Phase 3
N=158
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease
Pneumococcal Conjugate Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT00918580 ↗Enrolled (actual)
158
Serious AEs
17.9%
Results posted
Apr 2014
Primary outcome: Primary: 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 — 0.75; 0.89; 0.82; 0.75 fold rise
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent Pneumoccocal Conjugate Vaccine (Biological)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0.75; 0.89; 0.82; 0.75; 0.70; 1.05 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1 |
6.91; 4.72; 3.10; 5.50; 5.58; 4.76 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2 |
1.86; 1.80; 1.48; 1.24; 1.47; 2.08 | — |
| SECONDARY Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2 |
0.26; 0.38; 0.49; 0.22; 0.26; 0.44 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody |
1.01; 5.79; 3.01; 6.30; 1.40; 4.46 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2 |
1.94; 11.77; 4.50; 15.89; 2.64; 9.87 | — |
| SECONDARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) |
215; 626; 234; 628; 426; 94 | — |
| SECONDARY Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2 |
1107; 3412; 1690; 1595; 1604; 620 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00918580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.