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Completed

NCT Number: NCT04071158

A STUDY OF A RSV VACCINE WHEN GIVEN TOGETHER WITH TDAP IN HEALTHY NONPREGNANT WOMEN AGED BETWEEN 18 TO 49 YEARS

This phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49 years of age. This study will evaluate non-inferiority of RSV vaccine when given with Tdap and vice-versa.

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Key information

Conditions

Respiratory Tract Infection Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Corynebacterium Infections Diphtheria Gram-Positive Bacterial Infections Infections Respiratory Tract Diseases Respiratory Tract Infections Tetanus

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Atlanta, Stockbridge, Georgia, United States

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About this study

This Phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49 years of age.

The participants will be equally split into 5 treatment groups: One of a possible two dose levels of RSV vaccine (the higher dose level will be formulated with an aluminum hydroxide adjuvant) with either the Tdap or Placebo, or a Tdap and placebo combination.

This study will evaluate non-inferiority of the Tdap when co-administered with RSV vaccine candidate and vice-versa by measuring participants' immune response through appropriate antibody and component levels 1 month after vaccination.

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 who are of childbearing potential or not of childbearing potential. (Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.)
  • Willing and able to comply with all scheduled visits, treatment plan, lifestyle considerations, and other study procedures.
  • Expected to be available for the duration of the study and can be contacted by telephone during study participation.
  • Body mass index (BMI) of <40 kg/m2 at the time of the consent.
  • Capable of giving signed informed consent as which includes compliance with the requirements and restrictions listed within.

Exclusion criteria

  • Other 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 participant inappropriate for entry into this study.
  • Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the vaccines being administered in the study.
  • History of latex allergy.
  • Immunocompromised participants with known or suspected immunodeficiency, as determined by history, laboratory tests, and/or physical examination.
  • Any contraindication to Tdap (including encephalopathies).
  • History of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin dependent diabetes mellitus (type 1).
  • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  • Women who are pregnant or breastfeeding.
  • Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt of nonstudy RSV vaccine throughout the study.
  • Treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before investigational product administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
  • Receipt of blood/plasma products or immunoglobulin within 60 days before investigational product administration or planned receipt throughout the study.
  • Current alcohol abuse, marijuana abuse, or illicit drug use.
  • Vaccination within 5 years with DTaP or tetanus and diphtheria toxoids adsorbed (Td) vaccine before investigational product administration.
  • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
  • Current febrile illness (oral temperature ≥38.0C [≥100.4F]) or other acute illness within 48 hours before investigational product administration.
  • Receipt of any inactivated vaccine within 14 days and any live vaccine within 28 days before or anticipated receipt of any vaccine within the 14 days after investigational product administration.
  • Receipt of short-term (<14 days) systemic corticosteroids. Investigational product administration should be delayed until systemic corticosteroid use has been discontinued for at least 28 days. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids do not require temporary delay of investigational product administration.

Treatment and study plan

RSV vaccine

Biological

RSV vaccine

TDAP

Biological

Tetanus, Diphtheria, and Acellular Pertussis Vaccine

Placebo

Biological

Normal saline solution for injection (0.9% sodium chloride injection)

Primary outcomes

  1. Percentage of Participants Achieving Anti-Tetanus Toxoid (TTd) Antibody Concentrations of Greater Than or Equal to (>=) 0.1 International Units Per Milliliter (IU/mL) at 1 Month After Vaccination

    Time frame: 1 month after vaccination

    Percentage of participants achieving Anti-TTd antibody concentrations of >= 0.1 IU/mL at 1 month after vaccination were reported. The lower limit of quantitation (LLOQ) values for Anti-TTd was 0.05 IU/mL. Assay results below the LLOQ were set to 0.5*LLOQ. Data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) along with placebo/Tdap arm and not planned to be collected and analyzed for two RSV vaccine arms: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo), as pre-specified in protocol.

  2. Percentage of Participants Achieving Anti-Diphtheria Toxoid (DTd) Antibody Concentrations of >= 0.1 IU/mL at 1 Month After Vaccination

    Time frame: 1 month after vaccination

    Percentage of participants achieving Anti-DTd antibody concentrations of >= 0.1 IU/mL at 1 month after vaccination were reported. The LLOQ values for Anti- DTd= 0.037 IU/mL. Assay results below the LLOQ were set to 0.5*LLOQ. Data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) along with placebo/Tdap arm and not planned to be collected and analyzed for two RSV vaccine arms: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo), as pre-specified in protocol.

  3. Geometric Mean Concentration (GMC) and Geometric Mean Ratio (GMR) of Anti-Pertussis Antibodies 1 Month After Vaccination

    Time frame: 1 month after vaccination

    GMCs of anti-pertussis components: anti pertussis (anti-PT) toxin, anti filamentous hemagglutinin (FHA) and anti- pertactin (PRN) was measured and reported in descriptive section. LLOQ values for each component was: Anti-PT=0.9 endotoxin units per milliliter (EU/mL), Anti-FHA=2.9 EU/mL, and Anti-PRN=3.0 EU/mL. Assay results below LLOQ were set to 0.5*LLOQ. Descriptive data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) along with placebo/Tdap arm and not planned to be collected and analyzed for two RSV vaccine arms: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo), as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.

  4. Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies 1 Month After Vaccination Using 2.0 Fold Margin

    Time frame: 1 month after vaccination

    Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.

  5. Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies 1 Month After Vaccination Using 2.0 Fold Margin

    Time frame: 1 month after vaccination

    Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.

  6. Percentage of Participants With Prespecified Local Reactions Within 7 Days After Vaccination

    Time frame: Within 7 days after vaccination

    Local reactions included pain at injection site, redness and swelling recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (>) 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity.

  7. Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination

    Time frame: Within 7 days after vaccination

    Systemic reactions included fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

  8. Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination

    Time frame: Within 1 month after vaccination (up to 35 days)

    An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  9. Percentage of Participants With Medically Attended Adverse Events (MAE) and Serious Adverse Events (SAE)

    Time frame: Within 1 month after vaccination (up to 35 days)

    An medically attended adverse events (MAE) was defined as a non-serious AE that results in an evaluation at a medical facility. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Secondary outcomes

  1. Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies 1 Month After Vaccination Using 1.5 Fold Margin

    Time frame: 1 month after vaccination

    Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.

  2. Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies 1 Month After Vaccination Using 1.5 Fold Margin

    Time frame: 1 month after vaccination

    Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.

Other outcomes

  1. Percentage of Participants Achieving Anti-TTd Antibody Concentrations of >= 0.1 IU/mL Before Vaccination

    Time frame: Before vaccination on Day 1

    Percentage of participants achieving Anti-TTd antibody concentrations of >= 0.1 IU/mL 1 month before vaccination were reported. The LLOQ values for Anti-TTd = 0.05 IU/mL. Assay results below the LLOQ were set to 0.5*LLOQ. Data for this outcome measure was not planned to be collected and analyzed for RSV 120 mcg with placebo arm and RSV 240 mcg with aluminum hydroxide/placebo arm.

  2. Percentage of Participants Achieving Anti- DTd Antibody Concentrations of >= 0.1 IU/mL Before Vaccination

    Time frame: Before vaccination on Day 1

    Percentage of participants achieving Anti-DTd antibody concentrations of >= 0.1 IU/mL before vaccination were reported. The LLOQ values for Anti-DTd= 0.037 IU/mL. Assay results below the LLOQ were set to 0.5*LLOQ. Data for this outcome measure was not planned to be collected and analyzed for RSV 120 mcg with placebo arm and RSV 240 mcg with aluminum hydroxide/placebo arm.

  3. Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies Before Vaccination

    Time frame: Before vaccination on Day 1

    Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol.

  4. Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before Vaccination

    Time frame: Before vaccination on Day 1

    Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 2b, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) 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
2019
Primary completion
2019
Study completion
2019
First posted
Aug 28, 2019
Registry last updated
Feb 15, 2021

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

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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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