Clinical trial NCT00918580: Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease
Official title: A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Children With Sickle Cell Disease Previously Immunized With 23vPS Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Conjugate Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 158
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18 years of age. They will be given the vaccination twice, each vaccination separated by approximately 6 months.


Eligibility criteria: 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 component or contraindication to vaccination with pneumococcal conjugate vaccine.

Primary outcomes:
measure: 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
timeFrame: 1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2
Secondary outcomes:
measure: Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
timeFrame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
measure: Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
timeFrame: Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
measure: Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
timeFrame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
measure: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
timeFrame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
measure: Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
timeFrame: 1 year after 13vPnC Dose 2
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
timeFrame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
measure: Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
timeFrame: 1 year after 13vPnC Dose 2
Other outcomes:
measure: Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 1
timeFrame: Within 7 days after 13vPnC Dose 1
measure: Percentage of Participants With Prespecified Local Reactions: 13vPnC Dose 2
timeFrame: Within 7 days after 13vPnC Dose 2
measure: Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 1
timeFrame: Within 7 days after 13vPnC Dose 1
measure: Percentage of Participants With Prespecified Systemic Events: 13vPnC Dose 2
timeFrame: Within 7 days after 13vPnC Dose 2
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Bronx
country: United States
facility: Pfizer Investigational Site
state: New York
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Cairo
country: Egypt
facility: Pfizer Investigational Site
city: Cairo
country: Egypt
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Orbassano (TO)
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Beirut
country: Lebanon
facility: Pfizer Investigational Site
city: Beirut
country: Lebanon
facility: Pfizer Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Pfizer Investigational Site
state: Saudi
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
state: Cheshire
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: