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C4931004 - A Phase 3, Randomized Double-Blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Catch-Up Vaccination Regimen of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Children and Adolescents

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523445-10-00
Enrollment
480
Registered
2026-09-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-28

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

Conditions

Pneumoccoccal Immunisation

Brief summary

Prespecified local reactions (redness, swelling, and pain at the injection site), Prespecified systemic events: 1) ≥15 to <24 months of age (Cohort 1): Fever, decreased appetite, drowsiness/increased sleep, and irritability 2) ≥2 to <18 years of age (Cohort 2 and 3): Fever, fatigue, headache, muscle pain, and joint pain., AEs and SAEs, Pneumococcal serotype-specific IgG concentrations, Pneumococcal serotype-specific OPA titers.

Detailed description

Pneumococcal serotype-specific IgG concentrations, Pneumococcal serotype-specific OPA titers.

Interventions

DRUGPrevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent
DRUGadsorbed)
DRUGPF-07872412

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Prespecified local reactions (redness, swelling, and pain at the injection site), Prespecified systemic events: 1) ≥15 to <24 months of age (Cohort 1): Fever, decreased appetite, drowsiness/increased sleep, and irritability 2) ≥2 to <18 years of age (Cohort 2 and 3): Fever, fatigue, headache, muscle pain, and joint pain., AEs and SAEs, Pneumococcal serotype-specific IgG concentrations, Pneumococcal serotype-specific OPA titers.—

Secondary

MeasureTime frame
Pneumococcal serotype-specific IgG concentrations, Pneumococcal serotype-specific OPA titers.—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 29, 2026