1087Immunogenicity and Safety of 3-Dose Primary Vaccination with Combined DTPa-HBV-IPV/Hib Vaccine in Canadian Aboriginal and non-Aboriginal Infants
Bibliographic record
Abstract
Background. It has been observed that immune responses to vaccination can vary between populations, in particular that immune responses to Haemophilus influenzae type b (Hib) vaccines are lower in certain ethnic groups. This study was undertaken to assess the immune response of Canadian Aboriginals (First Nations, Inuit, Métis) to the Hib and hepatitis B virus (HBV) components of the combined hexavalent diphtheria, tetanus, acellular pertussis, HBV, inactivated poliovirus and Hib vaccine (DTPa-HBV-IPV/Hib; GlaxoSmithKline Vaccines). Methods. Phase IV, open-label, parallel-group study conducted at 3 centers in Canada (NCT00753649). Healthy Aboriginal and non-Aboriginal infants received DTPa-HBV-IPV/Hib at 2, 4 and 6 months of age. Immune responses to Hib polyribosyl ribitol phosphate (PRP) and HBV surface antigen (HBs) were measured 1 month post-dose 3. Medically-attended and serious adverse events (MAAEs/SAEs) were recorded up to 1 month post-dose 3. Results. Seroprotection against Hib and HBV, 1 month post-dose 3, was comparable in the 94 Aboriginal and 107 non-Aboriginal infants included in the per-protocol analysis (Table). Anti-PRP antibody geometric mean concentrations (GMCs) were 1.7 fold higher in Aboriginal infants (Table). Seroprotection rates and GMCs for Hib and HBV, with 95% confidence intervals 23.2% Aboriginal and 17.0% non-Aboriginal infants recorded MAAEs. 7 SAEs (bronchiolitis, pyrexia, bacterial pneumonia, respiratory syncytial virus infection and 3 cases of convulsion) were recorded in 6 Aboriginal infants; only 1 case (pyrexia) was assessed as vaccine-related; all SAEs had resolved by study end. Conclusion. 3-dose primary vaccination with DTPa-HBV-IPV/Hib elicited immune responses to the Hib and HBV antigens that were at least as high in Aboriginal as in non-Aboriginal Canadian infants. No safety concerns were identified. Disclosures. D. W. Scheifele, GlaxoSmithKline Vaccines: Grant Investigator, Research grant M. Ferguson, GlaxoSmithKline: Employed as an investigator at Colchester Research Group, which conducts multiple clinical trials with companies including GSK. PI in this study. My wife, Dr. Linda Ferguson, is CEO/Owner of CRG which has conducted clinical trials with multiple sponsors over the last 10 years; she has also received renumeration to present papers at conferences and discussions. D. Assudani, GlaxoSmithKline: Employee, Salary S. Kuriyakose, GlaxoSmithKline Pharmaceuticals: Employee, Salary O. Van Der Meeren, GlaxoSmithKline: Employee and Shareholder, Salary H. H. Han, GlaxoSmithKline: Employee and Shareholder, Salary
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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".