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Vaccines Pipeline
At GSK, our pipeline is focused on unlocking the science of the immune system, human genetics, and advanced technologies to develop vaccines and specialty medicines.
Our products in development progress through three stages: phase I, phase II, and phase III/registrational. Each of these phases allows us to assess the safety and efficacy of our investigational products to eventually provide data to support applications for regulatory approval.
View our ongoing, innovative research with vaccines.
Phase 1 Overview
This is the first time a new vaccine or medicine is tested in humans; it will usually be given to a small group of healthy volunteers, or it may be tested on patients who have the condition it is designed to treat. The principal objectives in phase I are to ensure the new vaccine or medicine presents no major safety issues, and to see clear evidence that it can reach the targeted body area and remain there long enough to deliver its potential benefits. We also seek to gain preliminary evidence the vaccine or medicine can offer therapeutic value or help to prevent the disease in question.
DISEASE STATES
MenABCWY 2nd Generation Vaccine Candidate GSK4023393*
Safety, effectiveness, and immunogenicity in healthy adolescents and adults 10 to 50 years of age
Chronic hepatitis B targeted immunotherapy GSK3528869*
Safety, efficacy, and immunogenicity study in adults 18-65 years of age with chronic hepatitis B
S. pneumoniae vaccine candidate GSK5101956*
Safety and tolerability in adults 18-64 years of age (Stage 1) and adults 65-85 years of age (Stage 2)
No studies exist in this phase
Klebsiella pneumoniae Tetravalent Bioconjugate Vaccine Candidate GSK4429016*
Multi-step study to assess safety and immunogenicity in healthy adults 18 to 40 and 55 to 70 years of age
Cytomegalovirus (CMV) vaccine candidate GSK3993129*
Safety, reactogenicity, and immunogenicity in healthy adults 18 to 50 years of age
mRNA COVID-19 2nd Gen vaccine candidate GSK4396687*
Safety and immunogenicity against SARS-CoV-2 in seropositive adults 18 years of age and older
mRNA Influenza vaccine candidate GSK4382276*
Safety and immunogenicity in healthy adults 18-55 and 65 years and older
Reactogenicity, safety, and immunogenicity in healthy adults aged 18-50 years (Phase 1) and 18-85 years of age (Phase 2)
Safety, reactogenicity, and immunogenicity in healthy adults 18-45 years and 60-80 years of age
iNTS (Invasive non-typhoidal salmonella prophylaxis) vaccine candidate GSK4077164*
Safety and immune response in adults 18-50 years of age
Therapeutic herpes simplex virus (HSV) vaccine candidate GSK3943104*
Safety and immunogenicity in healthy adults 18-40 years of age (Step 1) and 18-60 years of age with recurrent Herpes Simplex Virus-2 (Step2)
Gonorrhea Vaccine Candidate (GSK4348413)
Safety and efficacy in adults 18 to 50 years of age
Human Papillomavirus (HPV9-AS04) Vaccine Candidate GSK4106647*
Safety and immunogenicity in Women 16 to 26 years of age
Salmonella Typhoid/Paratyphoid A Vaccine Candidate GSK3536867*
Safety in adults 18 to 50 years of age
Phase 2 Overview
At this stage, the potential vaccine or medicine is usually tested to understand the effectiveness against the disease it is designed to treat and appropriate dosing levels. The performance of the medicine in one group of patients may be compared against another group of patients receiving a placebo (a treatment that looks the same as the potential new medicine but has no active ingredients) or an existing treatment.
DISEASE STATES
MenABCWY 2nd Generation Vaccine Candidate GSK4023393*
Safety, effectiveness, and immunogenicity in healthy adolescents and adults 10 to 50 years of age
Safety, tolerability, and immune response in healthy infants 2 months of age at enrollment
Chronic hepatitis B targeted immunotherapy GSK3528869*
Safety, efficacy, and immunogenicity study in adults 18-65 years of age with chronic hepatitis B
Therapeutic hepatitis B (CHBV ASO Combo) vaccine candidate GSK4388067*
Safety and immunogenicity in adults 18-65 years of age with chronic hepatitis B
S. pneumoniae vaccine candidate GSK5101956*
Safety and tolerability in adults 18-64 years of age (Stage 1) and adults 65-85 years of age (Stage 2)
S. pneumoniae vaccine candidate GSK5101955*
Safety and immunogenicity in healthy infants 2 months of age
Shigella vaccine candidate GSK3536852*
Assess efficacy, safety, and immunogenicity in healthy
adults 18 to 50 years of age
Klebsiella pneumoniae Tetravalent Bioconjugate Vaccine Candidate GSK4429016*
Multi-step study to assess safety and immunogenicity in healthy adults 18 to 40 and 55 to 70 years of age
Cytomegalovirus (CMV) vaccine candidate GSK3993129*
Safety, reactogenicity, and immunogenicity in healthy adults 18 to 50 years of age
mRNA COVID-19 2nd Gen vaccine candidate GSK4396687*
Safety and immune response in healthy adults
Varicella New Strain vaccine candidate GSK4178116*
Immune response and safety in healthy children 12 to 15 months of age
mRNA Influenza vaccine candidate GSK4382276*
Reactogenicity, safety, and immunogenicity in healthy adults aged 18-50 years (Phase 1) and 18-85 years of age (Phase 2)
iNTS (Invasive non-typhoidal salmonella prophylaxis) vaccine candidate GSK4077164*
Safety and immune response in adults 18-50 years of age
Therapeutic herpes simplex virus (HSV) vaccine candidate GSK3943104*
Safety and immunogenicity in healthy adults 18-40 years of age (Step 1) and 18-60 years of age with recurrent Herpes Simplex Virus-2 (Step2)
Gonorrhea Vaccine Candidate (GSK4348413)
Safety and efficacy in adults 18 to 50 years of age
Human Papillomavirus (HPV9-AS04) Vaccine Candidate GSK4106647*
Safety and immunogenicity in Women 16 to 26 years of age
Measles, Mumps, Rubella, Varicella New Strain Vaccine Candidate GSK4406371
Immunogenicity and safety in children 4 to 6 years of age
Phase 3 Overview
This phase consists of a much larger and potentially longer trial, often involving hundreds or possibly thousands of participants from a range of different countries. The principal objectives in phase III are to demonstrate the safety and effectiveness of the new vaccine or medicine in the typical patient likely to use it; confirm effective dosing levels; identify contraindications; build knowledge of the benefits of the vaccine or medicine and compare them with any risks; and compare results against any currently achieved by existing treatments. Regulators will determine how a new product should be used and which patients should qualify for it based on all the evidence from clinical and pre-clinical studies
DISEASE STATES
Meningococcal Group B Vaccine GSK3536829*
Safety and immunogenicity of Bexsero when administered concomitantly with MenACWY conjugate vaccine (Menveo) to healthy infants (V72_56)
Safety and immunogenicity of 13-valent pneumococcal vaccine and Bexsero when administered together with routine infant vaccines in healthy infants (V72_57)
Randomized, observer-blind study in adolescents and young adults assessing the effectiveness of 2 doses or 3 doses of Bexsero and of 2 doses of GSK's investigational MenABCWY vaccine against a diverse panel of 110 invasive MenB strains.
Randomized, observer-blind, multicenter study to assess the safety and immunogenicity of GSK's meningococcal group B vaccine when administered concomitantly with GSK's meningococcal MenACWY conjugate vaccine to healthy subjects of 16-18 years of age
MenABCWY 2nd Generation Vaccine Candidate GSK4023393*
Randomized, controlled, observer-blind study to evaluate safety and immunogenicity of GSK's meningococcal ABCWY vaccine when administered in healthy adolescents and adults, previously primed with meningococcal ACWY vaccine.
No studies exist in this phase
Footnotes
*In-license or other alliance relationship with third party.
