Status:
COMPLETED
Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9
Eligibility:
All Genders
48-63 years
Phase:
PHASE3
Brief Summary
This study will evaluate the immunogenicity and safety of concomitant administration of RotaTeq® (V260) and inactivated poliomyelitis vaccine (IPV) in Chinese infants. Its primary objective is to demo...
Eligibility Criteria
Inclusion
- Healthy Chinese infant 48 days to 63 days of age.
- Infant's legally acceptable representative provides written informed consent for the study.
Exclusion
- History of rotavirus disease, congenital gastrointestinal disorders, chronic diarrhea, failure to thrive, or abdominal surgery.
- History of intussusception.
- History of poliomyelitis.
- Clinical evidence of active gastrointestinal illness. Note: Infants with gastroesophageal reflux disease \[GERD\] may participate in the study if the GERD is well controlled with or without medication.
- Known or suspected impairment of immunological function, including severe combined immunodeficiency disease (SCID).
- Has a fever, with an axillary temperature ≥37.5°C (or equivalent) at the time of vaccination or within 24 hours prior to vaccination. Note: The Visit 1 may be rescheduled after complete resolution of febrile illness.
- Has acute disease.
- Has underlying diseases such as cardiovascular, renal, liver, or blood disease.
- History of known hypersensitivity to any components of rotavirus vaccine and/or IPV.
- Uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological diseases.
- Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- Resides in a household with an immunocompromised person, including individuals with congenital immunodeficiency (including SCID), human immunodeficiency virus (HIV) infection, leukemia, lymphoma, multiple myeloma, generalized malignance, chronic renal failure, organ or bone marrow transplantation, or with those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids.
- Any condition, which in the opinion of the investigator, may interfere with the evaluation of the study objectives.
- Prior administration of any rotavirus vaccines or poliovirus vaccines.
- Has received inactivated or recombinant vaccines within 14 days prior to Visit 1 or live vaccines within 28 days prior to Visit 1.
- Has received an investigational or non-registered product other than study vaccines or is planning to use such product during the study.
- Has received immunosuppressive therapies including systemic (intramuscular, oral, or intravenous) corticosteroids. Note: Participants using non-systemic corticosteroids (e.g., topical, ophthalmic, and inhaled) are considered eligible for the study.
- Has received a blood transfusion or blood products, including immunoglobulins or is planning to receive such product during the study.
- Has participated in another interventional study prior to Visit 1 or expected to anytime during the study.
- The infant's legally acceptable representative is unlikely to adhere to the study procedures, keep appointments or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period when study visits would need to be scheduled.
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is an investigational site or Sponsor staff member directly involved with this study.
Key Trial Info
Start Date :
August 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2021
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04481191
Start Date
August 25 2020
End Date
May 8 2021
Last Update
July 26 2024
Active Locations (1)
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1
Yangchun Center For Disease Prevention And Control ( Site 0001)
Yangchun, Guangdong, China, 529600