Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.
- Conditions
- PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
- Interventions
- Other: PlaceboBiological: Seasonal Inactivated Influenza VaccineBiological: 13-valent pneumococcal conjugate vaccine
- Registration Number
- NCT02124161
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 882
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Placebo+SIIV/13vPnC Placebo - 13vPnC+SIIV/Placebo Placebo - Placebo+SIIV/13vPnC 13-valent pneumococcal conjugate vaccine - 13vPnC+SIIV/Placebo Seasonal Inactivated Influenza Vaccine - 13vPnC+SIIV/Placebo 13-valent pneumococcal conjugate vaccine - Placebo+SIIV/13vPnC Seasonal Inactivated Influenza Vaccine -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2 An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up Within 168 to 196 days after Vaccination 2 An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes 1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC Serotype-specific OPA GMTs for each of the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were logarithmically transformed for analysis. Confidence intervals (CIs) for GMT were back-transformed based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint and "n" signifies participants with a determinate OPA titer to the given serotype.
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV) 1 month after Vaccination 1 HAI GMTs were computed for assay titers collected 1 month after Vaccination 1 by vaccine sequence for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). CIs were back-transformations of a CI based on the Student t distribution for the mean logarithm of the titers. HAI GMTs were calculated using all participants with available data for the specified blood draw. Here, "number of participants analyzed" signifies participants with a determinate HAI titer to the given strain.
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2 Within 28 to 42 days after Vaccination 2 An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1 Within 28 to 42 days after Vaccination 1 An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).
- Secondary Outcome Measures
Name Time Method 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 Immediately before Vaccination 2, 1 month after Vaccination 2 GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 2 to before Vaccination 2 (1 month after Vaccination 1) were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 2 and 1 month after Vaccination 2 blood draws. Here, "number of participants analyzed" signifies total participants who were evaluable at this timepoint and "n" signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 2 were analyzed.
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1 Immediately before Vaccination 1, 1 month after Vaccination 1 Fold rise 1 month after Vaccination 1 to before Vaccination 1 was calculated for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). GMFRs were calculated using all participants with available data from both the specified blood draws. CI for the GMFRs were back transformations of a CI based on the Student t distribution for mean fold rise. Here, "number of participants analyzed" signifies participants with valid and determinate assay results for specified strain at both the specified blood draws.
Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers Immediately before Vaccination 1, 1 month after Vaccination 1 Percentage of participants achieving seroconversion in HAI titers was defined as the percentage of participants with either before Vaccination 1 (pre-vaccination 1) HAI titer less than \<1:10 and after Vaccination 1 (post-vaccination 1) HAI titer \>=1:40 or before Vaccination 1 (pre-vaccination 1) HAI titer \>=1:10 and a minimum 4-fold rise in after Vaccination 1 (post-vaccination 1) HAI antibody titer with respect to before Vaccination 1 (pre-vaccination) titer for influenza virus strains. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint.
Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After Vaccination 1 for 13vPnC+QIV/Placebo, 1 month after Vaccination 2 for Placebo+QIV/13vPnC Percentage of participants achieving predefined OPA antibody titer \>= LLOQ for each of the 13 pneumococcal serotypes (LLOQs for each serotype OPA were set as- serotype 1: 18; serotype 3: 12; serotype 4: 21; serotype 5: 29; serotype 6A: 37; serotype 6B: 43; serotype 7F: 210; serotype 9V: 345; serotype 14: 35; serotype 18C: 31; serotype 19A: 18; serotype 19F: 48; and serotype 23F: 13) determined in blood samples of all participants were calculated. Exact, 2-sided 95% CIs based on the observed percentage of participants were determined by using Clopper and Pearson method. OPA titers were calculated using all participants with available data from 1 month after 13vPnC vaccination blood draw. Here, "number of participants analyzed" signifies the participants who were evaluable at this timepoint and "n" signifies participants with valid and determinate assay results to the specified serotype.
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 Immediately before Vaccination 1, 1 month after Vaccination 1 GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 1 to before Vaccination 1 were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 1 and 1 month after Vaccination 1 blood draws. Here, "n" signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 1 were analyzed.
Trial Locations
- Locations (37)
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
Optimal Research (Formerly Accelovance)
🇺🇸Huntsville, Alabama, United States
Radiant Research, Inc.
🇺🇸Murray, Utah, United States
Kaiser Permanente Vaccine Study Center
🇺🇸Oakland, California, United States
Kaiser Permanante South. Sacramento
🇺🇸Sacramento, California, United States
Benchmark Research
🇺🇸Fort Worth, Texas, United States
Kaiser Pemanente Santa Clara
🇺🇸Santa Clara, California, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Westside Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Meridian Clinical Research
🇺🇸Norfolk, Nebraska, United States
Clinical Research Advantage, Inc/Ridge Family Practice
🇺🇸Council Bluffs, Iowa, United States
Optimal Research, LLC
🇺🇸Mishawaka, Indiana, United States
United Medical Associates
🇺🇸Binghamton, New York, United States
Regional Clinical Research, Inc.
🇺🇸Endwell, New York, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
🇺🇸Cary, North Carolina, United States
PharmQuest
🇺🇸Greensboro, North Carolina, United States
PMG Research of Hickory, LLC
🇺🇸Hickory, North Carolina, United States
Clinical Trials of America, Inc.
🇺🇸Winston-Salem, North Carolina, United States
PMG Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Radiant Research, Inc
🇺🇸Columbus, Ohio, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Preferred Primary Care Physicians, Inc.
🇺🇸Carnegie, Pennsylvania, United States
Brandywine Clinical Research
🇺🇸Downingtown, Pennsylvania, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
PMG Research of Charleston
🇺🇸Mt. Pleasant, South Carolina, United States
Internal Medicine and Pediatric Associates of Bristol, PC
🇺🇸Bristol, Tennessee, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States
J. Lewis Research, Inc. / Jordan River Family Medicine
🇺🇸South Jordan, Utah, United States
Meridian Clinical Research, LLC
🇺🇸Omaha, Nebraska, United States
Clinical Research Center of Nevada, LLC
🇺🇸Las Vegas, Nevada, United States
Clinical Research Advantage, Inc.
🇺🇸Las Vegas, Nevada, United States
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
Johnson County Clin-Trials, Inc.
🇺🇸Lenexa, Kansas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States