Clinical trial NCT04481191: Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074)
Official title: A Phase 3 Randomized, Open-Label, Clinical Trial to Study the Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of V260 and Inactivated Poliomyelitis Vaccine (IPV) in Chinese Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2020-07-22
Enrollment: 400
Sex: ALL
Minimum age (years): 48
Maximum age (years): 63
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 demonstrate that the immunogenicity of IPV in the concomitant-use group is non-inferior to the immunogenicity of IPV in the staggered-use group. The hypothesis to be tested is: The seroconversion percentage at 1 month post dose 3 for poliovirus types 1, 2, and 3 in the concomitant-use group is non-inferior to those of the staggered-use group.


Eligibility criteria: Inclusion Criteria:

* Healthy Chinese infant 48 days to 63 days of age.
* Infant's legally acceptable representative provides written informed consent for the study.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
timeFrame: Baseline and 1 month postdose 3 of IPV (Month ~3.5)
Secondary outcomes:
measure: Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
timeFrame: 1 month postdose 3 of IPV (Month ~3.5)
measure: Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
timeFrame: 1 month post dose 3 of IPV (Month ~3.5)
measure: Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
timeFrame: 1 month postdose 3 of IPV (Month ~3.5)
measure: Percentage of Participants With Solicited Injection-Site Adverse Events
timeFrame: Up to 7 days following each IPV vaccination
measure: Percentage of Participants With Solicited Systemic Adverse Events
timeFrame: Up to 7 days following each RotaTeq and/or IPV vaccination
measure: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to approximately 3.5 months
Other outcomes:
Locations:
city: Yangchun
country: China
facility: Yangchun Center For Disease Prevention And Control ( Site 0001)
state: Guangdong
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Chen S, Ying Z, Liu Y, Li Y, Yu Y, Huang M, Huang Z, Ou Z, Liao Y, Zhang Y, Liu G, Zhao W, Fu R, Shou Q, Zheng M, Liao X, Tu Y, Stek J, Hartzel J, Li C, Zhang J. A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China. Hum Vaccin Immunother. 2024 Dec 31;20(1):2324538. doi: 10.1080/21645515.2024.2324538. Epub 2024 Mar 20.