Phase 3
N=1,116
Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00521586 ↗Enrolled (actual)
1,116
Serious AEs
1.1%
Results posted
Apr 2015
Primary outcome: Primary: Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1 — 84.0; 81.2; 71.1; 69.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13 valent pneumococcal conjugate vaccine (Biological)
- Age
- Adult · 50+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1 |
84.0; 81.2; 71.1; 69.5; 60.6; 60.3 | — |
| PRIMARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose |
4.05; 5.45; 1.15; 1.46; 2.35; 3.41 | — |
Summary
This study is to evaluate the safety, tolerability and immune response when 13-valent pneumococcal conjugate vaccine (13vPnC) and the trivalent inactivated flu vaccine (TIV) are given together to healthy adults aged 50-59 years who are naive to 23-valent pneumococcal polysaccharide vaccine (23vPS), or when the vaccines are given 1 month apart. It will also evaluate the immune response to 13vPnC once per year for 4 years and then to a second dose of 13vPnC given 5 years after the first dose.
Eligibility Criteria
Inclusion Criteria
- Male or female aged 50 to 59 years
- Determined by medical history, physical examination and clinical judgement to be eligible for the study
- Able to complete electronic diary
- Available for the 5 year 9 month duration of the study
Exclusion Criteria
- Previous vaccination with any licensed or experimental pneumococcal vaccine
- Allergic to egg proteins and chicken proteins
- History of Guillian-Barre syndrome
- Vaccination with TIV within 6 months before study start
- Vaccination with diphtheria-containing vaccine within 6 months of study start
- Serious chronic disorders including immunodeficiency or metastatic malignancy
- Known or suspected hypersensitivity to any vaccine or vaccine component
Data sourced from ClinicalTrials.gov (NCT00521586). 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.