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

A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections
• Intervention / Treatment: Biological: 13vPnC; Biological: Multivalent

Detailed Description

NOTE: Detailed description has not been entered.

• Study Type: Interventional
• Enrollment (Actual): 460
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Northwest Arkansas Pediatrics
  • California
    • Downey, California, United States, 90240
      • Premier Health Research Center, LLC
    • Huntington Beach, California, United States, 92648
      • St. Joseph Heritage Healthcare
    • Oakland, California, United States, 94611
      • Kaiser Permanente Oakland
    • Ontario, California, United States, 91762
      • Orange County Research Institute
    • Sacramento, California, United States, 95823
      • Kaiser Permanente South Sacramento
    • San Jose, California, United States, 95119
      • Kaiser Permanente San Jose
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Santa Clara
  • Louisiana
    • Haughton, Louisiana, United States, 71037
      • ACC Pediatric Research
    • Metairie, Louisiana, United States, 70006
      • MedPharmics, LLC
    • Shreveport, Louisiana, United States, 71103
      • University Health Shreveport
    • Shreveport, Louisiana, United States, 71103
      • LSUHSC Shreveport
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Children's Physicians, Creighton University Medical Center
  • New York
    • East Syracuse, New York, United States, 13057
      • Child Health Care Associates
  • North Carolina
    • Boone, North Carolina, United States, 28607
      • Blue Ridge Pediatric and Adolescent Medicine, Inc.
    • Raleigh, North Carolina, United States, 27609
      • Capitol Pediatrics & Adolescent Center PLLC
  • Ohio
    • Cincinnati, Ohio, United States, 45206
      • Cincinnati Children's Hospital Medical Center
    • Cincinnati, Ohio, United States, 45229-3039
      • Cincinnati Children's Hospital Medical Center
    • Cincinnati, Ohio, United States, 45245
      • Pediatric Associates of Mt. Carmel, Inc.
    • Cincinnati, Ohio, United States, 45206
      • Cincinnati Children's Medical Center
    • Cincinnati, Ohio, United States, 45225
      • Cincinnati Children's Hospital Medical Center
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association, Inc.
    • South Euclid, Ohio, United States, 44121
      • Senders Pediatrics
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74127
      • Oklahoma State University - Center for Health Sciences
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16506
      • Allegheny Health and Wellness Pavilion
    • Hermitage, Pennsylvania, United States, 16148
      • CCP - Kid's Way
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Associates
    • North Charleston, South Carolina, United States, 29406-9170
      • Palmetto Pediatrics, PA
  • Texas
    • Galveston, Texas, United States, 77555-1115
      • University of Texas Medical Branch
    • San Antonio, Texas, United States, 78240
      • Tekton Research, Inc.
  • Utah
    • Layton, Utah, United States, 84041
      • Wee Care Pediatrics
    • Murray, Utah, United States, 84107
      • Wasatch Pediatrics, Cottonwood Office
    • Roy, Utah, United States, 84067
      • Wee Care Pediatrics
    • South Jordan, Utah, United States, 84095
      • CopperView Medical Center
    • Syracuse, Utah, United States, 84075
      • Wee Care Pediatrics
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • Pediatric Research of Charlottesville, LLC
    • Charlottesville, Virginia, United States, 22902
      • Pediatric Associates of Charlottesville, PLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multivalent; Pneumococcal conjugate vaccines	Biological: Multivalent; Pneumococcal conjugate vaccine; Other Names: Pneumococcal conjugate vaccine
Active Comparator: Control; 13vPnC	Biological: 13vPnC; Pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Within 7 days after Vaccination 1
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).	Within 7 days after Vaccination 2
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).	Within 7 days after Vaccination 3
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).	Within 7 days after Vaccination 4
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).	Within 7 days after Vaccination 1
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).	Within 7 days after Vaccination 2
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).	Within 7 days after Vaccination 3
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).	Within 7 days after Vaccination 4
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.	From Vaccination 1 to 1 month after Vaccination 3 (up to 5 months)
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.	From Vaccination 4 to 1 month after Vaccination 4
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.	From Vaccination 1 to 6 months after Vaccination 4 (up to 16 months)
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.	From Vaccination 1 to 6 months after Vaccination 4 (duration of 16 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month after Vaccination 3
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.	1 month after Vaccination 3
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.	1 Month after Vaccination 4

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): February 11, 2020
• Study Completion (Actual): February 11, 2020

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): April 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 27, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: B7471003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No