Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations

GlaxoSmithKline128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

128

Conditions

Infections, Meningococcal

Interventions

MenACWYBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 24 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy male and female 2 month-old infants (55 - 89 days) on the day of consent. 2. 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. 3. Infants whose parents or legal guardians can comply with study procedures including follow-up Exclusion Criteria: 1. Previously received any meningococcal A, C, W and Y vaccines. 2. 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. 3. Progressive, unstable or uncontrolled clinical conditions. 4. 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. 5. 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. 6. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. 7. Received treatment with systemic administration corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth 8. 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. 9. Any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw. 10. 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. 11. Received or are planning to receive any investigational or non-registered medicinal product from birth and throughout the study. 12. Received oral or parenteral antibiotic treatment in the 3 days prior to the scheduled blood draw (topical antibiotics are acceptable, including antibiotic eye drops). 13. Relatives of site research staff working on this study.

Locations (6)

GSK Investigational Site

Ansan-si, South Korea

GSK Investigational Site

Incheon, South Korea

GSK Investigational Site

Jeonju, South Korea

GSK Investigational Site

Seongnam-si, South Korea

Outcomes

Primary Outcomes

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

Time frame: 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)

Time frame: 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)).

Time frame: 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.

Time frame: From Day 1 to Visit 6 (at 24 Months of age)

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At 13 months of age (Visit 5)