Phase 3
N=262
Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.
13-valent Pneumococcal Vaccine · Immunization · Safety · Antibody Response
Bottom Line
View on ClinicalTrials.gov: NCT01026038 ↗Enrolled (actual)
262
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcome: Primary: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine — 10.34; 12.79; 8.98; 31.62 mcg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent pneumococcal conjugate vaccine (Biological)
- Age
- Pediatric, Adult, Older Adult · 3+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine |
10.34; 12.79; 8.98; 31.62; 51.07; 35.38 | — |
| PRIMARY Percentage of Participants With Prespecified Local Reactions |
55.4; 55.8; 64.2; 50.5; 49.0; 56.9 | >0.990 |
| PRIMARY Percentage of Participants With Prespecified Systemic Events |
15.1; 28.6; 19.6; 2.2; 4.7; 2.2 | 0.075 |
| SECONDARY Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine |
0.17; 0.23; 0.18; 2.86; 4.10; 3.21 | — |
| SECONDARY Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine |
2.96; 4.66; 3.85; 17.78; 19.15; 16.26 | — |
| SECONDARY Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine |
8; 46; 45; 245; 247; 332 | — |
| SECONDARY Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine |
5465; 5208; 5487; 6684; 10042; 8983 | — |
| SECONDARY Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine |
— | — |
| SECONDARY Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine |
— | — |
Summary
This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.
Eligibility Criteria
Inclusion Criteria
- Healthy subjects at least 3 years of age, who received all 4 assigned doses of pneumococcal conjugate vaccine and completed Study 6096A1-008-EU (NCT00366678) for at least 24 months
Exclusion Criteria
- Vaccination with any licensed or investigational pneumococcal vaccine since completion of Study 6096A1-008-EU(NCT00366678).
- History of culture-proven invasive disease caused by S pneumoniae since the completion of Study 6096A1-008-EU (NCT00366678).
- Previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination
Data sourced from ClinicalTrials.gov (NCT01026038). 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.