Delay for pentavalent vaccine: a hospital based cross sectional study

Background: Young children are often at increased risk for illness and death related to infectious diseases, and vaccine delays may leave them vulnerable at ages with a high risk of contracting several vaccine-preventable diseases This study examined delay for each pentavalent vaccine in the universal immunization programme and the factors that influence untimely vaccinations.Methods: This was a hospital based cross sectional study done on 45 days to-12 months aged children attending the immunisation clinic held at government medical college and hospital Aurangabad, Maharashtra. Data was collected from the records on health card as well from mother with the help of pretested pre-structured questionnaire for predictors of delay.Results: Total 411 children aging 45 days to 12 months were enrolled in the study. For pentavalent 1 vaccine, 83.69% received vaccine without delay and 16.31% were delayed. 43.53% were delayed for pentavalent 2 vaccine, 224 children received pentavalent 3 vaccine, out of them 80.35% received within time whereas 19.65% were delayed. We found birth order, parent’s education, working status of mother, mother’s age below 18; parity had statistically significant association with delay. Unawareness about the right timings of vaccination and immunization schedules held at periphery, parents delaying vaccine for minor sickness of baby, were the main reasons observed for delay.Conclusions: A total 83.69% children received vaccine within the recommended time. Still 16.31% children experience delay for the vaccination. Reasons for delay observed can be overcome by appropriate counselling of mother by health care workers at the first time of vaccination which will improve the adherence and avoid delay in future to immunisation schedule.

Benign abducens nerve palsy: diagnosis by exclusion

Of all the cranial nerves, the abducens nerve has the longest intracranial course hence is most common cranial nerve to be affected secondary to any potentially devastating intracranial cause. It can indicate significant underlying pathology. Abducens or sixth cranial nerve innervates lateral rectus muscle and pathology of this nerve results in abduction deficiency of ipsilateral eye. Most of the time it will be unilateral but bilateral involvement is also well known. It can recurrent without any underlying identifiable pathology. The 6th nerve palsy is considered as benign after ruling out all possible causes. Benign causes account for just 9 to 14% of all 6th nerve palsies in children. Most of the time benign 6th nerve palsy occurs after viral infection or vaccination as an immunological reaction. In our case patient had history of pentavalent vaccination 1 month back. After thorough investigation and ruling out all possible causes it was attributed to post vaccination immunological reaction. which resolved spontaneously over 4months.

Nueva metodología para la formulación de la vacuna Heberpenta-L / New methodology for the formulation of the vaccine Heberpenta-L

La vacuna Heberpenta-L, está indicada para la inmunización activa contra la difteria, tétanos, tos ferina (pertussis), hepatitis B y Haemophilus influenzae tipo b. En el Centro Nacional de Biopreparados se diseñó una nueva planta de producción de productos parenterales, resultando la vacuna pentavalente uno de los productos recién introducidos. Con tal propósito se diseñó una nueva metodología para la formulación de la vacuna, adecuando los procedimientos normalizativos de operación vigentes a esta nueva instalación. La validación con medio de cultivo caldo triptona soya, resultó una de las etapas más importantes para garantizar, tanto las operaciones de esterilización y enfriamiento de las soluciones, como todos los pasos críticos en la formulación y operaciones asépticas para futuros productos. Se estableció una nueva metodología en el proceso de formulación para la preparación de las soluciones, la cual tuvo lugar en un área independiente al área de la formulación final del producto. Los resultados satisfactorios obtenidos en la formulación de tres lotes de consistencia de la vacuna Heberpenta-L, no solo garantizaron el cumplimiento de los requisitos de calidad establecidos para esta vacuna, sino que además constituyeron la base preliminar a largas campañas de otros productos.

The vaccine Heberpenta-L, is suitable for the active immunization against the diphtheria, tetanuses, ferocious cough (pertussis), hepatitis B and Haemophilus influenzae type b. In the National Center of Bioproducts a new plant of production of products parenterals was designed, being the vaccine pentavalent one of the recently introduced products. With such a purpose a new methodology was designed for the formulation of the vaccine, adapting the procedures effective operation normalizative to this new installation. The validation with cultura medium broth triptone soy was one of the most important stages to guarantee, so much the sterilization operations and cooling of the solutions, as all the critical steps in the formulation and aseptic operations for future products. A new methodology settled down in the formulation process for the preparation of the solutions, which took place in an independent locate to the locate of the final formulation of the product. The satisfactory results obtained in the formulation of three batch of consistency of the vaccine Heberpenta-L, they guaranteed the execution of the established requirements of quality for this vaccine and constituted the preliminary base to long campaigns of other products.

Immunogenicity and Safety of a DTaP-IPV//PRP~T Vaccine (Pentaxim) Booster Dose During the Second Year of Life in Indian Children Primed with the Same Vaccine.

Objective: To evaluate the immunogenicity and safety of a pentavalent (diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Hib polysaccharide-conjugate) combination vaccine booster dose. Design: Multicenter, open, Phase III clinical study. Setting: Two tertiary-care hospitals in Delhi and Vellore, India. Participants/patients: 207 healthy Indian children. Intervention: The DTaP-IPV//PR~NT vaccine (Pentaxim) was given at 18-19 months of age to children who had been primed with the same vaccine at 6,10,14 weeks of age. Main outcome measures: Immunogenicity was assessed before and 1 month after the booster. Safety was evaluated from parental reports, and investigator assessments. Results: At 18-19 months of age, before boosting, the SP rates against diphtheria, tetanus, poliovirus and PRP were 82.3-100%; 90.0% of participants had anti-PRP ≥0.15 μg/mL. Anti-poliovirus titers were ≥1:8 dilution in 97.9-98.4% of participants. Anti-PT and FHA titers (≥5 EU/mL) were detectable in 82.5% and 90.8% of participants, respectively. One month after the booster dose, SP rates were 99.5% for PRP (≥1.0 μg/mL), 100% for diphtheria, tetanus (≥0.1 IU/mL) and polioviruses (≥8:1/dilution). Seroconversion (4 fold post-booster increase in anti-PT and -FHA concentration) occurred in 96.8% and 91.7%, respectively. Geometric mean concentrations (GMC) increased from 11.7 to 353.1 EU/mL and from 18.2 to 363.4 EU/mL for anti-PT and anti- FHA, respectively. Anti-PRP GMC increased from 1.75 to 70.5 μg/ mL. Vaccine reactogenicity was low; severe solicited reactions were reported by <1.4% of participants. Conclusion: The DTaP-IPV//PRP-T vaccine booster at 18-19 months of age was well tolerated and induced strong antibody responses.