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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225365

Enrollment

666

Registered

2020-08-27

Start date

2020-09-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Pneumococcal infection

Interventions

investigational material(s) Generic name etc : INN of investigational material : - Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : control material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
safety efficacy confirmatory - Local Reactions After Dose - Systemic Events After Dose - Adverse Events From Dose 1 to 1 Month After Dose 3 - Adverse Events From Dose 4 to 1 Month After Dose 4 - Serious Adverse Events From Dose 1 to 1 Month After Dose 4 - Newly Diagnosed Chronic Medical Conditions From Dose 1 to 1 Month After Dose 4 - Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3	—

Measure

Time frame

safety efficacy confirmatory - Local Reactions After Dose - Systemic Events After Dose - Adverse Events From Dose 1 to 1 Month After Dose 3 - Adverse Events From Dose 4 to 1 Month After Dose 4 - Serious Adverse Events From Dose 1 to 1 Month After Dose 4 - Newly Diagnosed Chronic Medical Conditions From Dose 1 to 1 Month After Dose 4 - Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3

—

Secondary

Measure	Time frame
efficacy - Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 - Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 - Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 - Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3 - Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at Before Dose 4 - Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 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 - GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 - GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4	—

Measure

Time frame

efficacy - Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3 - Pre-defined Pneumococcal Serotype-specific IgG Concentrations at 1 Month After Dose 4 - Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4 - Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3 - Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at Before Dose 4 - Geometric Mean Titer (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 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 - GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4 - GMFR in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to 1 Month After Dose 4

—

Countries

Japan

Contacts

Public ContactClinical Trials Information Desk

Pfizer R&D Japan G.K.

clinical-trials@pfizer.com+81-3-5309-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026