Clinical trial NCT04530838: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-08-28
Enrollment: 668
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1
timeFrame: Within 7 Days after Dose 1
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 2
timeFrame: Within 7 Days after Dose 2
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 3
timeFrame: Within 7 Days after Dose 3
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 4
timeFrame: Within 7 Days after Dose 4
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 1
timeFrame: Within 7 Days After Dose 1
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 2
timeFrame: Within 7 Days After Dose 2
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 3
timeFrame: Within 7 Days After Dose 3
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 4
timeFrame: Within 7 Days After Dose 4
measure: Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3
timeFrame: Day 1 of Dose 1 to 1 Month after Dose 3
measure: Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4
timeFrame: From Dose 4 to 1 Month after Dose 4
measure: Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4
timeFrame: From Dose 1 to 1 Month after Dose 4
measure: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4
timeFrame: From Dose 1 to 1 Month after Dose 4
measure: Percentage of Participants With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3
timeFrame: 1 Month after Dose 3
Secondary outcomes:
measure: Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3
timeFrame: 1 Month after Dose 3
measure: Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4
timeFrame: 1 Month after Dose 4
measure: 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
timeFrame: 1 Month after Dose 3, before Dose 4 and 1 Month after Dose 4
measure: Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4
timeFrame: 1 Month after Dose 4
measure: Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4
timeFrame: 1 Month after Dose 3 to before Dose 4
measure: GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4
timeFrame: From 1 Month after Dose 3 to 1 Month after Dose 4
measure: GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4
timeFrame: From before Dose 4 to 1 Month after Dose 4
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center
state: Aichi
city: Toyota-shi
country: Japan
facility: TOYOTA Memorial Hospital
state: Aichi
city: Chiba-shi
country: Japan
facility: Tsubaki Children's Clinic
state: Chiba
city: Funabashi-city
country: Japan
facility: Sunrise Children's Clinic
state: Chiba
city: Isumi-city
country: Japan
facility: medical corporation Shigyo-no-kai Sotobo Children's Clinic
state: Chiba
city: Yotsukaido-shi
country: Japan
facility: Sou Clinic
state: Chiba
city: Yotsukaido-shi
country: Japan
facility: NHO Shimoshizu National Hospital
state: Chiba
city: Fukui-shi
country: Japan
facility: Fukui Aiiku Hospital
state: Fukui
city: Fukuoka-City
country: Japan
facility: Fukazawa Clinic
state: Fukuoka
city: Fukuoka-city
country: Japan
facility: Shindo children's clinic
state: Fukuoka
city: Fukuoka-city
country: Japan
facility: Inamitsu Children's Clinic
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Shimomura Pediatrics Clinic
state: Fukuoka
city: Iizuka
country: Japan
facility: Iizuka Hospital
state: Fukuoka
city: Kasuga-city
country: Japan
facility: Yokoyama Children'S Clinic
state: Fukuoka
city: Gifu-city
country: Japan
facility: Yajima Children's Clinic
state: Gifu
city: Ebetsu Shi
country: Japan
facility: Azuma kodomo katei clinic
state: Hokkaido
city: Sapporo shi
country: Japan
facility: Nishi Sapporo Pediatrics
state: Hokkaido
city: Sapporo
country: Japan
facility: Nakata pediatric clinic
state: Hokkaido
city: Akashi-City
country: Japan
facility: Yoshimura Child Clinic
state: Hyōgo
city: Kawasaki-shi
country: Japan
facility: Morino Kodomo Clinic
state: Kanagawa
city: Kumamoto Shi
country: Japan
facility: MIURA Children's Clinic
state: Kumamoto
city: Kumamoto-shi
country: Japan
facility: Sakuranbo Kodomo Clinic
state: Kumamoto
city: Kuwana-city
country: Japan
facility: Matsuda Pediatric Clinic
state: MIE
city: Nagano-shi
country: Japan
facility: Arakawa Family Clinic
state: Nagano
city: Kawachinagano
country: Japan
facility: NHO Osaka Minami Medical Center
state: Osaka
city: Osaka-City
country: Japan
facility: Aizenbashi Hospital
state: Osaka
city: Ureshino-shi
country: Japan
facility: NHO Ureshino Medical center
state: Saga
city: Hanyu-shi
country: Japan
facility: Hanyu General Hospital
state: Saitama
city: Kumagaya-shi
country: Japan
facility: Enomoto Clinic
state: Saitama
city: Ritto-Shi
country: Japan
facility: Saiseikai Shiga Hospital
state: Shiga
city: Fuchu-city
country: Japan
facility: Sakiyama Pediatric Clinic
state: Tokyo
city: Nishitokyo-shi
country: Japan
facility: Saitoh-Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Inami Pediatrics
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Sasamoto Children's Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Futaba Clinic
state: Tokyo
city: Suginami-ku
country: Japan
facility: Tamura Clinic
state: Tokyo
city: Kofu-city
country: Japan
facility: Childrens clinic of Kose
state: Yamanashi
city: Tsuru-shi
country: Japan
facility: Takei Clinic
state: Yamanashi
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: