Clinical trial NCT03512288: Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
Official title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumococcal Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-04-30
Enrollment: 460
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: A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants

Detailed description: NOTE: Detailed description has not been entered.

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 to be eligible for the study.

Exclusion Criteria:

* Previous vaccination with licensed or investigational pneumococcal vaccine.
* Prior receipt of diphtheria, tetanus, pertussis, or polio vaccines.
* 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 Vaccination 1
timeFrame: Within 7 days after Vaccination 1
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
timeFrame: Within 7 days after Vaccination 2
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
timeFrame: Within 7 days after Vaccination 3
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
timeFrame: Within 7 days after Vaccination 4
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
timeFrame: Within 7 days after Vaccination 1
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
timeFrame: Within 7 days after Vaccination 2
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
timeFrame: Within 7 days after Vaccination 3
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
timeFrame: Within 7 days after Vaccination 4
measure: Percentage of Participants With Adverse Events (AEs) From Vaccination 1 to 1 Month After Vaccination 3
timeFrame: From Vaccination 1 to 1 month after Vaccination 3 (up to 5 months)
measure: Percentage of Participants With Adverse Events (AEs) From Vaccination 4 to 1 Month After Vaccination 4
timeFrame: From Vaccination 4 to 1 month after Vaccination 4
measure: Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4
timeFrame: From Vaccination 1 to 6 months after Vaccination 4 (up to 16 months)
measure: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4
timeFrame: From Vaccination 1 to 6 months after Vaccination 4 (duration of 16 months)
Secondary outcomes:
measure: Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
timeFrame: 1 month after Vaccination 3
measure: Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
timeFrame: 1 month after Vaccination 3
measure: Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
timeFrame: 1 Month after Vaccination 4
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatrics
state: Arkansas
city: Downey
country: United States
facility: Premier Health Research Center, LLC
state: California
city: Huntington Beach
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland
state: California
city: Ontario
country: United States
facility: Orange County Research Institute
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente South Sacramento
state: California
city: San Jose
country: United States
facility: Kaiser Permanente San Jose
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara
state: California
city: Haughton
country: United States
facility: ACC Pediatric Research
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: University Health Shreveport
state: Louisiana
city: Omaha
country: United States
facility: Children's Physicians, Creighton University Medical Center
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: Raleigh
country: United States
facility: Capitol Pediatrics & Adolescent Center PLLC
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Pediatric Associates of Mt. Carmel, Inc.
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association, Inc.
state: Ohio
city: South Euclid
country: United States
facility: Senders Pediatrics
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma State University - Center for Health Sciences
state: Oklahoma
city: Erie
country: United States
facility: Allegheny Health and Wellness Pavilion
state: Pennsylvania
city: Hermitage
country: United States
facility: CCP - Kid's Way
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Pediatric Associates
state: South Carolina
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: North Charleston
country: United States
facility: Palmetto Pediatrics, PA
state: South Carolina
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: San Antonio
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Layton
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Murray
country: United States
facility: Wasatch Pediatrics, Cottonwood Office
state: Utah
city: Roy
country: United States
facility: Wee Care Pediatrics
state: Utah
city: South Jordan
country: United States
facility: CopperView Medical Center
state: Utah
city: Syracuse
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Associates of Charlottesville, PLC
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Senders S, Klein NP, Lamberth E, Thompson A, Drozd J, Trammel J, Peng Y, Giardina PC, Jansen KU, Gruber WC, Scott DA, Watson W. Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants in the United States. Pediatr Infect Dis J. 2021 Oct 1;40(10):944-951. doi: 10.1097/INF.0000000000003277.