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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

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Clinical Research Atlanta
Stockbridge, Georgia, 30281 United States
Contact
1-800-718-1021
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).

NCT03170609
Pfizer
Completed
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

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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
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 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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Group B Streptococcal Infections
  • Biological: Multivalent group B streptococcus vaccine
    Various formulations at three dose levels
  • Biological: Placebo
    Saline Control
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
363
June 13, 2018
June 13, 2018   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 49 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03170609
C1091001
Yes
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
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/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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