Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants

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

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).

Study Overview

• Status: Terminated
• Conditions: Pneumococcal Infections
• Intervention / Treatment: Biological: Multivalent; Biological: Prevnar 13

• Study Type: Interventional
• Enrollment (Actual): 565
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36607
      • Mobile Pediatric Clinic
  • Arkansas
    • Harrisburg, Arkansas, United States, 72432
      • Harrisburg Family Medical Center
  • California
    • Anaheim, California, United States, 92804
      • Emmaus Research Center, Inc.
    • Huntington Beach, California, United States, 92648
      • Hoag Memorial Hospital Presbyterian
    • Madera, California, United States, 93637
      • Madera Family Medical Group
    • Ontario, California, United States, 91762
      • Orange County Research Institute
    • Paramount, California, United States, 90723
      • Center for Clinical Trials, LLC
    • Paramount, California, United States, 90723
      • Center for Clinical Trials
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Gentle Medicine Associates
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • Homestead, Florida, United States, 33030
      • Next Phase Research Alliance
    • Miami, Florida, United States, 33184
      • Bio-Medical Research, LLC
    • Miami, Florida, United States, 33142
      • Acevedo Clinical Research Associates
    • Miami Lakes, Florida, United States, 33014
      • Crystal Biomedical Research, LLC
  • Georgia
    • Columbus, Georgia, United States, 31903
      • IACT Health
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Advocate Children's Hospital
  • Indiana
    • Mishawaka, Indiana, United States, 46544
      • MOC Research
  • Kentucky
    • Lexington, Kentucky, United States, 40517
      • Michael W. Simon, MD, PSC
    • Louisville, Kentucky, United States, 40243
      • All Children Pediatrics
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70806
      • Meridian Clinical Research, LLC
    • Metairie, Louisiana, United States, 70006
      • MedPharmics, LLC
    • Shreveport, Louisiana, United States, 71103
      • LSUHSC-Shreveport
    • Shreveport, Louisiana, United States, 71103
      • Ochsner-LSU Health Shreveport
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Floating Hospital for Children at Tufts Medical Center
    • Boston, Massachusetts, United States, 02111
      • Pediatric Phlebotomy
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center IDS - Pharmacy
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Children's Mercy Clinics on Broadway
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Children's Physicians Embassy Park
    • Omaha, Nebraska, United States, 68117
      • Children's Physicians Spring Valley
    • Omaha, Nebraska, United States, 68131
      • Creighton University Clinical Research Office
  • 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
  • Ohio
    • Dayton, Ohio, United States, 45409
      • Sugarcamp Family Research
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16506
      • Allegheny Health and Wellness Pavilion
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research
    • Greenville, South Carolina, United States, 29607
      • Parkside Pediatrics
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford Children's Specialty Clinic
    • Sioux Falls, South Dakota, United States, 57108
      • Sanford 69th & Louise Family Medicine
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford Research
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
  • Texas
    • Houston, Texas, United States, 77087
      • Pediatric Associates
    • Houston, Texas, United States, 77008
      • Ventavia Research Group
    • Houston, Texas, United States, 77054
      • Mercury Clinical Research
    • Keller, Texas, United States, 76248
      • Ventavia Research Group
    • San Antonio, Texas, United States, 78240
      • Tekton Research, Inc.
    • Spring, Texas, United States, 77389
      • Ventavia Research Group, LLC
  • Utah
    • Saint George, Utah, United States, 84790
      • Dixie Pediatrics
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Marshall Health

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1 - Coadministration; Multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13	Biological: Multivalent; Pneumococcal conjugate vaccine; Other Names: Pneumococcal conjugate vaccine; Biological: Prevnar 13; Pneumococcal conjugate vaccine
EXPERIMENTAL: Group 2 - Staggered Administration; Multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13	Biological: Multivalent; Pneumococcal conjugate vaccine; Other Names: Pneumococcal conjugate vaccine; Biological: Prevnar 13; Pneumococcal conjugate vaccine
ACTIVE_COMPARATOR: Group 3 - Control with Supplemental Dose; Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine	Biological: Multivalent; Pneumococcal conjugate vaccine; Other Names: Pneumococcal conjugate vaccine; Biological: Prevnar 13; 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 Dose 1	Local reactions were recorded using an electronic diary (e-diary) by participant's legally acceptable representative (LAR). 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 (greater than [>] 0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).	Within 7 Days After Dose 1
Percentage of Participants With Local Reactions Within 7 Days After Dose 2	Local reactions were recorded using an electronic diary by participant's LAR. 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 (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).	Within 7 Days After Dose 2
Percentage of Participants With Local Reactions Within 7 Days After Dose 3	Local reactions were recorded using an electronic diary by participant's LAR. 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 (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).	Within 7 Days After Dose 3
Percentage of Participants With Local Reactions Within 7 Days After Dose 4	Local reactions were recorded using an electronic diary by participant's LAR. 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 (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).	Within 7 Days After Dose 4
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD)	Local reactions were recorded using an electronic diary by participant's LAR. 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 (>0.0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7 cm). Pain at injection site was graded as mild (hurt if gently touched), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).	Within 7 Days After Supplemental Dose
Percentage of Participants With Systemic Events Within 7 Days After Dose 1	Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of greater than or equal to (>=) 38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. 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 (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).	Within 7 Days After Dose 1
Percentage of Participants With Systemic Events Within 7 Days After Dose 2	Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. 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 (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).	Within 7 Days After Dose 2
Percentage of Participants With Systemic Events Within 7 Days After Dose 3	Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. 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 (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).	Within 7 Days After Dose 3
Percentage of Participants With Systemic Events Within 7 Days After Dose 4	Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. 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 (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).	Within 7 Days After Dose 4
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose	Systemic events were recorded using an e-diary by participant's LAR and included fever, decreased appetite, drowsiness/increased sleep, and irritability. Fever was defined as rectal temperature of >=38.0 degree Celsius and categorized as >=38.0 to 38.4 degree Celsius,>38.4 to 38.9 degree Celsius, >38.9 to 40.0 degree Celsius and >40.0 degree Celsius. 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 (disabling, not interested in usual daily activity). Irritability: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted).	Within 7 Days After Supplemental Dose
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3	An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.	From Dose 1 to 1 Month After Dose 3 (up to duration of 5 months)
Percentage of Participants With Adverse Events (AEs) From Dose 4 to 1 Month After Dose 4	An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.	From Dose 4 to 1 Month After Dose 4 (up to duration of 1 month)
Percentage of Participants With Adverse Events (AEs) From Supplemental Dose to 1 Month After Supplemental Dose	An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.	From Supplemental Dose to 1 Month After Supplemental Dose (up to duration of 1 month)
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to End of the Study	An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect or that was considered to be an important medical event.	From Dose 1 to End of the Study (up to duration of 17 months)
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to End of the Study	An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long lasting in its effects.	From Dose 1 to End of the Study (up to duration of 17 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3	IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.	1 Month After Dose 3
Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3	Percentage of participants with pre-specified IgG concentration (>=0.35 microgram per milliliter) were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) at 1 month after Dose 3. Dose 3 was third dose of c7vPnC in Group 1 and Group 2, and third dose of Prevnar 13 in Group 3.	1 Month after Dose 3
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4	IgG GMCs were determined for each of 7 pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F ) at 1 month after Dose 4. Dose 4 was fourth dose of c7vPnC in Group 1 and Group 2, and fourth dose of Prevnar 13 in Group 3.	1 Month After Dose 4

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): November 5, 2020
• Study Completion (ACTUAL): November 5, 2020

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (ACTUAL): June 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 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: C3571002; 2020-005039-59 (EUDRACT_NUMBER)

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