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 GSK4023393A

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

Hepatitis B
Therapeutic hepatitis B vaccine candidate GSK3528869A (In-license or other alliance relationship with third party)

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

S. aureus
S. aureus vaccine candidate GSK 3878858A (In-license or other alliance relationship with third party)

Multi-step study to assess safety, immunogenicity, and efficacy in healthy adults 18-64 years of age with a recent S. aureus skin and soft tissue infection

S. pneumoniae
S. pneumoniae vaccine candidate AFX3772 (In-license or other alliance relationship with third party)

Safety and tolerability in adults 18-64 years of age (Stage 1) and adults 65-85 years of age (Stage 2)

Shigella
Shigella vaccine candidate GSK4069327A (In-license or other alliance relationship with third party)

Multi-step study to assess safety and immunogenicity in infants and adults 8 months to 50 years of age

Klebsiella pneumoniae
Klebsiella pneumoniae Tetravalent Bioconjugate Vaccine Candidate GSK4429016A (In-license or other alliance relationship with third party)

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 GSK3993129A

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

Clostridium Difficile
C. difficile vaccine candidate GSK2904545A (In-license or other alliance relationship with third party)

Multi-step study to assess safety, reactogenicity, and immunogenicity in healthy adults 18-45 and 50-70 years of age

COVID-19
mRNA COVID-19 2nd Gen vaccine candidate GSK4396687A (In-license or other alliance relationship with third party)

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 GSK4382276A (In-license or other alliance relationship with third party)

Safety and immunogenicity in healthy adults 18-55 and 65 years and older

iNTS (S. TYPHIMURIUM + S. ENTERITIDIS)
iNTS (Invasive non-typhoidal salmonella prophylaxis) vaccine candidate GSK4077164A (In-license or other alliance relationship with third party)

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

Therapeutic HSV
Therapeutic herpes simplex virus (HSV) vaccine candidate GSK3943104A (In-license or other alliance relationship with third party)

Safety and immunogenicity in adults

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 GSK4023393A

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
Therapeutic hepatitis B vaccine candidate GSK3528869A (In-license or other alliance relationship with third party)

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

Therapeutic hepatitis B (CHBV ASO Combo) vaccine candidate GSK4388067A (In-license or other alliance relationship with third party)

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

S. aureus
S. aureus vaccine candidate GSK 3878858A (In-license or other alliance relationship with third party)

Multi-step study to assess safety, immunogenicity, and efficacy in healthy adults 18-64 years of age with a recent S. aureus skin and soft tissue infection

S. pneumoniae
S. pneumoniae vaccine candidate AFX3772 (In-license or other alliance relationship with third party)

Safety and tolerability in adults 18-64 years of age (Stage 1) and adults 65-85 years of age (Stage 2)

Safety and immunogenicity in healthy infants 2 months of age

Shigella
Shigella vaccine candidate GSK4069327A (In-license or other alliance relationship with third party)

Multi-step study to assess safety and immunogenicity in infants and adults 8 months to 50 years of age

Klebsiella pneumoniae
Klebsiella pneumoniae Tetravalent Bioconjugate Vaccine Candidate GSK4429016A (In-license or other alliance relationship with third party)

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 GSK3993129A

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

Clostridium Difficile
No studies exist in this phase
COVID-19
SARS-CoV-2 (Sanofi) candidate vaccine (In-license or other alliance relationship with third party)

Immunogenicity and safety as a primary series and as a booster dose in adults 18 years and older

Varicella
Varicella New Strain vaccine candidate GSK4178116A

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

mRNA INFLUENZA
No studies exist in this phase
iNTS (S. TYPHIMURIUM + S. ENTERITIDIS)
iNTS (Invasive non-typhoidal salmonella prophylaxis) vaccine candidate GSK4077164A (In-license or other alliance relationship with third party)

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

Therapeutic HSV
Therapeutic herpes simplex virus (HSV) vaccine candidate GSK3943104A (In-license or other alliance relationship with third party)

Safety and immunogenicity in 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 GSK3536829A

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 GSK4023393A

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. aureus
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
SARS-CoV-2 (Sanofi) candidate vaccine (In-license or other alliance relationship with third party)

Immunogenicity and safety as a primary series and as a booster dose in adults 18 years and older

Efficacy and safety in adults 18 years of age and older

Immunogenicity and safety in adults 18 years and older when administered as a booster dose

SARS-CoV-2 (SK Bioscience) candidate vaccine (In-license or other alliance relationship with third party)

Immunogenicity and safety in adults 18 years of age and older

Immunogenicity and safety as a heterologous booster in adults 18 years of age and older

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