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Pneumovax 23

Phase 2

Streptococcus Pneumoniae Vaccines | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Apr 15, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment1,198

FDA Designations

No designations recorded

Clinical trial landscape

Pneumovax 23 · 1 trial · 1 indication

Phase 2 1
NCT00307008Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population.Streptococcus Pneumoniae Vaccines
COMPLETED1,198 Analytics
PHASE2COMPLETED
Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population.
Streptococcus Pneumoniae VaccinesUnlock trial analytics

Study Endpoints

Primary Endpoints

Response rate to 11 vaccine serotypes
One month post vaccination

Secondary Endpoints

Anti-polysaccharide total IgG ELISA for 11 vaccine pneumococcal serotypes
At all time points
Opsonophagocytic activity against 11 vaccine pneumococcal serotypes in a subset of subjects
At Day 0 and Day 30.
The rank of subjects from "poorest responder" to "best responder" based on the number of serotypes each subject responds to
One month post vaccination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -

Interventions

NameTypeDescription
Pneumovax 23™BIOLOGICALSingle dose intramuscular injection
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion criteria * Subjects who the investigator believes will comply with the requirements of the protocol. * A male or female \>= 65 years at the time of the first vaccination. * Written informed consent obtained from the subject. Exclusion criteria * Use of any investigational or non-registe...

Countries:Sweden
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Frequently asked questions about Pneumovax 23

What is Pneumovax 23 used for?

Pneumovax 23 is a vaccine used for Streptococcus pneumoniae, the bacterium that causes pneumococcal disease. It is being studied in an elderly population aged 65 years and older to evaluate the response rate to the licensed vaccine. The vaccine is intended to help protect against pneumococcal infections.

Who makes Pneumovax 23?

Pneumovax 23 is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical development of the vaccine for Streptococcus pneumoniae.

What phase is Pneumovax 23 in?

Pneumovax 23 is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the vaccine is still in clinical development.

What clinical trials is Pneumovax 23 in?

Pneumovax 23 has one completed clinical trial, NCT00307008, titled 'Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population.' This Phase 2 trial enrolled 1,198 participants in Sweden, all aged 65 years and older, and was a healthy volunteer study.

Is Pneumovax 23 a monoclonal antibody?

No, Pneumovax 23 is a vaccine, not a monoclonal antibody. It is designed to elicit an immune response against Streptococcus pneumoniae. The modality listed for the drug is monoclonal antibody, but the product is a vaccine used for immunization.