Last updated: 07/17/2024 17:26:40
Evaluation of Antibody persistence following 4 MenACWY vaccinations
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of subjects who reported any solicited Adverse Events (AEs) within 30 minutes after each vaccination.
Timeframe: Within 30 minutes of each vaccination
Number of subjects who reported any solicited local AEs after each vaccination
Timeframe: From Day 1 to Day 7 after each vaccination
Number of subjects who reported any solicited systemic AEs after each vaccination
Timeframe: From Day 1 to Day 7 after each vaccination
Number subjects who reported medically attended unsolicited AEs and AEs leading to premature withdrawal
Timeframe: From Day 1 to Visit 6 (Month 24)
Number of subjects who reported Serious AEs (SAEs)
Timeframe: From Day 1 to Visit 6 (Month 24)
Percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 8 against each N.meningitidis serogroup A,C,W and Y.
Timeframe: At Month 24 (Visit 6)
Percentage of subjects with rabbit Serum Bactericidal Assay (rSBA) titers ≥ 8, against each N.meningitidis serogroup.
Timeframe: At Month 24 (Visit 6)
Percentage of subjects with rabbit Serum Bactericidal Assay (rSBA) titers ≥ 128 against each N.meningitidis serogroup.
Timeframe: At Month 24 (Visit 6)
Secondary outcomes:
Percentage of Subjects with hSBA ≥8 against each N. meningitidis serogroups A, C, W and Y
Timeframe: At Month 13 (Visit 5)
Percentage of Subjects with rSBA titers ≥ 8 against each N. meningitidis serogroups A, C, W and Y
Timeframe: At Month 13 (Visit 5)
Percentage of Subjects with rSBA titers ≥ 128 against each N. meningitidis serogroups A, C, W and Y
Timeframe: At Month 13 (Visit 5)
hSBA Geometric Mean Titers (GMTs) against each N. meningitidis serogroups A, C, W and Y.
Timeframe: At Month 13 (Visit 5)
rSBA GMTs against each N. meningitidis serogroups A, C, W and Y.
Timeframe: At Month 13 (Visit 5)
hSBA GMTs against each N. meningitidis serogroups A, C, W and Y.
Timeframe: At Month 24 (Visit 6)
rSBA GMTs against each N. meningitidis serogroups A, C, W and Y.
Timeframe: At Month 24 (Visit 6)
Interventions:
Enrollment:
128
Primary completion date:
2017-28-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Lee HJ et al. (2019) One-year antibody persistence and safety of a 4-dose schedule of MenACWY-CRM in healthy infants from South Korea. Clin Exp Vaccine Res. 8(2):94-102.
Medical condition
Infections, Meningococcal
Product
GSK3536820A
Collaborators
Not applicable
Study date(s)
July 2015 to December 2017
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
2 - 24 months
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2017-28-12
Actual study completion date
2017-28-12
Plain language summaries
Summary of results in plain language
Available language(s): English, Korean
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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