Sex-differences in immunogenicity, reactogenicity and efficacy in response to vaccines in infants and young children

Sex-differences in immunogenicity, reactogenicity and efficacy in response to vaccines in infants and young children

This work is funded through a National Institute of Health Research Doctoral Research Fellowship (DRF-2015-08-048)

AJP has previously conducted studies on behalf of Oxford University funded by vaccine manufacturers, but no longer undertakes 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.
Data from 170 randomised controlled trials of vaccines will be combined (meta-analysed) and differences between boys and girls assessed. 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.

If clinically relevant sex-differences in responses to vaccines exist, then it may be possible to tailor vaccine doses to specific sexes. In addition, if substantial differences between the sexes exist, licensing of future new vaccines may require sufficient immunogenicity be demonstrated in the sex with the lower responses. 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.

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Medicine: Meningococcal Serogroups A, C, W-135 and Y Vaccine, Condition: Infections, Meningococcal, Phase: 3, Clinical Study ID: 104730, Sponsor: GSK" },{ "PostingID": 2206, "Title": "GSK-104756", "Description": "Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007

Medicine: Meningococcal Serogroups A, C, W-135 and Y Vaccine, Condition: Infections, Meningococcal, Phase: 3, Clinical Study ID: 104756, Sponsor: GSK" },{ "PostingID": 2207, "Title": "GSK-105239", "Description": "Booster Vaccination Study to Assess Immunogenicity & Safety of a Dose of GSK Biologicals' Mencevax™ ACWY & 1/5th of a Dose of Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study

Medicine: Meningococcal Serogroups A, C, W-135 and Y Vaccine, Condition: Infections, Meningococcal, Phase: 3, Clinical Study ID: 105239, Sponsor: GSK" },{ "PostingID": 2208, "Title": "GSK-105245", "Description": "Booster Vaccination Study to Assess Immunogenicity & Safety of a Dose of GSK Biologicals' Mencevax™ ACWY & 1/5th of a Dose of Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study

Medicine: Meningococcal Serogroups A, C, W-135 and Y Vaccine, Condition: Infections, Meningococcal, Phase: 3, Clinical Study ID: 105245, Sponsor: GSK" },{ "PostingID": 2213, "Title": "GSK-111345", "Description": "Long-term follow-up study to assess antibody persistence in children previously vaccinated with four doses of pneumococcal conjugate vaccine in primary vaccination study (105553) and booster vaccination study (107046)

Medicine: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), Condition: Infections, Streptococcal, Phase: 3, Clinical Study ID: 111345, Sponsor: GSK" },{ "PostingID": 2214, "Title": "GSK-109705", "Description": "Study of two formulations of GSK Biologicals' varicella vaccine given as a 2-dose course in the second year of life

Medicine: Varicella Vaccine, Condition: Varicella, Phase: 2, Clinical Study ID: 109705, 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®.

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 3, Clinical Study ID: 208136/039, 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

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 3, Clinical Study ID: 208136/040, 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

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 3, Clinical Study ID: 208136/041, Sponsor: GSK" },{ "PostingID": 2762, "Title": "GSK-108760", "Description": "Immunogenicity & safety study of GSK Biologicals' 208136 vaccine formulated with new measles and rubella working seeds

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 2, Clinical Study ID: 108760, 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

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 3, Clinical Study ID: 208136/038, 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

Medicine: Hepatitis A Vaccine, Inactivated, Condition: Hepatitis A, Phase: 3, Clinical Study ID: 208109/231, Sponsor: GSK" },{ "PostingID": 2806, "Title": "GSK-112036", "Description": "Persistence of antibodies after GSK Biologicals' meningococcal vaccine GSK134612 in toddlers

Medicine: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine, Condition: Infections, Meningococcal, Phase: 3, Clinical Study ID: 112036, 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

Medicine: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine, Condition: Infections, Meningococcal, Phase: 2, Clinical Study ID: 112021, 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

Medicine: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), Condition: Infections, Streptococcal, Phase: 3, Clinical Study ID: 109563, 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

Medicine: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), Condition: Infections, Streptococcal, Phase: 3, Clinical Study ID: 111346, 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.

Medicine: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), Condition: Infections, Streptococcal, Phase: 3, Clinical Study ID: 111347, 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 children

Medicine: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), Condition: Infections, Streptococcal, Phase: 3, Clinical Study ID: 112640, Sponsor: GSK" },{ "PostingID": 2813, "Title": "GSK-112909", "Description": "Booster vaccination with pneumococcal vaccine GSK1024850A in primed children and catch-up vaccination in unprimed children

Medicine: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), Condition: Infections, Streptococcal, Phase: 3, Clinical Study ID: 112909, Sponsor: GSK" },{ "PostingID": 2830, "Title": "GSK-100388", "Description": "Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (Varilrix™) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine

Medicine: Varicella Vaccine, Condition: Varicella, Phase: 3, Clinical Study ID: 100388, 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

Medicine: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine, Condition: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis, Phase: 3, Clinical Study ID: 759346/007, Sponsor: GSK" },{ "PostingID": 3308, "Title": "GSK-444563/007 (rota-007)", "Description": "Study to assess efficacy, immunogenicity, reactogenicity and safety of two doses of GSK Biologicals' oral live attenuated human rotavirus vaccine at different viral concentrations in healthy infants previously uninfected with human rotavirus and approximately 3 months of age

Medicine: Hepatitis B Vaccine, Recombinant, Condition: Hepatitis B, Phase: 2, Clinical Study ID: 444563/007 (rota-007), 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.

Medicine: Measles, Mumps, Rubella Vaccine, Condition: Measles; Mumps; Rubella, Phase: 2, Clinical Study ID: 104420, 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

Medicine: Measles, Mumps, Rubella Vaccine, Condition: Measles; Mumps; Rubella, Phase: 3, Clinical Study ID: 209762/136 (MeMuRu-136), 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.

Medicine: Measles, Mumps, Rubella Vaccine, Condition: Measles; Mumps; Rubella, Phase: 4, Clinical Study ID: 209762/147 (MeMuRu-147), 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 Biologicals' measles-mumps-rubella vaccine and GSK Biologicals' varicella vaccine containing human serum albumin with the modified formulations which do not contain HSA

Medicine: Measles, Mumps, Rubella Vaccine, Condition: Measles; Mumps; Rubella, Phase: 2, Clinical Study ID: 209762/148, Sponsor: GSK" },{ "PostingID": 3328, "Title": "GSK-209762/149 (MeMuRu-149)", "Description": "Phase IV, single-blind, randomised, multicenter study to evaluate immediate post-vaccination pain, reactogenicity and tolerance of GSK Biologicals' Measles-Mumps-Rubella vaccine (Priorix) administered as a second dose compared to Aventis-Pasteur-MSDs Measles-Mumps-Rubella vaccine (ROR Vax)

Medicine: Measles, Mumps, Rubella Vaccine, Condition: Measles; Mumps; Rubella, Phase: 4, Clinical Study ID: 209762/149 (MeMuRu-149), Sponsor: GSK" },{ "PostingID": 3329, "Title": "GSK-209762/150", "Description": "Double blind, randomized sequential study to compare immunogenicity and reactogenicity of current formulations of GSK Biologicals' measles-mumps-rubella vaccine and GSK Biologicals' varicella vaccine to investigational vaccination regimens

Medicine: Measles, Mumps, Rubella Vaccine, Condition: Measles; Mumps; Rubella, Phase: 3, Clinical Study ID: 209762/150, Sponsor: GSK" },{ "PostingID": 3330, "Title": "GSK-209762/151", "Description": "Phase II study to evaluate immunogenicity, reactogenicity and safety of GSK Biologicals' investigational vaccination regimen compared to the currently licensed GSK Biologicals' Priorix™ and Merck and Co.'s M-M-R®II vaccines when administered as a primary vaccination to healthy children aged 12-24 months

Medicine: Measles, Mumps, Rubella Vaccine, Condition: Measles; Mumps; Rubella, Phase: 2, Clinical Study ID: 209762/151, 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.

Medicine: Meningococcal Serogroups A, C, W-135 and Y Vaccine, Condition: Infections, Meningococcal, Phase: 2, Clinical Study ID: 404286/006, Sponsor: GSK" },{ "PostingID": 3332, "Title": "GSK-675187/001", "Description": "A Phase II, open, randomized, controlled study to evaluate the reactogenicity and safety of an investigational vaccination regimen in healthy toddlers aged 24-30 months.

Medicine: Meningococcal Serogroups A, C, W-135 and Y Vaccine, Condition: Infections, Meningococcal, Phase: 2, Clinical Study ID: 675187/001, 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

Medicine: Meningococcal Vaccine, Condition: Infections, Meningococcal, Phase: 2, Clinical Study ID: 711202/001, 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

Medicine: Meningococcal Vaccine, Condition: Infections, Meningococcal, Phase: 2, Clinical Study ID: 711202/008, 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™

Medicine: Meningococcal Vaccine, Condition: Infections, Meningococcal, Phase: 2, Clinical Study ID: 811936/001 (Hib-MenC-TT-001), Sponsor: GSK" },{ "PostingID": 3345, "Title": "GSK-444563/002 (rota-002)", "Description": "A phase I, double-blind, randomized, placebo-controlled study of the safety and reactogenicity of GSK Biologicals' live attenuated human rotavirus vaccine at 2 different virus concentrations in healthy seropositive children between 1 and 3 years of age, when given as a single oral administration

Medicine: Rotavirus Vaccine, Condition: Infections, Rotavirus, Phase: 1, Clinical Study ID: 444563/002 (rota-002), 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.

Medicine: Rotavirus Vaccine, Condition: Infections, Rotavirus, Phase: 2, Clinical Study ID: 444563/003 (rota-003), 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.

Medicine: Rotavirus Vaccine, Condition: Infections, Rotavirus, Phase: 2, Clinical Study ID: 444563/004, Sponsor: GSK" },{ "PostingID": 3348, "Title": "GSK-444563/005 (rota-005)", "Description": "Phase II, double-blind, randomized, placebo-controlled study of 2 doses of GSK Biologicals' 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

Medicine: Rotavirus Vaccine, Condition: Infections, Rotavirus, Phase: 2, Clinical Study ID: 444563/005 (rota-005), 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.

Medicine: Rotavirus Vaccine, Condition: Infections, Rotavirus, Phase: 2, Clinical Study ID: 444563/006, Sponsor: GSK" },{ "PostingID": 3350, "Title": "GSK-444563/014 (Rota-014)", "Description": "Study of safety, reactogenicity and immunogenicity of two doses of GSK Biologicals' 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

Medicine: Rotavirus Vaccine, Condition: Infections, Rotavirus, Phase: 2, Clinical Study ID: 444563/014 (Rota-014), 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

Medicine: Rotavirus Vaccine, Condition: Infections, Rotavirus, Phase: 2, Clinical Study ID: 444563/020, 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

Medicine: Rotavirus Vaccine, Condition: Infections, Rotavirus, Phase: 2, Clinical Study ID: 444563/021, 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

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 3, Clinical Study ID: 104690, Sponsor: GSK" },{ "PostingID": 3642, "Title": "GSK-208136/006 (MeMuRu-OKA-006)", "Description": "A phase II, open, randomized, multicentre study evaluating in healthy children 12-24 months of age, the safety and immunogenicity of GlaxoSmithKline Biologicals' combined Measles-Mumps-Rubella-Varicella vaccine (MeMuRu-OKA), compared to GlaxoSmithKline Biologicals' Varicella vaccine

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 2, Clinical Study ID: 208136/006 (MeMuRu-OKA-006), Sponsor: GSK" },{ "PostingID": 3643, "Title": "GSK-208136/013 (MeMuRu-OKA-013)", "Description": "Study to assess immunogenicity and safety of one dose of GSK Biologicals' live attenuated MMRV vaccine, co-administered with a booster dose of the GSK Biologicals' combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type b conjugate vaccine

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 3, Clinical Study ID: 208136/013 (MeMuRu-OKA-013), 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

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 2, Clinical Study ID: 208136/017 (MeMuRu-OKA-017), Sponsor: GSK" },{ "PostingID": 3645, "Title": "GSK-208136/018 (MeMuRu-OKA-018)", "Description": "Study to evaluate immunogenicity and safety of GSK Biologicals' MeMuRu-OKA vaccine compared to concomitant administrations of GSK Biologicals' Priorix™ and Varilrix™ vaccines

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 3, Clinical Study ID: 208136/018 (MeMuRu-OKA-018), Sponsor: GSK" },{ "PostingID": 3646, "Title": "GSK-208136/019 (MeMuRu-OKA-019)", "Description": "Study to evaluate immunogenicity and safety of one dose of GSK Biologicals' measles-mumps-rubella-varicella vaccine given to healthy children previously primed with one dose of measles-mumps-rubella vaccine

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 3, Clinical Study ID: 208136/019 (MeMuRu-OKA-019), 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.

Medicine: Measles, Mumps, Rubella Vaccine, Condition: Measles; Mumps; R" },{ "PostingID": 3670, "Title": "GSK-RTX114351", "Description": "Immunogenicity, reactogenicity and safety study of GlaxoSmithKline (GSK) Biologicals' oral live attenuated human rotavirus (HRV) vaccine in healthy Taiwanese infants who received hepatitis B immunoglobulin after birth.

Medicine: Rotavirus Vaccine, Condition: Infections, Rotavirus, Phase: 4, Clinical Study ID: RTX114351, Sponsor: GSK" },{ "PostingID": 3673, "Title": "GSK-208133/178", "Description": "A phase III, open-label, multi-centre study to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' live attenuated varicella vaccine (Varilrix™), given as a primary vaccination at 4.5 months and 6.5 months post-transplantation, in autologous stem cell/ bone marrow transplant recipients aged 18 years and older.

Medicine: Varicella Vaccine, Condition: Varicella, Phase: 2, Clinical Study ID: 208133/178, Sponsor: GSK" },{ "PostingID": 3707, "Title": "GSK-208136/007 (MeMuRu-OKA-007)", "Description": "Study to assess consistency of 3 production lots of GSK Biologicals' combined measles-mumps-rubella-varicella vaccine in terms of immunogenicity and safety, compared to administration of GSK Biologicals' measles-mumps-rubella vaccine and varicella vaccine in healthy children in their second year of life

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 3, Clinical Study ID: 208136/007 (MeMuRu-OKA-007), Sponsor: GSK" },{ "PostingID": 3708, "Title": "GSK-208136/014 (MeMuRu-OKA-014)", "Description": "Study to evaluate immunogenicity and safety of one dose of GSK Biologicals' 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

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 3, Clinical Study ID: 208136/014 (MeMuRu-OKA-014), Sponsor: GSK" },{ "PostingID": 3709, "Title": "GSK-208136/016 (MeMuRu-OKA-016)", "Description": "Study to assess immunogenicity and safety of two lots of GSK Biologicals' live attenuated measles-mumps-rubella-varicella vaccine, at two different titres, given as a single injection to healthy children with Biologicals' measles-mumps-rubella vaccine as control group

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 3, Clinical Study ID: 208136/016 (MeMuRu-OKA-016), Sponsor: GSK" },{ "PostingID": 3710, "Title": "GSK-208136/022 (MeMuRu-OKA-022)", "Description": "Study to evaluate immunogenicity and safety of one dose of GSK Biologicals' combined measles-mumps-rubella-varicella vaccine compared to concomitant administrations of GSK Biologicals' measles-mumps-rubella vaccine and varicella vaccine

Medicine: Combined Measles, Mumps, Rubella, Varicella Vaccine, Condition: Measles; Mumps; Rubella; Varicella, Phase: 3, Clinical Study ID: 208136/022 (MeMuRu-OKA-022), 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

Medicine: Meningococcal Serogroup B Vaccine, Condition: Infections, Meningococcal, Phase: 3, Clinical Study ID: V72P13, 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

Medicine: Meningococcal Serogroup B Vaccine, Condition: Infections, Meningococcal, Phase: 3, Clinical Study ID: V72P13E1, 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.

Medicine: Meningococcal Serogroup B Vaccine, Condition: Infections, Meningococcal, Phase: 2, Clinical Study ID: V72P12, Sponsor: GSK" },{ "PostingID": 3729, "Title": "GSK-347414/035", "Description": "A phase-III, open, controlled, follow-up clinical trial, with Prevenar as control, to assess the safety of GSK Biologicals' investigational vaccination regimen administered with DTPa-HBV-IPV/Hib to healthy children, previously vaccinated in infancy with the investigational vaccination regimen in a primary study in the Netherlands

Medicine: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), Condition: Infections, Streptococcal, Phase: 3, Clinical Study ID: 347414/035, Sponsor: GSK" }]

This proposal was superseded by Research Proposal ID 1629. Please reference this link: https://clinicalstudydatarequest.com/Posting.aspx?ID=14380