Table of Contents
- Trial overview
- Who was studied
- What was tested in the study
- Safety and reactogenicity endpoints
- Immune response endpoints
- Trial status and size
Trial overview
The trial in the source data is NCT05082285, titled MENACWY=MEN7B-003, and it studied GSKVX000000017986 as part of meningococcal vaccine research.[1] It was an interventional study, which means researchers gave vaccines and then measured safety and immune response.[1] The study was in Phase 1, an early stage that is usually used to learn more about safety and how the body responds to a vaccine.[1]
Who was studied
The trial focused on people who could receive vaccine injections and take part in scheduled follow-up visits, but the provided source does not list detailed eligibility rules.[1] The study enrolled 703 participants, which gives a sense of the size of the research group.[1]
What was tested in the study
The trial compared GSKVX000000017986 with other vaccines used in meningococcal and routine immunization research.[1] The brief summary says the study aimed to evaluate the safety and reactogenicity of two formulations of MenABCWY-2nd Gen vaccine, the MenABCWY-1st Gen vaccine, the MenB vaccine, and the MenACWY-TT vaccine.[1] Reactogenicity means the common short-term reactions after vaccination, such as pain, fever, or swelling.[1]
The intervention list shows several vaccine products used in the study, including Nimenrix, Prevenar 13, Rotarix, Infanrix hexa, Bexsero, and the vaccine product that contains GSKVX000000017986.[1] The study also looked at immune responses against meningococcal serogroups A, C, W, Y, and B.[1]
Safety and reactogenicity endpoints
The main safety endpoints were the number and percentage of participants with solicited administration site and systemic events during the 7 days after each vaccination.[1] Administration site events are reactions where the shot was given, and systemic events are whole-body reactions such as fever or tiredness.[1]
The study also measured unsolicited adverse events during the 30 days after each vaccination, including medically attended adverse events, serious adverse events, adverse events leading to withdrawal, and adverse events of special interest.[1] In simple terms, the researchers watched for any health problem after vaccination, especially problems that were serious or needed medical care.[1]
These safety outcomes were also followed throughout the study for medically attended adverse events, serious adverse events, adverse events leading to withdrawal, and adverse events of special interest.[1]
Immune response endpoints
The study measured immune response using human serum bactericidal assay, or hSBA, which tests whether blood can help kill meningococcal bacteria.[1] Researchers looked at the percentage of participants with hSBA titres at or above the lower limit of quantitation, as well as the hSBA geometric mean titres for each A, C, W, and Y serogroup and each serogroup B indicator strain.[1]
These blood tests were done at several time points, including 1 month after the second vaccination, before the third vaccination, and 1 month after the third vaccination.[1] The study also measured geometric mean ratios, which compare antibody levels at one time point with another time point.[1]
According to the brief summary, the immune response part of the study had two goals: to assess response against all serogroup B indicator strains and to assess response against serogroups A, C, W, and Y.[1]
Trial status and size
NCT05082285 was completed, so the study has finished collecting the planned data.[1] The enrollment number was 703 participants, which suggests a fairly large early-stage vaccine study.[1]
