A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, Lot-to-lot Consistency, 4-arm Study to Investigate the Safety and Immunogenicity of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 2,195
- 试验地点
- 19
- 主要终点
- For all participants: Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC)
研究概览
简要总结
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™).
The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations.
There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age, V06 separated from V05 by 30 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, participant's parent(s) / LAR(s), Sponsor study staff, investigators and study staff, will remain blinded during the study conduct, except dedicated study staff preparing/administering the study interventions who will be blinded regarding the PCV21 lot but unblinded regarding the participants, randomized in the 20vPCV arm. The unblinded study staff will not be involved in any safety evaluation.
入排标准
- 年龄范围
- 42 Days 至 89 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 42 to 89 days on the day of inclusion
- •Participants who are healthy as determined by medical evaluation including medical history and physical examination
- •Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable
排除标准
- •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy
- •History of microbiologically confirmed Streptococcus pneumoniae infection or disease
- •Any contraindication to the routine pediatric vaccine being administered in the study
- •History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy
- •Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances3
- •Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection.
- •Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection.
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- •Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration.
- •Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period
- •Previous vaccination against Streptococcus pneumoniae
- •Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus
- •Receipt of more than 1 dose of hepatitis B vaccine
- •Receipt of immune globulins, blood or blood-derived products since birth
- •Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- •Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
Group 1: PCV21
Participants will be administered via intramuscular injection (IM) PCV21 vaccine lot 1 for Doses 1, 2 and 3; PCV21 lot 1, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
干预措施: PCV21 vaccine (Biological)
Group 2: PCV21
Participants will be administered via IM injection PCV21 vaccine lot 2 for Doses 1, 2 and 3; PCV21 lot 2, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
干预措施: PCV21 vaccine (Biological)
Group 3: PCV21
Participants will be administered via IM injection PCV21 vaccine lot 3 for Doses 1, 2 and 3; PCV21 lot 3, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
干预措施: PCV21 vaccine (Biological)
Group 4: 20vPCV (Cohort A only)
Participants will be administered via IM injection 20vPCV at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
干预措施: 20vPCV licensed vaccine (Biological)
结局指标
主要结局
For all participants: Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC)
时间窗: 30 days after the third dose of PCV21 vaccine
Serotype specific IgG concentrations for all serotypes included in PCV21 vaccine as measured by electrochemiluminescence assay (ECL)
Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC)
时间窗: 30 days after the third dose of PCV21 vaccine
Serotype specific IgG concentrations for all serotypes included in PCV21 vaccine as measured by electrochemiluminescence assay (ECL)
次要结局
- For all participants: Serotype specific IgG concentration ≥ 0.35 µg/mL(30 days after the third dose of PCV21 vaccine)
- For all participants: Presence of any immediate adverse events (AEs)(Within 30 minutes after each vaccine injection)
- For participants in Cohort A (reactogenicity subset): Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection(Through 7 days after each vaccine injection)
- For all participants: Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs(Through 30 days after each vaccine injection)
- For all participants: Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study(Throughout the study (through 6 months post-last vaccine injection))
- Serotype specific IgG concentration ≥ 0.35 µg/mL(30 days after the third dose of PCV21 vaccine)
- Presence of any immediate adverse events (AEs)(Within 30 minutes after each vaccine injection)
- Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection(Through 7 days after each vaccine injection)
- Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs(Through 30 days after each vaccine injection)
- Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study(Throughout the study (through 6 months post-last vaccine injection))