CTRI/2015/12/006456已完成2 期
“A Phase 2, Prospective, Multi-Center, Randomized, Two-Arm, Active Controlled, Double-Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of Serum Institute of India’s 10-valent PneumococcalConjugate Vaccine (SIILPCV10) in Healthy Indian PCV-Naïve Toddlers (12 to 15 months)â€
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 3
- 主要终点
- Safety and Tolerability of SIILPCV10 vaccine following IM injection will be assessed for occurrence, severity, and relationship to vaccination of solicited (local and systemic) reactogenicity, unsolicited AEs, SAEs, and clinically significant hematological and biochemical measurements.
研究概览
简要总结
This is a Phase 2 randomized double-blind Safety and early Immunogenicity study in Indian PCV-naïve Toddlers, which will be conducted at three centers across India. The study is based on the hypothesis that intramuscular administration of SIILPCV10 in healthy Indian PCV-naïve Toddlers will be safe and well tolerated and elicit an immunogenic response to the pneumococcal antigens contained in the vaccine. On successful completion, this study will lead to a pivotal Phase 3 Non-Inferiority Safety and Immunogenicity study in Indian Infants, aimed at Indian Licensure of SIILPCV10.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 12.00 Month(s) 至 15.00 Month(s)（—）
- 性别
- All
入选标准
- •Toddlers will be eligible for enrolment if all of the following apply at the time of screening: •They are healthy Indian PCV-naïve toddlers who are 12 to 15 months of age inclusive, at Day 0 (randomization and first vaccination).
- •Note: -Toddler subjects will be eligible from the day they reach 12 months of age until the day before they reach 16 months.
- •â€œHealthy†toddlers are those without acute or chronic, clinically significant pulmonary, cardiovascular, hepatobiliary, gastrointestinal, renal, neurological, mental or hematological functional abnormality or illness that requires medical therapy, as determined by medical history or clinical assessment before entering the study.
- •PCV-naïve toddlers are those who have not been previously vaccinated with any licensed or investigational pneumococcal vaccine.
- •â€¢Toddlers must have a weight-for-age Z score of ≥-2 at the time of enrolment (WHO child growth standard).
- •â€¢Toddlers with an up-to-date minimal vaccination status for their age at the time of enrolment (“minimal†defined as single dose of BCG, 3 doses of OPV, DPT, and Hepatitis B, and single dose of Measles at the time of enrolment).
- •â€¢Toddler’s parent must provide voluntary written informed consent to have the toddler participate in the study and should be capable of comprehending and complying with study requirements and procedures, and be able and willing to complete subject diary and to return with the toddler for all scheduled follow up visits.
- •â€¢Toddler’s parent should have expressed availability with no plans to travel outside the study area for the duration of the study, and have a known place of residence, with access to a consistent means of telephone contact, either residential land line or cellular mobile.
- •â€¢Toddler’s parent must be willing to avoid giving herbal or other local traditional medications to the toddler for consumption (ingestion) during the course of the study.
排除标准
- •A Toddler who meets, any of the following criteria at screening will not be eligible for enrolment in the study: •Use of any investigational or non-registered medicinal product within 90 days prior to administration of study vaccine or planned use during the duration of the study.
- •â€¢History of previous vaccination against Streptococcus pneumoniae or history of suspect Streptococcus pneumoniae infection since birth.
- •â€¢History of administration of any non-study vaccine within 30 days prior to administration of study vaccine or planned vaccination during the course of study participation.
- •â€¢History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines.
- •â€¢History of anaphylactic reaction.
- •â€¢Any screening laboratory test result outside normal range and deemed by the PI to be clinically significant.
- •Each such assessment may be repeated once during the screening period, with the most recent laboratory value being used for evaluation of exclusion criteria.
- •â€¢Any abnormal vital sign deemed by the PI to be clinically significant.
- •Such an abnormal vital sign may be repeated once during the screening period for the toddler to remain eligible for randomization.
- •â€¢Acute illness (moderate or severe) and/or fever (axillary temperature ≥37.5°C).
- •Note: Subjects with an acute illness/fever may return once for a repeat screening visit within the 2-week screening period and still qualify for randomization if the acute illness has resolved.
- •A minimum of 72 hours following a documented fever must pass before the subject can be re-screened and vaccinated.
- •â€¢Receipt of antibiotics (oral or injected) within 5 days of randomization/vaccination.
- •â€¢Evidence by history taking alone (mothers will not be tested routinely) of exposure to an HIV-positive individual through maternal fetal transmission, breast milk, or other blood-borne mechanisms.
- •â€¢HIV and/or HBsAg positive serological tests at the time of screening.
- •Note: HIV seropositivity will result in a subject being excluded from the trial even though this may reflect maternal antibody transfer rather than HIV infection in the toddler.
- •In all such cases, standard follow-up measures would be instituted appropriately.
- •â€¢Family history of suspected primary immunodeficiency in first-degree relative.
- •â€¢Chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune modifying drugs prior to the administration of the study vaccine, including the use of glucocorticoids.
- •â€¢Administration of immunoglobulins and/or any blood products within the 6 months prior to administration of the study vaccine or anticipation of such administration during the study period.
- •â€¢Toddler or any first-degree relative (e.g. parent, siblings) with known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding (e.g. thalassemia, coagulation factor deficiencies).
- •â€¢History of meningitis or seizures or any neurological disorder.
- •â€¢Toddler who has had a sibling die of sudden infant death syndrome (SIDS) or die suddenly and without apparent other cause or preceding illness in the first year of life.
- •â€¢Evidence of a clinically significant congenital abnormality as judged by the PI.
- •â€¢Evidence of fetal alcohol syndrome or maternal history of alcohol abuse during pregnancy.
- •â€¢Toddler is a direct descendant (child or grandchild) of any person employed by the Sponsor, the Contract Research Organization (CRO), or the Study Site (including the PI and study site personnel).
- •â€¢Child in care (a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation).
- •The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above.
结局指标
主要结局
Safety and Tolerability of SIILPCV10 vaccine following IM injection will be assessed for occurrence, severity, and relationship to vaccination of solicited (local and systemic) reactogenicity, unsolicited AEs, SAEs, and clinically significant hematological and biochemical measurements.
时间窗: Solicited (local and systemic) reactogenicity during the first 7 days following each vaccination. | Unsolicited AEs through 28 days post final vaccination. | SAEs through 28 days post final vaccination. | Occurrence, severity, and relatedness of clinically significant hematological and biochemical measurements 7 days post first vaccination.
次要结局
- Safety: Safety & Tolerability of IM inj of SIILPCV10 vaccine will be evaluated vs Prevenar 13® for occurrence, severity & relationship to vaccination of solicited AEs (7-day post vac period), unsolicited AEs (28-day post vac period), SAEs (entire study period) and safety labs of clinical significance and related to first vaccination.(Immunogenicity: IgG ELISA (GMC, GMFR, % of Responders) and OPA (GMT) responses 28 days post completed vaccination will be evaluated, SIILPCV10 vs Prevenar 13®.)
研究者
研究点 (3)
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