NCT04819113

Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 76 Days – 104 Days
• Healthy volunteers: Accepted

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

Conditions

• Meningococcal Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Nimenrix	MenACWY-TT vaccine

Timeline

• Start date: 2021-04-09
• Primary completion: 2022-09-09
• Completion: 2022-09-09
• First posted: 2021-03-26
• Last updated: 2024-03-18
• Results posted: 2024-03-18

Locations

16 sites across 3 countries: Finland, Poland, Spain