CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 149 enrolled
Drug / intervention
Nimenrixbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04819113
NCT04819113Phase 3Completed

A PHASE 3B, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX(Registered) IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE

Pfizer·interventional·Posted Mar 26, 2021·Updated Mar 18, 2024

In Brief

A Phase 3 clinical trial evaluating Nimenrix for Meningococcal Vaccine. Completed, enrolled 149 participants across 16 sites in 3 countries.

Detailed Summary

This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age. Current posology allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months; and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12 months. This study will provide valuable immunogenicity and safety data for a single dose in healthy infants \<6 months of age, followed by the booster at 12 months

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFinland, Poland, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMar 26, 2021
Enrollment StartApr 9, 2021
Primary CompletionSep 9, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.3 years ago

Interventions

Nimenrixbiological

MenACWY-TT vaccine