A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY PREGNANT WOMEN AND THEIR INFANTS
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 6,000
- 试验地点
- 262
- 主要终点
- The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery
研究概览
简要总结
BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.
This study is seeking healthy pregnant participants:
- aged 49 or younger who can join.
- between 24 and 36 weeks of gestation ("Gestational age" is a medical term used to describe how far along your pregnancy is)
- had a fetal ultrasound examination performed with no major fetal abnormalities observed
- documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone.
A subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and/or pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and/or toddler (booster) doses.
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)
入排标准
- 年龄范围
- 1 Day 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maternal:
- •Healthy pregnant women ≤49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and who have no known increased risk of complications.
- •Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed.
- •Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization.
- •Capable of giving personal signed informed consent.
- •Willing to give informed consent for her infant to participate in the study.
排除标准
- •Maternal:
- •Prepregnancy body mass index (BMI) of >40 kg/m
- •Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study.
- •Prior pregnancy complications or abnormalities that, based on the investigator's judgment, may increase the risk associated with the participation in and completion of the study.
- •History of microbiologically proven invasive disease caused by GBS in the current pregnancy.
- •A known or suspected infection during the current pregnancy that may increase the risk of complications in pregnancy (eg, active tuberculosis, syphilis, primary genital herpes simplex, malaria).
- •Key Inclusion criteria- Infant Participants
- •- Evidence of a signed and dated ICD signed by the parent(s)/legally authorized representative or legal guardian
- •Key Exclusion Criteria - Infant Participants:
- •- Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.
- •Key Exclusion Criteria - Infant immunogenicity subset Participants:
- •- Children with a known or suspected contraindication to any vaccine administered in the infant vaccine immunogenicity subset.
- •Refer to the study contact for further eligibility details
研究组 & 干预措施
Infanrix
Commercially available combination vaccine containing diphtheria, tetanus, and pertussis
干预措施: Infanrix (Biological)
Pediarix
Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio
干预措施: Pediarix (Biological)
GBS6
Multivalent group B streptococcus vaccine
干预措施: Multivalent Group B streptococcus vaccine (Biological)
Placebo
Placebo
干预措施: Placebo (Biological)
Prevenar 20
Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
干预措施: Prevenar 20 (Biological)
Infanrix hexa
Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and Haemophilus influenzae type b (Hib)
干预措施: Infanrix hexa (Biological)
Prevnar 20
Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
干预措施: Prevnar 20 (Biological)
结局指标
主要结局
The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery
时间窗: 6 months after delivery
The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention
时间窗: Within 7 days
The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention
时间窗: Within 7 days
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events (AEs) from birth through 1 month of age
时间窗: Birth to 1 month of age
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting serious adverse events (SAEs) from birth through end of the study
时间窗: Through study completion, at least 1 year
To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS late onset disease thresholds in the GBS6 group to the placebo group
时间窗: Birth
The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery
时间窗: 6 months after delivery
To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS early onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth.
时间窗: Birth
The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention
时间窗: 1 month
To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS early onset disease thresholds in the GBS6 group to the placebo group
时间窗: Birth
To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS late onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth.
时间窗: Birth
The proportion of maternal participants reporting adverse events of special interest (AESIs) through 6 months after delivery.
时间窗: 6 months after delivery
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting medically attended adverse events (MAAEs) from birth through 6 months of age
时间窗: Birth to 6 months of age
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events of special interest (AESIs) from birth through end of study
时间窗: Through study completion, at least 1 year
次要结局
- To measure GBS serotype-specific opsonophagocytic titers in infant participants at birth by geometric mean ratio between GBS6 group versus placebo group and by the difference in seroresponse rates between GBS6 group and placebo group(Birth)
- To describe anti-CPS IgG antibody levels predicted to provide protection from invasive GBS disease (all disease) caused by the 6 individual vaccine serotypes in infants when GBS6 is administered to healthy pregnant women.(Birth)
- To describe anti-CPS IgG antibody levels in infant participants born to maternal participants vaccinated with GBS6.(Birth)
- To describe anti-CPS IgG antibody levels predicted to provide protection from invasive GBS LOD and EOD, separately, caused by the 6 individual vaccine serotypes (Ia, Ib, II, III, IV, and V) in infants when GBS6 is administered to healthy pregnant women.(Birth)
- To measure GBS serotype-specific IgG by geometric mean concentration in maternal participants at 1 month after vaccination and at delivery.(1 month after vaccination and at delivery)
- Compare the proportion of infants with anti-diphtheria toxoid and/or pneumococcal IgG responses at 1 month post-primary and toddler doses between GBS6 and placebo groups, including predefined IgG levels and geometric mean ratios.(1 month after the primary vaccination series and 1 month after the toddler dose)