C4801002 - A Phase 2, Randomized, Open-Label Trial to Describe the Safety and Immunogenicity of A Monovalent Pneumococcal Conjugate Candidate Administered As a 2-Dose Series in Healthy Toddlers 12 Through 15 Months of Age Who Previously Received PCV10 Primary Series in the European Union

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505154-18-00

Acronym

C4801002

Enrollment

100

Registered

2023-10-19

Start date

2023-11-02

Completion date

2024-05-27

Last updated

2024-04-03

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

Conditions

Pneumococcal Infections

Brief summary

Prompted local reactions (redness, swelling, and pain at the injection site), Prompted systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), Adverse events (AEs), Serious adverse events (SAEs)

Detailed description

Immunoglobulin G (IgG) concentrations for the candidate serotype, Opsonophagocytic activity (OPA) titers for the candidate serotype

Interventions

DRUGSynflorix suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (adsorbed)

DRUGPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Prompted local reactions (redness, swelling, and pain at the injection site), Prompted systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), Adverse events (AEs), Serious adverse events (SAEs)	—

Secondary

Measure	Time frame
Immunoglobulin G (IgG) concentrations for the candidate serotype, Opsonophagocytic activity (OPA) titers for the candidate serotype	—

Countries

Finland, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026