Clinical trial NCT03550313: Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants
Official title: A PHASE 2, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN WITH, OR SEPARATELY FROM, 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pneumococcal Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-06-08
Enrollment: 565
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine (Group 3).


Eligibility criteria: Inclusion Criteria:

* Male or female infant born at \>36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1).
* Healthy infant determined by medical history, physical examination, and clinical judgment.

Exclusion Criteria:

* Previous vaccination with licensed or investigational pneumococcal vaccine.
* Prior receipt of routine pediatric vaccines, with the exception of hepatitis B vaccine.
* Previous receipt of \>1 dose of hepatitis B vaccine.
* Prior hepatitis B vaccine must have been administered at age \<30 days.
* Major known congenital malformation or serious chronic disorder.
* Receipt of blood/plasma products or immunoglobulins.

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 1
timeFrame: Within 7 Days After Dose 1
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 2
timeFrame: Within 7 Days After Dose 2
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 3
timeFrame: Within 7 Days After Dose 3
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 4
timeFrame: Within 7 Days After Dose 4
measure: Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD)
timeFrame: Within 7 Days After Supplemental Dose
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 1
timeFrame: Within 7 Days After Dose 1
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 2
timeFrame: Within 7 Days After Dose 2
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 3
timeFrame: Within 7 Days After Dose 3
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 4
timeFrame: Within 7 Days After Dose 4
measure: Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose
timeFrame: Within 7 Days After Supplemental Dose
measure: Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
timeFrame: From Dose 1 to 1 Month After Dose 3 (up to duration of 5 months)
measure: Percentage of Participants With Adverse Events (AEs) From Dose 4 to 1 Month After Dose 4
timeFrame: From Dose 4 to 1 Month After Dose 4 (up to duration of 1 month)
measure: Percentage of Participants With Adverse Events (AEs) From Supplemental Dose to 1 Month After Supplemental Dose
timeFrame: From Supplemental Dose to 1 Month After Supplemental Dose (up to duration of 1 month)
measure: Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to End of the Study
timeFrame: From Dose 1 to End of the Study (up to duration of 17 months)
measure: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to End of the Study
timeFrame: From Dose 1 to End of the Study (up to duration of 17 months)
Secondary outcomes:
measure: Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3
timeFrame: 1 Month After Dose 3
measure: Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
timeFrame: 1 Month after Dose 3
measure: Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4
timeFrame: 1 Month After Dose 4
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mobile Pediatric Clinic
state: Alabama
city: Harrisburg
country: United States
facility: Harrisburg Family Medical Center
state: Arkansas
city: Anaheim
country: United States
facility: Emmaus Research Center, Inc.
state: California
city: Huntington Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Ontario
country: United States
facility: Orange County Research Institute
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials
state: California
city: Boynton Beach
country: United States
facility: Gentle Medicine Associates
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Homestead
country: United States
facility: Next Phase Research Alliance
state: Florida
city: Miami Lakes
country: United States
facility: Crystal Biomedical Research, LLC
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research, LLC
state: Florida
city: Columbus
country: United States
facility: IACT Health
state: Georgia
city: Park Ridge
country: United States
facility: Advocate Children's Hospital
state: Illinois
city: Mishawaka
country: United States
facility: MOC Research
state: Indiana
city: Lexington
country: United States
facility: Michael W. Simon, MD, PSC
state: Kentucky
city: Louisville
country: United States
facility: All Children Pediatrics
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research, LLC
state: Louisiana
city: Metairie
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: Shreveport
country: United States
facility: LSUHSC-Shreveport
state: Louisiana
city: Shreveport
country: United States
facility: Ochsner-LSU Health Shreveport
state: Louisiana
city: Boston
country: United States
facility: Floating Hospital for Children at Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Pediatric Phlebotomy
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center IDS - Pharmacy
state: Massachusetts
city: Kansas City
country: United States
facility: Children's Mercy Clinics on Broadway
state: Missouri
city: Omaha
country: United States
facility: Children's Physicians Embassy Park
state: Nebraska
city: Omaha
country: United States
facility: Children's Physicians Spring Valley
state: Nebraska
city: Omaha
country: United States
facility: Creighton University Clinical Research Office
state: Nebraska
city: East Syracuse
country: United States
facility: Child Health care Associates
state: New York
city: Boone
country: United States
facility: Blue Ridge Pediatric and Adolescent Medicine, Inc
state: North Carolina
city: Dayton
country: United States
facility: Sugarcamp Family Research
state: Ohio
city: Erie
country: United States
facility: Allegheny Health and Wellness Pavilion
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Greenville
country: United States
facility: Parkside Pediatrics
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Children's Specialty Clinic
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford Research
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford 69th & Louise Family Medicine
state: South Dakota
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Houston
country: United States
facility: Ventavia Research Group
state: Texas
city: Houston
country: United States
facility: Mercury Clinical Research
state: Texas
city: Houston
country: United States
facility: Pediatric Associates
state: Texas
city: Keller
country: United States
facility: Ventavia Research Group
state: Texas
city: San Antonio
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Spring
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Saint George
country: United States
facility: Dixie Pediatrics
state: Utah
city: Huntington
country: United States
facility: Marshall Health
state: West Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: