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Trial record 3 of 3 for:    "Diphtheria" | "Antacids"

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

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ClinicalTrials.gov Identifier: NCT04071158
Recruitment Status : Not yet recruiting
First Posted : August 27, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 680 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.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infection Biological: RSV Vaccine Biological: Tdap Biological: Placebo Phase 2

Detailed Description:

This Phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 680 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 710 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but the participant and all other study personnel, including the principal investigator, will be blinded.
Primary Purpose: Prevention
Official 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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 18, 2019
Estimated Study Completion Date : December 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lower RSV vaccine dose and Tdap
Lower RSV vaccine dose and Tdap
Biological: RSV Vaccine
RSV vaccine

Biological: Tdap
Tetanus, Diphtheria, and Acellular Pertussis Vaccine

Experimental: Lower RSV vaccine dose and Placebo
Lower RSV vaccine dose and Placebo
Biological: RSV Vaccine
RSV vaccine

Biological: Placebo
Normal saline solution for injection (0.9% sodium chloride injection)

Experimental: Higher RSV vaccine dose with Aluminum Hydroxide and Tdap
Higher RSV vaccine dose with Aluminum Hydroxide and Tdap
Biological: RSV Vaccine
RSV vaccine

Biological: Tdap
Tetanus, Diphtheria, and Acellular Pertussis Vaccine

Experimental: Higher RSV vaccine dose with Aluminum Hydroxide and Placebo
Higher RSV vaccine dose with Aluminum Hydroxide and Placebo
Biological: RSV Vaccine
RSV vaccine

Biological: Placebo
Normal saline solution for injection (0.9% sodium chloride injection)

Placebo Comparator: Placebo and Tdap
Normal saline solution for injection (0.9% sodium chloride injection) and Tdap
Biological: Tdap
Tetanus, Diphtheria, and Acellular Pertussis Vaccine

Biological: Placebo
Normal saline solution for injection (0.9% sodium chloride injection)




Primary Outcome Measures :
  1. Percentage of participants reporting local reactions and systemic events from day of vaccination (Day 1) until Day 7 [ Time Frame: From day of vaccination until 7 days after vaccination ]
    Describe local reactions and systemic events after 1 dose of investigational product

  2. Percentage of participants reporting Adverse Events (AE) within 1 month after vaccination [ Time Frame: Within 1 month after vaccination ]
    Describe adverse events (AE) after vaccination

  3. Percentage of participants reporting obstetric complications, medically attended adverse events (MAE) and serious adverse events (SAE) throughout the study [ Time Frame: Within 1 month after vaccination ]
    Describe all MAE and SAE throughout the study

  4. Difference in percentage of participants with anti-TTd antibody concentrations ≥0.1 IU/mL [ Time Frame: Within 1 month after vaccination ]
    Demonstrate that the immune responses induced by Tdap when administered concomitantly with the RSV vaccine

  5. Difference in percentage of participants with anti-DTd antibody concentrations ≥0.1 IU/mL [ Time Frame: Within 1 month after vaccination ]
    Demonstrate that the immune responses induced by Tdap when administered concomitantly with the RSV vaccine

  6. Geometric mean concentration (GMC) ratio, estimated by the ratio of the GMC of anti-PT antibodies [ Time Frame: Within 1 month after vaccination ]
    Demonstrate that the immune responses induced by Tdap when administered concomitantly with the RSV vaccine

  7. Geometric mean concentration (GMC) ratio, estimated by the ratio of the GMC of anti-FHA antibodies [ Time Frame: Within 1 month after vaccination ]
    Demonstrate that the immune responses induced by Tdap when administered concomitantly with the RSV vaccine

  8. Geometric mean concentration (GMC) ratio, estimated by the ratio of the GMC of anti-PRN antibodies [ Time Frame: Within 1 month after vaccination ]
    Demonstrate that the immune responses induced by Tdap when administered concomitantly with the RSV vaccine

  9. Geometric mean titer (GMT) ratio, estimated by the ratio of the GMT for RSV neutralizing antibody titers [ Time Frame: Within 1 month after vaccination ]
    Demonstrate that the immune responses induced by RSV vaccine when administered concomitantly with the Tdap


Secondary Outcome Measures :
  1. Differences in Anti-TTd, anti-TDd, and antipertussis components (anti PT, anti-FHA, and anti PRN) [ Time Frame: Baseline (pre-vaccination) and 1 month after vaccination ]
    Describe the immune responses elicited by Tdap when administered concomitantly with the RSV vaccine.

  2. Difference in RSV neutralizing antibody titers [ Time Frame: Baseline (pre-vaccination) and 1 month after vaccination ]
    Describe the immune responses elicited by RSV vaccine when administered concomitantly with the Tdap.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Healthy, non-pregnant women 18 to 49 years of age, who are of childbearing potential or not of childbearing potential.
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT04071158


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, Georgia
Clinical Research Atlanta Not yet recruiting
Stockbridge, Georgia, United States, 30281
United States, Hawaii
East-West Medical Research Institute Not yet recruiting
Honolulu, Hawaii, United States, 96814
United States, Kansas
Alliance for multispecialty research Not yet recruiting
Wichita, Kansas, United States, 67207
United States, Missouri
Sundance Clinical Research Not yet recruiting
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Meridian Clinical Research Not yet recruiting
Omaha, Nebraska, United States, 68134
United States, Oklahoma
Lynn Health Science Institute Not yet recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Rhode Island
Omega Medical Research Not yet recruiting
Warwick, Rhode Island, United States, 02886
United States, South Dakota
Meridian Clinical Research, LLC Not yet recruiting
Dakota Dunes, South Dakota, United States, 57049
United States, Texas
Benchmark Research Not yet recruiting
Austin, Texas, United States, 78705
Ventavia Research Group Not yet recruiting
Fort Worth, Texas, United States, 76104
Texas Center for Drug Development Not yet recruiting
Houston, Texas, United States, 77081
Clinical Trials of Texas, Inc. Not yet recruiting
San Antonio, Texas, United States, 78229
Clinical Trials of Texas Not yet recruiting
San Antonio, Texas, United States, 78229
DM Clinical Research Not yet recruiting
Tomball, Texas, United States, 77375
Martin Diagnostic Clinic Not yet recruiting
Tomball, Texas, United States, 77375
United States, Utah
J. Lewis Research, Inc. / Foothill Family Clinic South Not yet recruiting
Salt Lake City, Utah, United States, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South Not yet recruiting
Salt Lake City, Utah, United States, 84121
J. Lewis Research, Inc / Jordan River Family Medicine Not yet recruiting
South Jordan, Utah, United States, 84095
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04071158     History of Changes
Other Study ID Numbers: C3671004
First Posted: August 27, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Respiratory tract infection
Respiratory Syncytial Virus
RSV
Tdap
Tetanus
Diphtheria
Acellular Pertussis
Vaccine
Additional relevant MeSH terms:
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Antacids
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Aluminum Hydroxide
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents