BackgroundTo support vaccination programs in developing countries, a 4-dose vial presentation of pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) was developed. This study assessed immunologic non-inferiority and safety of the investigational PHiD-CV 4-dose versus licensed 1-dose vial presentation in infants.MethodsIn this phase III, mono-center, observer-blind study in Bangladesh, 6–10-week-old infants were randomized 1:1 to receive PHiD-CV primary vaccination (at ages 6, 10, 18 weeks) and a booster dose (at age 9 months) with a 4-dose vial (with preservative, 4DV group) or 1-dose vial (preservative-free, 1DV group). DTPw-HBV/Hib was (co)-administered per study protocol and polio, measles and rubella vaccines as part of the national immunization program. Non-inferiority of PHiD-CV 4-dose versus 1-dose vial for each vaccine pneumococcal serotype (VT) and vaccine-related serotype 19A in terms of antibody geometric mean concentration (GMC) was assessed (criterion: upper limit of 2-sided 95% confidence interval of antibody GMC ratios [1DV/4DV] <2-fold). Immune responses were measured. Solicited, unsolicited and serious adverse events (AEs) were evaluated.ResultsOf 320 infants (160 per group) vaccinated during the primary vaccination phase, 297 received a booster. Non-inferiority was demonstrated for each VT and 19A. One month post-primary vaccination, for most VT, ≥97.9% of infants in each group had antibody concentrations ≥0.2 μg/mL; for 19A ≥ 80.1% reached this threshold. Pneumococcal antibody responses and opsonophagocytic activity for each VT and 19A were within similar ranges between groups after primary and booster vaccination, as were anti-protein D responses. Booster immune responses were observed in both groups. Reported AEs were within similar ranges for both presentations.ConclusionImmunologic non-inferiority of PHiD-CV 4-dose vial (with preservative) versus PHiD-CV 1-dose vial (preservative-free) was demonstrated. Immune responses and reactogenicity following primary/booster vaccination were within similar ranges for both presentations. PHiD-CV 4-dose vial would help improve access and coverage in resource-limited countries.Clinical Trial Registry: NCT02447432. 相似文献
The purpose of this study was to investigate the relationship between the disc positions of temporomandibular joints (TMJ), the vertical and lateral mandibular displacement (VMD and LMD, respectively) and age in female adolescents with signs and symptoms of the temporomandibular disorders (TMD). The VMD and LMD were assessed, using posteroanterior (PA) cephalograms. The disc positions were assessed by magnetic resonance imaging (MRI) and categorized as follows: normal disc position, functional disc displacement and functional disc dislocation. Excluding patients with osteoarthritis, the total number of subjects was 54 female adolescents who were grouped into three: the bilateral normal disc position group, the unilateral or bilateral functional disc displacement group, and the unilateral or bilateral functional disc dislocation group. We compared the extent of VMD and LMD between the three groups, and investigated their correlation with age. Results indicate that functional disc displacement and dislocation are related to mandibular displacement, and VMD did not correlate with age but LMD did correlate with age. This study suggests that the onset of disc displacement is related to the mandibular displacement and disturbs normal growth of the mandible three-dimensionally. 相似文献
The purpose of this study was to determine whether 12.5 MHz ultrasonography (US) could be used to assess the presence or absence of temporomandibular joint (TMJ) internal derangement (ID). In 48 consecutive patients with TMJ disorders 192 TMJ positions were investigated by US to analyse the functional disc-condyle relationship (DCR). In order to compare the respective findings with those of a diagnostic method offering a high accuracy, coronal and sagittal magnetic resonance imaging was carried out immediately afterwards. With US showing a sensitivity of 0.58 and 0.75, and a specificity of 0.92 and 0.84 for disc displacement with and without reduction, the data revealed US to be marginal in detecting the presence, but sensitive in detecting the absence of the respective types of a TMJ ID. In addition, with a positive predictive value of 0.83 and 0.71, and a negative predictive value of 0.81 and 0.87 for disc displacement with and without reduction, the results indicate that US may be insufficient in establishing a correct diagnosis for the presence or absence of the respective types of TMJ ID. Regarding the diagnosis of absence or presence of TMJ ID, the results demonstrate high-resolution (HR)-US to be sensitive in detecting the absence, and reliable in predicting the presence of TMJ ID. In view of the fact that the 12.5 MHz US technique proved to be a reliable diagnostic aid for the detection of normal, and the prediction of abnormal DCR, the results of this study should be of further interest and encourage research in its potential uses and diagnostic capabilities. 相似文献
Objective: The null hypothesis was that mandibular amplitude, velocity, and variability during gum chewing are not altered in subjects with temporomandibular joint (TMJ) internal derangements (ID).
Methods: Thirty symptomatic subjects with confirmed ID consented to chew gum on their left and right sides while being tracked by an incisor-point jaw tracker. A gender and age matched control group (p > 0.67) volunteered to be likewise recorded. Student’s t-test compared the ID group’s mean values to the control group.
Results: The control group opened wider (p < 0.05) and chewed faster (p < 0.05) than the ID group. The mean cycle time of the ID group (0.929 s) was longer than the control group (0.751 s; p < 0.05) and more variable (p < 0.05).
Discussion: The ID group exhibited reduced amplitude and velocity but increased variability during chewing. The null hypothesis was rejected. Further study of adaptation to ID by patients should be pursued. 相似文献
The technical minutiae of the operation of open mandibular condylotomy and precision scaphoid staple osteosynthesis with meniscoplasty or meniscopexy is described and illustrated. The operation is regarded as an evolution of closed condylotomy described by Ward in 1961 and is indicated for those cases of severe and persistent temporomandibular joint pain and crepitus unresponsive to skilled conservative treatment over a reasonable time. The success of the procedure is probably the sequel of a partial denervation of the joint capsule associated with arthrotomy, the interruption of venous hypertension, the relocation of the mandibular condyle and enlargement of the joint space. The operation is also applicable to cases of active (and inactive) mandibular condylar hyperplasia wherein a condylar neck ostectomy and staple is used to ablate an active growth centre or correct a lesser degree of mandibular asymmetry. 相似文献