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Completed

NCT Number: NCT04766086

Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women

This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group B streptococcus vaccine administered concomitantly with Tdap in healthy nonpregnant women 18 through 49 years of age.

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Key information

Conditions

Group B Streptococcus Infections

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Alliance for Multispecialty Research, LLC, Newton, Kansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy women ≥18 and ≤49 years of age.
  • Participants who are willing and able to comply with scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures, including completion of the e-diary from Day 1 to Day 7 following administration of investigational product.
  • Healthy females at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
  • Expected to be available for the duration of the study and who can be contacted by telephone during study participation.
  • Capable of giving personal signed informed consent.

Exclusion criteria

  • Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (prior to vaccination)
  • 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 group B streptococcus.
  • Immunocompromised participants with known or suspected immunodeficiency.
  • Bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection.
  • Other acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Previous vaccination with any licensed or investigational GBS vaccine, or planned receipt during the participant's participation in the study (through the 1-month follow-up visit [Visit 2]).
  • Vaccination within 5 years with tetanus and diphtheria toxoids and acellular pertussis-containing vaccines (Tdap) before investigational product administration.
  • Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids
  • Vaccination with diphtheria- or CRM197-containing vaccine(s) from 6 months before investigational product administration, or planned receipt through the 1-month follow-up visit.
  • Receipt or planned receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration through the 1-month follow-up visit
  • Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation

Treatment and study plan

Multivalent Group B streptococcus vaccine

Biological

Multivalent Group B streptococcus vaccine

Tetanus, diphtheria, and acellular pertussis vaccine

Biological

Tetanus, diphtheria, and acellular pertussis vaccine

Other names: Tdap

Placebo

Biological

Saline control

Primary outcomes

  1. Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination

    Time frame: Day 1 (day of vaccination) to Day 7

    Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter [cm]). Grading: Grade 1/mild (greater than [>] 2.0 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.

  2. Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination

    Time frame: Day 1 (day of vaccination) to Day 7

    Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours [h]), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, chills, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.

  3. Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Vaccination

    Time frame: Day 1 (day of vaccination) through 1 Month post-vaccination

    An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. In this outcome measure results excluded data for local reactions and systemic events.

  4. Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 6 Months After Vaccination

    Time frame: Day 1 (day of vaccination) through 6 Months post-vaccination

    A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.

  5. Percentage of Participants Achieving Anti-tetanus Toxoid (Anti-TTd) and Anti-diphtheria Toxoid (Anti-DTd) Antibody Concentration >=0.1 IU/mL at 1 Month After Vaccination: GBS6 + Tdap and Placebo + Tdap Groups

    Time frame: 1 Month after Vaccination (Day 1, day of vaccination)

    IU/mL stands for international units per milliliter.

  6. Geometric Mean Concentration (GMC) of Anti-Pertussis Toxin (PT), Anti-Filamentous Hemagglutinin (FHA), and Anti-Pertactin (PRN) Antibodies; GMR of Anti-PT, Anti-FHA, and Anti-PRN for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination

    Time frame: 1 Month after Vaccination (Day 1, day of vaccination)

    GMCs of anti-PT, anti-FHA, and anti-PRN was reported as descriptive data for the GBS6 +Tdap and placebo + Tdap groups, along with associated 2-sided 95% confidence interval. GMR for anti-PT, anti-FHA and anti-PRN antibodies were estimated from the GBS6 + Tdap group to the placebo + Tdap group and reported as statistical data.

  7. GMC of GBS Capsular Polysaccharide (CPS) Serotype-Specific Immunoglobulin G (IgG) Antibodies; GMR of GBS CPS Serotype-specific IgG Antibodies for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination

    Time frame: 1 Month after Vaccination (Day 1, day of vaccination)

    GBS CPS serotype-specific IgG GMCs (Ia, Ib, II, III, IV, V) were reported as descriptive data for the GBS6+Tdap and GBS6+placebo groups, along with associated 2-sided 95% confidence interval. GMR of GBS CPS serotype-specific IgG antibodies were estimated from the GBS6 + Tdap group to the placebo + Tdap group and reported as statistical data.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 2B, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE WHEN ADMINISTERED CONCOMITANTLY WITH TETANUS, DIPHTHERIA, AND ACELLULAR PERTUSSIS VACCINE (TDAP) IN HEALTHY NONPREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2021
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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