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

NCT04530838 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: B74710162022-001146-38
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 38

Brief Summary

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

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (7)

• Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3

  1 Month after Dose 3

• Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4

  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

  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

  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

  1 Month after Dose 3 to before Dose 4

Study Arms (3)

20-valent pneumococcal conjugate vaccine (subcutaneous)

EXPERIMENTAL

20-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)

Biological: 20-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine (subcutaneous)

ACTIVE COMPARATOR

13-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)

Biological: 13-valent pneumococcal conjugate vaccine

20-valent pneumococcal conjugate vaccine (intramuscular)

EXPERIMENTAL

20-valent pneumococcal conjugate vaccine administered by intramuscular injection (IM)

Biological: 20-valent pneumococcal conjugate vaccine

Interventions

20-valent pneumococcal conjugate vaccine BIOLOGICAL

20-valent pneumococcal conjugate vaccine

20-valent pneumococcal conjugate vaccine (intramuscular); 20-valent pneumococcal conjugate vaccine (subcutaneous)

13-valent pneumococcal conjugate vaccine BIOLOGICAL

13-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine (subcutaneous)

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (38)

NHO Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

TOYOTA Memorial Hospital

Toyota-shi, Aichi-ken, 471-8513, Japan

Location

Tsubaki Children's Clinic

Chiba, Chiba, 260-0001, Japan

Location

Sunrise Children's Clinic

Funabashi, Chiba, 273-0035, Japan

Location

medical corporation Shigyo-no-kai Sotobo Children's Clinic

Isumi, Chiba, 299-4503, Japan

Location

Sou Clinic

Yotsukaido-shi, Chiba, 284-0001, Japan

Location

NHO Shimoshizu National Hospital

Yotsukaido-shi, Chiba, 284-0003, Japan

Location

Fukui Aiiku Hospital

Fukui-shi, Fukui, 910-0833, Japan

Location

Fukazawa Clinic

Fukuoka, Fukuoka, 813-0036, Japan

Location

Shindo children's clinic

Fukuoka, Fukuoka, 814-0121, Japan

Location

Shimomura Pediatrics Clinic

Fukuoka, Fukuoka, 819-0002, Japan

Location

Inamitsu Children's Clinic

Fukuoka, Fukuoka, 819-0041, Japan

Location

Iizuka Hospital

Iizuka, Fukuoka, 820-8505, Japan

Location

Yokoyama Children'S Clinic

Kasuga, Fukuoka, 816-0801, Japan

Location

Yajima Children's Clinic

Gifu, Gifu, 500-8212, Japan

Location

Azuma kodomo katei clinic

Ebetsu Shi, Hokkaido, 069-0816, Japan

Location

Nakata pediatric clinic

Sapporo, Hokkaido, 003-0023, Japan

Location

Nishi Sapporo Pediatrics

Sapporo, Hokkaido, 0630061, Japan

Location

Yoshimura Child Clinic

Akashi, Hyōgo, 674-0068, Japan

Location

Morino Kodomo Clinic

Kawasaki-shi, Kanagawa, 211-0063, Japan

Location

Sakuranbo Kodomo Clinic

Kumamoto, Kumamoto, 862-0924, Japan

Location

MIURA Children's Clinic

Kumamoto, Kumamoto, 862-0960, Japan

Location

Matsuda Pediatric Clinic

Kuwana, Mie-ken, 511-0865, Japan

Location

Arakawa Family Clinic

Nagano, Nagano, 381-0025, Japan

Location

NHO Osaka Minami Medical Center

Kawachi-Nagano, Osaka, 586-8521, Japan

Location

Aizenbashi Hospital

Osaka, Osaka, 556-0005, Japan

Location

NHO Ureshino Medical center

Ureshino-shi, Saga-ken, 843-0393, Japan

Location

Hanyu General Hospital

Hanyu-shi, Saitama, 348-0045, Japan

Location

Enomoto Clinic

Kumagaya-shi, Saitama, 360-0018, Japan

Location

Saiseikai Shiga Hospital

Ritto-Shi, Shiga, 520-3046, Japan

Location

Sakiyama Pediatric Clinic

Fuchū, Tokyo, 183-0042, Japan

Location

Saitoh-Clinic

Nishi-Tokyo-shi, Tokyo, 202-0004, Japan

Location

Inami Pediatrics

Setagaya-ku, Tokyo, 154-0002, Japan

Location

Sasamoto Children's Clinic

Setagaya-ku, Tokyo, 157-0066, Japan

Location

Futaba Clinic

Shinjuku-ku, Tokyo, 160-0017, Japan

Location

Tamura Clinic

Suginami-ku, Tokyo, 167-0052, Japan

Location

Childrens clinic of Kose

Kofu, Yamanashi, 400-0853, Japan

Location

Takei Clinic

Tsuru-shi, Yamanashi, 402-0025, Japan

Location

Related Publications (1)

• Ishihara Y, Fukazawa M, Enomoto S, de Solom R, Yamaji M, Kline M, Aizawa M, Peng Y, Kogawara O, Giardina PC, Tamimi N, Gruber WC, Watson W. A phase 3 randomized study to evaluate safety and immunogenicity of 20-valent pneumococcal conjugate vaccine in healthy Japanese infants. Int J Infect Dis. 2024 Apr;141:106942. doi: 10.1016/j.ijid.2024.01.009. Epub 2024 Jan 17.

  PMID: 38242195 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: September 16, 2020
• Primary Completion: April 2, 2022
• Study Completion: April 2, 2022
• Last Updated: April 21, 2023
• Results First Posted: April 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (38)