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

Phase 3
Completed
Conditions
Pneumococcal Disease
Interventions
Biological: 13-valent pneumococcal conjugate vaccine
Biological: 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
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
13-valent pneumococcal conjugate vaccine (subcutaneous)13-valent pneumococcal conjugate vaccine13-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)
20-valent pneumococcal conjugate vaccine (subcutaneous)20-valent pneumococcal conjugate vaccine20-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)
20-valent pneumococcal conjugate vaccine (intramuscular)20-valent pneumococcal conjugate vaccine20-valent pneumococcal conjugate vaccine administered by intramuscular injection (IM)
Primary Outcome Measures
NameTimeMethod
Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1Within 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 2Within 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 3Day 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 4Within 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 3Within 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 4From 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 4From 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 3Within 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 1Within 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 4Within 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 2Within 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 4From 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 31 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
NameTimeMethod
Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 31 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 41 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 4From 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 41 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 41 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 4From 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 41 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

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