Rotarix (Pneumococcal disease Vaccine) — Pipeline & Regulatory Status

Category Resource

Explore licensed vaccines, adverse event reporting data, and history for this disease.

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Development Phase Phase 3 Clinical Trial Primary Status

Platform Technology Conjugate vaccine Biologic Architecture

Target Indication Pneumococcal disease Pathogen / Antigen

Last Verified 2026-07-10 Tier 1 Multi-Source Checked

Multi-Jurisdiction Regulatory Status

Official licensing, rolling submissions, or authorization status tracked across major health authorities.

Regulatory Authority	Status & Details
US FDA	Not Filed / Pre-submission
EMA (Europe)	Not Filed / Pre-submission
Health Canada	Not Filed / Pre-submission
TGA (Australia)	Not Filed / Pre-submission

Scientific Profile & Documentation

Platform Architecture: Conjugate vaccine
Lead Developer: Sanofi
Next Expected Milestone: Primary completion (most advanced trial): 2027-09-10 (registry estimate)
Analyst & Development Notes: Auto-grouped from 4 ClinicalTrials.gov record(s) sharing intervention/sponsor. Phases and timelines are registry fields and may lag company disclosures.
Primary Source Documentation: ClinicalTrials.gov NCT06824181 →
Additional Sources & Literature: NCT06975878 on ClinicalTrials.gov (2026-07-10)
NCT06824194 on ClinicalTrials.gov (2026-07-10)
NCT07348692 on ClinicalTrials.gov (2026-07-10)

Registered Clinical Trials & Studies

Direct registry links to active, completed, or pivotal registration studies across phases.

NCT06824181 Phase 3 Clinical Trial

Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjug

Status: Active / Ongoing • Expected Readout: 2027-09-10

NCT06975878 Phase 3 Clinical Trial

Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Status: Active / Ongoing • Expected Readout: 2027-08-25

NCT06824194 Phase 3 Clinical Trial

Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

Status: Active / Ongoing • Expected Readout: 2027-10-22

NCT07348692 Phase 3 Clinical Trial

Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age

Status: Active / Ongoing • Expected Readout: 2027-06-07

Milestone Overview

Stage Verification

Phase 3 Clinical Trial confirmed as of 2026-07-10.
Target Milestone

Primary completion (most advanced trial): 2027-09-10 (registry estimate)

Vaccine Data Navigator Candidate Profile Registry:

This candidate profile is indexed across all clinical development levels (Preclinical through Phase 1–3, Regulatory Filing, and Licensure) from primary registry databases (ClinicalTrials.gov, WHO ICTRP, FDA CBER, EMA, Health Canada, TGA Australia). Data are updated continuously to track global biologic and vaccine pipelines.