This trial is evaluating whether Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine will improve 8 primary outcomes and 4 secondary outcomes in patients with Meningococcal Immunisation. Measurement will happen over the course of Day 01 (pre-vaccination).
This trial requires 1800 total participants across 8 different treatment groups
This trial involves 8 different treatments. Meningococcal Polysaccharide (Serogroups A, C, Y, And W) Tetanus Toxoid Conjugate Vaccine MenACYW Conjugate Vaccine is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.
Participation is compensated
You will be compensated for participating in this trial.
Vaccination of adolescent boys with a minimum age of 13 years is highly effective in preventing meningococcal invasive disease and has a much lower risk of disease recurrence than the meningococcal polysaccharide vaccine. Pneumococcal conjugate vaccinations appear to be even more effective than meningococcal polysaccharide vaccines.
A high index of suspicion should be used when vaccination with M-MenACWY or M-MenA has been administered. In addition, a high degree of suspicion should be applied to persons who are immunised against A, C or W meningococci.
There is very little agreement about the common treatments for meningococcal vaccination. There is a need for guidelines and an evidence-based national programme for meningococcal immunisation.
Meningococcal immunisation should be offered to all immunized adults. It provides protection against meningococcal disease and as an added benefit, can reduce the risk of meningococcal septic meningitis in recipients of combined vaccines. Vaccination with Meningococcal conjugate vaccine (CVCD) is recommended routinely between the ages of 10–19 years. More than half of the cases of meningococcal disease are in children younger than 10 years of age and the majority of these reside in developing countries. CVDC is a major public health problem in several countries in the developing world. As such, vaccination is considered very important even in the developed world.
The number of people going to visit their paediatrician for meningococcal vaccination has increased over the last decade (2002-2008). These changes may be due to greater awareness of the disease and possible concerns about meningococcal illness among parents. However, there is still a lot of work to be done to reach the target of 100% vaccination rates among adolescents in the United States and beyond.
Meningococcal immunisation should only be considered where the benefit to the person's health would exceed the cost to the healthcare system, and in an individual's best judgements based on their risk of disease. This can be complicated by vaccination campaigns which encourage people with asymptomatic infections to receive meningococcal vaccination. A review of both the cost effectiveness and the risks of this advice is not yet available.
Meningococcal vaccines are used in conjunction with other treatments. For this reason, information obtained in RCTs that use an active comparison design should be analysed with caution.
It is still unclear how and why adults are vaccinated against meningococcal disease and why it is not always followed by a pertussis or tetanus vaccine.
Meningococcal vaccine is one of the most effective vaccines to prevent disease in meningococcal meningitis. But its benefit is limited under routine immunisation programs due to its poor cost-effectiveness and its low uptake. The clinical trials in this study would be effective in improving the effectiveness and cost-effectiveness of meningococcal vaccines and, specifically in the development of a meningococcal vaccines for all countries and under all vaccine schedule and schedules, they could help to formulate global guidelines and standards of meningococcal vaccines.
Despite many new discoveries, there has been no new effective vaccine for preventing meningococcal disease in the past decade. Recent advances, however, have been made in regards to improving the safety of meningococcal vaccines including the development of MCC (MenC). Since MCC is the only meningococcal vaccine that does not cause B(+) listeria meningitis, there is concern that vaccinations may not be safe if administered to patients with compromised immune systems such as the elderly or immunocompromised. Currently the only vaccine that is effective for meningococcal infection is Bacteroides and Ciprofloxacin.
Findings from a recent study did not demonstrate any safety issue resulting from a menPOMP vaccine. It did not demonstrate more than 2% of cases with fever exceeding 39.0 °C after injection. It also did not demonstrate any efficacy of either vaccine against a 4C:2B disease. The lack of efficacy data from the serogroup y menPOMP vaccine suggests the possibility that meningococcal vaccines currently available are insufficient for this serogroup. Although further studies are necessary, we propose that clinicians should use the menNOCP vaccine for meningococcal diseases and recommend a 4C:2B:C/4C vaccine in cases of unknown serogroup.
Both vaccines significantly reduced the numbers of meningococcal serogroups A, c, and y isolates, and this was associated (P<0.05) with a significant decrease in the number of cases of invasive disease.