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Trial record 1 of 1 for:    NCT04258995
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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

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ClinicalTrials.gov Identifier: NCT04258995
Recruitment Status : Completed
First Posted : February 6, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 4, 2020
First Posted Date  ICMJE February 6, 2020
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE February 11, 2020
Actual Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2020)
  • Percentage of participants reporting prompted local reactions within 14 days following investigational product administration (redness, swelling, and pain at the injection site). [ Time Frame: Day 15 ]
    Describe local reactions after one dose of investigational product.
  • Percentage of participants reporting prompted systemic events within 14 days following investigational product administration (fever, nausea/vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain). [ Time Frame: Day 15 ]
    Describe systemic events after one dose of investigational product.
  • Percentage of participants reporting adverse events within 1 month following investigational product administration. [ Time Frame: 1 month after vaccination ]
    Describe adverse events after one dose of investigational product.
  • Percentage of participants reporting medically attended adverse events and serious adverse events within 6 months following investigational product administration. [ Time Frame: 6 months after vaccination ]
    Describe medically attended adverse events and serious adverse events after one dose of investigational product.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2020)
  • Group B streptococcus serotype-specific immunoglobulin G geometric mean concentrations measured before and 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
    Assess group B streptococcus serotype-specific immunoglobulin G geometric mean concentrations after one dose of investigational product.
  • Group B streptococcus serotype-specific opsonophagocytic activity geometric mean titers measured before and 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
    Assess group B streptococcus serotype-specific opsonophagocytic activity geometric mean titers after one dose of investigational product.
  • Group B streptococcus serotype-specific immunoglobulin G geometric mean fold rise from before to 1 month after booster vaccination [ Time Frame: 1 month after vaccination ]
    Assess group B streptococcus serotype-specific immunoglobulin G geometric mean fold rise after one dose of investigational product.
  • Group B streptococcus serotype-specific opsonophagocytic activity geometric mean fold rise measured before and 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
    Assess group B streptococcus serotype-specific opsonophagocytic activity geometric mean fold rise after one dose of investigational product.
  • Group B streptococcus serotype-specific immunoglobulin G geometric mean concentrations measured 1 month after vaccination stratified by baseline prevaccination status (before the primary vaccination). [ Time Frame: 1 month after vaccination ]
    Assess group B streptococcus serotype - specific immunoglobulin G geometric mean concentration after one dose of investigational product stratified by baseline prevaccination status (before the primary vaccination).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • Experimental: GBS6 no aluminum phosphate (GBS6 no AlPO4)
    Intervention: Biological: Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)
  • Experimental: GBS6 with aluminum phosphate (GBS6 with AlPO4)
    Intervention: Biological: Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)
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 Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2020)
151
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2020)
297
Actual Study Completion Date  ICMJE September 15, 2020
Actual Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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.

Exclusion Criteria:

  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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 51 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 NCT04258995
Other Study ID Numbers  ICMJE C1091007
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
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2020

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