A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS
NCT04258995
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
1. Healthy adults (male and female) at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
2. Participants who were enrolled in the C1091001 study, received GBS6, and completed the 1-month blood draw.
1. Pregnant female participants; breastfeeding female participants; positive urine
pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (prior to
vaccination); and WOCBP who are, in the opinion of the investigator, sexually active
and at risk for pregnancy and fertile men and WOCBP who are unwilling or unable to use
effective methods of contraception as outlined in this protocol from the signing of
the informed consent until at least 3 months after the last dose of investigational
product.
2. Acute or chronic medical or psychiatric condition 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. Chronic medical conditions include human immunodeficiency virus, chronic
hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C
virus infection.
3. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis)
to any vaccine.
4. History of microbiologically proven invasive disease caused by group B streptococcus
(Streptococcus agalactiae).
5. Previous vaccination with any licensed or investigational group B streptococcus
vaccine (other than GBS6), or planned receipt during the participant's participation
in the study (through 6-month telephone call).
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| Descriptive Information | |||||||
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| Brief Title ICMJE | A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS | ||||||
| Official Title ICMJE | A PHASE 2, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS | ||||||
| Brief Summary | This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a primary GBS6 dose, to healthy adult males and nonpregnant women. The study will determine whether individuals who received a primary dose of GBS6 have additional benefit following a booster dose. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Intervention Model Description: There are two arms in the study however based on the prior formulation received participants can only be enrolled into one predetermined arm in the study. Participants are assigned by an interactive response technology (IRT) based on prior formulation received. Masking: None (Open Label)Primary Purpose: Prevention | ||||||
| Condition ICMJE | Group B Streptococcal Infections | ||||||
| Intervention ICMJE | Biological: Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)
2 formulations at 1 dose level Other Name: GBS6 | ||||||
| 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 | Not yet recruiting | ||||||
| Estimated Enrollment ICMJE | 297 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | November 11, 2020 | ||||||
| Estimated Primary Completion Date | November 11, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 51 Years (Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04258995 | ||||||
| Other Study ID Numbers ICMJE | C1091007 | ||||||
| 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 | February 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||