Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine for Meningococcal Immunisation

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Effectiveness
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Safety
Investigational Site Number 6300001, San Juan, Puerto Rico
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Meningococcal Immunisation

Study Summary

Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants

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Treatment Effectiveness

Study Objectives

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).

Day 01 (pre-vaccination)
Antibody titers in the primary panel of MenB strains before primary vaccination
Day 30
Antibody titers against each of Men A, C, W, and Y strains
Antibody titers in the secondary panel of MenB strains (stage 1 and 2 only)
Day 396
Antibody titers in the primary panel of MenB strains after each vaccination
Day 30 (post-vaccination)
Antibody titers in the primary panel of MenB strains after primary vaccination
Day 396
Antibody titers in the primary panel of MenB strains (stage 2 only)
Day 07
Number of participants with out-of-range biological test results
Month 6
Number of participants with medically attended adverse events (MAAE)s
Number of participants with serious adverse events (SAEs)
Day 30
Number of participants with unsolicited AEs
Within 30 minutes after vaccination
Number of participants with immediate adverse events (AEs)
Day 7
Number of participants with solicited injection site reactions or systemic reactions

Trial Safety

Trial Design

8 Treatment Groups

Stage 1: vaccine comparator(s)
Stage 1: MenB vaccine formulation(s)
Placebo group

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.

Stage 1: MenB vaccine formulation(s)Assigned MenB vaccine formulation or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181
Stage 2: MenB vaccine formulation(s)Assigned MenB vaccine formulation, MenQuadfi vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of leading MenB vaccine formulation single injection at Day 366
Stage 4: MenB vaccine formulation(s)Assigned MenB vaccine formulation, Routine Vaccines (RV)s and MenQuadfi vaccine single injection in the respective dosing at 2 months of ages [moa] (Day 01), 4moa (Day 61) and 12 moa
Stage 3: Men B vaccine formulation(s)Assigned MenB vaccine formulation and/or MenQuadfi vaccine single injection in the respective dosing schedule at Day 01 and Day 61
Stage 1: vaccine comparator(s)Bexsero vaccine or Trumenba vaccine or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181
Stage 3: MenQuadfi vaccine and vaccine comparatorMenQuadfi vaccine single injection at Day 01 or Bexsero vaccine single injection at Day 01 and Day 61
Stage 2: vaccine comparator(s)Bexsero vaccine or Trumenba vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of Bexsero vaccine single injection at Day 366
Stage 4: MenQuadfi vaccine and vaccine comparatorMenQuadfi vaccine or Bexsero vaccine and RVs in the respective dosing schedule at 2 months of ages [moa] (Day 01), 4moa (Day 61) and 12 moa
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neisseria meningitidis group A capsular polysaccharide tetanus toxoid conjugate antigen
FDA approved
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months after last vaccination
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 months after last vaccination for reporting.

Closest Location

Investigational Site Number 8400001 - Canoga Park, CA

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
, including the first dose and any subsequent dose, regardless of whether the woman is using contraception show original
-For US: Aged 10 to 25 years on the day of inclusion ("10-25 years" means from the day of the 10th birthday to the day before the 26th birthday) For EU: Aged 42 to 89 days or 12 to 18 months or 10 to 50 years on the day of inclusion ("42 to 89 days" means from 42 days after birth to the 89th day after birth; "12-18 months" means from the12th month after birth to the day before the 19th month after birth; "10-50 years" means from the day of the 10th birthday to the day before the 51st birthday Participants or participant and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures Covered by health insurance (applicable depending on local regulations) Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgement of the Investigator Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile OR Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 4 weeks after the last study intervention administration.
Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche OR Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 4 weeks after the last study intervention administration A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) the day of any dose of study intervention -For infants: Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention - - -

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can meningococcal immunisation be cured?

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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.

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What are the signs of meningococcal immunisation?

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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.

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What are common treatments for meningococcal immunisation?

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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.

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What is meningococcal immunisation?

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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.

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How many people get meningococcal immunisation a year in the United States?

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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.

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What causes meningococcal immunisation?

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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.

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Is meningococcal polysaccharide (serogroups a, c, y, and w) tetanus toxoid conjugate vaccine menacyw conjugate vaccine typically used in combination with any other treatments?

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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.

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What is the primary cause of meningococcal immunisation?

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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.

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Who should consider clinical trials for meningococcal immunisation?

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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.

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Have there been any new discoveries for treating meningococcal immunisation?

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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.

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Has meningococcal polysaccharide (serogroups a, c, y, and w) tetanus toxoid conjugate vaccine menacyw conjugate vaccine proven to be more effective than a placebo?

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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.

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How does meningococcal polysaccharide (serogroups a, c, y, and w) tetanus toxoid conjugate vaccine menacyw conjugate vaccine work?

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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.

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