Back to results20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
Primary Purpose
Pneumococcal Disease
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Disease
Eligibility Criteria
Inclusion Criteria:
- Japanese male or female infants ≥2 months to ≤6 months at the time of consent.
- Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion Criteria:
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
- Major known congenital malformation or serious chronic disorder.
- History of microbiologically proven invasive disease caused by S pneumoniae.
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Sites / Locations
- NHO Nagoya Medical Center
- TOYOTA Memorial Hospital
- Tsubaki Children's Clinic
- Sunrise Children's Clinic
- medical corporation Shigyo-no-kai Sotobo Children's Clinic
- Sou Clinic
- NHO Shimoshizu National Hospital
- Fukui Aiiku Hospital
- Fukazawa Clinic
- Shindo children's clinic
- Inamitsu Children's Clinic
- Shimomura Pediatrics Clinic
- Iizuka Hospital
- Yokoyama Children'S Clinic
- Yajima Children's Clinic
- Azuma kodomo katei clinic
- Nishi Sapporo Pediatrics
- Nakata pediatric clinic
- Yoshimura Child Clinic
- Morino Kodomo Clinic
- MIURA Children's Clinic
- Sakuranbo Kodomo Clinic
- Matsuda Pediatric Clinic
- Arakawa Family Clinic
- NHO Osaka Minami Medical Center
- Aizenbashi Hospital
- NHO Ureshino Medical center
- Hanyu General Hospital
- Enomoto Clinic
- Saiseikai Shiga Hospital
- Sakiyama Pediatric Clinic
- Saitoh-Clinic
- Inami Pediatrics
- Sasamoto Children's Clinic
- Futaba Clinic
- Tamura Clinic
- Childrens clinic of Kose
- Takei Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
20-valent pneumococcal conjugate vaccine (subcutaneous)
13-valent pneumococcal conjugate vaccine (subcutaneous)
20-valent pneumococcal conjugate vaccine (intramuscular)
Arm Description
20-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)
13-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)
20-valent pneumococcal conjugate vaccine administered by intramuscular injection (IM)
Outcomes
Primary Outcome Measures
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1
Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature greater than or equal to (>=) 37.5 degree Celsius (C), and categorized as >=37.5 to 38.4 degree C, greater than (>)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 (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 included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 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 (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 included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 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 (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 included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 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 (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 adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4
A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events.
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4
An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects.
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Pneumococcal serotype-specific IgG Concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. The predefined levels, >=0.35 micrograms/mL for all serotypes except for serotypes 5 (>=0.23 micrograms/mL), 6B (>=0.10 micrograms/mL) and 19A (>=0.12 micrograms/mL).
Secondary Outcome Measures
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3
Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5*LLOQ.
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4
Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4
20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. OPA titers were determined in randomly selected subsets of sera from each vaccine group.
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4
Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The predefined levels, >=0.35 micrograms/mL for all serotypes except for serotypes 5 (>=0.23 micrograms/mL), 6B (>=0.10 micrograms/mL) and 19A (>=0.12 micrograms/mL).
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to before Dose 4 was reported from participants in Dose 3 evaluable immunogenicity population.
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to 1 month after Dose 4 was reported from participants in both the Dose 3 and Dose 4 evaluable immunogenicity population.
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from before Dose 4 to 1 month after Dose 4 was reported from participants in the Dose 4 evaluable immunogenicity population.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04530838
Brief Title
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
Official Title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY UNBLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY JAPANESE INFANTS
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
April 2, 2022 (Actual)
Study Completion Date
April 2, 2022 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
668 (Actual)
8. Arms, Groups, and Interventions
Arm Title
20-valent pneumococcal conjugate vaccine (subcutaneous)
Arm Type
Experimental
Arm Description
20-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)
Arm Title
13-valent pneumococcal conjugate vaccine (subcutaneous)
Arm Type
Active Comparator
Arm Description
13-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)
Arm Title
20-valent pneumococcal conjugate vaccine (intramuscular)
Arm Type
Experimental
Arm Description
20-valent pneumococcal conjugate vaccine administered by intramuscular injection (IM)
Intervention Type
Biological
Intervention Name(s)
20-valent pneumococcal conjugate vaccine
Intervention Description
20-valent pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
13-valent pneumococcal conjugate vaccine
Intervention Description
13-valent pneumococcal conjugate vaccine
Primary Outcome Measure Information:
Title
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1
Description
Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.
Time Frame
Within 7 Days after Dose 1
Title
Percentage of Participants With Local Reactions Within 7 Days After Dose 2
Description
Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.
Time Frame
Within 7 Days after Dose 2
Title
Percentage of Participants With Local Reactions Within 7 Days After Dose 3
Description
Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.
Time Frame
Within 7 Days after Dose 3
Title
Percentage of Participants With Local Reactions Within 7 Days After Dose 4
Description
Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm.
Time Frame
Within 7 Days after Dose 4
Title
Percentage of Participants With Systemic Events Within 7 Days After Dose 1
Description
Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature greater than or equal to (>=) 37.5 degree Celsius (C), and categorized as >=37.5 to 38.4 degree C, greater than (>)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 (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 included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 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 (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 included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 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 (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 included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degree C and categorized as >=37.5 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 (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 Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
Description
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time Frame
Day 1 of Dose 1 to 1 Month after Dose 3
Title
Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4
Description
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time Frame
From Dose 4 to 1 Month after Dose 4
Title
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4
Description
A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events.
Time Frame
From Dose 1 to 1 Month after Dose 4
Title
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4
Description
An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects.
Time Frame
From Dose 1 to 1 Month after Dose 4
Title
Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
Description
Pneumococcal serotype-specific IgG Concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. The predefined levels, >=0.35 micrograms/mL for all serotypes except for serotypes 5 (>=0.23 micrograms/mL), 6B (>=0.10 micrograms/mL) and 19A (>=0.12 micrograms/mL).
Time Frame
1 Month after Dose 3
Secondary Outcome Measure Information:
Title
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3
Description
Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5*LLOQ.
Time Frame
1 Month after Dose 3
Title
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4
Description
Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
Time Frame
1 Month after Dose 4
Title
Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4
Description
20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. OPA titers were determined in randomly selected subsets of sera from each vaccine group.
Time Frame
1 Month after Dose 3, before Dose 4 and 1 Month after Dose 4
Title
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4
Description
Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The predefined levels, >=0.35 micrograms/mL for all serotypes except for serotypes 5 (>=0.23 micrograms/mL), 6B (>=0.10 micrograms/mL) and 19A (>=0.12 micrograms/mL).
Time Frame
1 Month after Dose 4
Title
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4
Description
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to before Dose 4 was reported from participants in Dose 3 evaluable immunogenicity population.
Time Frame
1 Month after Dose 3 to before Dose 4
Title
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4
Description
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from 1 month after Dose 3 to 1 month after Dose 4 was reported from participants in both the Dose 3 and Dose 4 evaluable immunogenicity population.
Time Frame
From 1 Month after Dose 3 to 1 Month after Dose 4
Title
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4
Description
GMFR of pneumococcal 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The GMFR from before Dose 4 to 1 month after Dose 4 was reported from participants in the Dose 4 evaluable immunogenicity population.
Time Frame
From before Dose 4 to 1 Month after Dose 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Japanese male or female infants ≥2 months to ≤6 months at the time of consent.
Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion Criteria:
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
Major known congenital malformation or serious chronic disorder.
History of microbiologically proven invasive disease caused by S pneumoniae.
Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
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
NHO Nagoya Medical Center
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
TOYOTA Memorial Hospital
City
Toyota-shi
State/Province
Aichi
ZIP/Postal Code
471-8513
Country
Japan
Facility Name
Tsubaki Children's Clinic
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-0001
Country
Japan
Facility Name
Sunrise Children's Clinic
City
Funabashi-city
State/Province
Chiba
ZIP/Postal Code
273-0035
Country
Japan
Facility Name
medical corporation Shigyo-no-kai Sotobo Children's Clinic
City
Isumi-city
State/Province
Chiba
ZIP/Postal Code
299-4503
Country
Japan
Facility Name
Sou Clinic
City
Yotsukaido-shi
State/Province
Chiba
ZIP/Postal Code
284-0001
Country
Japan
Facility Name
NHO Shimoshizu National Hospital
City
Yotsukaido-shi
State/Province
Chiba
ZIP/Postal Code
284-0003
Country
Japan
Facility Name
Fukui Aiiku Hospital
City
Fukui-shi
State/Province
Fukui
ZIP/Postal Code
910-0833
Country
Japan
Facility Name
Fukazawa Clinic
City
Fukuoka-City
State/Province
Fukuoka
ZIP/Postal Code
813-0036
Country
Japan
Facility Name
Shindo children's clinic
City
Fukuoka-city
State/Province
Fukuoka
ZIP/Postal Code
814-0121
Country
Japan
Facility Name
Inamitsu Children's Clinic
City
Fukuoka-city
State/Province
Fukuoka
ZIP/Postal Code
819-0041
Country
Japan
Facility Name
Shimomura Pediatrics Clinic
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
819-0002
Country
Japan
Facility Name
Iizuka Hospital
City
Iizuka
State/Province
Fukuoka
ZIP/Postal Code
820-8505
Country
Japan
Facility Name
Yokoyama Children'S Clinic
City
Kasuga-city
State/Province
Fukuoka
ZIP/Postal Code
816-0801
Country
Japan
Facility Name
Yajima Children's Clinic
City
Gifu-city
State/Province
Gifu
ZIP/Postal Code
500-8212
Country
Japan
Facility Name
Azuma kodomo katei clinic
City
Ebetsu Shi
State/Province
Hokkaido
ZIP/Postal Code
069-0816
Country
Japan
Facility Name
Nishi Sapporo Pediatrics
City
Sapporo shi
State/Province
Hokkaido
ZIP/Postal Code
0630061
Country
Japan
Facility Name
Nakata pediatric clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0023
Country
Japan
Facility Name
Yoshimura Child Clinic
City
Akashi-City
State/Province
Hyōgo
ZIP/Postal Code
674-0068
Country
Japan
Facility Name
Morino Kodomo Clinic
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
211-0063
Country
Japan
Facility Name
MIURA Children's Clinic
City
Kumamoto Shi
State/Province
Kumamoto
ZIP/Postal Code
862-0960
Country
Japan
Facility Name
Sakuranbo Kodomo Clinic
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
862-0924
Country
Japan
Facility Name
Matsuda Pediatric Clinic
City
Kuwana-city
State/Province
MIE
ZIP/Postal Code
511-0865
Country
Japan
Facility Name
Arakawa Family Clinic
City
Nagano-shi
State/Province
Nagano
ZIP/Postal Code
381-0025
Country
Japan
Facility Name
NHO Osaka Minami Medical Center
City
Kawachinagano
State/Province
Osaka
ZIP/Postal Code
586-8521
Country
Japan
Facility Name
Aizenbashi Hospital
City
Osaka-City
State/Province
Osaka
ZIP/Postal Code
556-0005
Country
Japan
Facility Name
NHO Ureshino Medical center
City
Ureshino-shi
State/Province
Saga
ZIP/Postal Code
843-0393
Country
Japan
Facility Name
Hanyu General Hospital
City
Hanyu-shi
State/Province
Saitama
ZIP/Postal Code
348-0045
Country
Japan
Facility Name
Enomoto Clinic
City
Kumagaya-shi
State/Province
Saitama
ZIP/Postal Code
360-0018
Country
Japan
Facility Name
Saiseikai Shiga Hospital
City
Ritto-Shi
State/Province
Shiga
ZIP/Postal Code
520-3046
Country
Japan
Facility Name
Sakiyama Pediatric Clinic
City
Fuchu-city
State/Province
Tokyo
ZIP/Postal Code
183-0042
Country
Japan
Facility Name
Saitoh-Clinic
City
Nishitokyo-shi
State/Province
Tokyo
ZIP/Postal Code
202-0004
Country
Japan
Facility Name
Inami Pediatrics
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
154-0002
Country
Japan
Facility Name
Sasamoto Children's Clinic
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
157-0066
Country
Japan
Facility Name
Futaba Clinic
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0017
Country
Japan
Facility Name
Tamura Clinic
City
Suginami-ku
State/Province
Tokyo
ZIP/Postal Code
167-0052
Country
Japan
Facility Name
Childrens clinic of Kose
City
Kofu-city
State/Province
Yamanashi
ZIP/Postal Code
400-0853
Country
Japan
Facility Name
Takei Clinic
City
Tsuru-shi
State/Province
Yamanashi
ZIP/Postal Code
402-0025
Country
Japan
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=B7471016
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
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