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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
Safety, effectiveness, and immunogenicity in healthy adolescents and adults 10 to 50 years of age
Safety, efficacy, and immunogenicity study in adults 18-65 years of age with chronic hepatitis B
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
Safety and tolerability in adults 18-64 years of age (Stage 1) and adults 65-85 years of age (Stage 2)
Multi-step study to assess safety and immunogenicity in infants and adults 8 months to 50 years of age
Multi-step study to assess safety and immunogenicity in healthy adults 18 to 40 and 55 to 70 years of age
Safety, reactogenicity, and immunogenicity in healthy adults 18 to 50 years of age
Multi-step study to assess safety, reactogenicity, and immunogenicity in healthy adults 18-45 and 50-70 years of age
Safety and immunogenicity against SARS-CoV-2 in seropositive adults 18 years of age and older
Safety and immunogenicity in healthy adults 18-55 and 65 years and older
Safety and immune response in adults 18-50 years of age
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
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
Safety, efficacy, and immunogenicity study in adults 18-65 years of age with chronic hepatitis B
Safety and immunogenicity in adults 18-65 years of age with chronic hepatitis B
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
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
Multi-step study to assess safety and immunogenicity in infants and adults 8 months to 50 years of age
Multi-step study to assess safety and immunogenicity in healthy adults 18 to 40 and 55 to 70 years of age
Safety, reactogenicity, and immunogenicity in healthy adults 18 to 50 years of age
Immunogenicity and safety as a primary series and as a booster dose in adults 18 years and older
Immune response and safety in healthy children 12 to 15 months of age
Safety and immune response in adults 18-50 years of age
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
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
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.
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
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
