Simultaneous administration of meningococcal C conjugate vaccine and diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine in children: a randomized double-blind study.
Bibliographic record
Abstract
BACKGROUND: Meningococcal C disease can be life-threatening in infants, young children and adolescents. New conjugate vaccines are immunogenic in young infants and induce immunologic memory, so we should consider incorporating them into the routine childhood immunization program. The objective of this study was to measure the safety and immunogenicity of a meningococcal C conjugate vaccine when given with routine childhood vaccines. METHODS: We carried out a randomized, double-blind, controlled clinical trial at children's hospitals in 3 Canadian cities. A convenience sample of 351 healthy 2-month-old infants was enrolled from the community and randomly allocated to receive either meningococcal C conjugate vaccine or the control (hepatitis B) vaccine. All participants received a concurrent injection of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTaP-IPV-Hib) conjugate vaccine in the opposite limb. Participants were immunized at 2, 4, 6 and 15 months of age; adverse events were recorded after each dose. Serum bactericidal and ELISA meningococcal antibody levels in the participants were measured at 6, 7, 15 and 16 months of age; diphtheria, tetanus, H. influenzae type b, poliovirus and pertussis antibodies were measured at 7 months of age. A total of 323 (92%) participants completed all aspects of the study. The proportion of participants who suffered adverse events after each vaccine dose was the primary safety outcome. Geometric mean antibody titres and the proportion of participants with protective antibody levels after immunization were the primary immunologic outcomes. RESULTS: After 2 doses of the meningococcal C conjugate vaccine 99% of participants achieved a protective ( > or = 1:8) bactericidal meningococcal serogroup C antibody level, and after 3 doses this rate increased to 100%. Antibody levels to the concomitant vaccine antigens in the group receiving meningococcal C vaccine were similar to those in the control group except for higher antidiphtheria antibody titres (p < 0.001). Local injection site reactions (redness and induration) after the meningococcal conjugate vaccine were more frequent than after hepatitis B vaccine but less frequent than after the DTaP-IPV-Hib vaccine. CONCLUSIONS: The meningococcal C conjugate vaccine can be safely and effectively administered at the same visit as the other vaccine antigens routinely given to infants in Canada.
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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 | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.002 |
| 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".