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13-valent Pneumoccocal Conjugate Vaccine

Phase 3

Pneumococcal Conjugate Vaccine | Vaccine | Infectious Disease |Pfizer, Inc.|Trials Updated: Apr 21, 2014

Development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jun 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment158

FDA Designations

No designations recorded

Clinical trial landscape

13-valent Pneumoccocal Conjugate Vaccine · 1 trial · 1 indication

Phase 3 1
NCT00918580Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell DiseasePneumococcal Conjugate Vaccine
COMPLETED158 Analytics
PHASE3COMPLETED
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease
Pneumococcal Conjugate VaccineUnlock trial analytics

Study Endpoints

Primary Endpoints

Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2

GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 1 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.

Secondary Endpoints

Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
13-valent Pneumoccocal Conjugate VaccineBIOLOGICAL2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.
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Eligibility Criteria

Age Range6 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Male or female subject between the ages of \>=6 to \<18 years. * Diagnosis of SCD * 23vPS vaccination at least 6 months prior to enrollment. Exclusion Criteria: * Previous vaccination with pneumococcal conjugate vaccine. * Previous reaction to any vaccine or vaccine-related ...

Countries:United StatesEgyptFranceItalyLebanonSaudi ArabiaUnited Kingdom
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Frequently asked questions about 13-valent Pneumoccocal Conjugate Vaccine

What is the 13-valent Pneumococcal Conjugate Vaccine?

The 13-valent Pneumococcal Conjugate Vaccine is a vaccine developed by Pfizer, Inc. (ticker: PFE) for pneumococcal conjugate vaccination. It is designed to protect against pneumococcal disease and has been studied in children with sickle cell disease, a population at elevated risk for pneumococcal infections.

What is the 13-valent Pneumococcal Conjugate Vaccine used for in pneumococcal conjugate vaccination?

The 13-valent Pneumococcal Conjugate Vaccine is used for pneumococcal conjugate vaccination. It has been evaluated in a Phase 3 study in children with sickle cell disease, a group at higher risk of pneumococcal infection. The vaccine is intended to provide protection against the pneumococcal serotypes included in its formulation.

Who makes the 13-valent Pneumococcal Conjugate Vaccine?

Pfizer, Inc. (ticker: PFE) is the developer of the 13-valent Pneumococcal Conjugate Vaccine. Pfizer is a global pharmaceutical company that discovers, develops, and manufactures vaccines and medicines across multiple therapeutic areas, including infectious disease.

What phase is the 13-valent Pneumococcal Conjugate Vaccine in?

The 13-valent Pneumococcal Conjugate Vaccine has been studied in a Phase 3 clinical trial. That trial, NCT00918580, is completed. The vaccine is an investigational product in the context of this development program and is not described as approved in the available information.

What clinical trials is the 13-valent Pneumococcal Conjugate Vaccine in?

The 13-valent Pneumococcal Conjugate Vaccine has been evaluated in one completed Phase 3 trial, NCT00918580, titled "Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease." The trial enrolled 158 participants across the United States, Egypt, France, Italy, Lebanon, Saudi Arabia, and the United Kingdom.