Phase 4
N=882
Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.
PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
Bottom Line
View on ClinicalTrials.gov: NCT02124161 ↗Enrolled (actual)
882
Serious AEs
1.2%
Results posted
Jul 2016
Primary outcome: Primary: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes — 75; 83; 41; 49 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 13-valent pneumococcal conjugate vaccine (Biological); Seasonal Inactivated Influenza Vaccine (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes |
75; 83; 41; 49; 587; 824 | — |
| PRIMARY Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV) |
115; 113; 226; 196; 28; 26 | — |
| PRIMARY Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1 |
15.3; 11.9; 1.4; 0 | — |
| PRIMARY Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2 |
10.4; 12.5; 1.6; 1.4 | — |
| PRIMARY Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination |
15.3; 12.5; 1.4; 1.4 | — |
| PRIMARY Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up |
2.5; 2.7; 1.1; 1.4 | — |
| SECONDARY Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) |
77.3; 80.1; 79.4; 83.7; 88.6; 92.1 | 0.333 |
| SECONDARY Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1 |
3.6; 3.4; 9.1; 3.0; 13.7; 8.9 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2 |
3.6; 3.9; 10.4; 3.3; 17.9; 9.5 | — |
| SECONDARY Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers |
29.3; 24.2; 27.9; 31.6; 21.3; 22.3 | 0.094 |
| SECONDARY Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1 |
2.4; 2.2; 2.3; 2.4; 2.1; 2.2 | — |
Summary
The purpose of this study is to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated influenza vaccine to adults 50 years and older who have previously received 23-valent pneumococcal polysaccharide vaccine.
Eligibility Criteria
Inclusion Criteria
- Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
- Male or female adults 50 years of age or older.
- Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1 year prior to study enrollment.
- Negative urine pregnancy test for all female subjects who are of child bearing potential.
Exclusion Criteria
- Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational pneumococcal conjugate vaccine.
- History of severe adverse reactions associated with any vaccine or vaccine-related component.
- Allergic to egg proteins (egg or egg products) and chicken proteins.
- History of Guillain-Barré syndrome.
- Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
- Documented S pneumoniae infection within the past 5 years before investigational product administration.
Data sourced from ClinicalTrials.gov (NCT02124161). 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.