Clinical trial NCT04819113: Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 149
Sex: ALL
Minimum age (years): 76
Maximum age (years): 104
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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 criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Previous anaphylactic reaction to any vaccine or vaccine-related component.
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
* History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
* Significant neurological disorder or history of seizure (including simple febrile seizure).
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Family history of congenital or hereditary immunodeficiency.
* Other medical or psychiatric condition, including recent or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Major known congenital malformation or serious chronic disorder.
* Previous vaccination with any meningococcal vaccine containing groups A, C, W, or Y.

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
timeFrame: Within 7 days after vaccination 2
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
timeFrame: Within 7 days after vaccination 2
measure: Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2
timeFrame: Within 7 days after vaccination 2
measure: Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 2
timeFrame: Within 30 days after vaccination 2
measure: Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 2
timeFrame: Within 30 days after vaccination 2
measure: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 30 Days After Vaccination 2
timeFrame: Within 30 days after vaccination 2
measure: Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2
timeFrame: Within 30 minutes after vaccination 2
measure: Percentage of Participants Achieving Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 for Each Serogroup, Neisseria Meningitidis Group (Men) A, MenC, MenW-135 and MenY at Baseline: Post Dose 2 Evaluable Immunogenicity Population
timeFrame: At baseline (before vaccination 1)
measure: Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population
timeFrame: 1 month after vaccination 1
measure: Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
timeFrame: At vaccination 2
measure: Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
timeFrame: 1 month after vaccination 2
measure: Geometric Mean Titers (GMTs) of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline: Post Dose 2 Evaluable Immunogenicity Population
timeFrame: At baseline (before vaccination 1)
measure: GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population
timeFrame: 1 month after vaccination 1
measure: GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
timeFrame: At vaccination 2
measure: GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
timeFrame: 1 month after vaccination 2
Secondary outcomes:
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
timeFrame: Within 7 days after vaccination 1
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
timeFrame: Within 7 days after vaccination 1
measure: Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1
timeFrame: Within 7 days after vaccination 1
measure: Percentage of Participants With AEs Within 30 Days After Vaccination 1
timeFrame: Within 30 days after vaccination 1
measure: Percentage of Participants With SAEs and NDCMCs: Within 30 Days After Vaccination 1, From 1 Month After Vaccination 1 to 9 Months After Vaccination 1, From Vaccination 1 to 9 Months After Vaccination 1
timeFrame: Within 30 days after vaccination 1, from 1 month after vaccination 1 to 9 months after vaccination 1 and from vaccination 1 to 9 months after vaccination 1
measure: Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1
timeFrame: Within 30 minutes after vaccination 1
measure: Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
timeFrame: At baseline (before vaccination 1) and 1 month after vaccination 1
measure: Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
timeFrame: At baseline (before vaccination 1) and 1 month after vaccination 1
measure: GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
timeFrame: At baseline (before vaccination 1) and 1 month after vaccination 1
measure: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
timeFrame: At baseline (before vaccination 1) and 1 month after vaccination 1
measure: Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
timeFrame: At baseline (before vaccination 1) and 1 month after vaccination 1
measure: GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
timeFrame: At baseline (before vaccination 1) and 1 month after vaccination 1
measure: Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
timeFrame: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
measure: Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
timeFrame: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
measure: GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
timeFrame: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
measure: Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
timeFrame: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere Vaccine Research Clinic
state: Pirkanmaa
city: Järvenpää
country: Finland
facility: Jarvenpaa Vaccine Research Center
state: Uusimaa
city: Espoo
country: Finland
facility: Espoo Vaccine Research Clinic
city: Helsinki
country: Finland
facility: FVR, Etelä-Helsingin rokotetutkimusklinikka
city: Helsinki
country: Finland
facility: Helsinki South Vaccine Research Clinic
city: Helsinki
country: Finland
facility: Helsinki East Vaccine Research Clinic
city: Jarvenpaa
country: Finland
facility: Jarvenpaa Vaccine Research Center
city: Turku
country: Finland
facility: Turku Vaccine Research Clinic
city: Bydgoszcz
country: Poland
facility: IN VIVO Bydgoszcz
city: Bydgoszcz
country: Poland
facility: NZOZ Przychodnia Vitamed
city: Krakow
country: Poland
facility: Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
city: Lodz
country: Poland
facility: GRAVITA. Diagnostyka i Leczenie nieplodnosci
city: Trzebnica
country: Poland
facility: Szpital im. Św. Jadwigi Śląskiej w Trzebnicy
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario
state: A Coruna
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Sevilla
country: Spain
facility: Instituto Hispalense de Pediatria
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: