Comparative Immunogenicity and Safety of Measles-Mumps-Rubella Vaccine When Administered Using Needle Free Injection System to That with Conventional Needle-Syringe in India: A Randomized, Parallel Group Study
Bibliographic record
Abstract
B S Ratta,1,* Ankur Naik,2,* Sarvesh Mutha3,* 1Consultant Paediatric Surgeon, Ruby Hall Clinic, Pune, India; 2Chief Technology Officer, IntegriMedical Private Limited, Pune, India; 3Chief Business Officer, IntegriMedical Private Limited, Pune, India*These authors contributed equally to this workCorrespondence: Ankur Naik, Email ankur@integrimedical.comIntroduction: Pain due to injection and fear of needles is documented barriers to vaccination in children. Needle-Free Injection System ie N-FIS®, is an innovative delivery solution that addresses these limitations. To demonstrate its performance, study was conducted to compare immunogenicity and safety of the MMR vaccine when administered by N-FIS, to that administered using needle-syringe and needle.Methodology: This was a prospective, randomized, parallel group study (January–September 2024). Eligible participants 9– 12 months of age were administered MMR vaccine 0.5 mL, subcutaneously using either N-FIS® or syringe. Immunogenicity and safety were assessed before and 28 days post vaccination.Results: A total of 60 infants with mean age of 10.5 months were enrolled in the study. At 28 day post dose 1 there was a significant and comparable rise in the MMR GMTs between the two groups. Similarly, at 28 day post vaccination, there was a significant rise in the proportions of seropositive subjects and the rates were comparable between the two groups (Measles: 100% vs 83%, p = 0.046; Mumps: 96.1% vs 95.8%, p = 0.999, Rubella: 92.3% vs 100%, p = 0.491). N-FIS was well tolerated and significantly lower number of subjects experienced pain (12% with N-FIS vs 33% with syringe). No serious or severe adverse events were reported.Conclusion: Administration of MMR vaccine using N-FIS induced robust and comparable immune responses to that observed with use of Needle-syringe and was well tolerated providing an alternative to paediatrician over conventional delivery system.Keywords: needle free injection system, immunogenicity, measles, mumps, rubella
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".