A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
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
1 other identifier
interventional
511
1 country
18
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2017
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2017
CompletedStudy Start
First participant enrolled
October 12, 2017
CompletedFirst Posted
Study publicly available on registry
October 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2019
CompletedResults Posted
Study results publicly available
June 4, 2020
CompletedJune 4, 2020
May 1, 2020
1.6 years
October 10, 2017
May 15, 2020
May 15, 2020
Conditions
Outcome Measures
Primary Outcomes (12)
Stage 1: Percentage of Participants With Local Reactions 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.
within 14 days after vaccination
Stage 2: Percentage of Participants With Local Reactions 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.
within 14 days after vaccination
Stage 1: Percentage of Participants With Systemic Events 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.
within 14 days after vaccination
Stage 2: Percentage of Participants With Systemic Events 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.
within 14 days after vaccination
Stage 1: Percentage of Participants With Adverse Events (AEs) 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.
within 1 month after vaccination
Stage 2: Percentage of Participants With Adverse Events (AEs) 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.
within 1 month after vaccination
Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) 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.
within 6 months after vaccination
Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) 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.
within 6 months after vaccination
Stage 1: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) 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.
within 6 months after vaccination
Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) 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.
within 6 months after vaccination
Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) 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.
within 12 months after vaccination
Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) 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.
within 12 months after vaccination
Secondary Outcomes (4)
Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination
1 month after vaccination
Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination
within 1 month after vaccination
Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination
before Vaccination to 1 month after Vaccination
Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination
before Vaccination to 1 month after Vaccination
Study Arms (4)
Stage 1 multivalent (ages 50-64 years)
EXPERIMENTALmultivalent
Stage 1 Tdap (ages 50-64 years)
ACTIVE COMPARATORTdap
Stage 2 multivalent (ages 65-85 years)
EXPERIMENTALmultivalent
Stage 2 polysaccharide (ages 65-85 years)
ACTIVE COMPARATORpolysaccharide
Interventions
Pneumococcal conjugate vaccine
23-valent pneumococcal polysaccharide vaccine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (18)
Achieve Clinical Research LLC
Birmingham, Alabama, 35216, United States
Core Healthcare Group
Cerritos, California, 90703, United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406, United States
Augusta Family Practice
Augusta, Kansas, 67010, United States
Heartland Research Associates, LLC
Augusta, Kansas, 67010, United States
Axtell Clinic, P.A.
Newton, Kansas, 67114, United States
Heartland Research Associates, LLC
Newton, Kansas, 67114, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67205, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701, United States
Meridian Clinical Research LLC
Omaha, Nebraska, 68134, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Medical Research South, LLC
Goose Creek, South Carolina, 29445, United States
J. Lewis Research Incorporated, Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Incorporated/Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Related Publications (1)
Essink B, Peterson J, Yacisin K, Lal H, Mirza S, Xu X, Scully IL, Scott DA, Gruber WC, Jansen KU, Watson W. A randomized phase 1/2 study of the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in healthy adults 50 through 85 years of age. Hum Vaccin Immunother. 2021 Aug 3;17(8):2691-2699. doi: 10.1080/21645515.2021.1890511. Epub 2021 Mar 4.
PMID: 33661716DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Observer-blinded
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2017
First Posted
October 18, 2017
Study Start
October 12, 2017
Primary Completion
May 24, 2019
Study Completion
May 24, 2019
Last Updated
June 4, 2020
Results First Posted
June 4, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
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.