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

 
Meningococcal Disease

MenABCWY 2nd Generation Vaccine Candidate GSK4023393*

Safety, effectiveness, and immunogenicity in healthy adolescents and adults 10 to 50 years of age

Hepatitis B

Chronic hepatitis B targeted immunotherapy GSK3528869* 

Safety, efficacy, and immunogenicity study in adults 18-65 years of age with chronic hepatitis B

S. pneumoniae

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)

Shigella

No studies exist in this phase

Klebsiella pneumoniae

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

Cytomegalovirus (CMV) vaccine candidate GSK3993129*

Safety, reactogenicity, and immunogenicity in healthy adults 18 to 50 years of age

COVID-19

mRNA COVID-19 2nd Gen vaccine candidate GSK4396687*

Safety and immunogenicity against SARS-CoV-2 in seropositive adults 18 years of age and older

Varicella
No studies exist in this phase
mRNA INFLUENZA

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 (S. TYPHIMURIUM + S. ENTERITIDIS)

iNTS (Invasive non-typhoidal salmonella prophylaxis) vaccine candidate GSK4077164*

Safety and immune response in adults 18-50 years of age

Therapeutic HSV

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

Gonorrhea Vaccine Candidate (GSK4348413)

Safety and efficacy in adults 18 to 50 years of age

Human Papillomavirus (HPV)

Human Papillomavirus (HPV9-AS04) Vaccine Candidate GSK4106647*

Safety and immunogenicity in Women 16 to 26 years of age

Salmonella Typhoid/Paratyphoid A

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

 
Meningococcal Disease

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

Hepatitis B

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

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

Shigella vaccine candidate GSK3536852*

Assess efficacy, safety, and immunogenicity in healthy
adults 18 to 50 years of age

Klebsiella pneumoniae

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

Cytomegalovirus (CMV) vaccine candidate GSK3993129*

Safety, reactogenicity, and immunogenicity in healthy adults 18 to 50 years of age

Clostridium Difficile
No studies exist in this phase
COVID-19

mRNA COVID-19 2nd Gen vaccine candidate GSK4396687*

Safety and immune response in healthy adults

Varicella

Varicella New Strain vaccine candidate GSK4178116*

Immune response and safety in healthy children 12 to 15 months of age

mRNA INFLUENZA

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 (S. TYPHIMURIUM + S. ENTERITIDIS)

iNTS (Invasive non-typhoidal salmonella prophylaxis) vaccine candidate GSK4077164*

Safety and immune response in adults 18-50 years of age

Therapeutic HSV

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

Gonorrhea Vaccine Candidate (GSK4348413)

Safety and efficacy in adults 18 to 50 years of age

Human Papillomavirus (HPV)

Human Papillomavirus (HPV9-AS04) Vaccine Candidate GSK4106647*

Safety and immunogenicity in Women 16 to 26 years of age

MMRV New Strain

Measles, Mumps, Rubella, Varicella New Strain Vaccine Candidate GSK4406371

Immunogenicity and safety in children 4 to 6 years of age

Respiratory Syncytial Virus

Respiratory Syncytial Virus Vaccine, Adjuvanted

Immunogenicity and safety in adults 18 years and older with lung or kidney transplant compared to healthy adults

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 Disease

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, 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 1st Generation Vaccine Candidate GSK3536819* 

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, 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.

Hepatitis B
No studies exist in this phase
S. pneumoniae
No studies exist in this phase
Shigella
No studies exist in this phase
Klebsiella pneumoniae
No studies exist in this phase
Cytomegalovirus
No studies exist in this phase
Clostridium Difficile
No studies exist in this phase
COVID-19

No studies exist in this phase

Varicella
No studies exist in this phase
mRNA INFLUENZA
No studies exist in this phase
iNTS (S. TYPHIMURIUM + S. ENTERITIDIS)
No studies exist in this phase
Therapeutic HSV
No studies exist in this phase
Respiratory Syncytial Virus

Respiratory Syncytial Virus Vaccine, Adjuvanted    

Efficacy, safety, and immune response in preventing LRTD in adults 60 years and older

Immunogenicity and safety in adults 50-59 years of age compared to 60 years and older

Footnotes

*In-license or other alliance relationship with third party.