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PhtD vaccine with/without adjuvant

Phase 1

Pneumococcal Disease | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jan 14, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

PhtD vaccine with/without adjuvant · 1 trial · 1 indication

Phase 1 1
NCT01767402Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine in Healthy AdultsPneumococcal Disease
COMPLETED150 Analytics
PHASE1COMPLETED
Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine in Healthy Adults
Pneumococcal Disease
NCT01767402150
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Study Endpoints

Primary Endpoints

Occurrence, intensity and relationship of any solicited local and general signs and symptoms
During a 7-day follow up period (i.e. Days 0-6) after each vaccine dose
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms
During a 30-day follow up period (i.e. Days 0-29) after each vaccine dose
Occurrence of all serious adverse events (SAEs)
During the 12 months of the study
Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA)
One month after the first injection

Secondary Endpoints

Number and percentage of subjects with normal or abnormal values, for biochemical assessments and for hematological analysis
At month 0, 1, 3 and 12
Anti-PhtD antibody concentration in all groups (measured by ELISA)
At 12 months after the first vaccination
Anti-PhtD antibody avidity (measured by ELISA)
At month 0, 1, 3 and 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
PhtD Group 1EXPERIMENTALSubjects will receive PhtD vaccine formulation 1 without any adjuvant.
PhtD Group 2EXPERIMENTALSubjects will receive adjuvanted PhtD vaccine formulation 2.
PhtD Group 3EXPERIMENTALSubjects will receive adjuvanted PhtD vaccine formulation 3.
PhtD Group 4EXPERIMENTALSubjects will receive adjuvanted PhtD vaccine formulation 4.
PhtD Group 5EXPERIMENTALSubjects will receive adjuvanted PhtD vaccine formulation 5.
23 PPV GroupACTIVE_COMPARATORSubjects will receive the Pneumovax 23TM vaccine and NaCl.

Interventions

NameTypeDescription
PhtD vaccine with/without adjuvantBIOLOGICALTwo doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2.
Pneumovax 23TMBIOLOGICALOne dose of Pneumovax 23TM vaccine administered intramuscularly in the deltoid region of the right arm at month 0.
NaClBIOLOGICALOne dose administered intramuscularly in the deltoid region of the right arm at month 2.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 18 and 45 years at the time of the first vaccination. * Written informed consent obtained from the subject. * Fr...

Countries:Belgium
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Frequently asked questions about PhtD vaccine with/without adjuvant

What is PhtD vaccine with/without adjuvant used for?

PhtD vaccine with/without adjuvant is used for pneumococcal disease, a bacterial infection caused by Streptococcus pneumoniae. It is an investigational vaccine being studied in healthy adults to evaluate its safety, reactogenicity, and immunogenicity. The vaccine is designed to elicit an immune response against the pneumococcal protein PhtD.

Who makes PhtD vaccine with/without adjuvant?

PhtD vaccine with/without adjuvant is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical research to evaluate the vaccine's potential in preventing pneumococcal disease.

What phase is PhtD vaccine with/without adjuvant in?

PhtD vaccine with/without adjuvant is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities and is still being studied for safety and immunogenicity in clinical trials.

What clinical trials is PhtD vaccine with/without adjuvant in?

PhtD vaccine with/without adjuvant has one completed Phase 1 clinical trial, identified as NCT01767402. This study evaluated the safety, reactogenicity, and immunogenicity of the pneumococcal protein PhtD vaccine in healthy adults in Belgium. The trial enrolled 150 participants and was active-controlled.

Is PhtD vaccine with/without adjuvant the same as PhtD vaccine?

PhtD vaccine with/without adjuvant refers to the pneumococcal protein PhtD vaccine that can be administered either alone or with an adjuvant. The clinical trial NCT01767402 studied the vaccine with or without adjuvant, comparing formulations to assess safety and immune responses.