Clinical trial NCT03313050: A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumococcal Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-10-18
Enrollment: 511
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination
timeFrame: within 14 days after vaccination
measure: Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination
timeFrame: within 14 days after vaccination
measure: Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination
timeFrame: within 14 days after vaccination
measure: Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination
timeFrame: within 14 days after vaccination
measure: Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
timeFrame: within 1 month after vaccination
measure: Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
timeFrame: within 1 month after vaccination
measure: Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
timeFrame: within 6 months after vaccination
measure: Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
timeFrame: within 6 months after vaccination
measure: Stage 1: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
timeFrame: within 6 months after vaccination
measure: Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
timeFrame: within 6 months after vaccination
measure: Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination
timeFrame: within 12 months after vaccination
measure: Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination
timeFrame: within 12 months after vaccination
Secondary outcomes:
measure: Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination
timeFrame: 1 month after vaccination
measure: Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination
timeFrame: within 1 month after vaccination
measure: Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination
timeFrame: before Vaccination to 1 month after Vaccination
measure: Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination
timeFrame: before Vaccination to 1 month after Vaccination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research LLC
state: Alabama
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Augusta
country: United States
facility: Augusta Family Practice
state: Kansas
city: Augusta
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Newton
country: United States
facility: Axtell Clinic, P.A.
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research LLC
state: Nebraska
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Goose Creek
country: United States
facility: Medical Research South, LLC
state: South Carolina
city: Salt Lake City
country: United States
facility: J. Lewis Research Incorporated, Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Incorporated/Foothill Family Clinic South
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.