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 Adults 18 To 49 Years Of Age

NCT03170609

Last updated date
Study Location
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Group B Streptococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-49 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Healthy adults (male and female) 18 to 49 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.

2. Negative urine pregnancy test at Visit 1 for all female subjects who are of childbearing potential.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Male subjects and female subjects of childbearing potential who are unwilling or
unable to use a highly effective method of contraception as outlined in this protocol
for 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 subject 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, or planned receipt during the subject's participation in the study (through
the last blood draw).

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Group B Streptococcal InfectionsA 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 Adults 18 To 49 Years Of Age
NCT03170609
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  2. Bardstown, Kentucky
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  4. Salt Lake City, Utah
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18 Years+
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Advanced Information
Descriptive Information
Brief 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 Adults 18 To 49 Years Of Age
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 ADULTS 18 TO 49 YEARS OF AGE
Brief Summary This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study evaluating the investigational multivalent group B streptococcus vaccine. Healthy adults aged 18 to 49 years of age with no history of group B streptococcal vaccination will be randomized to receive either a single intramuscular dose of multivalent group B streptococcus vaccine (various formulations at 3 dose levels) or a placebo (saline control).
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)
Primary Purpose: Prevention
Condition  ICMJE Group B Streptococcal Infections
Intervention  ICMJE
  • Biological: Multivalent group B streptococcus vaccine
    Various formulations at three dose levels
  • Biological: Placebo
    Saline Control
Study Arms  ICMJE
  • Experimental: Lowest dose formulation a
    Multivalent group B streptococcus vaccine
    Intervention: Biological: Multivalent group B streptococcus vaccine
  • Experimental: Middle dose formulation a
    Multivalent group B streptococcus vaccine
    Intervention: Biological: Multivalent group B streptococcus vaccine
  • Experimental: Highest dose formulation a
    Multivalent group B streptococcus vaccine
    Intervention: Biological: Multivalent group B streptococcus vaccine
  • Experimental: Lowest dose formulation b
    Multivalent group B streptococcus vaccine
    Intervention: Biological: Multivalent group B streptococcus vaccine
  • Experimental: Middle dose formulation b
    Multivalent group B streptococcus vaccine
    Intervention: Biological: Multivalent group B streptococcus vaccine
  • Experimental: Highest dose formulation b
    Multivalent group B streptococcus vaccine
    Intervention: Biological: Multivalent group B streptococcus vaccine
  • Placebo Comparator: Placebo
    Saline control
    Intervention: Biological: Placebo
Publications * Absalon J, Segall N, Block SL, Center KJ, Scully IL, Giardina PC, Peterson J, Watson WJ, Gruber WC, Jansen KU, Peng Y, Munson S, Pavliakova D, Scott DA, Anderson AS. Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial. Lancet Infect Dis. 2020 Sep 3. pii: S1473-3099(20)30478-3. doi: 10.1016/S1473-3099(20)30478-3. [Epub ahead of print]

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2018)
365
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2017)
363
Actual Study Completion Date  ICMJE June 25, 2018
Actual Primary Completion Date June 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy adults (male and female) 18 to 49 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.
  2. Negative urine pregnancy test at Visit 1 for all female subjects who are of childbearing potential.

Exclusion Criteria:

  1. Male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for 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 subject 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, or planned receipt during the subject's participation in the study (through the last blood draw).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03170609
Other Study ID Numbers  ICMJE C1091001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP