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

Last updated on August 30, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Respiratory Tract Infection
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-49 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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

- Capable of giving signed informed consent as which includes compliance with the
requirements and restrictions listed within.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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
( 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 ( 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.

NCT04071158
Pfizer
Not yet recruiting
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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[email protected]

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