Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04819113
Other study ID # C0921062
Secondary ID 2020-005059-19
Status Completed
Phase Phase 3
First received
Last updated
Start date April 9, 2021
Est. completion date September 9, 2022

Study information

Verified date August 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 149
Est. completion date September 9, 2022
Est. primary completion date September 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 76 Days to 104 Days
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Nimenrix
MenACWY-TT vaccine

Locations

Country Name City State
Finland Espoo Vaccine Research Clinic Espoo
Finland FVR, Etelä-Helsingin rokotetutkimusklinikka Helsinki
Finland Helsinki East Vaccine Research Clinic Helsinki
Finland Helsinki South Vaccine Research Clinic Helsinki
Finland Jarvenpaa Vaccine Research Center Jarvenpaa
Finland Jarvenpaa Vaccine Research Center Järvenpää Uusimaa
Finland Tampere Vaccine Research Clinic Tampere Pirkanmaa
Finland Turku Vaccine Research Clinic Turku
Poland IN VIVO Bydgoszcz Bydgoszcz
Poland NZOZ Przychodnia Vitamed Bydgoszcz
Poland Centrum Badan Klinicznych Jagiellonskie Centrum Innowacji sp. z o.o. Krakow
Poland GRAVITA. Diagnostyka i Leczenie nieplodnosci Lodz
Poland Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy Trzebnica
Spain Hospital Universitario HM Sanchinarro Madrid
Spain CHUS - Hospital Clinico Universitario Santiago de Compostela A Coruna
Spain Instituto Hispalense de Pediatria Sevilla

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Finland,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 Local reactions included pain at injection site, redness and swelling and were recorded by the participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (>) 0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Exact 2-sided confidence interval (CI) was based on the Clopper and Pearson method. Within 7 days after vaccination 2
Primary Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 Systemic events included fever, decreased appetite, increased sleep and irritability and were recorded by the participant's parents/legal guardians in an e-diary. Fever was defined as temperature greater than or equal to (>=) 38.0 degrees (deg) Celsius (C), categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C; decreased appetite graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed; increased sleep graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with daily activity and severe: disabling, not interested in usual daily activity; irritability graded as mild: easily consolable, moderate: required increased attention and severe: inconsolable, crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method. Within 7 days after vaccination 2
Primary Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2 The use of antipyretic medication was recorded by the participant's parents/legal guardians in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method. Within 7 days after vaccination 2
Primary Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 2 An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure. Within 30 days after vaccination 2
Primary Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 2 An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method. Within 30 days after vaccination 2
Primary Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 30 Days After Vaccination 2 An NDCMC was defined as a significant disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method. Within 30 days after vaccination 2
Primary Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2 Immediate AEs were defined as AEs occurring within the first 30 minutes after administration of the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Within 30 minutes after vaccination 2
Primary 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 Percentage of participants achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline in participants who received vaccinations 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. Analysis was performed on Post Dose (PD) 2 Evaluable Immunogenicity Population (EIP) (PD2 EIP). At baseline (before vaccination 1)
Primary 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 Percentage of participants achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after vaccination 1 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. 1 month after vaccination 1
Primary 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 Percentage of participants achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. At vaccination 2
Primary 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 Percentage of participants achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. 1 month after vaccination 2
Primary 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 GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution). At baseline (before vaccination 1)
Primary 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 GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution). 1 month after vaccination 1
Primary GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution). At vaccination 2
Primary 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 GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution). 1 month after vaccination 2
Secondary Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 Local reactions included pain at injection site, redness and swelling and were recorded by the participant's parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Exact 2-sided CI was based on the Clopper and Pearson method. Within 7 days after vaccination 1
Secondary Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 Systemic events included fever, decreased appetite, increased sleep and irritability and were recorded in e-diary. Fever was defined as temperature >=38.0 deg C, categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C; decreased appetite graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed; increased sleep graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with daily activity and severe: disabling, not interested in usual daily activity; irritability graded as mild: easily consolable, moderate: required increased attention and severe: inconsolable, crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method. Within 7 days after vaccination 1
Secondary Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1 The use of antipyretic medication was recorded by the participant's parents/legal guardians in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method. Within 7 days after vaccination 1
Secondary Percentage of Participants With AEs Within 30 Days After Vaccination 1 An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. Within 30 days after vaccination 1
Secondary 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 An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An NDCMC was defined as a significant disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method. 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
Secondary Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1 Immediate AEs were defined as AEs occurring within the first 30 minutes after administration of the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Within 30 minutes after vaccination 1
Secondary 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 Percentage of participants achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after Vaccination 1 in participants who received Vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. Analysis was performed on post-dose 1 (PD1) evaluable immunogenicity population (EIP). At baseline (before vaccination 1) and 1 month after vaccination 1
Secondary 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 Percentage of participants achieving rSBA titer >= 1:128 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after vaccination 1 in participants who received vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. At baseline (before vaccination 1) and 1 month after vaccination 1
Secondary 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 GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution). At baseline (before vaccination 1) and 1 month after vaccination 1
Secondary 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 Percentage of participants achieving hSBA titers >= 1:4 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after vaccination 1 in participants who received Vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. At baseline (before vaccination 1) and 1 month after vaccination 1
Secondary 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 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 in participants who received Vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. At baseline (before vaccination 1) and 1 month after vaccination 1
Secondary 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 GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the hSBA titers (based on the Student t distribution). At baseline (before vaccination 1) and 1 month after vaccination 1
Secondary 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 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 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
Secondary 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 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 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
Secondary 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 GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the hSBA titers (based on the Student t distribution). At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
Secondary 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 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 in Participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
See also
  Status Clinical Trial Phase
Terminated NCT04645966 - A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants Phase 2
Completed NCT01299480 - A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years Phase 2
Completed NCT01323270 - A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years. Phase 2
Completed NCT04440163 - MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age Phase 3
Completed NCT04440176 - A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules Phase 2
Completed NCT03509051 - Prospective Study on the Vaccine Response to Meningococcal B Vaccine After Allogeneic Stem Cell Transplantation N/A
Completed NCT02975596 - MenB Vaccine: Implementation Via Information, Empowerment and Accessibility N/A
Completed NCT03263403 - Non Inferiority Trial of Locally Manufactured Meningococcal ACWY Vaccine 'Ingovax ACWY' in Bangladesh. Phase 2/Phase 3
Completed NCT04893811 - Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age Phase 4
Completed NCT03135834 - A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age. Phase 3
Completed NCT01830855 - A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years Phase 3