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
Location: See all (14) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 3 months
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Male or female infants born at >36 weeks of gestation and who are 3 months of age (≥76 to ≤104 days) at the time of consent (the day of birth is considered day of life 1).

• Participants whose parent(s)/legal guardian(s) is willing and able to comply with scheduled visits, treatment plan, and other study procedures.

• Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

• Participants who are available for the duration of the study and whose parent(s)/legal guardian(s) can be contacted by telephone during study participation.

• Participants whose parent(s)/legal guardian(s) is capable of giving signed informed consent.

Locations
Other Locations
Finland
Espoo Vaccine Research Clinic
Espoo
Helsinki East Vaccine Research Clinic
Helsinki
Helsinki South Vaccine Research Clinic
Helsinki
Jarvenpaa Vaccine Research Center
Jarvenpaa
Tampere Vaccine Research Clinic
Tampere
Turku Vaccine Research Clinic
Turku
Poland
IN VIVO Bydgoszcz
Bydgoszcz
NZOZ Vitamed
Bydgoszcz
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow
GRAVITA. Diagnostyka i Leczenie nieplodnosci
Lodz
Szpital im. Św. Jadwigi Śląskiej w Trzebnicy
Trzebnica
Spain
Hospital Universitario HM Sanchinarro
Madrid
CHUS - Hospital Clinico Universitario
Santiago De Compostela
Instituto Hispalense de Pediatria
Sevilla
Time Frame
Start Date: April 9, 2021
Completion Date: September 9, 2022
Participants
Target number of participants: 149
Treatments
Experimental: Nimenrix
Nimenrix
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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