Clinical trial NCT02446691: Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infections, Meningococcal
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-05-18
Enrollment: 128
Sex: ALL
Minimum age (years): 2
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination.
timeFrame: Within 30 minutes of each vaccination
measure: Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination
timeFrame: From Day 1 to Day 7 after each vaccination
measure: Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination.
timeFrame: From Day 1 to Day 7 after each vaccination
measure: Number of Subjects With Any Medically Attended Unsolicited AEs and AEs Leading to Premature Withdrawal
timeFrame: From Day 1 to Visit 6 (at 24 Months of age)
measure: Number of Subjects With Serious AEs (SAEs)
timeFrame: From Day 1 to Visit 6 (At 24 months of age)
measure: 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.
timeFrame: At 24 months of age (Visit 6)
measure: Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age
timeFrame: At 24 months of age (Visit 6)
measure: Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age
timeFrame: At 24 months of age (Visit 6)
Secondary outcomes:
measure: Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
timeFrame: At 13 months of age (Visit 5)
measure: Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
timeFrame: At 13 months of age (Visit 5)
measure: Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
timeFrame: At 13 months of age (Visit 5)
measure: hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age
timeFrame: At 24 months of age (Visit 6)
measure: rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age
timeFrame: At 24 months of age (Visit 6)
measure: hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
timeFrame: At 13 months of age (Visit 5)
measure: rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age.
timeFrame: At 13 months of age (Visit 5)
Other outcomes:
Locations:
city: Ansan si
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeonju
country: Korea, Republic of
facility: GSK Investigational Site
city: Seongnam si
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: