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NCT04530838 Clinical Trial

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

Pneumococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04530838
Other study ID # B7471016
Secondary ID 2022-001146-38
Status Completed
Phase Phase 3
First received
Last updated
Start date September 16, 2020
Est. completion date April 2, 2022

Study information
Verified date March 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 668
Est. completion date April 2, 2022
Est. primary completion date April 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Months to 6 Months
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
• 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine

Locations
Country Name City State
Japan Yoshimura Child Clinic Akashi-City Hyogo
Japan Tsubaki Children's Clinic Chiba-shi Chiba
Japan Azuma kodomo katei clinic Ebetsu Shi Hokkaido
Japan Sakiyama Pediatric Clinic Fuchu-city Tokyo
Japan Fukui Aiiku Hospital Fukui-shi Fukui
Japan Fukazawa Clinic Fukuoka-City Fukuoka
Japan Inamitsu Children's Clinic Fukuoka-city Fukuoka
Japan Shindo children's clinic Fukuoka-city Fukuoka
Japan Shimomura Pediatrics Clinic Fukuoka-shi Fukuoka
Japan Sunrise Children's Clinic Funabashi-city Chiba
Japan Yajima Children's Clinic Gifu-city Gifu
Japan Hanyu General Hospital Hanyu-shi Saitama
Japan Iizuka Hospital Iizuka Fukuoka
Japan medical corporation Shigyo-no-kai Sotobo Children's Clinic Isumi-city Chiba
Japan Yokoyama Children'S Clinic Kasuga-city Fukuoka
Japan NHO Osaka Minami Medical Center Kawachinagano Osaka
Japan Morino Kodomo Clinic Kawasaki-shi Kanagawa
Japan Childrens clinic of Kose Kofu-city Yamanashi
Japan Enomoto Clinic Kumagaya-shi Saitama
Japan MIURA Children's Clinic Kumamoto Shi Kumamoto
Japan Sakuranbo Kodomo Clinic Kumamoto-shi Kumamoto
Japan Matsuda Pediatric Clinic Kuwana-city MIE
Japan Arakawa Family Clinic Nagano-shi Nagano
Japan NHO Nagoya Medical Center Nagoya-shi Aichi
Japan Saitoh-Clinic Nishitokyo-shi Tokyo
Japan Aizenbashi Hospital Osaka-City Osaka
Japan Saiseikai Shiga Hospital Ritto-Shi Shiga
Japan Nakata pediatric clinic Sapporo Hokkaido
Japan Nishi Sapporo Pediatrics Sapporo shi Hokkaido
Japan Inami Pediatrics Setagaya-ku Tokyo
Japan Sasamoto Children's Clinic Setagaya-ku Tokyo
Japan Futaba Clinic Shinjuku-ku Tokyo
Japan Tamura Clinic Suginami-ku Tokyo
Japan TOYOTA Memorial Hospital Toyota-shi Aichi
Japan Takei Clinic Tsuru-shi Yamanashi
Japan NHO Ureshino Medical center Ureshino-shi Saga
Japan NHO Shimoshizu National Hospital Yotsukaido-shi Chiba
Japan Sou Clinic Yotsukaido-shi Chiba

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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