary vaccination course with GSK Biologicals' MenC-TT (1 formulation) & GSK Biologicals' Hib-MenC-TT (2 formulations) or Meningitec™ in healthy toddlers aged 12-15 mths primed in study 711202/001, Sponsor: GSK"},{"PostingID":3338,"Title":"GSK-811936/001 (Hib-MenC-TT-001)","Description":"Phase 2, open, randomized, controlled study to demonstrate the non-inferiority of the meningococcal serogroup C immune response and the superiority of the Hib immune response of GSK Biologicals' Haemophilus influenzae type b-meningococcal C-TT conjugate vaccine administered with Infanrix™ penta versus Meningitec™ administered with Infanrix™, Sponsor: GSK"},{"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, Sponsor: GSK"},{"PostingID":3346,"Title":"GSK-444563/003 (rota-003)","Description":"A phase II, double-blind, randomized, placebo-controlled, dose-escalating, stepwise study to assess safety, reactogenicity and immunogenicity of GlaxoSmithKline Biologicals' live attenuated human rotavirus (HRV) vaccine in healthy infants previously uninfected with human rotavirus., Sponsor: GSK"},{"PostingID":3347,"Title":"GSK-444563/004","Description":"A study to assess the efficacy, immunogenicity and safety of two doses of oral live attenuated human rotavirus (HRV) vaccine (Rotarix) in healthy infants., Sponsor: GSK"},{"PostingID":3348,"Title":"GSK-444563/005 (rota-005)","Description":"Phase II, double-blind, randomized, placebo-controlled study of 2 doses of GSK Bios' live attenuated human rotavirus vaccine at different virus concentrations (10 5.2 and 10 6.4 ffu) in healthy infants following a 0, 2 month schedule and previously uninfected with human rotavirus, Sponsor: GSK"},{"PostingID":3349,"Title":"GSK-444563/006","Description":"To assess the efficacy, immuno & safety of 2 doses of GSK HRV vaccine at different virus concentrations in healthy infants aged 2 months & previously uninfected with HRV, concurrently given with DTPw-HBV, Hib., Sponsor: GSK"},{"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, Sponsor: GSK"},{"PostingID":3350,"Title":"GSK-444563/014 (Rota-014)","Description":"Study of safety, reactogenicity and immunogenicity of two doses of GSK Bio's oral live attenuated human rotavirus vaccine co-administered with either oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in healthy infants in South Africa, Sponsor: GSK"},{"PostingID":3351,"Title":"GSK-444563/020","Description":"Phase II, double-blind randomised, placebo controlled clinical dose-range study to assess immunogenicity and reactogenicity of an investigational vaccination regimen, and to assess immunogenicity of OPV orally co-administered to healthy infants at 2, 4 and 6 months of age, Sponsor: GSK"},{"PostingID":3352,"Title":"GSK-444563/021","Description":"Phase II, double-blind, randomized, placebo-controlled clinical study to assess immunogenicity and reactogenicity of doses of a modified vaccine formulation versus GSK Biologicals' live attenuated human rotavirus vaccine when orally administered to healthy infants at 2, 4 and 6 months of age, Sponsor: GSK"},{"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, Sponsor: GSK"},{"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, Sponsor: GSK"},{"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, Sponsor: GSK"},{"PostingID":341,"Title":"GSK-105555","Description":"A phase II, multicentre booster study to evaluate booster vaccination with GSK Biologicals' 10-valent pneumococcal conjugate vaccine or to evaluate the immune memory following the administration of a single dose of 23-valent plain polysaccharide vaccine in healthy children, previously vaccinated in infancy in the primary study 11PN-PD-DIT-002 (103488), Sponsor: GSK"},{"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), Sponsor: GSK"},{"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., Sponsor: GSK"},{"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, Sponsor: GSK"},{"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, Sponsor: GSK"},{"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, Sponsor: GSK"},{"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., Sponsor: GSK"},{"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., Sponsor: GSK"},{"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, Sponsor: GSK"},{"PostingID":359,"Title":"GSK-101197 (DTPa -127)","Description":"An open, multicentric, phase IV clinical trial to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' combined diphtheria-tetanus-acellular pertussis vaccine (Infanrix™) administered to healthy infants at 2, 4 and 6 months of age., Sponsor: GSK"},{"PostingID":361,"Title":"GSK-104871","Description":"A multicentric study to compare the immunogenicity, safety & reactogenicity of GSK Biologicals' DTPa-IPV vaccine vs. co-administration of GSK's DTPa vaccine & Sanofi-Pasteurs' IPV vaccine at different injection sites, to healthy children, Sponsor: GSK"},{"PostingID":363,"Title":"GSK-208355/125 (APV-125)","Description":"A phase III, open, multicenter study of the safety of Infanrix® when administered as a booster dose at 15 to 18 months of age following primary immunization in studies 217744/084 and 217744/085 (Subjects from DTaP-HepB-IPV-084 and DTaP-HepB-IPV-085), Sponsor: GSK"},{"PostingID":3641,"Title":"GSK-104690","Description":"Blinded, randomized study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals' measles-mumps-rubella-varicella candidate vaccine given to healthy children during the second year of life, Sponsor: GSK"},{"PostingID":3642,"Title":"GSK-208136/006 (MeMuRu-OKA-006)","Description":"Study evaluating in healthy children safety and immunogenicity of GSK Bios' combined Measles-Mumps-Rubella-Varicella vaccine, compared to GSK Bios' Varicella and Measles-Mumps-Rubella vaccines admind as separate injections, Sponsor: GSK"},{"PostingID":3643,"Title":"GSK-208136/013 (MeMuRu-OKA-013)","Description":"Study to assess immunogenicity and safety of one dose of GSK Bios' live attenuated MMRV vaccine, co-admind with a booster dose of the GSK Bios' combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type b conjugate vaccine, Sponsor: GSK"},{"PostingID":3644,"Title":"GSK-208136/017 (MeMuRu-OKA-017)","Description":"Study to assess immunogenicity, reactogenicity and safety of a 2nd dose of GlaxoSmithKline Biologicals' measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine given in healthy children of 5 to 6 years of age, Sponsor: GSK"},{"PostingID":3645,"Title":"GSK-208136/018 (MeMuRu-OKA-018)","Description":"Study to evaluate immunogenicity and safety of GSK Bios' MeMuRu-OKA vaccine compared to concomitant administrations of GSK Bios' Priorix™ and Varilrix™ vaccines, Sponsor: GSK"},{"PostingID":3646,"Title":"GSK-208136/019 (MeMuRu-OKA-019)","Description":"Study to evaluate immunogenicity and safety of one dose of GSK Bios' measles-mumps-rubella-varicella vaccine given to healthy children previously primed with one dose of measles-mumps-rubella vaccine, Sponsor: GSK"},{"PostingID":3669,"Title":"GSK-111870","Description":"A phase II, randomized, observer blind, controlled, multicenter study to assess immunogenicity and antibody persistence following vaccination with GSK's candidate combined measles, mumps, and rubella vaccine (MMR) versus M-M-R® II as a first dose, both administered subcutaneously at 12-15 months of age, concomitantly with hepatitis A vaccine (HAV), varicella vaccine (VV) and pneumococcal conjugate vaccine (PCV) but at separate sites., Sponsor: GSK"},{"PostingID":3707,"Title":"GSK-208136/007 (MeMuRu-OKA-007)","Description":"Study to assess consistency of 3 production lots of GSK Bios' combined measles-mumps-rubella-varicella vaccine in terms of immunogenicity and safety, compared to administration of GSK Bios' measles-mumps-rubella vaccine and varicella vaccine in healthy children in their second year of life, Sponsor: GSK"},{"PostingID":3708,"Title":"GSK-208136/014 (MeMuRu-OKA-014)","Description":"Study to evaluate immunogenicity and safety of one dose of GSK Bios' combined measles-mumps-rubella-varicella vaccine given to healthy children previously primed with one dose of measles-mumps-rubella vaccine in their second year of life and presumed seronegative for varicella, Sponsor: GSK"},{"PostingID":3709,"Title":"GSK-208136/016 (MeMuRu-OKA-016)","Description":"Study to assess immunogenicity and safety of two lots of GSK Bios' live attenuated measles-mumps-rubella-varicella vaccine, at two different titres, given as a single injection to healthy children with GSK Bios' measles-mumps-rubella vaccine as control group, Sponsor: GSK"},{"PostingID":3710,"Title":"GSK-208136/022 (MeMuRu-OKA-022)","Description":"Study to evaluate immunogenicity and safety of one dose of GSK Bios' combined measles-mumps-rubella-varicella vaccine compared to concomitant administrations of GSK Bios' measles-mumps-rubella vaccine and varicella vaccine, Sponsor: GSK"},{"PostingID":3726,"Title":"GSK-V72P13","Description":"A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants, Sponsor: GSK"},{"PostingID":3727,"Title":"GSK-V72P13E1","Description":"A Phase 3, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13, Sponsor: GSK"},{"PostingID":3728,"Title":"GSK-V72P12","Description":"A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules., Sponsor: GSK"},{"PostingID":3922,"Title":"GSK-404286/001","Description":"Feasibility Double-blindDTPa-HBV-IPV/HIB-MenC control : DTPa-HBV-IPV + HiberixLot D21798A2;D21799B2;DCH002A46;DCH003A46;Hib400A47/MInfants 2-3 months, Sponsor: GSK"},{"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, Sponsor: GSK"},{"PostingID":4324,"Title":"GSK-112595","Description":"Impact on nasopharyngeal carriage, acute otitis media, immunogenicity and safety of GSK Biologicals' pneumococcal conjugate vaccine 1024850A, Sponsor: GSK"},{"PostingID":436,"Title":"GSK-106208","Description":"To assess reactogenicity and immunogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine, when co-administered with GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (Infanrix™ hexa) at 2, 4 and 6 months of age., Sponsor: GSK"},{"PostingID":4590,"Title":"GSK-104105","Description":"Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine, Sponsor: GSK"},{"PostingID":4591,"Title":"GSK-104106","Description":"Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine, Sponsor: GSK"},{"PostingID":4592,"Title":"GSK-103494","Description":"Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine, Sponsor: GSK"},{"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, Sponsor: GSK"},{"PostingID":465,"Title":"GSK-105554","Description":"Phase IIIa randomized, controlled study to assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate vaccine, when administered as a 3-dose primary immunization course before 6 months of age, Sponsor: GSK"},{"PostingID":466,"Title":"GSK-106623","Description":"Multicentre immune memory study in healthy children following a 3 dose primary vaccination with Prevenar or GSK Biologicals' pneumococcal conjugate vaccine via the administration of a single booster dose of Pneumovax 23, Sponsor: GSK"},{"PostingID":467,"Title":"GSK-107058","Description":"Evaluate immunogenicity, safety & reactogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine given as catch-up immunization in children older than 7 mo of age or as 3-dose primary immunization in children before 6 mo of age, Sponsor: GSK"},{"PostingID":468,"Title":"GSK-107706","Description":"To assess safety, reactogenicity & immunogenicity of a booster dose of pneumococcal conjugate vaccine, co-admin with GSK Biologicals' MMRV vaccine in children (2nd yr of life) primed with the pneumococcal conjugate vaccine in study 105553., Sponsor: GSK"},{"PostingID":469,"Title":"GSK-107737","Description":"Study to assess the safety and immunogenicity of GSK Biologicals 10-valent pneumococcal conjugate vaccine when Co-administered with DTPa-HBV-IPV/Hib (Infanrix-Hexa) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life., Sponsor: GSK"},{"PostingID":470,"Title":"GSK-110142","Description":"Non-inferiority of co-administration of GSK Biologicals'pneumococcal conjugate vaccine GSK1024850A with DTPa-IPV-Hib versus co-administration with DTPa-HBV-IPV/Hib., Sponsor: GSK"},{"PostingID":471,"Title":"GSK-111736","Description":"Vaccination course in children primed and boosted with pneumococcal vaccine GSK 1024850A and in age-matched unprimed children, Sponsor: GSK"},{"PostingID":472,"Title":"GSK-112807","Description":"Vaccination with the pneumococcal vaccine GSK 1024850A or Prevenar™ at approximately 4 years of age in children primed with 3 doses of GSK 1024850A vaccine or Prevenar™ and boosted with 23-valent pneumococcal plain polysaccharide vaccine, Sponsor: GSK"},{"PostingID":473,"Title":"GSK-113151","Description":"Primary vaccination course with the pneumococcal vaccine GSK 1024850A, in healthy infants in Vietnam when co-administered with GSK Biologicals' Infanrix hexa™ (DTPa-HBV-IPV/Hib) vaccine, Sponsor: GSK"},{"PostingID":509,"Title":"GSK-107017","Description":"Multicentre study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant administration of GSK Biologicals' 10-valent pneumococcal conjugate, Infanrix hexa and Rotarix vaccines, Sponsor: GSK"},{"PostingID":510,"Title":"GSK-444563/023","Description":"A placebo-controlled, multi-country & multi-center study to assess the efficacy, safety & immunogenicity of 2 doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine in healthy infants, Sponsor: GSK"}]