CTRI/2025/02/081007已完成2/3 期
A Randomized, Open label, Multicenter, Phase II / III study to assess and compare the immunogenicity and safety of NUCOVAC®-11 {Pneumococcal Polysaccharide conjugate vaccine (Adsorbed), 11 valent} of Panacea Biotec Ltd. with PREVENAR 13® of Pfizer Inc. in healthy infants (3+1 immunization schedule)
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 446
- 试验地点
- 7
- 主要终点
- To evaluate the immune response in terms of serotype-specific IgG concentrations induced
研究概览
简要总结
The clinical trial is a randomized, open-label, multicenter Phase II/III study designed to assess and compare the immunogenicity and safety of NUCOVAC®-11 (11-valent Pneumococcal Polysaccharide Conjugate Vaccine) with PREVENAR 13® in healthy infants. The primary objective is to evaluate the immune response, measured through serotype-specific IgG concentrations, four weeks after a three-dose primary immunization series. Secondary objectives include assessing immune responses after a booster dose, serum OPA titers, and comparing safety and reactogenicity between the two vaccines. The study involves 446 participants (223 per arm), with a subset undergoing additional antibody testing. Conducted over 18 months, the study includes a primary immunization phase (doses at 6–8 weeks, 10–12 weeks, and 14–16 weeks) and a booster phase (at 15–18 months). Participants will be monitored for adverse events, with blood samples collected for immunogenicity analysis.
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 between 6 to 8 weeks of age Both Inclusive on the day of enrollment whose parents or LAR willing to participate and give written informed consent prior to the study entry
- •Infants with good health as determined by Medical history Physical examination Clinical judgment of the investigator
- •Infants judged to be able to attend all scheduled study visits and to comply with trial procedures
- •Weight of the Infant at enrolment visit greater than or equal to 3.2 kg
- •Infants with an up to date minimal vaccination status at the time of enrollment as per UIP schedule as per local or regional protocols Inclusion Criteria for Booster Immunization Phase
- •Infants who have completed primary immunization series of the study vaccine in the present study.
排除标准
- •Exclusion Criteria for Primary Immunization Phase:
- •The parents or LAR are unwilling or unable to give written informed consent to participate in the study
- •Infants 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
- •Infants 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
- •Infants who have received any Pneumococcal vaccine prior to enrollment
- •Bleeding disorder, contraindicating IM vaccination or receipt of anticoagulants in the 3 weeks preceding inclusion
- •History of Human Immunodeficiency Virus HIV, hepatitis B or hepatitis C in infant or mother
- •Presence of evolving or changing neurological disorder
- •Infants with history of seizures
- •Axillary temperature greater than or equal to 38 degree 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
- •Infants 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
- •Infants who have received any blood products, cytotoxic agents or radiotherapy
- •Infants with history of anaphylaxis or any serious vaccine reaction or allergy to any vaccine component
- •Infants 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 or third dose
- •Generalized allergic reaction within 48 hours of administration of previous vaccine dose
- •Encephalopathy
- •Axillary temperature of greater than 40 degree Celsius within 48 hours of previous vaccine dose
- •Inconsolable persisting crying defined as greater than 3 hours within 48 hours of previous vaccination
- •Generalized cyanosis within 48 hours of previous vaccine dose
- •Any serious reaction after previous dose which can compromise the safety of the subject if continued in the trial Exclusion Criteria for Booster immunization Phase
- •Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 3 days
- •Infants who have already received pneumococcal vaccine booster dose other than Investigational vaccine from other resources from different doctor or hospital
- •Bleeding disorder contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding booster dose
- •History of Human Immunodeficiency Virus HIV hepatitis B or hepatitis C in infant after primary immunization
- •Presence of evolving or changing neurological disorder after primary immunization
- •Infants 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 booster vaccination including systemic corticosteroids or those who have received a parenteral immunoglobulin preparation
- •Infant 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.
结局指标
主要结局
To evaluate the immune response in terms of serotype-specific IgG concentrations induced
时间窗: Day 0 and Day 84
by 11 common serotypes of NUCOVAC®-11 vaccine alone and in comparison, to 13-valent PREVENAR 13®, 1 month after three dose series.
时间窗: Day 0 and Day 84
次要结局
- 1. To evaluate the immune response in terms of serotype-specific IgG concentrations(induced by 11 common serotypes of NUCOVAC®-11 vaccine alone and in comparison, to)
研究者
Dr LALITENDU MOHANTY
Panacea Biotec Limited
研究点 (7)
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