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Pneumococcal

Phase 3

Infections, Streptococcal | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jan 2, 2020

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment3,412

FDA Designations

No designations recorded

Clinical trial landscape

Pneumococcal · 8 trials · 11 indications

Phase 3 5Phase 2 3
NCT00333450Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.Infections, Streptococcal
COMPLETED120 Analytics
NCT00334334Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.Infections, Streptococcal
COMPLETED1,572 Analytics
NCT00307554A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority StudyInfections, Streptococcal
COMPLETED1,600 Analytics
NCT00307541Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate VaccineInfections, Streptococcal
COMPLETED120 Analytics
NCT00169507Study of Immunological Memory Induced in Children by a Full 4 Dose Vaccination Schedule of 11 Valent Pneumococcal Conjugate Vaccine by Giving 1 Dose of Aventis Pasteur's 23-valent Pneumococcal Polysaccharide Vaccine (Pneumo 23)Prophylaxis Pneumococcal Vaccine
COMPLETED100 Analytics
PHASE3COMPLETED
Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.
Infections, StreptococcalUnlock trial analytics
PHASE3COMPLETED
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
Infections, StreptococcalUnlock trial analytics
PHASE3COMPLETED
A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority Study
Infections, StreptococcalUnlock trial analytics
PHASE3COMPLETED
Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Infections, StreptococcalUnlock trial analytics
PHASE3COMPLETED
Study of Immunological Memory Induced in Children by a Full 4 Dose Vaccination Schedule of 11 Valent Pneumococcal Conjugate Vaccine by Giving 1 Dose of Aventis Pasteur's 23-valent Pneumococcal Polysaccharide Vaccine (Pneumo 23)
Prophylaxis Pneumococcal VaccineUnlock trial analytics

Study Endpoints

Primary Endpoints

Antibody concentrations against pneumococcal serotypes 1 month post-booster
Post at least 1 dose: rectal fever >39°C
Lot-to-lot consistency: antibody (Ab) concentrations to pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and to carrier protein PD
Non-inferiority of 10-valent pneumococcal conjugate vaccine (pooled data of 3 10-Pn-PD-DiT vaccine groups) w.r.t. Prevenar: all anti-pneumococcal serotypes Ab concentrations>=0.20 µg/mL
1 month post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL
Antibody concentrations (ELISA) to pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F 10-15 days after the single dose of Aventis Pasteur's 23-valent pneumococcal polysaccharide vaccine (Pneumo 23).
After each dose: Grade 3 AEs
1 mth after admin. of booster dose with either GSK Biologicals' 10Pn-PD-DiT vaccine or 1 mth after admin. of single dose of unconjugated 23- valent pneumococcal polysaccharide vaccine (Pneumovax™ 23), anti-pneumococcal serotypes 1,4,5,6B,7F,9V,14,18C,
1 month after d3, antibody concentrations to pneumo. serotypes 1,3,4,5,6B,7F,9V,14,18C,19Fand23F.Occurrence of: solicited local and general symptoms within 8 days after each vaccination; unsolicited adverse events within 31 days after each vaccination
1 Month after dose 3

Secondary Endpoints

Immunogenicity pre and post-booster and safety (follow up of SAEs)
Post each dose: solicited/unsolicited AEs (4/31 days), SAEs (whole study); post dose 2 & 3: Ab conc to vaccine antigens
After each vaccination, occurrence of: solicited local, general symptoms within 4 days;
After each vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Pneumococcal vaccineBIOLOGICAL -
Pneumococcal (vaccine)BIOLOGICAL -
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Eligibility Criteria

Age Range11 Months to 14 Months
SexALL
Healthy VolunteersYes
Study Sites30

Inclusion: * healthy children between 11-14 months old who received primary vaccination with Prevnar or GSK Biologicals' pneumococcal conjugate vaccine. Exclusion: * children having received or planning to receive any investigational products, vaccines not foreseen in the protocol and immune modi...

Countries:GermanyPolandSpainFinlandFranceSlovakiaChile
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Frequently asked questions about Pneumococcal

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.