Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04071158
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04071158
Recruitment Status : Recruiting
First Posted : August 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 26, 2019
First Posted Date  ICMJE August 27, 2019
Last Update Posted Date November 27, 2019
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date December 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 are non-inferior (2.0-fold margin)
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Change History Complete list of historical versions of study NCT04071158 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
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 are non-inferior (1.5-fold margin)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures
 (submitted: November 25, 2019)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A STUDY OF A RSV VACCINE WHEN GIVEN TOGETHER WITH TDAP IN HEALTHY NONPREGNANT WOMEN AGED BETWEEN 18 TO 49 YEARS
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Respiratory Tract Infection
Intervention  ICMJE
  • Biological: RSV Vaccine
    RSV vaccine
  • Biological: Tdap
    Tetanus, Diphtheria, and Acellular Pertussis Vaccine
  • Biological: Placebo
    Normal saline solution for injection (0.9% sodium chloride injection)
Study Arms  ICMJE
  • Experimental: Lower RSV vaccine dose and Tdap
    Lower RSV vaccine dose and Tdap
    Interventions:
    • Biological: RSV Vaccine
    • Biological: Tdap
  • Experimental: Lower RSV vaccine dose and Placebo
    Lower RSV vaccine dose and Placebo
    Interventions:
    • Biological: RSV Vaccine
    • Biological: Placebo
  • Experimental: Higher RSV vaccine dose with Aluminum Hydroxide and Tdap
    Higher RSV vaccine dose with Aluminum Hydroxide and Tdap
    Interventions:
    • Biological: RSV Vaccine
    • Biological: Tdap
  • Experimental: Higher RSV vaccine dose with Aluminum Hydroxide and Placebo
    Higher RSV vaccine dose with Aluminum Hydroxide and Placebo
    Interventions:
    • Biological: RSV Vaccine
    • Biological: Placebo
  • Placebo Comparator: Placebo and Tdap
    Normal saline solution for injection (0.9% sodium chloride injection) and Tdap
    Interventions:
    • Biological: Tdap
    • Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 1, 2019)
710
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2019)
680
Estimated Study Completion Date  ICMJE December 18, 2019
Estimated Primary Completion Date December 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
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.
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04071158
Other Study ID Numbers  ICMJE C3671004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP