CTRI/2022/11/047443进行中（未招募）3 期
A Randomized, Double-Blind, Multi-center, Phase III Study to Assess and Compare the Immunogenicity and Safety of the 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-TT) with PREVENAR 13® of Pfizer Inc. in Healthy Infants in India
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Prospective subjects will only be eligible for randomization if all of the following inclusion criteria, and none of the exclusion criteria, are met at the time of screening:
- •Inclusion Criteria for Primary Immunization Phase:
- •1. Healthy PCV-naïve subjects between 6-8 weeks of age (both inclusive) on the day of enrolment, whose parents/LARs are willing to participate and give written informed consent prior to the study entry.
- •2. Subjects with good health as determined by:
- •a)Medical history.
- •b)Physical examination.
- •c)Clinical judgment of the investigator.
- •3. 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.
- •4. Subjects must have been born full-term, at randomization.
- •5. Weight of the infant at enrolment visit = 3.2 kg.
- •6. 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).
- •Inclusion Criteria for Booster Immunization Phase:
- •1. Subjects with good health as determined by:
- •a)Medical history.
- •b)Physical examination.
- •c)Clinical judgment of the investigator.
- •2. Subjects who have completed primary immunization series of the investigational vaccine in the present study.
排除标准
- •Exclusion Criteria for the first dose:
- •1. The parents or LARs are unwilling or unable to give written informed consent to participate in the study.
- •2. Subjects who have participated in another trial of an investigational agent within 30 days prior to enrolment.
- •3. Planned participation in another clinical trial during the present trial period.
- •4. Subjects whose families are planning to leave the area of the study site before the end of the study period.
- •5. History of culture-proven invasive disease caused by S. pneumoniae.
- •6. Subjects who have received any Pneumococcal vaccine prior to
- •7. Bleeding disorder, contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding screening.
- •8. History of infections with Human Immunodeficiency Virus (HIV), hepatitis B virus, or hepatitis C virus in the infant or mother.
- •9. Presence of evolving or changing neurological disorder.
- •10. Subjects with history of seizures.
- •11. Axillary temperature = 40.0°C in past 3 days.
- •12. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 3 days.
- •13. Planned or elective surgery during the course of the study.
- •14. 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.
- •15. Subjects who have received any blood products, cytotoxic agents or radiotherapy.
- •16. 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.
- •17. 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
- •1. Generalized allergic reaction in past 3 days .
- •2. Seizures.
- •3. Encephalopathy.
- •4. Axillary temperature of > 40.0°C in past 3 days. .
- •5. Inconsolable persisting crying (defined as > 3 hours in past 3 days).
- •6. Generalized cyanosis within past 3 days. .
- •7. 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:
- •1. Subjects who have participated in another trial after primary immunization.
- •2. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 3 days.
- •3. History of culture-proven invasive disease caused by S. pneumonia after primary immunization.
- •4. Subjects who have already received pneumococcal vaccine booster dose (other than investigational vaccine) from other resources (from different doctor/hospital).
- •5. Bleeding disorder, contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding booster dose.
- •6. History of infections with Human Immunodeficiency Virus (HIV),hepatitis B virus, or hepatitis C virus in the infant after primary immunization.
- •7. Presence of evolving or changing neurological disorder after primary immu
研究者
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