20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

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

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

Study Overview

• Status: Completed
• Conditions: Pneumococcal Disease
• Intervention / Treatment: Biological: 20-valent pneumococcal conjugate vaccine; Biological: 13-valent pneumococcal conjugate vaccine

• Study Type: Interventional
• Enrollment (Actual): 668
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 460-0001
      • NHO Nagoya Medical Center
    • Toyota-shi, Aichi, Japan, 471-8513
      • Toyota Memorial Hospital
  • Chiba
    • Chiba-shi, Chiba, Japan, 260-0001
      • Tsubaki Children's Clinic
    • Funabashi-city, Chiba, Japan, 273-0035
      • Sunrise Children's Clinic
    • Isumi-city, Chiba, Japan, 299-4503
      • medical corporation Shigyo-no-kai Sotobo Children's Clinic
    • Yotsukaido-shi, Chiba, Japan, 284-0001
      • Sou Clinic
    • Yotsukaido-shi, Chiba, Japan, 284-0003
      • NHO Shimoshizu National Hospital
  • Fukui
    • Fukui-shi, Fukui, Japan, 910-0833
      • Fukui Aiiku Hospital
  • Fukuoka
    • Fukuoka-City, Fukuoka, Japan, 813-0036
      • Fukazawa Clinic
    • Fukuoka-city, Fukuoka, Japan, 814-0121
      • Shindo Children's Clinic
    • Fukuoka-city, Fukuoka, Japan, 819-0041
      • Inamitsu Children's Clinic
    • Fukuoka-shi, Fukuoka, Japan, 819-0002
      • Shimomura Pediatrics Clinic
    • Iizuka, Fukuoka, Japan, 820-8505
      • Iizuka Hospital
    • Kasuga-city, Fukuoka, Japan, 816-0801
      • Yokoyama Children'S Clinic
  • Gifu
    • Gifu-city, Gifu, Japan, 500-8212
      • Yajima Children's Clinic
  • Hokkaido
    • Ebetsu Shi, Hokkaido, Japan, 069-0816
      • Azuma kodomo katei clinic
    • Sapporo, Hokkaido, Japan, 003-0023
      • Nakata pediatric clinic
    • Sapporo shi, Hokkaido, Japan, 0630061
      • Nishi Sapporo Pediatrics
  • Hyōgo
    • Akashi-City, Hyōgo, Japan, 674-0068
      • Yoshimura Child Clinic
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 211-0063
      • Morino Kodomo Clinic
  • Kumamoto
    • Kumamoto Shi, Kumamoto, Japan, 862-0960
      • MIURA Children's Clinic
    • Kumamoto-shi, Kumamoto, Japan, 862-0924
      • Sakuranbo Kodomo Clinic
  • MIE
    • Kuwana-city, MIE, Japan, 511-0865
      • Matsuda Pediatric Clinic
  • Nagano
    • Nagano-shi, Nagano, Japan, 381-0025
      • Arakawa Family Clinic
  • Osaka
    • Kawachinagano, Osaka, Japan, 586-8521
      • NHO Osaka Minami Medical Center
    • Osaka-City, Osaka, Japan, 556-0005
      • Aizenbashi Hospital
  • Saga
    • Ureshino-shi, Saga, Japan, 843-0393
      • NHO Ureshino Medical Center
  • Saitama
    • Hanyu-shi, Saitama, Japan, 348-0045
      • Hanyu General Hospital
    • Kumagaya-shi, Saitama, Japan, 360-0018
      • Enomoto Clinic
  • Shiga
    • Ritto-Shi, Shiga, Japan, 520-3046
      • Saiseikai Shiga Hospital
  • Tokyo
    • Fuchu-city, Tokyo, Japan, 183-0042
      • Sakiyama Pediatric Clinic
    • Nishitokyo-shi, Tokyo, Japan, 202-0004
      • Saitoh-Clinic
    • Setagaya-ku, Tokyo, Japan, 154-0002
      • Inami Pediatrics
    • Setagaya-ku, Tokyo, Japan, 157-0066
      • Sasamoto Children's Clinic
    • Shinjuku-ku, Tokyo, Japan, 160-0017
      • Futaba Clinic
    • Suginami-ku, Tokyo, Japan, 167-0052
      • Tamura Clinic
  • Yamanashi
    • Kofu-city, Yamanashi, Japan, 400-0853
      • Childrens Clinic of Kose
    • Tsuru-shi, Yamanashi, Japan, 402-0025
      • Takei Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 6 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20-valent pneumococcal conjugate vaccine (subcutaneous); 20-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)	Biological: 20-valent pneumococcal conjugate vaccine; 20-valent pneumococcal conjugate vaccine
Active Comparator: 13-valent pneumococcal conjugate vaccine (subcutaneous); 13-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)	Biological: 13-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Experimental: 20-valent pneumococcal conjugate vaccine (intramuscular); 20-valent pneumococcal conjugate vaccine administered by intramuscular injection (IM)	Biological: 20-valent pneumococcal conjugate vaccine; 20-valent pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 7 Days after Dose 1
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.	Within 7 Days after Dose 2
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.	Within 7 Days after Dose 3
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.	Within 7 Days after Dose 4
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).	Within 7 Days After Dose 1
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).	Within 7 Days After Dose 2
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).	Within 7 Days After Dose 3
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).	Within 7 Days After Dose 4
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.	Day 1 of Dose 1 to 1 Month after Dose 3
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.	From Dose 4 to 1 Month after Dose 4
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.	From Dose 1 to 1 Month after Dose 4
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.	From Dose 1 to 1 Month after Dose 4
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).	1 Month after Dose 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Month after Dose 3
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.	1 Month after Dose 4
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.	1 Month after Dose 3, before Dose 4 and 1 Month after Dose 4
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).	1 Month after Dose 4
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.	1 Month after Dose 3 to before Dose 4
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.	From 1 Month after Dose 3 to 1 Month after Dose 4
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.	From before Dose 4 to 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): September 16, 2020
• Primary Completion (Actual): April 2, 2022
• Study Completion (Actual): April 2, 2022

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

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; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: B7471016; 2022-001146-38 (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
• product manufactured in and exported from the U.S.: Yes