A STUDY OF A RSV VACCINE WHEN GIVEN TOGETHER WITH TDAP IN HEALTHY NONPREGNANT WOMEN AGED BETWEEN 18 TO 49 YEARS
Condition: Respiratory Tract Infection
MeSH terms: Respiratory Tract Infections
Intervention: RSV Vaccine; Tdap; Placebo
Intervention description: RSV vaccine; Tetanus, Diphtheria, and Acellular Pertussis Vaccine; Normal saline solution for injection (0.9% sodium chloride injection)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
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.
Enrollment: 713.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory tract infection; Respiratory Syncytial Virus; RSV; Tdap; Tetanus; Diphtheria; Acellular Pertussis; Vaccine

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.
    

Eligibility 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.