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

Primary Purpose

Pneumococcal Infections

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Multivalent
Prevnar 13
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.

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.

Sites / Locations

  • Mobile Pediatric Clinic
  • Harrisburg Family Medical Center
  • Emmaus Research Center, Inc.
  • Hoag Memorial Hospital Presbyterian
  • Madera Family Medical Group
  • Orange County Research Institute
  • Center for Clinical Trials, LLC
  • Center for Clinical Trials
  • Gentle Medicine Associates
  • Avail Clinical Research, LLC
  • Next Phase Research Alliance
  • Crystal Biomedical Research, LLC
  • Acevedo Clinical Research Associates
  • Bio-Medical Research, LLC
  • IACT Health
  • Advocate Children's Hospital
  • MOC Research
  • Michael W. Simon, MD, PSC
  • All Children Pediatrics
  • Meridian Clinical Research, LLC
  • MedPharmics, LLC
  • LSUHSC-Shreveport
  • Ochsner-LSU Health Shreveport
  • Floating Hospital for Children at Tufts Medical Center
  • Pediatric Phlebotomy
  • Tufts Medical Center IDS - Pharmacy
  • Children's Mercy Clinics on Broadway
  • Children's Physicians Embassy Park
  • Children's Physicians Spring Valley
  • Creighton University Clinical Research Office
  • Child Health care Associates
  • Blue Ridge Pediatric and Adolescent Medicine, Inc
  • Sugarcamp Family Research
  • Allegheny Health and Wellness Pavilion
  • Coastal Pediatric Research
  • Parkside Pediatrics
  • Sanford Children's Specialty Clinic
  • Sanford Research
  • Sanford 69th & Louise Family Medicine
  • Holston Medical Group
  • Ventavia Research Group
  • Mercury Clinical Research
  • Pediatric Associates
  • Ventavia Research Group
  • Tekton Research, Inc.
  • Ventavia Research Group, LLC
  • Dixie Pediatrics
  • Marshall Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Group 1 - Coadministration

Group 2 - Staggered Administration

Group 3 - Control with Supplemental Dose

Arm Description

Multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13

Multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13

Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 25, 2018
Last Updated
November 29, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03550313
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Study vaccinations and blood draws were halted due to adequacy of a smaller dataset and study feasibility issues. It was not based on any safety concerns.
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 5, 2020 (Actual)
Study Completion Date
November 5, 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
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).

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
None (Open Label)
Allocation
Randomized
Enrollment
565 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Coadministration
Arm Type
Experimental
Arm Description
Multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13
Arm Title
Group 2 - Staggered Administration
Arm Type
Experimental
Arm Description
Multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13
Arm Title
Group 3 - Control with Supplemental Dose
Arm Type
Active Comparator
Arm Description
Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine
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)
Prevnar 13
Intervention Description
Pneumococcal conjugate vaccine
Primary Outcome Measure Information:
Title
Percentage of Participants With Local Reactions Within 7 Days After Dose 1
Description
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).
Time Frame
Within 7 Days After Dose 1
Title
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Description
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).
Time Frame
Within 7 Days After Dose 2
Title
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Description
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).
Time Frame
Within 7 Days After Dose 3
Title
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Description
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).
Time Frame
Within 7 Days After Dose 4
Title
Percentage of Participants With Local Reactions Within 7 Days After Supplemental Dose (SD)
Description
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).
Time Frame
Within 7 Days After Supplemental Dose
Title
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Description
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).
Time Frame
Within 7 Days After Dose 1
Title
Percentage of Participants With Systemic Events Within 7 Days After Dose 2
Description
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).
Time Frame
Within 7 Days After Dose 2
Title
Percentage of Participants With Systemic Events Within 7 Days After Dose 3
Description
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).
Time Frame
Within 7 Days After Dose 3
Title
Percentage of Participants With Systemic Events Within 7 Days After Dose 4
Description
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).
Time Frame
Within 7 Days After Dose 4
Title
Percentage of Participants With Systemic Events Within 7 Days After Supplemental Dose
Description
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).
Time Frame
Within 7 Days After Supplemental Dose
Title
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
Description
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Time Frame
From Dose 1 to 1 Month After Dose 3 (up to duration of 5 months)
Title
Percentage of Participants With Adverse Events (AEs) From Dose 4 to 1 Month After Dose 4
Description
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Time Frame
From Dose 4 to 1 Month After Dose 4 (up to duration of 1 month)
Title
Percentage of Participants With Adverse Events (AEs) From Supplemental Dose to 1 Month After Supplemental Dose
Description
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Time Frame
From Supplemental Dose to 1 Month After Supplemental Dose (up to duration of 1 month)
Title
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to End of the Study
Description
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.
Time Frame
From Dose 1 to End of the Study (up to duration of 17 months)
Title
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to End of the Study
Description
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.
Time Frame
From Dose 1 to End of the Study (up to duration of 17 months)
Secondary Outcome Measure Information:
Title
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 3
Description
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.
Time Frame
1 Month After Dose 3
Title
Percentage of Participants Achieving Prespecified Level of Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Description
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.
Time Frame
1 Month after Dose 3
Title
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Dose 4
Description
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.
Time Frame
1 Month After Dose 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. 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.
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
Mobile Pediatric Clinic
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Facility Name
Harrisburg Family Medical Center
City
Harrisburg
State/Province
Arkansas
ZIP/Postal Code
72432
Country
United States
Facility Name
Emmaus Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Madera Family Medical Group
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Orange County Research Institute
City
Ontario
State/Province
California
ZIP/Postal Code
91762
Country
United States
Facility Name
Center for Clinical Trials, LLC
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Center for Clinical Trials
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Gentle Medicine Associates
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Next Phase Research Alliance
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Crystal Biomedical Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Acevedo Clinical Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
Bio-Medical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Facility Name
IACT Health
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31903
Country
United States
Facility Name
Advocate Children's Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
MOC Research
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46544
Country
United States
Facility Name
Michael W. Simon, MD, PSC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40517
Country
United States
Facility Name
All Children Pediatrics
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40243
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
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
Ochsner-LSU Health Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Floating Hospital for Children at Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Pediatric Phlebotomy
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Tufts Medical Center IDS - Pharmacy
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Children's Mercy Clinics on Broadway
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Children's Physicians Embassy Park
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Children's Physicians Spring Valley
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68117
Country
United States
Facility Name
Creighton University Clinical Research Office
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
Sugarcamp Family Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Allegheny Health and Wellness Pavilion
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
Coastal Pediatric Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Parkside Pediatrics
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Sanford Children's Specialty Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford Research
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford 69th & Louise Family Medicine
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Ventavia Research Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Mercury Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Pediatric Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77087
Country
United States
Facility Name
Ventavia Research Group
City
Keller
State/Province
Texas
ZIP/Postal Code
76248
Country
United States
Facility Name
Tekton Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Ventavia Research Group, LLC
City
Spring
State/Province
Texas
ZIP/Postal Code
77389
Country
United States
Facility Name
Dixie Pediatrics
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Marshall Health
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
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
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3571002
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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