An Open Label, Randomized, Multicenter study to Evaluate and Compare the Immunogenicity and Reactogenicity of EasySixTM (New Fully Liquid Hexavalent DTwP-HepB-Hib-IPV Vaccine, Panacea Biotec Ltd.) with Pentavac SD® (Pentavalent DTwP-HepB/Hib Vaccine, Serum Institute of India Ltd.) Co Administered with Imovax Polio® (Salk Based Inactivated Polio Vaccine, Sanofi Pasteur India Pvt. Ltd.) in Healthy Infants.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 284
- 试验地点
- 3
- 主要终点
- Proportion of subjects achieving seroprotection against diphtheria, tetanus, Hepatitis B, Hib; seroresponsiveness against pertussis; seroconversion against Polio virus type 1, type 2 and type 3, 4 weeks after three dose vaccination series of DTwP-HepB-Hib-IPV vaccine in the two treatment groups
研究概览
简要总结
An Open Label, Randomized, Multicenter study to Evaluate and Compare the Immunogenicity and Reactogenicity of EasySixTM (New Fully Liquid Hexavalent DTwP-HepB-Hib-IPV Vaccine, Panacea Biotec Ltd.) with Pentavac SD® (Pentavalent DTwP-HepB/Hib Vaccine, Serum institute of India Ltd.) Co Administered with Imovax Polio® (Salk Based Inactivated Polio Vaccine; Sanofi Pasteur India Pvt. Ltd.) in Healthy Infants
The study will enroll Infants 6-10 weeks of age. Subjects will be randomized to receive either 3-dose primary vaccination series of Fully liquid hexavalent DTwP-HepB-Hib-IPV vaccine (EasySixTM) of Panacea Biotec Ltd. as a single intramuscular injection or Pentavac SD® (Pentavalent DTwP-HepB/Hib Vaccine, Serum Institute of India Ltd.) Co Administered with Imovax Polio® (Salk Based Inactivated Polio Vaccine, Sanofi Pasteur India Pvt. Ltd.) as two separate injections intramuscularly. The vaccinations will be done at 0, 4 and 8 weeks of enrollment. Local and solicited reactions will be observed on each vaccination day (up to 30 minutes) and on 4 subsequent days (day 0-3) after each dose. Adverse events will also be monitored for 28 days after each vaccination. Blood samples will be obtained from subjects at visit 1(before first vaccination and at visit 4 (Follow up visit) for estimation of Anti-diphtheria, Anti-tetanus, Anti-PRP, Anti- HBsAg, Anti-pertussis, Anti pertussis toxin antibodies and neutralizing antibodies against polio. The samples will be sent to Panacea’s central laboratory for analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 42.00 Day(s) 至 70.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Infants 6-10 weeks of age, whose parents/LAR willing to give written informed consent prior to the study entry.
- •2.Infants with good health as determined by: • Medical history • Physical examination • Clinical judgment of the investigator 3.Judged to be able to attend all scheduled study visits and to comply with trial procedures.
排除标准
- •1.Infants weighing  3.3 Kg at the time of enrollment.
- •2.Infants less than 6 weeks or more than 10 weeks of age.
- •3.Known HBsAg positivity in mother.
- •4.Infants having history of immunization with vaccine other than zero polio, BCG and birth dose of HepB 5.Infants with history of infection potentially related to any of the agents targeted by the DPT-HepB-Hib-IPV vaccine 6.Presence of evolving or changing neurological disorder or Infants with history of seizures before receiving the vaccine.
- •Initiation or continuation of pertussis vaccination should be deferred until an evolving neurological disorder can be excluded.
- •7.History of household contact and/or intimate exposure to an individual with suspected poliomyelitis.
- •8.Fever >38o C in past 3 days 9.Any evidence of acute illness or infection within past 7 days.
- •10.Planned or elective surgery during the course of the study.
- •11.Infants with a known or suspected impairment of the immune function (congenital or hereditary), or those receiving immunosuppressive therapy, or received immunosuppressive therapy prior to study entry (including systemic or high doses of inhaled corticosteroids) or those who have received a parenteral immunoglobulin preparation 12.Infants who have received any blood products, cytotoxic agents or radiotherapy.
- •13.Infants with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component.
- •14.Have any clinically significant chronic disease (for example, cardiac, pulmonary, renal, gastrointestinal, hepatic, endocrine, cancer, skin or psychiatric disease or disorder or autoimmune disease under treatment) or major congenital defects, such that it would endanger the volunteer’s wellbeing or which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •15.Any evidence of thrombocytopenia or a bleeding disorder.
- •16.Infants who have participated in another trial or received an investigational agent within 30 days of enrolment.
结局指标
主要结局
Proportion of subjects achieving seroprotection against diphtheria, tetanus, Hepatitis B, Hib; seroresponsiveness against pertussis; seroconversion against Polio virus type 1, type 2 and type 3, 4 weeks after three dose vaccination series of DTwP-HepB-Hib-IPV vaccine in the two treatment groups
时间窗: Day 0 and Day 84
次要结局
- •Incidence of solicited local and systemic reactions within 4 days of each vaccine dose (day 0-3).(•Incidence of unsolicited adverse events up to 4 weeks after last vaccination.)