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A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age

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ClinicalTrials.gov Identifier: NCT03313050
Recruitment Status : Completed
First Posted : October 18, 2017
Results First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 10, 2017
First Posted Date  ICMJE October 18, 2017
Results First Submitted Date  ICMJE May 15, 2020
Results First Posted Date  ICMJE June 4, 2020
Last Update Posted Date June 4, 2020
Actual Study Start Date  ICMJE October 12, 2017
Actual Primary Completion Date May 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2020)
  • Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination [ Time Frame: within 14 days after vaccination ]
    Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (>) 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.
  • Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination [ Time Frame: within 14 days after vaccination ]
    Local reactions included pain at injection site, swelling and redness recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.
  • Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination [ Time Frame: within 14 days after vaccination ]
    Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees Celsius (C), >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.
  • Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination [ Time Frame: within 14 days after vaccination ]
    Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees C, >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.
  • Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination [ Time Frame: within 1 month after vaccination ]
    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (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 AEs and Non-SAEs.
  • Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination [ Time Frame: within 1 month after vaccination ]
    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. 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 AEs and Non-SAEs.
  • Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination [ Time Frame: within 6 months after vaccination ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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.
  • Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination [ Time Frame: within 6 months after vaccination ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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.
  • Stage 1: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination [ Time Frame: within 6 months after vaccination ]
    An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.
  • Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination [ Time Frame: within 6 months after vaccination ]
    An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.
  • Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination [ Time Frame: within 12 months after vaccination ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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.
  • Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination [ Time Frame: within 12 months after vaccination ]
    An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • Percentage of subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at injection site) in each age group [ Time Frame: 14 days after vaccination ]
    Describe prompted local reactions after vaccination.
  • Percentage of subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain) in each age group [ Time Frame: 14 days after vaccination ]
    Describe prompted systemic events after vaccination.
  • Percentage of subjects reporting adverse events within 1 month after vaccination in each age group [ Time Frame: 1 month after vaccination ]
    Describe adverse events after vaccination.
  • Percentage of subjects reporting serious adverse events and newly diagnosed chronic medical conditions within 6 months (both Stage 1 and Stage 2) [ Time Frame: 6 months after vaccination ]
    Describe SAEs and NDCMCs after vaccination.
  • Percentage of subjects reporting serious adverse events and newly diagnosed chronic medical conditions within 12months (Stage 2 only) [ Time Frame: 12 months after vaccination ]
    Describe SAEs and NDCMCs after vaccination.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2020)
  • Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination [ Time Frame: 1 month after vaccination ]
    Antibody-mediated serum OPA against the 7 pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ in the analysis. Evaluable immunogenicity population = EIP.
  • Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination [ Time Frame: within 1 month after vaccination ]
    Antibody-mediated serum OPA against the 7 common pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
  • Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination [ Time Frame: before Vaccination to 1 month after Vaccination ]
    GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
  • Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination [ Time Frame: before Vaccination to 1 month after Vaccination ]
    GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • Pneumococcal serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at 1 month after vaccination [ Time Frame: 1 month after vaccination ]
    Describe pneumococcal serotype-specific OPA GMTs after vaccination.
  • Pneumococcal serotype-specific OPA geometric mean fold rises (GMFRs) from before vaccination to 1 month after vaccination [ Time Frame: 1 month after vaccination ]
    Describe pneumococcal serotype-specific OPA GMFRs after vaccination.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
Official Title  ICMJE A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY ADULTS 50 THROUGH 85 YEARS OF AGE
Brief Summary

This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage.

In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).

In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 >=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Observer-blinded
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE
  • Biological: Multivalent
    Pneumococcal conjugate vaccine
  • Biological: Tdap
    Tetanus, diphtheria, acellular pertussis vaccine
  • Biological: polysaccharide
    23-valent pneumococcal polysaccharide vaccine
Study Arms  ICMJE
  • Experimental: Stage 1 multivalent (ages 50-64 years)
    multivalent
    Intervention: Biological: Multivalent
  • Active Comparator: Stage 1 Tdap (ages 50-64 years)
    Tdap
    Intervention: Biological: Tdap
  • Experimental: Stage 2 multivalent (ages 65-85 years)
    multivalent
    Intervention: Biological: Multivalent
  • Active Comparator: Stage 2 polysaccharide (ages 65-85 years)
    polysaccharide
    Intervention: Biological: polysaccharide
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: October 8, 2018)
511
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2017)
506
Actual Study Completion Date  ICMJE May 24, 2019
Actual Primary Completion Date May 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Stage 1: Healthy male or female adults 50 to 64 years of age with no history of pneumococcal vaccination
  • Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 >= 2 months prior to investigational product administration

Exclusion Criteria:

  • Stage 1: Vaccination within 12 months before investigational product administration with diphtheria-, pertussis-, or tetanus-containing vaccine
  • Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior dose of Prevnar 13
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (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 NCT03313050
Other Study ID Numbers  ICMJE C3571001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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 May 2020

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