A Phase 2, Observer-blind, Active-controlled, Randomized Dose-finding Study in Healthy Infants to Assess the Safety, Reactogenicity and Immunogenicity of 3 Dose Levels of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains Compared to Conventional Salk IPV, in a 6, 10 and 14 Weeks of Age Immunization Schedule, and Co-administered With Diphtheria, Tetanus, Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B, Pneumococcal Conjugate and Rotavirus Vaccines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 3
- 主要终点
- Number of Participants with Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to assess the safety and reactogenicity of 3 different dose levels of inactivated poliovirus vaccine based on Sabin strains (sIPV) in healthy participants, using conventional Salk IPV (cIPV) as an active control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 39 Days 至 59 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study participant is a boy or a girl, who is eligible for expanded programme on immunization (EPI) vaccinations (that is, inactivated poliovirus vaccine [IPV], Diphtheria, Tetanus, whole cell Pertussis [DTwP]-Haemophilus influenzae type b [Hib]-Hepatitis B virus [HBV] and 13-valent Pneumococcal conjugate vaccine [PCV13]) at Weeks 6, 10 and 14 and Rotavirus vaccination at Weeks 6 and 14
- •Study participant has born after a normal term pregnancy (greater than or equal to [>=]37 weeks) and with a birth weight of >=2.5 kilogram (kg)
- •Study participant must be healthy as confirmed by the investigator on the basis of physical examination, vital signs and medical history, including the course of the pregnancy and relevant medical history of the mother, such as but not limited to human immunodeficiency virus, Hepatitis B virus (HBV), hepatitis C virus status or other significant disease that might impact the participant's health. Information about the course of the pregnancy and relevant medical history of the mother is obtained from the mother in person and at the discretion of the investigator without the need for official documentation or testing
- •Each study participant and his or her legally acceptable representative must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- •Study participant and his or her legally acceptable representative are available and reachable for all scheduled study visits and telephone contacts within the allowed window
排除标准
- •Contraindication to intramuscular (IM) injections and blood draws (venipuncture) for example, bleeding disorders
- •Known allergies, hypersensitivity, or intolerance to 1 of the excipients of IPV based on Sabin strains (sIPV) or conventional Salk IPV (cIPV) or any other vaccine component in the participant or mother
- •Received polio vaccine or were previously infected with poliovirus
- •Known or suspected autoimmune disease or persistent impairment/alteration of the immune function
- •Known neurological disease including seizures, congenital defects, or genetic disorders (for example, Down syndrome)
研究组 & 干预措施
Group 1: Low Dose IPV Based on Sabin Strains (sIPV)
Participants will receive intramuscular (IM) injection of the low dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of conventional Salk IPV (cIPV) at approximately 24 weeks after the third vaccination (38 weeks of age).
干预措施: sIPV (Biological)
Group 1: Low Dose IPV Based on Sabin Strains (sIPV)
Participants will receive intramuscular (IM) injection of the low dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of conventional Salk IPV (cIPV) at approximately 24 weeks after the third vaccination (38 weeks of age).
干预措施: cIPV (Biological)
Group 2: Intermediate Dose sIPV
Participants will receive IM injection of the intermediate dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age).
干预措施: sIPV (Biological)
Group 2: Intermediate Dose sIPV
Participants will receive IM injection of the intermediate dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age).
干预措施: cIPV (Biological)
Group 3: High Dose sIPV
Participants will receive IM injection of the high dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age).
干预措施: sIPV (Biological)
Group 3: High Dose sIPV
Participants will receive IM injection of the high dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age).
干预措施: cIPV (Biological)
Group 4: Conventional Salk IPV (cIPV)
Participants will receive IM injection of cIPV (3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age).
干预措施: cIPV (Biological)
结局指标
主要结局
Number of Participants with Serious Adverse Events (SAEs)
时间窗: Approximately up to 36 weeks
Number of participants with SAEs will be reported. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
时间窗: 7 days after first vaccination
Number of participants with solicited local and systemic AEs will be determined up to 7 days after first vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.
Number of Participants with Solicited Local and Systemic AEs
时间窗: 7 days after third vaccination
Number of participants with solicited local and systemic AEs will be determined up to 7 days after third vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.
Number of Participants Discontinued due to AEs
时间窗: Approximately up to 36 weeks
Number of participants discontinued from vaccinations or from the study due to AEs will be reported.
Number of Participants with Unsolicited AEs
时间窗: 28 days after third vaccination
Number of participants with unsolicited AEs will be determined up to 28 days after third vaccination. Unsolicited AEs will include all AEs for which the participant's legally acceptable representative(s) is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), and death (Grade 5).
次要结局
- Percentage of Participants with Seroconversion(28 days after the third vaccination)
- Poliovirus Type- and Strain-specific Neutralizing Antibody (NAb) Responses(28 days after the third vaccination)
- Percentage of Participants with Seroprotection(28 days after the third vaccination)