20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
- Conditions
- Pneumococcal Disease
- Interventions
- Biological: 13-valent pneumococcal conjugate vaccineBiological: 20-valent pneumococcal conjugate vaccine
- Registration Number
- NCT04530838
- Lead Sponsor
- Pfizer
- Brief Summary
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 668
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 13-valent pneumococcal conjugate vaccine (subcutaneous) 13-valent pneumococcal conjugate vaccine 13-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC) 20-valent pneumococcal conjugate vaccine (subcutaneous) 20-valent pneumococcal conjugate vaccine 20-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC) 20-valent pneumococcal conjugate vaccine (intramuscular) 20-valent pneumococcal conjugate vaccine 20-valent pneumococcal conjugate vaccine administered by intramuscular injection (IM)
- Primary Outcome Measures
Name Time Method Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1 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 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 Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 Day 1 of 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 Local Reactions Within 7 Days After Dose 4 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 3 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 Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4 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 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 Local Reactions Within 7 Days After Dose 3 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 Systemic Events Within 7 Days After Dose 1 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 4 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 Systemic Events Within 7 Days After Dose 2 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 AEs From Dose 4 to 1 Month After Dose 4 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 Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 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
Name Time Method Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 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 Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4 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.
GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4 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.
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 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.
Percentage of Participants With Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 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).
GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 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.
Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4 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.
Trial Locations
- Locations (38)
Inami Pediatrics
🇯🇵Setagaya-ku, Tokyo, Japan
Saitoh-Clinic
🇯🇵Nishitokyo-shi, Tokyo, Japan
Futaba Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Sakiyama Pediatric Clinic
🇯🇵Fuchu-city, Tokyo, Japan
Tamura Clinic
🇯🇵Suginami-ku, Tokyo, Japan
Shindo children's clinic
🇯🇵Fukuoka-city, Fukuoka, Japan
Iizuka Hospital
🇯🇵Iizuka, Fukuoka, Japan
NHO Nagoya Medical Center
🇯🇵Nagoya-shi, Aichi, Japan
Sunrise Children's Clinic
🇯🇵Funabashi-city, Chiba, Japan
TOYOTA Memorial Hospital
🇯🇵Toyota-shi, Aichi, Japan
Tsubaki Children's Clinic
🇯🇵Chiba-shi, Chiba, Japan
NHO Shimoshizu National Hospital
🇯🇵Yotsukaido-shi, Chiba, Japan
Fukui Aiiku Hospital
🇯🇵Fukui-shi, Fukui, Japan
medical corporation Shigyo-no-kai Sotobo Children's Clinic
🇯🇵Isumi-city, Chiba, Japan
Sou Clinic
🇯🇵Yotsukaido-shi, Chiba, Japan
Fukazawa Clinic
🇯🇵Fukuoka-City, Fukuoka, Japan
Inamitsu Children's Clinic
🇯🇵Fukuoka-city, Fukuoka, Japan
Yajima Children's Clinic
🇯🇵Gifu-city, Gifu, Japan
Shimomura Pediatrics Clinic
🇯🇵Fukuoka-shi, Fukuoka, Japan
Azuma kodomo katei clinic
🇯🇵Ebetsu Shi, Hokkaido, Japan
Yokoyama Children'S Clinic
🇯🇵Kasuga-city, Fukuoka, Japan
Nishi Sapporo Pediatrics
🇯🇵Sapporo shi, Hokkaido, Japan
Nakata pediatric clinic
🇯🇵Sapporo, Hokkaido, Japan
MIURA Children's Clinic
🇯🇵Kumamoto Shi, Kumamoto, Japan
Yoshimura Child Clinic
🇯🇵Akashi-City, Hyōgo, Japan
Sakuranbo Kodomo Clinic
🇯🇵Kumamoto-shi, Kumamoto, Japan
Arakawa Family Clinic
🇯🇵Nagano-shi, Nagano, Japan
NHO Osaka Minami Medical Center
🇯🇵Kawachinagano, Osaka, Japan
Aizenbashi Hospital
🇯🇵Osaka-City, Osaka, Japan
Morino Kodomo Clinic
🇯🇵Kawasaki-shi, Kanagawa, Japan
NHO Ureshino Medical center
🇯🇵Ureshino-shi, Saga, Japan
Matsuda Pediatric Clinic
🇯🇵Kuwana-city, MIE, Japan
Saiseikai Shiga Hospital
🇯🇵Ritto-Shi, Shiga, Japan
Hanyu General Hospital
🇯🇵Hanyu-shi, Saitama, Japan
Enomoto Clinic
🇯🇵Kumagaya-shi, Saitama, Japan
Childrens clinic of Kose
🇯🇵Kofu-city, Yamanashi, Japan
Sasamoto Children's Clinic
🇯🇵Setagaya-ku, Tokyo, Japan
Takei Clinic
🇯🇵Tsuru-shi, Yamanashi, Japan