Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations

NCT02446691 | Completed Phase 4 Results

• 3 other identifiers: 205336V59_752014-005392-90
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 6

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.

Conditions

Infections, Meningococcal

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (7)

• Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age

  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

  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

  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

  At 24 months of age (Visit 6)

• rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age

  At 24 months of age (Visit 6)

Study Arms (1)

MenACWY Group

EXPERIMENTAL

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

Interventions

MenACWY BIOLOGICAL

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.

MenACWY Group

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Ansan-si, 425 707, South Korea

Location

GSK Investigational Site

Incheon, 400 711, South Korea

Location

GSK Investigational Site

Jeonju, 561 712, South Korea

Location

GSK Investigational Site

Seongnam-si, 463 707, South Korea

Location

GSK Investigational Site

Seoul, 110 744, South Korea

Location

GSK Investigational Site

Seoul, 158 710, South Korea

Location

MeSH Terms

Conditions

Meningococcal Infections

Interventions

MenACWY

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

sss42438@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 18, 2015
• Study Start: July 13, 2015
• Primary Completion: December 28, 2017
• Study Completion: December 28, 2017
• Last Updated: June 27, 2019
• Results First Posted: April 1, 2019

Record last verified: 2019-06

Locations

KR (6)