Safety and Immunogenicity of Two Formulations of a Hexavalent Diphtheria-Tetanus-Acellular Pertussis-Inactivated Poliovirus-<i>Haemophilus influenzae</i>b Conjugate-Hepatitis B Vaccine in 15 to 18 Month-Old Children
Bibliographic record
Abstract
Combination vaccines decrease the number of injections and improve parental satisfaction and vaccination schedule compliance. In a phase 1, randomized, partially-blinded, single-dose booster study, we evaluated two formulations of an investigational liquid hexavalent vaccine containing diphtheria, tetanus, acellular pertussis (5-component), inactivated poliovirus, Haemophilus influenzae b conjugate and hepatitis B surface antigen (DTaP-IPV-Hib-HBV) in 60 healthy toddlers, 15 to 18 months of age, who had been primed with three doses of a licensed pentavalent diphtheria, tetanus, acellular pertussis (5-component), inactivated poliovirus, Haemophilus influenzae b conjugate (DTaP-IPV//PRP-T) vaccine. The DTaP-IPV//PRP-T vaccine was used as a control in 30 subjects. The investigational formulations, which contained the same DTaP-IPV components, differed only in Hib (content and conjugate) and HBV (content) (PRP-T/HBV10 = 12 mug Hib tetanus toxoid conjugate with 10 microg HBsAg; PRP-OMPC/HBV15 = 6 microg Hib Neisseria meningitidis outer membrane protein complex with 15 microg HBsAg). Injection-site pain, redness and swelling were reported by 46.7%, 46.7%, and 20.0% of the licensed vaccine recipients, 43.3%, 43.3%, and 26.7% of PRP-T/HBV10 recipients and 70.0%, 46.7%, and 46.7% of PRP-OMPC/HBV15 recipients, respectively. Fever > or = 37.8 degrees C and irritability were reported by 0% and 16.7% of licensed vaccine recipients, 10.3% and 23.3% of PRP-T/HBV10 recipients and 30.0% and 16.7% of PRP-OMPC/HBV15 recipients, respectively. There were no apparent differences between the groups in the proportion of participants achieving predefined, threshold or seroprotective immune responses. Geometric mean antibody levels for all antigens were similar except for anti-PRP levels, which were 19.0 microg/mL in recipients of the licensed vaccine, 40.8 microg/mL in PRP-T/HBV10 recipients and 9.4 microg/mL in PRP-OMPC/HBV15 recipients. We conclude that the hexavalent formulations appear generally well tolerated and immunogenic as a booster dose in these toddlers.
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.001 | 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 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".