A Phase IV, Open labelled, Randomized, Controlled Study to Assess the Immunogenicity and Effect on Pneumococcal Nasopharyngeal Carriage of reduced two dose schedule (1+1) of Pneumococcal Conjugate Vaccines 10-valent PNEUMOSIL and 14 valent PNEUBEVAX-14 as compared to their recommended three dose schedule (2+1) in Healthy Indian Infants.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- To compare the immunogenicity response with reduced two dose schedule (1+1) of PNEUMOSIL and PNEUBEVAX-14® as compared to their recommended three dose schedule (2 + 1) at 10 months of age (four weeks after the booster dose) in healthy Indian infants.
研究概览
简要总结
Globally, Pneumococcal Conjugate Vaccines have gained substantial success in reducing invasive pneumococcal disease; however, the high cost of PCV remains one of the major hurdles in its’ programmatic inclusion and sustainability. A reduced two-dose (1+1) schedule of PCV has been shown to offer optimal immune protection in countries with mature PCV programs. This approach not only reduces the vaccination costs including the logistic and operational costs, but also alleviates the complex childhood vaccination program thus facilitating improved coverage.
The reduced dose schedule 1+1 of PCV10 and PCV13 has been evaluated in different regions worldwide. All the sites have shown similar immunogenicity and VT carriage reduction using the 1+1 schedule compared with the three-dose schedules. The UK pivotal trial, the first study evaluating a 1+1 schedule of PCV13 (PREVNAR®), has shown that serotype-specific immune responses following a booster dose at 12 months of age were similar or superior to those after a 2+1 schedule. This immunogenicity study laid the foundation for a reduced-dose 1+1 schedule in countries with mature PCV programs (11).
The 1+1 study in India conducted before the PCV rollout showed that 1+1 schedules of both PCV13 (PREVNAR®) and PCV10 (SYNFLORIX®) achieved immune protection in Indian children during the second year of life which was comparable to WHO- WHO-recommended 3-dose schedules. The study showed that the reduced dose schedule (1+1) of the PCV13 (PREVNAR®) resulted in a significant 13VT-carriage reduction in the second year of life (14).
Presently, there are no data available on immunogenicity or clinical efficacy for the 1+1 schedule of PNEUMOSIL® and PNEUBEVAX-14®. As these vaccines have been rolled out in the government program of India and are likely to be rolled out in other low and middle-income countries, the evidence on the effectiveness of the 1+1 schedule of PNEUMOSIL® and PNEUBEVAX-14® can help the policymakers to implement this reduced dose schedule in the near future. The proposed study plans to assess the effect of PNEUMOSIL® and PNEUBEVAX-14® in a 1+1 schedule compared to the existing 2+1 schedule on immunogenicity and NP carriage in healthy Indian infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 42.00 Day(s) 至 56.00 Day(s)（—）
- 性别
- All
入选标准
- •Healthy infants as established by medical history and clinical examination 6-8 weeks (42-56 days) of age at the time of enrolment.
- •Written informed consent obtained from the parent(s) of infants Parent who intends to remain in the study area with the child during the study period and will be ready to comply with the protocol.
排除标准
- •Presence of fever on the day of enrolment (≥38.0oC) (temporary exclusion) Any acute illness at the time of enrolment (temporary exclusion) Concurrent participation in another clinical trial during study period.
- •Weight-for-height z-score ≤-3SD Presence of significant systemic disorder as determined by medical history and/or physical examination Prior receipt of any pneumococcal vaccine Known sensitivity or allergy to any components of the study vaccine Major congenital or genetic defect Receipt of any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
- •History of chronic administration (defined as more than 14 days) of immune-suppressants including corticosteroids.
- •Any medical or social condition that in the opinion of the PI may interfere with the protocol adherence or pose a risk to the participant.
结局指标
主要结局
To compare the immunogenicity response with reduced two dose schedule (1+1) of PNEUMOSIL and PNEUBEVAX-14® as compared to their recommended three dose schedule (2 + 1) at 10 months of age (four weeks after the booster dose) in healthy Indian infants.
时间窗: 10 months of age
次要结局
- To compare the functional serotype specific antibody response as measured by opsonophagocytic assay (OPA) with reduced two dose schedule (1+1) of PNEUMOSIL® and PNEUBEVAX-14® as compared to their regular three dose (2+1) at 10 months of age (4 weeks after the booster dose) in healthy Indian infants.(At 10 months of age)
- To assess the impact of reduced two dose schedule (1+1) of PNEUMOSIL® and PNEUBEVAX-14® on nasopharyngeal carriage of vaccine serotypes (VTs) of S. pneumoniae at 15 months of age (6 months after receipt of the booster dose) as compared to their recommended three dose schedule (2+1) in healthy Indian infants.(At 15 months of age)
研究者
Dr Ashish Bavdekar
KEM Hospital Research Centre