Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants

NCT03765073 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: C10910022020-005074-96
• Study Type: interventional
• Target: 1,208
• Locations: 3 countries
• Sites: 35

Brief Summary

Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and then in healthy pregnant women (various formulations at three dose levels), and finally in healthy pregnant women at a selected dose level/formulation.

Conditions

Group B Streptococcus Infections

Outcome Measures

Primary Outcomes (45)

• Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1

  Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter \[cm\]). Grading: Grade 1/mild (greater than \[\>\] 2.5 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.

  Day 1 (day of vaccination) to Day 7 after Primary Dose

• Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1

  Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter \[cm\]). Grading: Grade 1/mild (greater than \[\>\] 2.5 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.

  Day 1 (day of vaccination) to Day 7 after booster dose

• Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1

  Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours \[h\]), Grade 2/moderate: (\>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.

  Day 1 (day of vaccination) to Day 7 after primary dose

• Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1

  Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours \[h\]), Grade 2/moderate: (\>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.

  Day 1 (day of vaccination) to Day 7 after booster dose

• Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Primary Dose: Non-Pregnant Participants Stage 1

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.

  Day 1 (day of vaccination) through 1 Month post primary dose

• Percentage of Participants Reporting AEs Through 1 Month After Booster Dose: Non-Pregnant Participants Stage 1

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.

  Day 1 (day of vaccination) through 1 Month post booster dose

• Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.

  Day 1 (day of vaccination) through 6 Months post primary dose

• Percentage of Participants Reporting Serious Adverse Events (SAEs) Through 6 Months After Primary Dose: Non-Pregnant Participants Stage 1

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.

  Day 1 (day of vaccination) through 6 Months post primary dose

• Percentage of Participants Reporting MAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.

  Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose

• Percentage of Participants Reporting SAEs Approximately 7 to 12 Months After Booster Dose: Non-Pregnant Participants Stage 1

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.

  Day 1 (day of vaccination) through approximately 7 to 12 months post booster dose

• Number of Participants With Clinical Laboratory Abnormalities at 2 Week Follow-up Visit: Maternal Participants Stage 2

  Hemoglobin: Grade 1, Platelets High: Grade 2, White blood cells decreased: Grade 1, Neutrophils (Absolute): Grade 1, Basophils (Absolute): Grade 2, Lymphocytes Low (Absolute): Grade1, Blood urea nitrogen (bun): Grade 1, Aspartate aminotransferase (AST): Grade 2, Alanine aminotransferase (ALT): Grade 1 and 3 and Alkaline phosphate: Grade 1. Grades were considered as 1: mild, 2: moderate, 3: severe. Only categories with non-zero values were reported for this outcome measure.

  2 weeks after vaccination in Stage 2

• Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 2

  Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (\> 2.5 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.

  Day 1 (day of vaccination) to Day 7 after Vaccination

• Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination: Maternal Participants Stage 3

  Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 cm). Grading: Grade 1/mild (\> 2.5 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.

  Day 1 (day of vaccination) to Day 7 after Vaccination

• Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 2

  Systemic events were recorded in e-diary. Fever: oral temperature \>=38.0 deg C and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (\>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.

  Day 1 (day of vaccination) to Day 7 after Vaccination

• Percentage of Participants Reporting Systemic Events Within 7 Days Following Administration of Investigational Product: Maternal Participants Stage 3

  Systemic events were recorded in e-diary. Fever: oral temperature \>=38.0 deg C and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 h), Grade 2/moderate: (\>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.

  Day 1 (day of vaccination) to Day 7 after Vaccination

• Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 2

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.

  Day 1 (day of vaccination) through 1 Month post vaccination

• Percentage of Participants Reporting AEs Through 1 Month After Administration of Investigational Product: Maternal Participants Stage 3

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency.

  Day 1 (day of vaccination) through 1 Month post vaccination

• Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.

  Day 1 (day of vaccination) through 12 Month post delivery

• Percentage of Participants With SAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.

  Day 1 (day of vaccination) through 12 Month post delivery

• Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 2

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.

  Day 1 (day of vaccination) through 12 Month post delivery

• Percentage of Participants With MAEs From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. Examples of AEs included but were not limited to abnormal test findings; clinically significant signs and symptoms; changes in physical examination findings; hypersensitivity; progression/worsening of underlying disease; drug abuse; drug dependency. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.

  Day 1 (day of vaccination) through 12 Month post delivery

• Percentage of Participants With Obstetric Complications From Visit 1 Through 12 Months Post-delivery: Maternal Participants Stage 2

  Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.

  Day 1 (day of vaccination) through 12 Month post delivery

• Percentage of Participants With Obstetric Complications From Day 1 Through 12 Months Post-delivery: Maternal Participants Stage 3

  Obstetric complications such as: prepartum period, intrapartum period and postpartum period were reported in this outcome measure.

  Day 1 (day of vaccination) through 12 Month post delivery

• Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 2

  Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.

  At delivery

• Percentage of Participants With Each Delivery Outcome and Delivery Mode: Maternal Participants Stage 3

  Delivery Outcome included full term live delivery, premature live delivery, Stillbirth, induced/elective abortion and unknown. Mode of delivery included: vaginal delivery, Cesarean section: elective, semi-elective and emergency were reported in this outcome measure.

  At delivery

• Percentage of Participants With Gestational Age at Birth: Infant Participants Stage 2

  Gestational age of participants at birth in weeks included: greater than or equal to (\>=)24 weeks to less than (\<) 28 weeks, \>=28 weeks to \<34 weeks, \>=34 weeks to \<37 weeks, \>=37 weeks to \<42 weeks, \>=42 weeks.

  At Birth

• Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 2

  APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 1 minute were reported in this outcome measure.

  At 1 minute of Birth

• Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 5 Minutes: Infant Participants Stage 2

  APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. APGAR score at 5 minute were reported in this outcome measure.

  At 5 minutes of Birth

• Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 2

  The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at \<37 weeks 0 days, \>=37 weeks to \<42 weeks, \>=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.

  At Birth

• Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 2

  Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.

  At Birth

• Number of Participants With Vital Status: Infant Participants Stage 2

  Participants according to vital status as: live or neonatal death were reported in this outcome measure.

  At Birth

• Number of Participants With Gestational Age of Participants at Birth: Infant Participants Stage 3

  Gestational age of participants at birth in weeks included: greater than or equal to (\>=)24 weeks to less than (\<) 28 weeks, \>=28 weeks to \<34 weeks, \>=34 weeks to \<37 weeks, \>=37 weeks to \<42 weeks, \>=42 weeks.

  At 1 minute of Birth

• Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute: Infant Participants Stage 3

  APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 1 minute were reported in this outcome measure.

  At 1 minute of Birth

• APGAR Score at 5 Minutes: Infant Participants Stage 3

  APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low. Appearance, pulse, grimace, activity, and respiration (APGAR) score at 5 minute were reported in this outcome measure.

  At 5 minutes of Birth

• Number of Participants According to Age Determined by Ballard Score: Infant Participants Stage 3

  The Ballard score is a commonly used technique of gestational age assessment. It assists healthcare providers in determining if an infant is premature, on time, or post-term based on physical traits. This scoring allows for the estimation of age in the range of 26 weeks to 44 weeks Participants according to age determined by Ballard score: at \<37 weeks 0 days, \>=37 weeks to \<42 weeks, \>=42 weeks were reported in this outcome measure. Ballard score was not conducted routinely/mandatory.

  At Birth

• Number of Participants With Newborn Assessment at Birth: Infant Participants Stage 3

  Participants with newborn assessment at birth included: normal, congenital malformation/anomaly, other neonatal problem were reported in this outcome measure.

  At 5 minutes of Birth

• Number of Participants With Vital Status: Infant Participants Stage 3

  Participants according to vital status as: live or neonatal death were reported in this outcome measure.

  At Birth

• Number of Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 2

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.

  From Birth to 6 Weeks

• Numberof Participants With AEs From Birth to 6 Weeks of Age: Infant Participants Stage 3

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage.

  From Birth to 6 Weeks

• Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 2

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.

  From Birth to 12 Months

• Number of Participants With SAEs From Birth to 12 Months of Age: Infant Participants Stage 3

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.

  From Birth to 12 Months

• Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 2

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.

  From Birth to 12 Months

• Number of Participants With MAEs From Birth to 12 Months of Age: Infant Participants Stage 3

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.

  From Birth to 12 Months

• Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 2

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.

  From Birth to 12 Months

• Percentage of Participants With Adverse Events of Special Interest From Birth to 12 Months of Age: Infant Participants Stage 3

  An AE was any untoward medical occurrence in a study participant administered a study intervention or medical device; the event need not necessarily had a causal relationship with the treatment or usage. AEs of special interest included: major congenital anomalies, developmental delay and suspected or confirmed GBS infection.

  From Birth to 12 Months

Secondary Outcomes (10)

• Geometric Mean Concentration (GMCs) of Group B Streptococcus (GBS) Serotype-Specific Immunoglobulin G (IgG) at 1 Month After Primary Dose: Non-Pregnant Women Stage 1

  At 1 Month After primary Dose

• GMCs of GBS Serotype-specific IgG Before and 1 Month, 3 Months, and 6 Months After a Booster Dose: Non Pregnant Women Stage 1

  Before (immediately before booster vaccination) and at 1, 3 and 6 Months After vaccination as Booster Dose

• GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2

  At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery

• GMCs of GBS Serotype-specific IgG at 2 Weeks, 1 Month After Vaccination and at Delivery: Maternal Participants Stage 3

  At 2 Weeks after Vaccination, 1 Month After Vaccination and at Delivery

• GBS6 Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination and at Delivery: Maternal Participants Stage 2

  At 1 Month After Vaccination and at Delivery

Study Arms (12)

Stage 1 - Highest dose formulation a

EXPERIMENTAL

Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women

Biological: Multivalent Group B streptococcus vaccine

Stage 1 - Highest dose formulation b

EXPERIMENTAL

Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women

Biological: Multivalent Group B streptococcus vaccine

Stage 2 - Lowest dose formulation a

EXPERIMENTAL

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Biological: Multivalent Group B streptococcus vaccine

Stage 2 - Lowest dose formulation b

EXPERIMENTAL

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Biological: Multivalent Group B streptococcus vaccine

Stage 2 - Middle dose formulation a

EXPERIMENTAL

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Biological: Multivalent Group B streptococcus vaccine

Stage 2 - Middle dose formulation b

EXPERIMENTAL

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Biological: Multivalent Group B streptococcus vaccine

Stage 2 - Highest dose formulation a

EXPERIMENTAL

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Biological: Multivalent Group B streptococcus vaccine

Stage 2 - Highest dose formulation b

EXPERIMENTAL

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Biological: Multivalent Group B streptococcus vaccine

Stage 3 - Selected dose and formulation

EXPERIMENTAL

Multivalent group B streptococcus vaccine - Stage 3 Pregnant women

Biological: Multivalent Group B streptococcus vaccine

Stage 1 Placebo

PLACEBO COMPARATOR

Saline control

Biological: Placebo

Stage 2 Placebo

PLACEBO COMPARATOR

Saline control

Biological: Placebo

Stage 3 Placebo

PLACEBO COMPARATOR

Saline control

Biological: Placebo

Interventions

Multivalent Group B streptococcus vaccine BIOLOGICAL

Various formulations at three dose levels

Stage 1 - Highest dose formulation a; Stage 1 - Highest dose formulation b; Stage 2 - Highest dose formulation a; Stage 2 - Highest dose formulation b; Stage 2 - Lowest dose formulation a; Stage 2 - Lowest dose formulation b; Stage 2 - Middle dose formulation a; Stage 2 - Middle dose formulation b; Stage 3 - Selected dose and formulation

Placebo BIOLOGICAL

Saline control

Stage 1 Placebo; Stage 2 Placebo; Stage 3 Placebo

Eligibility Criteria

• Age: 0 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Negative urine pregnancy test at Visit 1 (prior to vaccination).
• Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening.
• Participant must have received investigational product at Visit 1.
• Healthy nonpregnant female determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for booster vaccination and received investigational product at Visit 1.
• Negative urine pregnancy test at Visit 6 (prior to vaccination).
• Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening.
• Healthy females \>=18 and \<=40 years of age who are \>=27 0/7 (Stage 2) or \>=24 0/7 (Stage 3) to \<=35 6/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and at no increased risk for complications and no significant fetal abnormalities observed on ultrasound performed at any time prior to study entry and/or at the screening visit.
• Documented negative HIV antibody, HBV surface antigen, HCV antibody, and syphilis tests at screening.
• Evidence of a signed and dated ICD signed by the parent(s). Parent(s) willing and able to comply with scheduled visits, investigational plan, laboratory tests, and other study procedures.

You may not qualify if:

• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
• History of microbiologically proven invasive disease caused by GBS (S agalactiae).
• Previous vaccination with any licensed or investigational GBS vaccine (other than GBS6 received as a primary vaccination at Visit 1), or planned receipt during the participant's participation in the study (through the last blood draw).
• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
• History of microbiologically proven invasive disease caused by GBS (S agalactiae).
• Previous vaccination with any licensed or investigational group B streptococcus vaccine, or planned receipt during the participant's participation in the study (through the last blood draw).
• Prepregnancy body mass index (BMI) of ≥40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used.
• A prior history of or current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation.
• Major illness of the mother or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response.
• Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (35)

Velocity Clinical Research

Mobile, Alabama, 36608, United States

Location

Velocity Clinical Research, Phoenix

Phoenix, Arizona, 85006, United States

Location

Chemidox Clinical Trials Inc.

Lancaster, California, 93534, United States

Location

Chemidox Clinical Trials Inc

Lancaster, California, 93534, United States

Location

Emerson Clinical Research Institute

Washington D.C., District of Columbia, 20009, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Clinical Research Prime Rexburg

Rexburg, Idaho, 83440, United States

Location

Lakeview Regional Medical Center

Covington, Louisiana, 70433, United States

Location

MedPharmics

Covington, Louisiana, 70433, United States

Location

St. Tammany Parish Hospital

Covington, Louisiana, 70433, United States

Location

North Oaks Medical Center

Hammond, Louisiana, 70403, United States

Location

North Oaks Obstetrics & Gynecology

Hammond, Louisiana, 70403, United States

Location

Velocity Clinical Research

Slidell, Louisiana, 70458, United States

Location

Boeson Research

Missoula, Montana, 59804, United States

Location

Community Hospital

Missoula, Montana, 59804, United States

Location

The Birth Center

Missoula, Montana, 59804, United States

Location

Meridian Clinical Research

Hastings, Nebraska, 68901, United States

Location

Frontier Pediatric Care (Follow-Up Visits for Infant Participants)

Lincoln, Nebraska, 68506, United States

Location

Bryan Women's Care Physicians (Maternal Visits & Obstetric Exams)

Lincoln, Nebraska, 68510, United States

Location

Be Well Clinical Studies

Lincoln, Nebraska, 68516, United States

Location

Lowcountry Women's Specialists

Summerville, South Carolina, 29485, United States

Location

Summerville Medical Center

Summerville, South Carolina, 29485, United States

Location

Coastal Pediatric Research

Summerville, South Carolina, 29486, United States

Location

Sentara Leigh Hospital

Norfolk, Virginia, 23502, United States

Location

The Group for Women

Norfolk, Virginia, 23502, United States

Location

Tidewater Physicians for Women

Norfolk, Virginia, 23502, United States

Location

Wits Reproductive Health and HIV Institute

Johannesburg, Gauteng, 2001, South Africa

Location

Respiratory and Meningeal Pathogens Research Unit (RMPRU)

Soweto, Gauteng, 1862, South Africa

Location

Charlotte Maxeke Johannesburg Academic Hospital

Parktown, Johannesburg, Gauteng, 2196, South Africa

Location

Empilweni Services and Research Unit (ESRU)

Coronationville, Johannesburg, 2093, South Africa

Location

Khayelitsha District Hospital (KDH)

Khayelitsha, Western Cape, 7784, South Africa

Location

Michael Mapongwana Community Health Centre

Khayelitsha, Western Cape, 7784, South Africa

Location

Site B

Khayelitsha, Western Cape, 7784, South Africa

Location

FAMCRU

Parow Valley, Western Cape, 7505, South Africa

Location

St George's University Hospitals NHS Foundation Trust

London, Tooting, SW17 0QT, United Kingdom

Location

Related Publications (2)

• Cutland CL, Sawry S, Fairlie L, Barnabas S, Frajzyngier V, Roux JL, Izu A, Kekane-Mochwari KE, Vika C, De Jager J, Munson S, Jongihlati B, Stark JH, Absalon J. Obstetric and neonatal outcomes in South Africa. Vaccine. 2024 Feb 27;42(6):1352-1362. doi: 10.1016/j.vaccine.2024.01.054. Epub 2024 Feb 3.

  PMID: 38310014 DERIVED

• Madhi SA, Anderson AS, Absalon J, Radley D, Simon R, Jongihlati B, Strehlau R, van Niekerk AM, Izu A, Naidoo N, Kwatra G, Ramsamy Y, Said M, Jones S, Jose L, Fairlie L, Barnabas SL, Newton R, Munson S, Jefferies Z, Pavliakova D, Silmon de Monerri NC, Gomme E, Perez JL, Scott DA, Gruber WC, Jansen KU. Potential for Maternally Administered Vaccine for Infant Group B Streptococcus. N Engl J Med. 2023 Jul 20;389(3):215-227. doi: 10.1056/NEJMoa2116045.

  PMID: 37467497 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the participant, will be blinded.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 5, 2018
• Study Start: January 14, 2019
• Primary Completion: March 4, 2024
• Study Completion: March 4, 2024
• Last Updated: August 5, 2025
• Results First Posted: August 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (26); ZA (8); GB (1)