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Trial record 1 of 1 for:    NCT02124161
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Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.

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ClinicalTrials.gov Identifier: NCT02124161
Recruitment Status : Completed
First Posted : April 28, 2014
Results First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 24, 2014
First Posted Date  ICMJE April 28, 2014
Results First Submitted Date  ICMJE May 23, 2016
Results First Posted Date  ICMJE July 1, 2016
Last Update Posted Date July 1, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
  • Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes [ Time Frame: 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) [ Time Frame: 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 1 [ Time Frame: 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).
  • Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2 [ Time Frame: 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 13vPnC Vaccination [ Time Frame: 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 [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
  • The pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) [ Time Frame: 1 month ]
  • The hemagglutination inhibition (HAI) geometric mean titers (GMTs) for each influenza virus strain in the SIIV [ Time Frame: 1 month ]
  • The number and proportion of subjects with adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
  • Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) [ Time Frame: 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 [ Time Frame: 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.
  • 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 [ Time Frame: 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.
  • Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers [ Time Frame: 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.
  • Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
  • The percentage of subjects achieving pneumococcal serotype-specific OPA titers greater than or equal to the lower limit of quantitation (LLOQ). [ Time Frame: 1 month ]
  • The pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs). [ Time Frame: 1 month ]
  • The proportion of subjects achieving seroconversion in HAI titers. [ Time Frame: 1 month ]
  • The HAI GMFRs for each influenza virus strain. [ Time Frame: 1 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.
Official Title  ICMJE A Phase 4, Randomized, Double-blind Trial To Evaluate The Immunogenicity And Safety Of A 13-valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Seasonal Inactivated Influenza Vaccine In Adults 50 Years And Older Who Received 1 Or More Doses Of 23-valent Pneumococcal Polysaccharide Vaccine Prior To Study Enrollment.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE
Intervention  ICMJE
  • Biological: 13-valent pneumococcal conjugate vaccine
    One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
    Other Name: 13vPnC
  • Biological: Seasonal Inactivated Influenza Vaccine
    One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.
    Other Name: SIIV
  • Other: Placebo
    One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
Study Arms  ICMJE
  • 13vPnC+SIIV/Placebo
    Interventions:
    • Biological: 13-valent pneumococcal conjugate vaccine
    • Biological: Seasonal Inactivated Influenza Vaccine
    • Other: Placebo
  • Placebo+SIIV/13vPnC
    Interventions:
    • Other: Placebo
    • Biological: Seasonal Inactivated Influenza Vaccine
    • Biological: 13-valent pneumococcal conjugate vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2014)
882
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. Male or female adults 50 years of age or older.
  3. Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1 year prior to study enrollment.
  4. Negative urine pregnancy test for all female subjects who are of child bearing potential.

Exclusion Criteria:

  1. Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational pneumococcal conjugate vaccine.
  2. History of severe adverse reactions associated with any vaccine or vaccine-related component.
  3. Allergic to egg proteins (egg or egg products) and chicken proteins.
  4. History of Guillain-Barré syndrome.
  5. Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
  6. Documented S pneumoniae infection within the past 5 years before investigational product administration.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02124161
Other Study ID Numbers  ICMJE B1851138
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP