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 |
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Recruitment Status :
Completed
First Posted : December 5, 2018
Last Update Posted : March 19, 2024
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Group B Streptococcus Infections | Biological: Multivalent Group B streptococcus vaccine Biological: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1214 participants |
| 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 participant, will be blinded. |
| 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 NONPREGNANT WOMEN AND PREGNANT WOMEN 18 TO 40 YEARS OF AGE AND THEIR INFANTS |
| Actual Study Start Date : | January 14, 2019 |
| Actual Primary Completion Date : | March 4, 2024 |
| Actual Study Completion Date : | March 4, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Stage 1 - Highest dose formulation a
Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
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Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels |
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Experimental: Stage 1 - Highest dose formulation b
Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
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Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels |
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Experimental: Stage 2 - Lowest dose formulation a
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
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Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels |
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Experimental: Stage 2 - Lowest dose formulation b
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
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Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels |
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Experimental: Stage 2 - Middle dose formulation a
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
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Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels |
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Experimental: Stage 2 - Middle dose formulation b
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
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Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels |
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Experimental: Stage 2 - Highest dose formulation a
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
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Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels |
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Experimental: Stage 2 - Highest dose formulation b
Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
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Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels |
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Experimental: Stage 3 - Selected dose and formulation
Multivalent group B streptococcus vaccine - Stage 3 Pregnant women
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Biological: Multivalent Group B streptococcus vaccine
Various formulations at three dose levels |
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Placebo Comparator: Stage 1 Placebo
Saline control
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Biological: Placebo
Saline control |
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Placebo Comparator: Stage 2 Placebo
Saline control
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Biological: Placebo
Saline control |
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Placebo Comparator: Stage 3 Placebo
Saline control
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Biological: Placebo
Saline control |
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). [ 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 primary and booster doses 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 the primary and booster doses 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 SAEs through 6 months following administration of the primary dose of investigational product. [ Time Frame: 6 months following administration 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. [ Time Frame: 2 weeks following administration of investigational product ]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). [ Time Frame: Day 7 ]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). [ Time Frame: Day 7 ]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. [ Time Frame: 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). [ Time Frame: 12 months after delivery ]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). [ Time Frame: Delivery ]Describe delivery outcomes (live birth, delivery mode) for maternal participants.
- Percentages of infant participants with specific birth outcomes. [ Time Frame: Birth ]Describe specific birth outcomes for infant participants.
- Percentages of infant participants with AEs from birth to 6 weeks of age. [ Time Frame: 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. [ 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 participants through 12 months of age.
- Percentages of nonpregnant women reporting SAEs approximately 7 to 12 months following the booster doses of investigational product. [ Time Frame: 7 to 12 months following administration 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. [ Time Frame: 6 months following administration 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. [ Time Frame: 7 to 12 months following administration 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. [ 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 IgG GMCs measured at 2 weeks after vaccination in maternal participants. [ Time Frame: 2 weeks after vaccination ]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. [ Time Frame: Birth ]Describe GBS serotype-specific IgG GMCs in infant participants measured at birth.
- GBS serotype-specific OPA GMTs in infant participants measured at birth. [ Time Frame: 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. [ Time Frame: 1 month after vaccination ]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. [ Time Frame: Delivery ]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. [ Time Frame: 1 month after vaccination ]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. [ Time Frame: Delivery ]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 [ Time Frame: Before booster vaccination ]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 [ Time Frame: 1 month after booster vaccination ]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 [ Time Frame: 3 months after booster vaccination ]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 [ Time Frame: 6 months after booster vaccination ]Describe GBS serotype-specific IgG GMCs measured 6 months after a booster vaccination in nonpregnant women
Information from the National Library of Medicine
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| Ages Eligible for Study: | 0 Years to 40 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765073
Locations
Show 48 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT03765073 |
| Other Study ID Numbers: |
C1091002 2020-005074-96 ( EudraCT Number ) |
| First Posted: | December 5, 2018 Key Record Dates |
| Last Update Posted: | March 19, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |