A Prospective, Multicentre, Randomized, Phase II study seamlesslyfollowed by a Phase III study to evaluate the Safety, Tolerability andImmunogenicity of the candidate GEMCOVAC-19 (COVID-19vaccine) in healthy pediatric subjects of 5 to less than 18 years
试验速览
- 阶段
- 2/3 期
- 状态
- Other
- 入组人数
- 800
- 试验地点
- 13
- 主要终点
- Safety (Phase II )
研究概览
简要总结
The current study is designed as a prospective, randomized, Phase II study seamlessly followed by a Phase III study in two age groups-12 - <18 years and 5 - 11 years. The study is an active-controlled study with COVAXIN® as the comparator vaccine for age group 12 - <18 years whereas the study is a placebo-controlled study for age group 5 - 11 years. The study will be conducted in 4 parts: Part 1: Phase II in 12 - <18 years age group, Part 2: Phase III in 12 - <18 age group, Part 3: Phase II in 5 - 11 years age group, Part 4: Phase III in 5 - 11 years age group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria for Phase II: 1.Male and female subjects’ 5- <18 years. 2.Healthy as judged by medical history, physical and other examination or screening laboratory assessments or other investigations and in the clinical opinion of the Investigator. 3.Age group
- •<18 years: Subject’s parent should be capable and willing to give voluntary written informed consent and subject should be capable and willing to give voluntary assent prior to inclusion in the study. 4.Age group:
- •11 years: Subject’s parent should be capable and willing to give voluntary written informed consent prior to inclusion in the study 5.Negative / Non-reactive RT-PCR screening of nasopharyngeal swabs/suitable sample for SARS CoV-2 6.Subject/ subject’s parent is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary. Inclusion Criteria for Phase III: 1.Male and female subjects’
- •<18 years. 2.Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator. 3.Age group
- •<18 years: Subject’s parent should be capable and willing to give voluntary written informed consent and subject’s should be capable and willing to give voluntary assent form prior to inclusion in the study. 4.Age group:
- •11 years: Subject’s parent should be capable and willing to give voluntary written informed consent prior to inclusion in the study. 5.Subject’s parent/subjects is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary.
排除标准
- •Exclusion Criteria for Phase II: 1.Subject with a recent history of COVID-19 infection within 3 months of Screening.2.Subjects received an investigational vaccine or vaccine which have been granted an emergency use to prevent COVID-19 infection.3.Protocol defined laboratory assessments outside the range/limit defined in Appendix
- •Any other laboratory value if ≥ Grade 2 as per DAIDs* criteria* Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected version 2.1, July 2017, of the US National Institutes of Health4.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days5.Any significant illness or any other current or pre-existing health condition (e.g., any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints.6.History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.7.Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature ≥ 38°C or ≥ 100.4 °F or its equivalent for axillary and tympanic) within 48 hours prior to vaccination.8.History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease.9.Subjects willing to get married and planning for pregnancy within 4 months of study participation (only applicable for participants of
- •(smaller than)18 years age).10.Prior major surgery or any radiation therapy within 4 weeks of Screening visit.11.Positive serologic test for HIV 1 and 2, HBsAg and HCV. 12.Current (within 14 days prior to Screening visit) or anticipated concomitant immune modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day).13.Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination.14.Eczema or other significant skin lesion or infection at the site of vaccination. 15.Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit. 16.Bleeding diathesis or condition associated with prolonged bleeding.17.Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate.18.Any other condition which in the opinion of the Investigator may affect subject’s safety or participation.Exclusion Criteria for Phase III: 1.Subject with a recent history of COVID-19 infection within 3 months from Screening2.Subjects received an investigational vaccine or vaccine which have been granted an emergency use to prevent COVID-19 infection.3.Any significant illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints.4.History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine.5.Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature ≥ 38°C or ≥ 100.4 °F or its equivalent for axillary and tympanic) within 48 hours prior to vaccination.6.History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease.7.Subjects who are planning to get married and get pregnant in next 4 months (only applicable for participants of
- •(smaller than)18 years age).8.Prior major surgery or any radiation therapy within 4 weeks of Screening visit.9.A known case of HIV 1 and 2, HBsAg and HCV.10.Current (within 14 days prior to Screening visit) or anticipated concomitant immune modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day).11.Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination.12.Eczema or other significant skin lesion or infection at the site of vaccination. 13.Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit. 14.Bleeding diathesis or condition associated with prolonged bleeding.15.Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate.16.Any other condition which in the opinion of the Investigator may affect subject’s safety or participation.
结局指标
主要结局
Safety (Phase II )
时间窗: Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. | At Day 57. | At Day 43.
Occurrence and severity of local and systemic reactogenicity adverse events,
时间窗: Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. | At Day 57. | At Day 43.
unsolicited events and serious adverse events (SAE)
时间窗: Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. | At Day 57. | At Day 43.
Immunogenicity (Phase II and III)
时间窗: Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. | At Day 57. | At Day 43.
Age group: 12 - Less than 18 years
时间窗: Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. | At Day 57. | At Day 43.
Geometric mean titer (GMT) of SARS-CoV-2 specific serum neutralizing antibody levels using live virus [Plaque Reduction Neutralization Test (PRNT)]
时间窗: Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. | At Day 57. | At Day 43.
Age group: 5 - 11 years
时间窗: Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. | At Day 57. | At Day 43.
GMT as measured by IgG-ELISA against SARS-CoV-2 Spike protein
时间窗: Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. | At Day 57. | At Day 43.
次要结局
- Age Group 12 to less than 18((Phase II and III))
- Age Group 5 to 11 year old((Phase II and III))