Research archive

A study to investigate the safety, efficacy and immunogenicity of mRNA-1010 candidate influenza vaccine compared with a licensed influenza vaccine in adults ≥50 years of age.

A phase 3/3b, randomized, observer-blind, multicenter clinical study to evaluate the efficacy, safety and immunogenicity of an MF59-adjuvanted inactivated influenza vaccine compared to a non-adjuvanted influenza vaccine in adults ≥65 years of age. Season II.

A Phase 3, randomized, controlled, partially blind, immuno-bridging study to evaluate immunogenicity, reactogenicity, safety and the occurrence of RSVassociated respiratory tract illness after administration of a single dose of GSK’s RSVPreF3 OA investigational vaccine in adults aged 60 years and older.

An extension and crossover vaccination study on the immune response and safety of a vaccine against respiratory syncytial virus given to adults 60 years of age and above who participated in RSV OA=ADJ-006 study.

Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of an intranasal Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL).

A Phase 3, randomized, double-blind study to evaluate the safety, tolerability, and immunogenicity of V116 in children and adolescents with increased risk
of pneumococcal disease.

A parallel-group, prevention, phase 3, modified double-blind, 2-arm, study to investigate the immunogenicity and describe the safety of a quadrivalent meningococcal conjugate vaccine (MenACYW conjugate vaccine) compared with Nimenrix® when administered in a 1+1 schedule in healthy infants and toddlers at 6 and 12 months of age.

An observational cross-sectional descriptive carriage study in children aged 15 to 35 months attending day care centers. The aim of the study is to describe the current prevalence of nasopharyngeal pneumococcal carriage and serotype distribution in young children in Finland.

A Phase 2, Randomized, Open-Label Trial to Describe the Safety and immunogenicity of a monovalent pneumococcal conjugate candidate administered as a 2-dose series in healthy toddlers 11 through 15 months of age who previously received the PCV10 primary series.

A phase 3/3b, randomized, observer-blind, multicenter clinical study to evaluate the efficacy, safety and immunogenicity of an MF59-adjuvanted quadrivalent subunit inactivated influenza vaccine compared to a quadrivalent influenza vaccine in adults ≥65 years of age. Season I.

An open-label multi-center enabling study to evaluate influenza-like illnesses and severe influenza disease in adults aged 65 years and above.

A multi-center, multi-national, prospective surveillance study of Respiratory syncytial virus disease in infants and toddlers 6 to < 22 months of age.

A non-randomized, open label, multi-country, cohort study to describe the safety of study participants who received RSVPreF3 maternal vaccination (any dose) from previous RSV MAT studies (RSV MAT-001, MAT-004, MAT-010, MAT-011, MAT-009, MAT-012 and MAT-039) during any pregnancy conceived post vaccination.

A phase 2 randomized, double-blind, multicenter study to evaluate the safety and immunogenicity of three different potency levels of V181 dengue quadrivalent vaccine rDENVΔ30 (live, attenuated) in healthy adults.

A phase 3 multicenter, randomized, partially blinded, palivizumab controlled study to evaluate the safety, efficacy and pharmacokinetics of MK-1654 in infants and children at increased risk for severe RSV disease.

A phase 3 randomized, double-blind, active comparator-controlled, lot- to-lot consistency study to evaluate the safety, tolerability and immunogenicity of V116 in adults 18 to 49 years of age.

A Phase IIIb, open-label, multi-center study to evaluate the immunogenicity and safety of a booster dose and describe the immune persistence of the priming dose of MenACYW conjugate vaccine in children in the European Union who had been vaccinated 5 years earlier as toddlers with MenACYW conjugate vaccine as part of the MET51 study.

A phase III, open-label, randomized, controlled, multi-country study to evaluate the immune response, safety and reactogenicity of an RSVPreF3 OA investigational vaccine when co-administered with FLU aQIV (inactivated influenza vaccine – adjuvanted) in adults aged 65 years and above.

A Phase 3 multicenter, placebo-controlled, randomized, observer-blinded trial to evaluate the efficacy, safety, tolerability, immunogenicity and lot consistency of a 6-valent Ospa-based Lyme disease vaccine in healthy participants ≥5 years of age.

A randomized, observer-blind, placebo-controlled, multicenter, phase 3 study to assess the efficacy, safety, and immunogenicity of a plant-derived quadrivalent VLP. A Phase 2b randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of MEDI8897, a monoclonal antibody with an extended half-life against respiratory syncytial virus, in healthy preterm infants.

Phase IV, randomized, open-label, controlled, two-arm, multi-center study in Italy and Finland in 396 infants who will receive a 2+1 dose regimen (at 3, 5, and 12 months of age [MoA]) with hexavalent DTaP-IPV-HB-PRP~T combined vaccine administered concomitantly with 13-valent pneumococcal polysaccharide conjugate (PCV13) vaccine, and concomitantly (at 3, 5, and 12 MoA) or sequentially (at 4, 6, and 13 MoA) with meningococcal group B (4CMenB) vaccine.

A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age.

A Phase 2/3, randomized, observer-blind, placebo-controlled study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA vaccine targeting respiratory syncytial sirus (RSV), in adults ≥ 60 Years of Age.

A Phase 3 study to evaluate the efficacy, immunogenicity, and safety of respiratory syncytial virus (RSV) prefusion F subunit vaccine in adults 60 years of age and older.

A phase 3B, open-label study to evaluate safety and immunogenicity of NIMENRIX® in healthy infants, given at 3 and 12 months of age.

A Phase III, randomized, double-blind, placebo-controlled multi-country study to demonstrate efficacy of a single dose of RSV MAT (RSVPreF3) vaccine (GSK3888550A), administered IM to healthy pregnant women 18 to 45 years of age, for prevention of RSV LRTI in their infants up to 6 months of age.

phase 3, randomized, open-label, multi-country study to evaluate the immunogenicity, safety, reactogenicity and persistence of a single dose of the RSVPreF3 OA investigational vaccine and different revaccination schedules in adults aged 60 years and above.

A phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of MEDI8897, a monoclonal antibody with an extended half-life against respiratory syncytial virus, in healthy late preterm and term infants (MELODY).

A Phase 3, observer-blind, randomized, multicountry study to evaluate the lot-to-lot consistency of GSK’s investigational RSV maternal vaccine and the immune response, safety and reactogenicity of RSV maternal vaccine when co-administered with GSK’s quadrivalent influenza D-QIV vaccine in healthy non-pregnant women 18-49 years of age.

A Phase II, randomised, partially blinded study to assess the safety, tolerability and immunogenicity of meningococcal combined ABCWY vaccine when administered to healthy infants.

A Phase 3, randomized, placebo-controlled, observer-blind, multi-country study to demonstrate the efficacy of a single dose of GSK’s RSVPreF3 OA investigational vaccine in adults aged 60 years and above.

A phase 1, open-label dose finding study to evaluate safety, tolerability, and immunogenicity and phase 2/3 placebo controlled, observer-blinded safety, tolarability, and immunogenicity study of a SARS-COV-2 RNA vaccine candidate against COVID-19 in healthy children under 12 years of age.

A controlled study of immunogenicity and safety of the investigational vYF candidate vaccine in comparison to Stamaril in adults aged 18–59 years.

A phase 3b, open-label, multi-country, multi-centre, long-term follow-up study of ZOSTER-049 (follow- up of ZOSTER-006/022 studies) to assess the prophylactic efficacy, safety and persistence of immune response of a Herpes Zoster subunit vaccine and assessment of persistence of immune response and safety of 1 or 2 additional doses administered in ZOSTER-049 in 2 subgroups of older adults.

A phase 3 randomized, double-blind, placebo-controlled efficacy study of an Ad26.RSV.preF-based vaccine in the prevention of lower respiratory Tract disease caused by RSV in adults aged 60 years and older.

A hepatitis B vaccine challenge study to demonstrate the durability of protection against hepatitis B virus infection in healthy children vaccinated approximately 9 years previously with a 2- or 3-dose infant series and toddler dose of vaxelis®.

A phase III, randomized, controlled, observer-blind study to demonstrate effectiveness, immunogenicity and safety of GSK’s meningococcal Group B and combined ABCWY vaccines when administered to healthy adolescents and young adults.

A phase 2b/3 double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of MK-1654 in healthy pre-term and full-term infants.

A Phase 2/3 randomized, double-blind, palivizumab-controlled study to evaluate the safety of MEDI8897, a monoclonal antibody with an extended half-life against respiratory syncytial virus, in high-risk children (MEDLEY).

A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine given as a series of 2infant doses and 1 toddler dose in healthy infants.

Phase III randomized double- or observer-blinded placebo-controlled trial to evaluate the efficacy and safety of a respiratory syncytial virus (RSV) prefusion F subunit vaccine in infants born to women vaccinated during pregnancy.

A phase 3, multicenter, randomized, double-blind, active-comparatorcontrolled study to evaluate the safety, tolerability and immunogenicity of a 3-dose regimen of V114 in healthy infants (PNEU-PED-EU-2). A Phase 3 randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of MEDI8897, a monoclonal antibody with an extended half-life against respiratory syncytial virus, in healthy late preterm and term infants (MELODY).

Phase III modified double-blind ranomized active-controlled multi-center trial to compare the immunogenicity adn describe the safety of a single dose of MenACWY conjugate vaccine to single dose of licensed NeisVac-C® or Nimenrix® in toddlers in Europe.

A Randomized, placebo-controlled, double-blind, phase 1/2a study to evaluate the safety, reactogenicity and immunogenicity of Ad26.RSV.preF in RSV-seronegative and RSV-seropositive toddlers 12 to 24 months of age.

A phase 3, multicenter, randomized, double-blind, active-comparator controlled study to evaluate the safety, tolerability and Immunogenicity of a 3-dose regimen of V114 in Healthy Infants (PNEU-PED-EU-2).

A Phase 3, multicenter, randomized, double-blind, active comparator-controlled, lot-to-lot consistency study to evaluate the safety, tolerability, and immunogenicity of V114 in healthy adults 50 years of age or older (PNEU-TRUE).

A Phase 3, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of catch-up vaccination regimens of V114 in healthy infants, children, and adolescents (PNEU- PLAN).

A phase 3 multicenter, randomized, double-blind, active comparatorcontrolled study to evaluate the safety and tolerability of v114 in healthy infants (pneu-x).

Immunogenicity and safety study of an investigational quadrivalent meningococcal conjugate vaccine when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in europe.

Phase IV, open-label, multi-center study, in children vaccinated with two infant primary series doses at 3 and 5 months of age and a toddler booster at 11-12 months of age with Hexyon® or Infanrix hexa® in Study A3L38 in Finland, without Hepatitis B vaccination at birth.

Double-blind, randomized, placebo-controlled phase 2b, multi-center study to evaluate the safety, tolerability, efficacy and immunogenicity of a 2-dose and a 3-dose regimen of V160 (Cytomegalovirus [CMV] Vaccine) in healthy seronegative women 16 to 35 years of age.

A Phase 2b randomized, controlled, observer-blind multi-center study to evaluate safety and immunogenicity of different formulations of GSK Biologicals’ Meningococcal ACWY conjugate vaccine (GSK3536820A and Menveo) administered to healthy adolecents and young adults 10 to 40 years of age.

A Phase 1/2, randomized, observer-blind, controlled, multi-center study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals’ RSV investigational vaccine based on viral proteins encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A) in infants.

A Randomized, observer-blind, active comparator-controlled, multicenter, phase 3 study to assess the efficacy, safety, and immunogenicity of a plant-derived quadrivalent VLP influenza vaccine in adults 65 years of age and older.

A Phase III, open-label, multi-center study to describe the immune persistence of the priming dose and describe the immunogenicity and safety of a booster dose of MenACYW conjugate vaccine in children in Finland who had been vaccinated 3 years earlier as toddlers with either MenACYW conjugate vaccine or Nimenrix® as part of the MET54 study.

A double-blind randomized controlled trial to assess the lot-to-lot consistency of Sci-B-Vac™ in adults.

A Phase 3 double-blind randomized controlled trial to compare the immunogenicity and safety of a three-dose regimen of Sci-B-Vac™ to a three-dose regimen of Engerix-B® in adults.

Satunnaistettu, kaksoissokkoutettu, vaiheen 1/2a tutkimus, jossa arvioidaan Ad26.RSV.preF-valmisteen turvallisuutta, siedettävyyttä ja immunogeenisuutta 18–50-vuotiailla aikuisilla ja RSV-seropositiivisilla 12–24 kuukauden ikäisillä lapsilla.

A Phase III, randomized, active-controlled, observer-blinded study to assess the immunogenicity, safety and tolerability of bivalent rLP2086 when administered as a 2-dose regimen and the first-in-human study to describe the immunogenicity, safety and tolerability of a bivalent rLP2086 containing pentavalent vaccine (MenABCWY) in healthy subjects ≥ 10 to <26 years of age.

A phase III/IV, stratified, randomized, observer blind, multicenter clinical study to evaluate the efficacy, safety and immunogenicity of a cell-based quadrivalent subunit influenza virus vaccine compared to non-influenza comparator vaccine in subjects ≥ 2 years to <18 years of age.

A randomized, observer-blind, placebo-controlled, multicenter, phase 3 study to assess the efficacy, safety, and immunogenicity of a plant-derived quadrivalent vlp influenza vaccine in adults 18-64 years of age.

Phase IV, randomized, blind observer, controlled, multi-center, study to assess immunogenicity and safety of quadrivalent influenza vaccine (VaxigripTetra®) in Pregnant Women.

A phase II, double-blind, randomized, multicenter trial to evaluate the safety, tolerability, and immunogenicity of V114 compared to Prevenar 13™ in healthy infants.

A phase 3, placebo-controlled, randomized, observer-blinded study to evaluate the efficasy, safety and tolerability of a Clostridium difficile -vaccine in adults 50 years of age and older.

An open-label phase III clinical trial to study the immunogenicity and tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in adult women (27- to 45-year-olds) compared to young adult women (16 to 26 year olds).

A phase III b open-label, multi-country, multi-centre, long-term follow-up study (zoe-ltfu) of studies 110390 and 113077 (zoster-006/022) to assess the prophylactic efficacy, safety, and immunogenicitypersistence of gsk biologicals’ herpes zoster subunit (hz/su) vaccine and assessment of 1 or 2 additionaldoses on a 0 or 0, 2-month schedule in two subgroups of older adults.