Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations

Study Overview
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Brief Summary
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This is Phase IV, Open label, Multicenter study. Subject's parents and/or legal guardian will be provided information about the trial. If interested and if eligible, they will then be asked to provide signed informed consent. The initial study visit can occur immediately after signed informed consent has been obtained. Approximately 135 subjects will be enrolled to receive 4 doses of intramuscular MenACWY vaccine at 2, 4, 6 and 12 months of age.

Official Title
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A Phase IV, Open-Label, Multi-Center Study to Evaluate the Safety and the 1-year Persistence of Antibody Response Among Children Who Received 4 Doses of the GSK MenACWY Conjugate Vaccine at 2, 4, 6 and 12 Months of Age in South Korea

Conditions
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Infections, Meningococcal

Intervention / Treatment
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* Biological: MenACWY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female 2 month-old infants (55 - 89 days) on the day of consent. Infants whose parents or legal guardians have voluntary given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. Infants whose parents or legal guardians can comply with study procedures including follow-up Exclusion Criteria: Previously received any meningococcal A, C, W and Y vaccines. Previous confirmed or suspected disease caused by N. meningitidis or who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection at any time since birth. Progressive, unstable or uncontrolled clinical conditions. A history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component, such as latex allergy. Experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature ≥ 38.0°C [100.4°F]) within the previous 3 days. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. Received treatment with systemic administration corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin) at any time since birth and for the full length of the study. Any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw. Any condition which, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. Received or are planning to receive any investigational or non-registered medicinal product from birth and throughout the study. Received oral or parenteral antibiotic treatment in the 3 days prior to the scheduled blood draw (topical antibiotics are acceptable, including antibiotic eye drops). Relatives of site research staff working on this study.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MenACWY Group<br>Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who will receive 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly at 2,4,6 ad 12 months of age. | Biological: MenACWY<br>* Four Intramuscular doses of MenACWY vaccine at 2, 4, 6 and 12 months of age followed by two blood samples at 13 and 24 months of age.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Solicited signs and symptoms occurring within 30 minutes following each vaccination, include solicited local events (e.g. injection site erythema, induration and tenderness -threshold for Erythema and Induration: Type II- None [<10mm], Any[>=10 mm]), solicited systemic events (e.g. change in eating habits, sleepiness, irritability, vomiting, diarrhea, fever[ body temperature >=38°C measured preferably via tympanic route]), and any other solicited event like use of analgesic/antipyretics for treatment or for prophylaxis | Within 30 minutes of each vaccination | 
| Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination | Solicited local AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed local symptoms include injection site erythema, injection site induration and injection site tenderness. Any = incidence of a particular symptom regardless of intensity grade.Threshold for Erythema and Induration: Type II None (<10 mm), Any (>=10 mm) | From Day 1 to Day 7 after each vaccination | 
| Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Solicited systemic AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed systemic symptoms include change in eating habits, sleepiness, irritability, vomiting, diarrhea and fever (body temperature ≥ 38°C (100.4°F)). | From Day 1 to Day 7 after each vaccination | 
| Number of Subjects With Any Medically Attended Unsolicited AEs and AEs Leading to Premature Withdrawal | An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject parent(s)/legal guardian(s)] who has signed the informed consent. All medically attended unsolicited AEs were collected from Day 1 to Visit 6. | From Day 1 to Visit 6 (at 24 Months of age) | 
| Number of Subjects With Serious AEs (SAEs) | Subjects reporting SAEs from day 1 to visit 6 (at 24 months of age) were assessed. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in one or more of the following: death, is life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. | From Day 1 to Visit 6 (At 24 months of age) | 
| Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age. | To assess antibody persistence against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement. | At 24 months of age (Visit 6) | 
| Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age | To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement | At 24 months of age (Visit 6) | 
| Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age | To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement | At 24 months of age (Visit 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement. | At 13 months of age (Visit 5) | 
| Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement. | At 13 months of age (Visit 5) | 
| Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement. | At 13 months of age (Visit 5) | 
| hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age | To assess persistence of antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine. | At 24 months of age (Visit 6) | 
| rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age | To assess persistence of antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine. | At 24 months of age (Visit 6) | 
| hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | To assess antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine. | At 13 months of age (Visit 5) | 
| rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age. | To assess antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine. | At 13 months of age (Visit 5) |