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

Pneumococcal Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03313050
• Other study ID #: C3571001
• Status: Completed
• Phase: Phase 2
• Start date: October 12, 2017
• Est. completion date: May 24, 2019

Study information

• Verified date: May 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: May 24, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• Multivalent
Pneumococcal conjugate vaccine
• Tdap
Tetanus, diphtheria, acellular pertussis vaccine
• polysaccharide
23-valent pneumococcal polysaccharide vaccine

Locations

Country	Name	City	State
United States	Augusta Family Practice	Augusta	Kansas
United States	Heartland Research Associates, LLC	Augusta	Kansas
United States	Kentucky Pediatric/Adult Research	Bardstown	Kentucky
United States	Achieve Clinical Research LLC	Birmingham	Alabama
United States	Core Healthcare Group	Cerritos	California
United States	PMG Research of Charlotte, LLC	Charlotte	North Carolina
United States	Medical Research South, LLC	Goose Creek	South Carolina
United States	Axtell Clinic, P.A.	Newton	Kansas
United States	Heartland Research Associates, LLC	Newton	Kansas
United States	Meridian Clinical Research, LLC	Norfolk	Nebraska
United States	Meridian Clinical Research LLC	Omaha	Nebraska
United States	J. Lewis Research Incorporated, Foothill Family Clinic	Salt Lake City	Utah
United States	J. Lewis Research, Incorporated/Foothill Family Clinic South	Salt Lake City	Utah
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	Omega Medical Research	Warwick	Rhode Island
United States	Advanced Clinical Research	West Jordan	Utah
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 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.	1 month after vaccination
Secondary	Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 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.	within 1 month after vaccination
Secondary	Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-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.	before Vaccination to 1 month after Vaccination
Secondary	Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-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.	before Vaccination to 1 month after Vaccination

External Links

•   To obtain contact information for a study center near you, click here.