search
Back to results

Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Multivalent
13vPnC
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections

Eligibility Criteria

42 Days - 98 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northwest Arkansas Pediatrics
  • Premier Health Research Center, LLC
  • St. Joseph Heritage Healthcare
  • Kaiser Permanente Oakland
  • Orange County Research Institute
  • Kaiser Permanente South Sacramento
  • Kaiser Permanente San Jose
  • Kaiser Permanente Santa Clara
  • ACC Pediatric Research
  • MedPharmics, LLC
  • LSUHSC Shreveport
  • University Health Shreveport
  • Children's Physicians, Creighton University Medical Center
  • Child Health Care Associates
  • Blue Ridge Pediatric and Adolescent Medicine, Inc.
  • Capitol Pediatrics & Adolescent Center PLLC
  • Cincinnati Children's Hospital Medical Center
  • Cincinnati Children's Medical Center
  • Cincinnati Children's Hospital Medical Center
  • Cincinnati Children's Hospital Medical Center
  • Pediatric Associates of Mt. Carmel, Inc.
  • Ohio Pediatric Research Association, Inc.
  • Senders Pediatrics
  • Oklahoma State University - Center for Health Sciences
  • Allegheny Health and Wellness Pavilion
  • CCP - Kid's Way
  • Thomas Jefferson University
  • Coastal Pediatric Associates
  • Coastal Pediatric Research
  • Palmetto Pediatrics, PA
  • University of Texas Medical Branch
  • Tekton Research, Inc.
  • Wee Care Pediatrics
  • Wasatch Pediatrics, Cottonwood Office
  • Wee Care Pediatrics
  • CopperView Medical Center
  • Wee Care Pediatrics
  • Pediatric Associates of Charlottesville, PLC
  • Pediatric Research of Charlottesville, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multivalent

Control

Arm Description

Pneumococcal conjugate vaccines

13vPnC

Outcomes

Primary Outcome Measures

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. 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 (0.5 to 2.0 centimeter [cm]), moderate (greater than [>] 2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. 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 (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. 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 (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. 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 (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as greater than or equal to (>=) 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).
Percentage of Participants With Adverse Events (AEs) From Vaccination 1 to 1 Month After Vaccination 3
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship.
Percentage of Participants With Adverse Events (AEs) From Vaccination 4 to 1 Month After Vaccination 4
An AE was any untoward medical occurrence in study participant who received study vaccine without regard to possibility of causal relationship.
Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4
An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4
An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.

Secondary Outcome Measures

Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Pre-specified levels of serotypes were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 microgram per milliliter, for serotype 5: >=0.23 microgram per milliliter, for serotype 6B: >=0.10 microgram per milliliter and for serotype 19A: >=0.12 microgram per milliliter.
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

Full Information

First Posted
April 11, 2018
Last Updated
February 27, 2021
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT03512288
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
February 11, 2020 (Actual)
Study Completion Date
February 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multivalent
Arm Type
Experimental
Arm Description
Pneumococcal conjugate vaccines
Arm Title
Control
Arm Type
Active Comparator
Arm Description
13vPnC
Intervention Type
Biological
Intervention Name(s)
Multivalent
Other Intervention Name(s)
Pneumococcal conjugate vaccine
Intervention Description
Pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
13vPnC
Intervention Description
Pneumococcal conjugate vaccine
Primary Outcome Measure Information:
Title
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Description
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. 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 (0.5 to 2.0 centimeter [cm]), moderate (greater than [>] 2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Time Frame
Within 7 days after Vaccination 1
Title
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Description
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. 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 (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Time Frame
Within 7 days after Vaccination 2
Title
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Description
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. 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 (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Time Frame
Within 7 days after Vaccination 3
Title
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Description
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. 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 (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).
Time Frame
Within 7 days after Vaccination 4
Title
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Description
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as greater than or equal to (>=) 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).
Time Frame
Within 7 days after Vaccination 1
Title
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Description
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).
Time Frame
Within 7 days after Vaccination 2
Title
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Description
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).
Time Frame
Within 7 days after Vaccination 3
Title
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Description
Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).
Time Frame
Within 7 days after Vaccination 4
Title
Percentage of Participants With Adverse Events (AEs) From Vaccination 1 to 1 Month After Vaccination 3
Description
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship.
Time Frame
From Vaccination 1 to 1 month after Vaccination 3 (up to 5 months)
Title
Percentage of Participants With Adverse Events (AEs) From Vaccination 4 to 1 Month After Vaccination 4
Description
An AE was any untoward medical occurrence in study participant who received study vaccine without regard to possibility of causal relationship.
Time Frame
From Vaccination 4 to 1 month after Vaccination 4
Title
Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4
Description
An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.
Time Frame
From Vaccination 1 to 6 months after Vaccination 4 (up to 16 months)
Title
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4
Description
An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.
Time Frame
From Vaccination 1 to 6 months after Vaccination 4 (duration of 16 months)
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
Description
Pre-specified levels of serotypes were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 microgram per milliliter, for serotype 5: >=0.23 microgram per milliliter, for serotype 6B: >=0.10 microgram per milliliter and for serotype 19A: >=0.12 microgram per milliliter.
Time Frame
1 month after Vaccination 3
Title
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
Description
IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time Frame
1 month after Vaccination 3
Title
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
Description
IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time Frame
1 Month after Vaccination 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
98 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Northwest Arkansas Pediatrics
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Premier Health Research Center, LLC
City
Downey
State/Province
California
ZIP/Postal Code
90240
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Kaiser Permanente Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Orange County Research Institute
City
Ontario
State/Province
California
ZIP/Postal Code
91762
Country
United States
Facility Name
Kaiser Permanente South Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Kaiser Permanente San Jose
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
Kaiser Permanente Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
ACC Pediatric Research
City
Haughton
State/Province
Louisiana
ZIP/Postal Code
71037
Country
United States
Facility Name
MedPharmics, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
LSUHSC Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
University Health Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Children's Physicians, Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Child Health Care Associates
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Blue Ridge Pediatric and Adolescent Medicine, Inc.
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28607
Country
United States
Facility Name
Capitol Pediatrics & Adolescent Center PLLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
Cincinnati Children's Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45225
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Pediatric Associates of Mt. Carmel, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Ohio Pediatric Research Association, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Senders Pediatrics
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Oklahoma State University - Center for Health Sciences
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74127
Country
United States
Facility Name
Allegheny Health and Wellness Pavilion
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
CCP - Kid's Way
City
Hermitage
State/Province
Pennsylvania
ZIP/Postal Code
16148
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Coastal Pediatric Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Coastal Pediatric Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Palmetto Pediatrics, PA
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406-9170
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-1115
Country
United States
Facility Name
Tekton Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Wee Care Pediatrics
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Wasatch Pediatrics, Cottonwood Office
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Wee Care Pediatrics
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
Facility Name
CopperView Medical Center
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Wee Care Pediatrics
City
Syracuse
State/Province
Utah
ZIP/Postal Code
84075
Country
United States
Facility Name
Pediatric Associates of Charlottesville, PLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Pediatric Research of Charlottesville, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
34525007
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.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7471003
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants

We'll reach out to this number within 24 hrs