Preparedness for and Response to Meningococcal Outbreaks: Safety Results. of a Randomized Controlled Trial of Two Schedules of 4CMenB Vaccine in Adolescents and Young Adults
Bibliographic record
Abstract
Background. Emergency vaccination programs are often needed when outbreaks of Meningococcal B (MenB) disease in young adults attending university occur. The four-component MenB vaccine (4CMenB, Bexsero, Novartis, GlaxoSmithKline) is authorized for persons 2 months through 17 years in Canada, but there is limited data on safety and immunogenicity in persons >17 years or on various dosing schedules. Methods. A randomized, controlled, observer-blinded trial comparing an accelerated 4CMenB schedule (0, 21 days) compared to a standard schedule (0, 60 days) was conducted during the academic year (September 2015–April 2016) in persons 17–25 years of age, in stable health and attending school, at three sites. The first dose in both groups was 4CMenB vaccine. Solicited local and systemic adverse events (AE) days 0–6 post vaccine and unsolicited events days 0–21 were collected on memory aides. Analysis of immune responses on Days 0, 21, 42, 81, and 180 is underway. Results. Among 121 participants the mean age was 21.4 years (range 17.0–26.0); 69.4% (n = 84) were female. Any solicited AE occurred in 100%, 73.7%, and 78.0% post doses 1, 2, and 3, respectively. One serious AE (fractured patella) occurred. The most common solicited AE Day 0–6 was local: pain at the injection site in 99.2%, 64.4%, and 71.2% after doses 1, 2, and 3, respectively, followed by systemic muscles aches in 52.9%, 33.1%, and 35.6%, respectively. Drowsiness Day 0–6 occurred in in 38%, 27.1%, and 29.7% and nausea in 18.2%, 17.8%, and 16.9% of participants after doses 1, 2, and 3, respectively. Fever was only reported in 2 participants (1.7%), after dose 2. Overall, a Grade 1 AE occurred in 33.9%, 32.2%, and 30.5%, any Grade 2 AE in 30.6%, 11.9%, and 13.6%, and a Grade 3 AE in 5.8%, 5.9%, and 6.8% of participants after doses 1, 2, and 3. Conclusion. A multicenter rapid clinical trial of a 4CMenB vaccine was conducted by the Clinical Trials Network of CIRN. Pain at the injection site and muscle aches were highest after the first (unblinded) dose. Systemic muscle aches, drowsiness, and nausea were common after all doses. Fever was not common and AEs did not interfere with study completion (120/121 participants received three doses). The safety profile in this age group and using this schedule are similar to that observed in younger adolescents. Disclosures. J. Langley, Pfizer, GSK: Investigator, Research grant B. J. Ward, Pfizer: Investigator, Grant recipient S. Mcneil, Sanofi Pasteur, GSK, Merck, Novartis: Investigator, Grant recipient
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.007 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".