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Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults

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ClinicalTrials.gov Identifier: NCT03760146
Recruitment Status : Completed
First Posted : November 30, 2018
Results First Posted : December 29, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults

Condition or disease Intervention/treatment Phase
Pneumococcal Disease Biological: 20vPnC Biological: 13vPnC Biological: PPSV23 Other: Saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3902 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 YEARS OF AGE AND OLDER
Actual Study Start Date : December 12, 2018
Actual Primary Completion Date : December 9, 2019
Actual Study Completion Date : December 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 60 years and above 20vPnC/Saline
20vPnC and saline
Biological: 20vPnC
20vPnC

Other: Saline
Placebo

Active Comparator: 60 years and above 13vPnC/PPSV23
13vPnC and PPSV23
Biological: 13vPnC
Pneumococcal conjugate vaccine

Biological: PPSV23
Pneumococcal polysaccharide vaccine
Other Name: Pneumovax 23

Experimental: 50 through 59 years of age 20vPnC
20vPnC
Biological: 20vPnC
20vPnC

Experimental: 18 through 49 years of age 20vPnC
20vPnC
Biological: 20vPnC
20vPnC

Active Comparator: 50 through 59 years of age 13vPnC
13vPnC
Biological: 13vPnC
Pneumococcal conjugate vaccine

Active Comparator: 18 through 49 years of age 13vPnC
13vPnC
Biological: 13vPnC
Pneumococcal conjugate vaccine




Primary Outcome Measures :
  1. Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts [ Time Frame: Within 10 days after 20vPnC or 13vPnC ]
    Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. 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).

  2. Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts [ Time Frame: Within 7 days after 20vPnC or 13vPnC ]
    Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (>=) 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).

  3. Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts [ Time Frame: Within 1 month after 20vPnC or 13vPnC ]
    An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.

  4. Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts [ Time Frame: Within 6 months after 20vPnC or 13vPnC ]
    An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.

  5. Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts [ Time Frame: Within 6 months after 20vPnC or 13vPnC ]
    An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.

  6. Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population [ Time Frame: 1 month after Vaccination 1 ]
    OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.

  7. Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP) [ Time Frame: 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline"; 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23" ]
    OPA GMTs were determined for serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.


Secondary Outcome Measures :
  1. Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population [ Time Frame: 1 month after vaccination ]
    OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.

  2. Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population [ Time Frame: 1 month after vaccination ]
    OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA geometric mean and 2-sided 95% CIs were calculated.

  3. Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population [ Time Frame: Before Vaccination 1 to 1 month after Vaccination 1 ]
    OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

  4. Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population [ Time Frame: From before Vaccination 1 to 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or From before Vaccination 1 to 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23" ]
    OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.

  5. Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population [ Time Frame: Before vaccination to 1 month after vaccination ]
    OPA GMFR is the ratio of OPA GMT, 1 month after vaccination to before vaccination OPA GMT. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

  6. Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population [ Time Frame: Before Vaccination 1 to 1 month after Vaccination 1 ]
    Percentage of participants with a >=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

  7. Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP [ Time Frame: Before Vaccination 1 to 1 month after Vaccination 1 for "Cohort 1: 20vPnC/Saline"; Before Vaccination 1 to 1 month after Vaccination 2 for "Cohort 1: 13vPnC/PPSV23" ]
    Percentage of participants with a >=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.

  8. Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population [ Time Frame: Before vaccination to 1 month after vaccination ]
    Percentage of participants with a >=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

  9. Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population [ Time Frame: 1 month after Vaccination 1 ]
    The percentage of participants with OPA titers >=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

  10. Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population [ Time Frame: 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23" ]
    The percentage of participants with OPA titers >=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F.

  11. Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population [ Time Frame: 1 month after vaccination ]
    The percentage of participants with OPA titers >=LLOQ along with corresponding 2-sided 95% CIs were calculated 1 month after vaccination for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure were planned to be analyzed for the 20vPnC groups of Cohorts 2 and 3 only.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female adults >/= 18 years of age (from the 18th birthday) at enrollment and older.
  2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
  3. Negative urine pregnancy test at Visit1 for all subjects who are of childbearing potential.

Exclusion Criteria:

  1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
  2. History of microbiologically proven invasive disease caused by S pneumoniae.
  3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
  4. Pregnant female subjects or breastfeeding female subjects.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760146


Locations
Show Show 68 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] February 11, 2019
Statistical Analysis Plan  [PDF] November 25, 2019

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03760146    
Other Study ID Numbers: B7471007
2018-004279-11 ( EudraCT Number )
First Posted: November 30, 2018    Key Record Dates
Results First Posted: December 29, 2020
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs