A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2-arm Study to Investigate the Safety and Immunogenicity of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 1,092
- 试验地点
- 93
- 主要终点
- Seroresponse rate for PCV21 and 15vPCV serotypes
研究概览
简要总结
This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 15vPCV (Vaxneuvance, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines in infants aged from approximately 2 months (42 to 112 days).
The study duration per participant will be up to approximately 20 months. The study vaccines (either PCV21 or 15-valent pneumococcal vaccines) will be administered at approximately 2, 4, and 11 to 15 months of age or at approximately 2, 3, 4, and 11 to 15 months of age (for preterm infants). Routine pediatric vaccines will be given at the same timepoints, as per local practice / recommendations.
• There will be 5 (for full-term infants) or 6 (for preterm infants) study visits:
- Full-term infants: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 30 days, V04 at 11 months of age until 15 months of age, V05 separated from V04 by 30 days.
- Preterm infants: Visit (V)01, V02 separated from V01 by 30 days, V03 separated from V02 by 30 days, V04 separated from V03 by 30 days, V05 at 11 months of age until 15 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
Modified double-blind
- Blinding for vaccine group assignment: participants and participant's parent(s) / legally acceptable representative(s) (LARs), outcome assessors, Investigators, laboratory personnel, and Sponsor study staff
- No blinding for vaccine group assignment: those preparing and administering the study interventions
入排标准
- 年龄范围
- 42 Days 至 112 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 42 to 112 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 as assessed by the investigator
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •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 vaccines being administered in the study
- •History of seizure or significant stable or progressive neurological 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 substances
- •Laboratory-confirmed or known thrombocytopenia, as reported by the parent/legally acceptable representative (LAR), 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. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- •Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration, except for oral rotavirus vaccine, which may be received anytime during the study including at study visits and for influenza vaccination or meningococcal b vaccine, which may be received at least 14 days before or 14 days after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations.
- •Previous vaccination against S. pneumoniae
- •Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and 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) a 2-dose primary series of PCV21 at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of PCV21 co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice
干预措施: PCV21 vaccine (Biological)
Group 1: PCV21
Participants will be administered via intramuscular injection (IM) a 2-dose primary series of PCV21 at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of PCV21 co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice
干预措施: Hexyon vaccine (Biological)
Group 1: PCV21
Participants will be administered via intramuscular injection (IM) a 2-dose primary series of PCV21 at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of PCV21 co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice
干预措施: M-M-RvaxPro vaccine (Biological)
Group 1: PCV21
Participants will be administered via intramuscular injection (IM) a 2-dose primary series of PCV21 at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of PCV21 co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice
干预措施: Varivax vaccine (Biological)
Group 2: 15vPCV
Participants will be administered via intramuscular injection (IM) a 2-dose primary series of 15vPCV at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of 15vPCV co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice
干预措施: Vaxneuvance vaccine (Biological)
Group 2: 15vPCV
Participants will be administered via intramuscular injection (IM) a 2-dose primary series of 15vPCV at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of 15vPCV co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice
干预措施: Hexyon vaccine (Biological)
Group 2: 15vPCV
Participants will be administered via intramuscular injection (IM) a 2-dose primary series of 15vPCV at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of 15vPCV co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice
干预措施: M-M-RvaxPro vaccine (Biological)
Group 2: 15vPCV
Participants will be administered via intramuscular injection (IM) a 2-dose primary series of 15vPCV at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of 15vPCV co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice
干预措施: Varivax vaccine (Biological)
结局指标
主要结局
Seroresponse rate for PCV21 and 15vPCV serotypes
时间窗: 30 days post-toddler dose
Serotype specific IgG concentration ≥ 0.35 µg/mL
IgG concentration for PCV21 and 15vPCV serotypes
时间窗: 30 days post-toddler dose
Serotype specific IgG Geometric Mean Concentration (GMC)
次要结局
- Anti-varicella Ab concentrations(30 days post-toddler dose)
- Anti- hepatitis B surface antigen (HBsAg) Ab(30 days post-toddler dose)
- Anti- polyribosylribitol phosphate (PRP) Ab(30 days post-toddler dose)
- Anti-poliovirus types (1, 2, and 3) Ab(30 days post-toddler dose)
- Anti-diphtheria Ab concentrations(30 days post-primary series)
- Anti-tetanus Ab concentrations(30 days post-primary series)
- Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA))(30 days post-toddler dose)
- Anti-measles Ab concentrations(30 days post-toddler dose)
- Anti-mumps Ab concentrations(30 days post-toddler dose)
- Anti-rubella Ab concentrations(30 days post-toddler dose)
- Anti HBsAg concentrations(30 days post-primary series)
- Anti-PRP Ab concentrations(30 days post-primary series)
- Anti-poliovirus types (1, 2, and 3) Ab titers(30 days post-primary series)
- Anti-pertussis Ab concentrations (PT and FHA)(30 days post-primary series)
- Serotype specific OPA titers for all serotypes included in PCV21(30 days post-toddler dose)
- 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(Through 30 days after each vaccine injection)
- Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)(Throughout the study (through 6 months post-last vaccine injection), approximately 20 months)
- Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection)(Throughout the study (through 6 months post-last vaccine injection), approximately 20 months)
- Anti-diphtheria Ab concentrations(30 days post-toddler dose)
- Anti-tetanus Ab concentrations(30 days post-toddler dose)
- Serotype specific OPA titers for all serotypes included in PCV21(30 days post-primary series)