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Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants

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ClinicalTrials.gov Identifier: NCT03765073
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 4, 2018
First Posted Date  ICMJE December 5, 2018
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE January 14, 2019
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
  • Percentages of nonpregnant women reporting prompted local reactions within 7 days following administration of investigational product (pain at the injection site, redness, and swelling). [ Time Frame: Day 7 ]
    Describe prompted local reactions for nonpregnant women following investigational product administration.
  • Percentages of nonpregnant women reporting prompted systemic events within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain). [ Time Frame: Day 7 ]
    Describe prompted systemic events for nonpregnant women following investigational product administration.
  • Percentages of nonpregnant women reporting adverse events (AEs) through 1 month following administration of investigational product. [ Time Frame: 1 month following administration of investigational product ]
    Describe AEs for nonpregnant women occurring through 1 month following administration of investigational product.
  • Percentages of nonpregnant women reporting medically attended adverse events (MAEs) and serious adverse events (SAEs) through 6 months following administration of investigational product. [ Time Frame: 6 months following administration of investigational product ]
    Describe MAEs and SAEs for nonpregnant women through 6 months following administration of investigational product.
  • Percentages of sentinel-cohort maternal subjects (Stage 2 only) with clinical laboratory abnormalities following administration of investigational product at the 2-week follow-up visit. [ Time Frame: 2 weeks following administration of investigational product ]
    Describe clinical laboratory abnormalities for maternal subjects (Stage 2 only) following administration of investigational product at 2-week follow-up visit.
  • Percentages of maternal subjects reporting prompted local reactions within 7 days following administration of investigational product (pain at the injection site, redness, and swelling). [ Time Frame: Day 7 ]
    Describe prompted local reactions for maternal subjects within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).
  • Percentages of maternal subjects reporting prompted systemic events within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain). [ Time Frame: Day 7 ]
    Describe prompted systemic events for maternal subjects within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).
  • Percentages of maternal subjects reporting AEs through 1 month after administration of investigational product. [ Time Frame: 1 month after administration of investigational product ]
    Describe AEs through 1 month after administration of investigational product.
  • Percentages of maternal subjects with SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) throughout the study (Visit 1 through the 12-month postdelivery study visit). [ Time Frame: 12 months after delivery ]
    Describe SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) for maternal subjects throughout the study (Visit 1 through the 12-month postdelivery study visit).
  • Percentages of maternal subjects with each delivery outcome (live birth, delivery mode). [ Time Frame: Delivery ]
    Describe delivery outcomes (live birth, delivery mode) for maternal subjects.
  • Percentages of infant subjects with specific birth outcomes. [ Time Frame: Birth ]
    Describe specific birth outcomes for infant subjects.
  • Percentages of infant subjects with AEs from birth to 6 weeks of age. [ Time Frame: 6 weeks of age ]
    Describe AEs for infant subjects from birth to 6 weeks of age.
  • Percentages of infant subjects with SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs through 12 months of age. [ Time Frame: 12 months of age ]
    Describe SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs for infant subjects through 12 months of age.
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
  • Percentages of nonpregnant women reporting prompted local reactions within 7 days following administration of investigational product (pain at the injection site, redness, and swelling). [ Time Frame: Day 7 ]
    Describe prompted local reactions for nonpregnant women following investigational product administration.
  • Percentages of nonpregnant women reporting prompted systemic events within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain). [ Time Frame: Day 7 ]
    Describe prompted systemic events for nonpregnant women following investigational product administration.
  • Percentages of nonpregnant women reporting adverse events (AEs) through 1 month following administration of investigational product. [ Time Frame: 1 month following administration of investigational product ]
    Describe AEs for nonpregnant women occurring through 1 month following administration of investigational product.
  • Percentages of nonpregnant women reporting medically attended adverse events (MAEs) and serious adverse events (SAEs) through 6 months following administration of investigational product. [ Time Frame: 6 months following administration of investigational product ]
    Describe MAEs and SAEs for nonpregnant women through 6 months following administration of investigational product.
  • Percentages of sentinel-cohort maternal subjects (Stage 2 only) with clinical laboratory abnormalities following administration of investigational product at the 2-week follow-up visit. [ Time Frame: 2 weeks following administration of investigational product ]
    Describe clinical laboratory abnormalities for maternal subjects (Stage 2 only) following administration of investigational product at 2-week follow-up visit.
  • Percentages of maternal subjects reporting prompted local reactions within 7 days following administration of investigational product (pain at the injection site, redness, and swelling). [ Time Frame: Day 7 ]
    Describe prompted local reactions for maternal subjects within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).
  • Percentages of maternal subjects reporting prompted systemic events within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain). [ Time Frame: Day 7 ]
    Describe prompted systemic events for maternal subjects within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).
  • Percentages of maternal subjects reporting AEs through 1 month after administration of investigational product. [ Time Frame: 1 month after administration of investigational product ]
    Describe AEs through 1 month after administration of investigational product.
  • Percentages of maternal subjects with SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) throughout the study (Visit 1 through the 12-month postdelivery study visit). [ Time Frame: 12 months after delivery ]
    Describe SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) for maternal subjects throughout the study (Visit 1 through the 12-month postdelivery study visit).
  • Percentages of maternal subjects with each delivery outcome (live birth, delivery mode). [ Time Frame: Delivery ]
    Describe delivery outcomes (live birth, delivery mode) for maternal subjects.
  • Percentages of infant subjects with specific birth outcomes. [ Time Frame: Birth ]
    Describe specific birth outcomes for infant subjects.
  • Percentages of infant subjects with AEs from birth to 6 weeks of age. [ Time Frame: 6 weeks of age ]
    Describe AEs for infant subejcts from birth to 6 weeks of age.
  • Percentages of infant subjects with SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs through 12 months of age. [ Time Frame: 12 months of age ]
    Describe SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs for infant subjects through 12 months of age.
Change History Complete list of historical versions of study NCT03765073 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
  • Group B streptococcus (GBS) serotype-specific IgG geometric mean concentrations (GMCs) 1 month after vaccination in nonpregnant women. [ Time Frame: 1 month after vaccination ]
    Describe GBS serotype-specific IgG geometric mean concentrations (GMCs) 1 month after vaccination in nonpregnant women.
  • GBS serotype-specific OPA geometric mean titers (GMTs) measured 1 month after vaccination in nonpregnant women. [ Time Frame: 1 month after vaccination ]
    Describe GBS serotype-specific OPA geometric mean titers (GMTs) measured 1 month after vaccination in nonpregnant women.
  • GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination and at delivery in maternal subjects. [ Time Frame: 2 weeks after vaccination ]
    Describe GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination in maternal subjects.
  • GBS serotype-specific OPA GMTs measured at 2 weeks after vaccination and at delivery in maternal subjects. [ Time Frame: 2 weeks after vaccination ]
    Describe GBS serotype-specific OPA GMTs measured at 2 after vaccination in maternal subjects.
  • GBS serotype-specific IgG GMCs in infant subjects measured at birth. [ Time Frame: Birth ]
    Describe GBS serotype-specific IgG GMCs in infant subjects measured at birth.
  • GBS serotype-specific OPA GMTs in infant subjects measured at birth. [ Time Frame: Birth ]
    Describe GBS serotype-specific OPA GMTs in infant subjects measured at birth.
  • GBS serotype-specific IgG GMCs measured at 1 month after vaccination in maternal subjects. [ Time Frame: 1 month after vaccination ]
    Describe GBS serotype-specific IgG GMCs measured at 1 month after vaccination in maternal subjects.
  • GBS serotype-specific IgG GMCs measured at delivery in maternal subjects. [ Time Frame: Delivery ]
    Describe GBS serotype-specific IgG GMCs measured at delivery in maternal subjects.
  • GBS serotype-specific OPA GMTs measured at 1 month after vaccination in maternal subjects. [ Time Frame: 1 month after vaccination ]
    Describe GBS serotype-specific OPA GMTs measured at 1 month after vaccination in maternal subjects.
  • GBS serotype-specific OPA GMTs measured at delivery in maternal subjects. [ Time Frame: Delivery ]
    Describe GBS serotype-specific OPA GMTs measured at delivery in maternal subjects.
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 Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants
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 NONPREGNANT WOMEN AND PREGNANT WOMEN 18 TO 40 YEARS OF AGE AND THEIR INFANTS
Brief Summary This Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and then in healthy pregnant women (various formulations at three dose levels), and finally in healthy pregnant women at a selected dose level/formulation.
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)
Masking Description:
This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the subject, will be blinded.
Primary Purpose: Prevention
Condition  ICMJE Group B Streptococcus Infections
Intervention  ICMJE
  • Biological: Multivalent Group B streptococcus vaccine
    Various formulations at three dose levels
  • Biological: Placebo
    Saline control
Study Arms  ICMJE
  • Experimental: Stage 1 - Highest dose formulation a
    Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 1 - Highest dose formulation b
    Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 2 - Lowest dose formulation a
    Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 2 - Lowest dose formulation b
    Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 2 - Middle dose formulation a
    Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 2 - Middle dose formulation b
    Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 2 - Highest dose formulation a
    Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 2 - Highest dose formulation b
    Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 3 - Selected dose and formulation
    Multivalent group B streptococcus vaccine - Stage 3 Pregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Placebo Comparator: Stage 1 Placebo
    Saline control
    Intervention: Biological: Placebo
  • Placebo Comparator: Stage 2 Placebo
    Saline control
    Intervention: Biological: Placebo
  • Placebo Comparator: Stage 3 Placebo
    Saline control
    Intervention: Biological: Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2018)
586
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria Stage 1 Nonpregnant Women:

  • Healthy nonpregnant females 18 to 40 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.
  • Negative urine pregnancy test at Visit 1 (prior to vaccination).
  • Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening.

Inclusion Criteria Stage 2 and 3 Maternal Subjects:

  • Healthy females >=18 and <=40 years of age who are between 27 0/7 and 35 6/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and at no increased risk for complications and no significant fetal abnormalities observed on ultrasound performed at any time prior to study entry and/or at the screening visit.
  • Documented negative HIV antibody, HBV surface antigen, HCV antibody, and syphilis tests at screening.

Inclusion Criteria Stage 2 and 3 Infant Subjects:

Evidence of a signed and dated ICD signed by the parent(s). Parent(s) willing and able to comply with scheduled visits, investigational plan, laboratory tests, and other study procedures.

Exclusion Criteria Stage 1 Nonpregnant Women:

  • Acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior 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.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
  • History of microbiologically proven invasive disease caused by GBS (S agalactiae).
  • 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).

Exclusion criteria Stage 2 and 3 Maternal Subjects:

  • Acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior 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.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.
  • History of microbiologically proven invasive disease caused by GBS (S agalactiae).
  • 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).
  • Body mass index (BMI) of >=40 kg/m2 at the time of the screening visit.
  • A prior history of or current pregnancy complications or abnormalities that will increase the risk associated with the subject's participation.
  • Major illness of the mother or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in, and completion of, the study or could preclude the evaluation of the subject's response.

Exclusion criteria Stage 2 and 3 Infant Subjects:

Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03765073
Other Study ID Numbers  ICMJE C1091002
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 February 2019

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