This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 1 for:    C1091001
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT03170609
First received: May 26, 2017
Last updated: September 6, 2017
Last verified: September 2017
  Purpose
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).

Condition Intervention Phase
Group B Streptococcal Infections Biological: Multivalent group B streptococcus vaccine Biological: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of subjects 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 subjects 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 subjects 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 sentinel-cohort subjects with clinical laboratory abnormalities following investigational product administration at the 1-week follow-up visit. [ Time Frame: Day 14 ]
    Describe clinical laboratory abnormalities in sentinel-cohort subjects after one dose of investigational product.

  • Percentage of subjects 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.


Secondary Outcome Measures:
  • Group B streptococcus serotype-specific immunoglobulin G geometric mean concentrations measured 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.


Estimated Enrollment: 363
Actual Study Start Date: June 5, 2017
Estimated Study Completion Date: June 13, 2018
Estimated Primary Completion Date: June 13, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lowest dose formulation a
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Various formulations at three dose levels
Experimental: Middle dose formulation a
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Various formulations at three dose levels
Experimental: Highest dose formulation a
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Various formulations at three dose levels
Experimental: Lowest dose formulation b
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Various formulations at three dose levels
Experimental: Middle dose formulation b
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Various formulations at three dose levels
Experimental: Highest dose formulation b
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Various formulations at three dose levels
Placebo Comparator: Placebo
Saline control
Biological: Placebo
Saline Control

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03170609

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
United States, Georgia
Clinical Research Atlanta Recruiting
Stockbridge, Georgia, United States, 30281
United States, Kentucky
Kentucky Pediatric / Adult Research Recruiting
Bardstown, Kentucky, United States, 40004
United States, Utah
J. Lewis Research, Inc. / Foothill Family Clinic Recruiting
Salt Lake City, Utah, United States, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South Recruiting
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03170609     History of Changes
Other Study ID Numbers: C1091001
Study First Received: May 26, 2017
Last Updated: September 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
URL: http://

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

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017