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
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
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.
Stage 1 Nonpregnant Women:
- Acute or chronic 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 subject 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 subject's
participation in the study (through the last blood draw).
Exclusion criteria Stage 2 and 3 Maternal Subjects:
- Acute or chronic 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 subject 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 subject's participation in the study (through
the last blood draw).
- Body mass index (BMI) of >=40 kg/m2 at the time of the screening visit.
- A prior history of or current pregnancy complications or abnormalities that will
increase the risk associated with the subject'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 subject's
participation in, and completion of, the study or could preclude the evaluation of the
subject's response.
Exclusion criteria Stage 2 and 3 Infant Subjects:
Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | 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 | ||||||
| Official Title ICMJE | A PHASE 1/2, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY NONPREGNANT WOMEN AND PREGNANT WOMEN 18 TO 40 YEARS OF AGE AND THEIR INFANTS | ||||||
| Brief Summary | This 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. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Double (Participant, Investigator) Masking Description: 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 subject, will be blinded. Primary Purpose: Prevention
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| Condition ICMJE | Group B Streptococcus Infections | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE | 586 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | December 27, 2022 | ||||||
| Estimated Primary Completion Date | December 27, 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria Stage 1 Nonpregnant Women:
Inclusion Criteria Stage 1 Booster Vaccination:
Inclusion Criteria Stage 2 and 3 Maternal Subjects:
Inclusion Criteria Stage 2 and 3 Infant Subjects: 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:
Exclusion criteria Stage 2 and 3 Maternal Subjects:
Exclusion criteria Stage 2 and 3 Infant Subjects: Infant who is a direct descendant (eg, child or grandchild) of the study personnel. | ||||||
| Sex/Gender ICMJE |
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| Ages ICMJE | up to 40 Years (Child, Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | South Africa | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03765073 | ||||||
| Other Study ID Numbers ICMJE | C1091002 2020-005074-96 ( EudraCT Number ) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||||
| Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||