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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

Primary Purpose

Group B Streptococcus Infections

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Multivalent Group B streptococcus vaccine
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Group B Streptococcus Infections

Eligibility Criteria

0 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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 1 Booster Vaccination:

  • Participant must have received investigational product at Visit 1.
  • Healthy nonpregnant female determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for booster vaccination and received investigational product at Visit 1.
  • Negative urine pregnancy test at Visit 6 (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 Participants:

  • Healthy females >=18 and <=40 years of age who are >=27 0/7 (Stage 2) or >=24 0/7 (Stage 3) to <=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 Participants:

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:

  • Other 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 participant 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 GBS vaccine (other than GBS6 received as a primary vaccination at Visit 1), or planned receipt during the participant's participation in the study (through the last blood draw).

Exclusion criteria Stage 2 and 3 Maternal Participants:

  • Other 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 participant 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 participant'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 participant'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 participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response.

Exclusion criteria Stage 2 and 3 Infant Participants:

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

Sites / Locations

  • MedPharmics, LLC
  • MedPharmics, LLC
  • Chemidox Clinical Trials Inc.
  • Chemidox Clinical Trials Inc
  • Emerson Clinical Research Institute
  • Clinical Research Prime
  • Clinical Research Prime Rexburg
  • Lakeview Regional Medical Center
  • MedPharmics
  • St. Tammany Parish Hospital
  • Velocity Clinical Research, Covington
  • North Oaks Medical Center
  • North Oaks Obstetrics & Gynecology
  • MedPharmics, LLC (Recruitment Call Center)
  • MedPharmics, LLC
  • MedPharmics, LLC
  • Velocity Clinical Research, Slidell
  • Boeson Research
  • Community Hospital
  • The Birth Center
  • Meridian Clinical Research
  • Frontier Pediatric Care (Follow-Up Visits for Infant Participants)
  • Bryan Women's Care Physicians (Maternal Visits & Obstetric Exams)
  • Be Well Clinical Studies
  • Meridian Clinical Research, LLC
  • MedPharmics, LLC
  • Velocity Clinical Research
  • Lowcountry Women's Specialists
  • Summerville Medical Center
  • Coastal Pediatric Research
  • St. Davids Medical Center
  • Tekton Research, Inc
  • Sentara Leigh Hospital
  • The Group for Women
  • Tidewater Physicians for Women
  • Wits Reproductive Health and HIV Institute
  • Respiratory and Meningeal Pathogens Research Unit (RMPRU)
  • Empilweni Services and Research Unit (ESRU)
  • Charlotte Maxeke Johannesburg Academic Hospital
  • Khayelitsha Hospital
  • Michael Mapongwana Community Health Centre
  • FAMCRU
  • St George's University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Stage 1 - Highest dose formulation a

Stage 1 - Highest dose formulation b

Stage 2 - Lowest dose formulation a

Stage 2 - Lowest dose formulation b

Stage 2 - Middle dose formulation a

Stage 2 - Middle dose formulation b

Stage 2 - Highest dose formulation a

Stage 2 - Highest dose formulation b

Stage 3 - Selected dose and formulation

Stage 1 Placebo

Stage 2 Placebo

Stage 3 Placebo

Arm Description

Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women

Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Multivalent group B streptococcus vaccine - Stage 2 Pregnant women

Multivalent group B streptococcus vaccine - Stage 3 Pregnant women

Saline control

Saline control

Saline control

Outcomes

Primary Outcome Measures

Percentages of nonpregnant women reporting prompted local reactions within 7 days following primary and booster doses of investigational product (pain at the injection site, redness, and swelling).
Describe prompted local reactions for nonpregnant women following investigational product administration.
Percentages of nonpregnant women reporting prompted systemic events within 7 days following primary and booster doses of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).
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 the primary and booster doses of investigational product.
Describe AEs for nonpregnant women occurring through 1 month following administration of investigational product.
Percentages of nonpregnant women reporting SAEs through 6 months following administration of the primary dose of investigational product.
Describe SAEs for nonpregnant women through 6 months following administration of investigational product.
Percentages of sentinel-cohort maternal participants (Stage 2 only) with clinical laboratory abnormalities following administration of investigational product at the 2-week follow-up visit.
Describe clinical laboratory abnormalities for maternal participants (Stage 2 only) following administration of investigational product at 2-week follow-up visit.
Percentages of maternal participants reporting prompted local reactions within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).
Describe prompted local reactions for maternal participants within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).
Percentages of maternal participants reporting prompted systemic events within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).
Describe prompted systemic events for maternal participants within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).
Percentages of maternal participants reporting AEs through 1 month after administration of investigational product.
Describe AEs through 1 month after administration of investigational product.
Percentages of maternal participants with SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) throughout the study (Visit 1 through the 12-month postdelivery study visit).
Describe SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) for maternal participants throughout the study (Visit 1 through the 12-month postdelivery study visit).
Percentages of maternal participants with each delivery outcome (live birth, delivery mode).
Describe delivery outcomes (live birth, delivery mode) for maternal participants.
Percentages of infant participants with specific birth outcomes.
Describe specific birth outcomes for infant participants.
Percentages of infant participants with AEs from birth to 6 weeks of age.
Describe AEs for infant participants from birth to 6 weeks of age.
Percentages of infant participants with SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs through 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 participants through 12 months of age.
Percentages of nonpregnant women reporting SAEs approximately 7 to 12 months following the booster doses of investigational product.
Describe SAEs for nonpregnant women 7 to 12 months following administration of investigational product.
Percentages of nonpregnant women reporting medically attended adverse events (MAEs) through 6 months following administration of the primary dose of investigational product.
Describe MAEs for nonpregnant women through 6 months following administration of investigational product.
Percentages of nonpregnant women reporting medically attended adverse events (MAEs) approximately 7 to 12 months following the booster doses of investigational product.
Describe MAEs for nonpregnant women 7 to 12 months following administration of investigational product.

Secondary Outcome Measures

Group B streptococcus (GBS) serotype-specific IgG geometric mean concentrations (GMCs) 1 month after vaccination in nonpregnant women.
Describe GBS serotype-specific IgG geometric mean concentrations (GMCs) 1 month after vaccination in nonpregnant women.
GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination in maternal participants.
Describe GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination in maternal participants.
GBS serotype-specific IgG GMCs in infant participants measured at birth.
Describe GBS serotype-specific IgG GMCs in infant participants measured at birth.
GBS serotype-specific OPA GMTs in infant participants measured at birth.
Describe GBS serotype-specific OPA GMTs in infant participants measured at birth.
GBS serotype-specific IgG GMCs measured at 1 month after vaccination in maternal participants.
Describe GBS serotype-specific IgG GMCs measured at 1 month after vaccination in maternal participants.
GBS serotype-specific IgG GMCs measured at delivery in maternal participants.
Describe GBS serotype-specific IgG GMCs measured at delivery in maternal participants.
GBS serotype-specific OPA GMTs measured at 1 month after vaccination in maternal participants.
Describe GBS serotype-specific OPA GMTs measured at 1 month after vaccination in maternal participants.
GBS serotype-specific OPA GMTs measured at delivery in maternal participants.
Describe GBS serotype-specific OPA GMTs measured at delivery in maternal participants.
GBS serotype-specific IgG geometric mean concentrations (GMCs) measured before a booster vaccination in nonpregnant women
Describe GBS serotype-specific IgG GMCs measured before a booster vaccination in nonpregnant women
GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 1 month after a booster vaccination in nonpregnant women
Describe GBS serotype-specific IgG GMCs measured 1 month after a booster vaccination in nonpregnant women
GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 3 months after a booster vaccination in nonpregnant women
Describe GBS serotype-specific IgG GMCs measured 3 months after a booster vaccination in nonpregnant women
GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 6 months after a booster vaccination in nonpregnant women
Describe GBS serotype-specific IgG GMCs measured 6 months after a booster vaccination in nonpregnant women

Full Information

First Posted
December 4, 2018
Last Updated
September 26, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03765073
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
March 10, 2024 (Anticipated)
Study Completion Date
March 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Group B Streptococcus Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
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 participant, will be blinded.
Allocation
Randomized
Enrollment
1210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage 1 - Highest dose formulation a
Arm Type
Experimental
Arm Description
Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
Arm Title
Stage 1 - Highest dose formulation b
Arm Type
Experimental
Arm Description
Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
Arm Title
Stage 2 - Lowest dose formulation a
Arm Type
Experimental
Arm Description
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Arm Title
Stage 2 - Lowest dose formulation b
Arm Type
Experimental
Arm Description
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Arm Title
Stage 2 - Middle dose formulation a
Arm Type
Experimental
Arm Description
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Arm Title
Stage 2 - Middle dose formulation b
Arm Type
Experimental
Arm Description
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Arm Title
Stage 2 - Highest dose formulation a
Arm Type
Experimental
Arm Description
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Arm Title
Stage 2 - Highest dose formulation b
Arm Type
Experimental
Arm Description
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Arm Title
Stage 3 - Selected dose and formulation
Arm Type
Experimental
Arm Description
Multivalent group B streptococcus vaccine - Stage 3 Pregnant women
Arm Title
Stage 1 Placebo
Arm Type
Placebo Comparator
Arm Description
Saline control
Arm Title
Stage 2 Placebo
Arm Type
Placebo Comparator
Arm Description
Saline control
Arm Title
Stage 3 Placebo
Arm Type
Placebo Comparator
Arm Description
Saline control
Intervention Type
Biological
Intervention Name(s)
Multivalent Group B streptococcus vaccine
Intervention Description
Various formulations at three dose levels
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Saline control
Primary Outcome Measure Information:
Title
Percentages of nonpregnant women reporting prompted local reactions within 7 days following primary and booster doses of investigational product (pain at the injection site, redness, and swelling).
Description
Describe prompted local reactions for nonpregnant women following investigational product administration.
Time Frame
Day 7
Title
Percentages of nonpregnant women reporting prompted systemic events within 7 days following primary and booster doses of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).
Description
Describe prompted systemic events for nonpregnant women following investigational product administration.
Time Frame
Day 7
Title
Percentages of nonpregnant women reporting adverse events (AEs) through 1 month following administration of the primary and booster doses of investigational product.
Description
Describe AEs for nonpregnant women occurring through 1 month following administration of investigational product.
Time Frame
1 month following administration of investigational product
Title
Percentages of nonpregnant women reporting SAEs through 6 months following administration of the primary dose of investigational product.
Description
Describe SAEs for nonpregnant women through 6 months following administration of investigational product.
Time Frame
6 months following administration of investigational product
Title
Percentages of sentinel-cohort maternal participants (Stage 2 only) with clinical laboratory abnormalities following administration of investigational product at the 2-week follow-up visit.
Description
Describe clinical laboratory abnormalities for maternal participants (Stage 2 only) following administration of investigational product at 2-week follow-up visit.
Time Frame
2 weeks following administration of investigational product
Title
Percentages of maternal participants reporting prompted local reactions within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).
Description
Describe prompted local reactions for maternal participants within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).
Time Frame
Day 7
Title
Percentages of maternal participants reporting prompted systemic events within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).
Description
Describe prompted systemic events for maternal participants within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).
Time Frame
Day 7
Title
Percentages of maternal participants reporting AEs through 1 month after administration of investigational product.
Description
Describe AEs through 1 month after administration of investigational product.
Time Frame
1 month after administration of investigational product
Title
Percentages of maternal participants with SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) throughout the study (Visit 1 through the 12-month postdelivery study visit).
Description
Describe SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) for maternal participants throughout the study (Visit 1 through the 12-month postdelivery study visit).
Time Frame
12 months after delivery
Title
Percentages of maternal participants with each delivery outcome (live birth, delivery mode).
Description
Describe delivery outcomes (live birth, delivery mode) for maternal participants.
Time Frame
Delivery
Title
Percentages of infant participants with specific birth outcomes.
Description
Describe specific birth outcomes for infant participants.
Time Frame
Birth
Title
Percentages of infant participants with AEs from birth to 6 weeks of age.
Description
Describe AEs for infant participants from birth to 6 weeks of age.
Time Frame
6 weeks of age
Title
Percentages of infant participants with SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs through 12 months of age.
Description
Describe SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs for infant participants through 12 months of age.
Time Frame
12 months of age
Title
Percentages of nonpregnant women reporting SAEs approximately 7 to 12 months following the booster doses of investigational product.
Description
Describe SAEs for nonpregnant women 7 to 12 months following administration of investigational product.
Time Frame
7 to 12 months following administration of investigational product
Title
Percentages of nonpregnant women reporting medically attended adverse events (MAEs) through 6 months following administration of the primary dose of investigational product.
Description
Describe MAEs for nonpregnant women through 6 months following administration of investigational product.
Time Frame
6 months following administration of investigational product
Title
Percentages of nonpregnant women reporting medically attended adverse events (MAEs) approximately 7 to 12 months following the booster doses of investigational product.
Description
Describe MAEs for nonpregnant women 7 to 12 months following administration of investigational product.
Time Frame
7 to 12 months following administration of investigational product
Secondary Outcome Measure Information:
Title
Group B streptococcus (GBS) serotype-specific IgG geometric mean concentrations (GMCs) 1 month after vaccination in nonpregnant women.
Description
Describe GBS serotype-specific IgG geometric mean concentrations (GMCs) 1 month after vaccination in nonpregnant women.
Time Frame
1 month after vaccination
Title
GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination in maternal participants.
Description
Describe GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination in maternal participants.
Time Frame
2 weeks after vaccination
Title
GBS serotype-specific IgG GMCs in infant participants measured at birth.
Description
Describe GBS serotype-specific IgG GMCs in infant participants measured at birth.
Time Frame
Birth
Title
GBS serotype-specific OPA GMTs in infant participants measured at birth.
Description
Describe GBS serotype-specific OPA GMTs in infant participants measured at birth.
Time Frame
Birth
Title
GBS serotype-specific IgG GMCs measured at 1 month after vaccination in maternal participants.
Description
Describe GBS serotype-specific IgG GMCs measured at 1 month after vaccination in maternal participants.
Time Frame
1 month after vaccination
Title
GBS serotype-specific IgG GMCs measured at delivery in maternal participants.
Description
Describe GBS serotype-specific IgG GMCs measured at delivery in maternal participants.
Time Frame
Delivery
Title
GBS serotype-specific OPA GMTs measured at 1 month after vaccination in maternal participants.
Description
Describe GBS serotype-specific OPA GMTs measured at 1 month after vaccination in maternal participants.
Time Frame
1 month after vaccination
Title
GBS serotype-specific OPA GMTs measured at delivery in maternal participants.
Description
Describe GBS serotype-specific OPA GMTs measured at delivery in maternal participants.
Time Frame
Delivery
Title
GBS serotype-specific IgG geometric mean concentrations (GMCs) measured before a booster vaccination in nonpregnant women
Description
Describe GBS serotype-specific IgG GMCs measured before a booster vaccination in nonpregnant women
Time Frame
Before booster vaccination
Title
GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 1 month after a booster vaccination in nonpregnant women
Description
Describe GBS serotype-specific IgG GMCs measured 1 month after a booster vaccination in nonpregnant women
Time Frame
1 month after booster vaccination
Title
GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 3 months after a booster vaccination in nonpregnant women
Description
Describe GBS serotype-specific IgG GMCs measured 3 months after a booster vaccination in nonpregnant women
Time Frame
3 months after booster vaccination
Title
GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 6 months after a booster vaccination in nonpregnant women
Description
Describe GBS serotype-specific IgG GMCs measured 6 months after a booster vaccination in nonpregnant women
Time Frame
6 months after booster vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 1 Booster Vaccination: Participant must have received investigational product at Visit 1. Healthy nonpregnant female determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for booster vaccination and received investigational product at Visit 1. Negative urine pregnancy test at Visit 6 (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 Participants: Healthy females >=18 and <=40 years of age who are >=27 0/7 (Stage 2) or >=24 0/7 (Stage 3) to <=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 Participants: 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: Other 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 participant 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 GBS vaccine (other than GBS6 received as a primary vaccination at Visit 1), or planned receipt during the participant's participation in the study (through the last blood draw). Exclusion criteria Stage 2 and 3 Maternal Participants: Other 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 participant 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 participant's participation in the study (through the last blood draw). Prepregnancy body mass index (BMI) of ≥40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used. A prior history of or current pregnancy complications or abnormalities that will increase the risk associated with the participant'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 participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response. Exclusion criteria Stage 2 and 3 Infant Participants: Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
MedPharmics, LLC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
MedPharmics, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Chemidox Clinical Trials Inc.
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Chemidox Clinical Trials Inc
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Emerson Clinical Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
Clinical Research Prime
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Clinical Research Prime Rexburg
City
Rexburg
State/Province
Idaho
ZIP/Postal Code
83440
Country
United States
Facility Name
Lakeview Regional Medical Center
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
MedPharmics
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
St. Tammany Parish Hospital
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Velocity Clinical Research, Covington
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
North Oaks Medical Center
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
North Oaks Obstetrics & Gynecology
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
MedPharmics, LLC (Recruitment Call Center)
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70508
Country
United States
Facility Name
MedPharmics, LLC
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70508
Country
United States
Facility Name
MedPharmics, LLC
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Velocity Clinical Research, Slidell
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Boeson Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Community Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
The Birth Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Meridian Clinical Research
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Facility Name
Frontier Pediatric Care (Follow-Up Visits for Infant Participants)
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Bryan Women's Care Physicians (Maternal Visits & Obstetric Exams)
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Be Well Clinical Studies
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
MedPharmics, LLC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Velocity Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Lowcountry Women's Specialists
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Summerville Medical Center
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Coastal Pediatric Research
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Facility Name
St. Davids Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Tekton Research, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Sentara Leigh Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
The Group for Women
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Tidewater Physicians for Women
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Wits Reproductive Health and HIV Institute
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2001
Country
South Africa
Facility Name
Respiratory and Meningeal Pathogens Research Unit (RMPRU)
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
1862
Country
South Africa
Facility Name
Empilweni Services and Research Unit (ESRU)
City
Coronationville
State/Province
Johannesburg
ZIP/Postal Code
2093
Country
South Africa
Facility Name
Charlotte Maxeke Johannesburg Academic Hospital
City
Parktown
State/Province
Johannesburg
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Khayelitsha Hospital
City
Khayelitsha
State/Province
Western CAPE
ZIP/Postal Code
7784
Country
South Africa
Facility Name
Michael Mapongwana Community Health Centre
City
Khayelitsha
State/Province
Western CAPE
ZIP/Postal Code
7784
Country
South Africa
Facility Name
FAMCRU
City
Parow Valley
State/Province
Western CAPE
ZIP/Postal Code
7505
Country
South Africa
Facility Name
St George's University Hospitals NHS Foundation Trust
City
London
State/Province
Tooting
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C1091002
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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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