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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Group B Streptococcus Infections

Treatments: Biological: Placebo; Biological: Multivalent Group B streptococcus vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03765073

C1091002

2020-005074-96 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,208 patients

Sex: All

Ages: Under 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Stage 1 Nonpregnant Women:

• Healthy nonpregnant females 18 to 40 years of age at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
• 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.

Inclusion Criteria Stage 1 Booster Vaccination:

• 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.

Inclusion Criteria Stage 2 and 3 Maternal Participants:

• 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.

Inclusion Criteria Stage 2 and 3 Infant Participants:

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.

Exclusion Criteria Stage 1 Nonpregnant Women:

• 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).

Exclusion criteria Stage 2 and 3 Maternal Participants:

• 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.

Exclusion criteria Stage 2 and 3 Infant Participants:

Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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1,208 participants in 12 patient groups, including a placebo group

Stage 1 - Highest dose formulation a

Experimental group

Description:

Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women

Treatment:

Biological: Multivalent Group B streptococcus vaccine

Stage 1 - Highest dose formulation b

Experimental group

Description:

Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women

Treatment:

Biological: Multivalent Group B streptococcus vaccine

Stage 2 - Lowest dose formulation a

Experimental group

Description:

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Treatment:

Biological: Multivalent Group B streptococcus vaccine

Stage 2 - Lowest dose formulation b

Experimental group

Description:

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Treatment:

Biological: Multivalent Group B streptococcus vaccine

Stage 2 - Middle dose formulation a

Experimental group

Description:

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Treatment:

Biological: Multivalent Group B streptococcus vaccine

Stage 2 - Middle dose formulation b

Experimental group

Description:

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Treatment:

Biological: Multivalent Group B streptococcus vaccine

Stage 2 - Highest dose formulation a

Experimental group

Description:

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Treatment:

Biological: Multivalent Group B streptococcus vaccine

Stage 2 - Highest dose formulation b

Experimental group

Description:

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Treatment:

Biological: Multivalent Group B streptococcus vaccine

Stage 3 - Selected dose and formulation

Experimental group

Description:

Multivalent group B streptococcus vaccine - Stage 3 Pregnant women

Treatment:

Biological: Multivalent Group B streptococcus vaccine

Stage 1 Placebo

Placebo Comparator group

Description:

Saline control

Treatment:

Biological: Placebo

Stage 2 Placebo

Placebo Comparator group

Description:

Saline control

Treatment:

Biological: Placebo

Stage 3 Placebo

Placebo Comparator group

Description:

Saline control

Treatment:

Biological: Placebo