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pneumococcal vaccine

Phase 2

Prophylactic Pneumococcal Diseases | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Oct 13, 2008

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

pneumococcal vaccine · 1 trial · 1 indication

Phase 2 1
NCT00327522Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.Prophylactic Pneumococcal Diseases
COMPLETED10 Analytics
PHASE2COMPLETED
Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.
Prophylactic Pneumococcal DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of solicited local & general symptoms (Day 0-7) and unsolicited symptoms (Day 0-30) after vaccination. Occurrence of serious adverse events during the entire study;
Frequencies of IgG PS-specific plasma cells (by B-cell ELISPOT) for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) prior to & 1 month post dose 1, 2 weeks & 1 month post dose 2
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Interventions

NameTypeDescription
pneumococcal vaccineBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * healthy male or female between 18 and 40 years of age * 23-valent pneumococcal polysaccharide vaccine naive adults. Exclusion Criteria: * Previous vaccination against Streptococcus pneumoniae. * History of pneumonia within 3 years prior to the first vaccination * Any confirm...

Countries:Belgium
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Frequently asked questions about pneumococcal vaccine

What is Pneumococcal used for?

Pneumococcal is a prophylactic vaccine developed by GSK plc for the prevention of pneumococcal diseases and streptococcal infections. It is also studied for use in acellular pertussis, hepatitis A, and other infectious conditions. The vaccine is intended for healthy children and is administered in multiple doses to establish immunological memory.

Who makes Pneumococcal?

Pneumococcal is developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The vaccine is part of GSK's infectious disease portfolio and has been studied in clinical trials across Europe, including Slovakia, Finland, France, Poland, Germany, and Spain.

What phase is Pneumococcal in?

Pneumococcal is in Phase 2 clinical development, though it has also been studied in Phase 3 trials. The vaccine is investigational and not yet approved for commercial use. Four clinical trials have been completed, with a total enrollment of 3,412 participants, all of which were uncontrolled and non-randomized studies.

What clinical trials is Pneumococcal in?

Pneumococcal has been studied in four completed clinical trials. NCT00169507 evaluated immunological memory in children after a 4-dose schedule of an 11-valent pneumococcal conjugate vaccine. NCT00307554 assessed lot-to-lot consistency of a 10-valent vaccine. NCT00307567 examined booster and immune memory responses, and NCT00334334 evaluated safety and immunogenicity.

Is Pneumococcal the same as Pneumo 23?

Pneumococcal is not the same as Pneumo 23, though they are related. Pneumo 23 is a 23-valent pneumococcal polysaccharide vaccine made by Aventis Pasteur, used as a booster in one of GSK's trials. GSK's Pneumococcal vaccine is a conjugate vaccine, and the two are distinct products with different formulations.

How does Pneumococcal work?

Pneumococcal is a prophylactic vaccine designed to prevent infections caused by Streptococcus pneumoniae. It works by exposing the immune system to pneumococcal antigens, stimulating the production of antibodies and immunological memory. This primes the body to recognize and fight the bacteria upon future exposure, reducing the risk of pneumococcal disease.