A Prospective, Randomized, Double-Blind, Multi-Center, Phase III Study To Assess And Compare The Immunogenicity And Safety Of The 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine In Healthy Indian Subjects.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 950
- 试验地点
- 6
- 主要终点
- Cohort 1 & 2
研究概览
简要总结
Pneumococcal disease remains a burden with a large unmet medical need in all age groups with changes in pneumococcal serotype prevalence observed globally, in part driven by antibiotic resistance. The prevention of risk factors assumes vital importance. The measures consist of reducing childhood wasting, lessening indoor and ambient air pollution, infection control practices and attempts at mitigating the susceptibility to pneumococcal diseases by vaccination. Vaccination against pneumococcal disease is a crucial preventive strategy and should be regarded as the key focus.
This study will be conducted in following phases:
For Cohort 1 & 2: After obtaining consent/assent, subjects will be screened, enrolled and randomized to one of the two study arms (A and B). Post study/visit specific evaluations, subjects will receive 1 dose of investigational vaccine, test vaccine (13-valent Pneumococcal Polysaccharide Conjugate Vaccine TT/DT) (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) developed by Beijing Minhai Biotechnology Co., Ltd or PREVENAR 13®, Pfizer Inc at Visit 1. The subjects’ condition will be followed up for 7 days post vaccination after dose to account for any AEs.
Follow-up phase: This phase will comprise of on-site follow-ups of the subjects 28 days after the vaccination (Visit 2).
For Cohort 3:
Primary immunization phase of the study (3+0): Subjects 6-8 weeks of age will be screened, enrolled and randomized to one of the two study arms (A and B), upon receipt of written informed consent from Parents/LARs. Subjects will receive 1 dose of investigational vaccine, test vaccine (13-valent Pneumococcal Polysaccharide Conjugate Vaccine TT/DT) (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) developed by Beijing Minhai Biotechnology Co., Ltd or PREVENAR 13®, Pfizer Inc at Visit 1 (6-8 weeks), Visit 2 (10-12 weeks) and Visit 3 (14-16 weeks), respectively (3 doses in total) with an interval of 4 weeks and a window period of +1 week. The subjects’ condition will be followed up for 7 days post vaccination after each dose (i.e., after Visit 1, 2 and 3) to account for any AEs
Follow-up phase: This phase will comprise of on-site follow-ups of the subjects 28 days after the 3rd dose (Visit 4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 42.00 Day(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •For Cohort 1 & 2
- •Healthy subjects aged 6 – 65 years (both inclusive) on the day of enrolment & subjects/ parents/ LARs are willing to participate and give written informed consent prior to the study entry.
- •Children & adolescents who have history of primary immunization with Pneumococcal vaccine or Adult who are pneumococcal vaccine naïve.
- •Subjects with good health as determined by: a) Medical history. b) Physical examination. c) Clinical judgment of the investigator
- •Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
- •Negative urine pregnancy test for all female subjects who are of childbearing potential. For Cohort 3
- •Healthy subjects aged
- •8 weeks (both inclusive) on the day of enrolment & parents/LARs are willing to participate and give written informed consent prior to the study entry.
- •Subjects with good health as determined by: a) Medical history b) Physical examination c) Clinical judgment of the investigator
- •Subject’s parents/LARs must be able to comprehend and comply with study requirements and procedures, and willing to complete subject diary and to return with the subject for all scheduled follow up visits.
- •Subjects must have been born full-term, at randomization.
- •Weight of the infant at enrolment visit ≥ 3.2 kg.
- •Subjects who have not received any Pneumococcal vaccine prior to enrolment.
- •Subjects with an up-to-date minimal vaccination status (includes, BCG vaccine, first dose of OPV, IPV and first dose of vaccine against Hep B, DPT and Hib that could be administered as pentavalent vaccine) at the time of enrolment as per UIP schedule (per local/regional protocols).
排除标准
- •Exclusion Criteria for the first dose (for all cohorts):
- •The subjects/parents or LARs are unwilling or unable to give written informed consent to participate in the study.
- •Subjects who have participated in another trial of an investigational agent within 30 days prior to enrolment.
- •Planned participation in another clinical trial during the present trial period.
- •Subjects who/whose families are planning to leave the area of the study site before the end of the study period.
- •History of culture-proven invasive disease caused by S.
- •pneumoniae.
- •Bleeding disorder, contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding screening.
- •History of infections with HIV, HBV, or HCV in the infant or mother.
- •Presence of evolving or changing neurological disorder.
- •Subjects with history of seizures.
- •Axillary temperature ≥40.0°C in past 3 days.
- •Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 3 days
- •Planned or elective surgery during the course of the study.
- •Subjects with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or having received immunosuppressive therapy within 1 month prior to study entry (including systemic corticosteroids) or those who have received a parenteral immunoglobulin preparation.
- •Subjects who have received any blood products, cytotoxic agents or radiotherapy.
- •Vaccination with any licensed or investigational pneumococcal vaccine within the last year
- •Subjects with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component.
- •This includes such reactions in older siblings and also includes all components of the UIP vaccines.
- •Subjects with any serious chronic disease or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives or compromise the safety of the subject.
- •Exclusion Criteria for the Second / Third Dose (For cohort 3 only)
- •Generalized allergic reaction in past 3 days
- •Encephalopathy
- •Generalized cyanosis within past 3 days 7.
结局指标
主要结局
Cohort 1 & 2
时间窗: Cohort 1 & 2 | 4 weeks after single dose. | Cohort 3: | 4 weeks after the 3rd dose
Serotype-specific IgG GMCs alone & in comparison to PREVENAR 13® 4 weeks after single dose.
时间窗: Cohort 1 & 2 | 4 weeks after single dose. | Cohort 3: | 4 weeks after the 3rd dose
GMFRs in serotype-specific IgG alone & in comparison to PREVENAR 13® from before vaccination to 4 weeks after single dose.
时间窗: Cohort 1 & 2 | 4 weeks after single dose. | Cohort 3: | 4 weeks after the 3rd dose
Percentage of subjects achieving serotype-specific pneumococcal IgG concentrations ≥ 0.35 μg/mL alone & in comparison to PREVENAR 13® from before vaccination to 4 weeks after single dose.
时间窗: Cohort 1 & 2 | 4 weeks after single dose. | Cohort 3: | 4 weeks after the 3rd dose
次要结局
- Immunogenicity Endpoints(For Infants (Cohort 3))
研究者
Dr. Virendra Nath Tripathi
New Leelamani Hospital near 14/116 C-1 parade chauraha Civil Lines Kanpur Uttar Pradesh 208001