Study Evaluating 13 Valent Pneumococcal Conjugate Vaccine With Trivalent Inactivated Influenza Vaccine
- Conditions
- Influenza
- Registration Number
- NCT00521586
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1116
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving at Least 4-fold Increase in Titer for Concomitant Trivalent Inactivated Influenza Vaccine (TIV) Antigens 1 Month After Dose 1 1 month after Dose 1 Percentage of participants achieving at least 4-fold increase in titer for concomitant Trivalent Inactivated Influenza Vaccine (TIV) were measured by standard Hemagglutination Inhibition Assay (HAI) for the A/H1, A/H3, and B vaccine strains.Exact, unconditional, 2-sided, 95% confidence intervals (CI) on the difference in proportions (13vPnC+TIV - Placebo+TIV) was calculated. N(number of participants analyzed)=participants with a determinate antibody titer to the given concomitant vaccine antigen. n=participants who met the prespecified level for the given antigen.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 1 month after 13vPnC Dose at year 0 Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for adult participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose at year 0 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Clinical Research Advantage, Inc.
🇺🇸Chandler, Arizona, United States
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Clinical Trials Center Pediatric Infectious Diseases and Clinical Trials
🇺🇸Aurora, Colorado, United States
Tampa Bay Medical Research, Inc.
🇺🇸Clearwater, Florida, United States
A. G. A. Clinical Trials
🇺🇸Hialeah, Florida, United States
Advanced Clinical Research
🇺🇸West Jordan, Utah, United States
Accelovance
🇺🇸Peoria, Illinois, United States
Suite 100
🇺🇸Riverdale, Maryland, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Radiant Research, Inc
🇺🇸St. Louis, Missouri, United States
Scroll for more (27 remaining)Clinical Research Advantage, Inc.🇺🇸Chandler, Arizona, United States