- ICH GCP
- US Clinical Trials Registry
- 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)
March 13, 2023 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Yangchun, Guangdong, China, 529600
- Yangchun Center For Disease Prevention And Control ( Site 0001)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Concomitant RotaTeq and IPV
Participants will receive RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular [IM] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 [Day 1]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
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Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution
Other Names:
0.5 mL dose IPV (Sabin strain based), administered via IM injection
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Active Comparator: Staggered RotaTeq and IPV
Participants will receive RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
|
Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution
Other Names:
0.5 mL dose IPV (Sabin strain based), administered via IM injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
Time Frame: Baseline and 1 month postdose 3 of IPV (Month ~3.5)
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The immunogenicity of IPV was measured using poliovirus serum neutralizing antibody assay of the National Institutes for Food and Drug Control (NIFDC), Beijing, China.
Serum conversion was defined as antibody titer ≥1:8 post-vaccination in baseline seronegative participants or ≥4-fold increase in titer post-vaccination in baseline seropositive participants.
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Baseline and 1 month postdose 3 of IPV (Month ~3.5)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
Time Frame: 1 month postdose 3 of IPV (Month ~3.5)
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The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
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1 month postdose 3 of IPV (Month ~3.5)
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Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
Time Frame: 1 month post dose 3 of IPV (Month ~3.5)
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The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
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1 month post dose 3 of IPV (Month ~3.5)
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Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
Time Frame: 1 month postdose 3 of IPV (Month ~3.5)
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The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
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1 month postdose 3 of IPV (Month ~3.5)
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Percentage of Participants With Solicited Injection-Site Adverse Events
Time Frame: Up to 7 days following each IPV vaccination
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Solicited injection-site adverse events (AEs) included erythema, swelling, induration, and pain at the IPV injection-site.
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Up to 7 days following each IPV vaccination
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Percentage of Participants With Solicited Systemic Adverse Events
Time Frame: Up to 7 days following each RotaTeq and/or IPV vaccination
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Solicited systemic AEs included diarrhea, vomiting, and elevated temperature (axillary temperature ≥37.5º
C).
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Up to 7 days following each RotaTeq and/or IPV vaccination
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Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame: Up to approximately 3.5 months
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The percentage of participants with SAEs is presented.
An SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or another important medical event.
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Up to approximately 3.5 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 25, 2020
Primary Completion (Actual)
May 8, 2021
Study Completion (Actual)
May 8, 2021
Study Registration Dates
First Submitted
July 20, 2020
First Submitted That Met QC Criteria
July 20, 2020
First Posted (Actual)
July 22, 2020
Study Record Updates
Last Update Posted (Actual)
March 15, 2023
Last Update Submitted That Met QC Criteria
March 13, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Gastrointestinal Diseases
- Neuromuscular Diseases
- Central Nervous System Infections
- Enterovirus Infections
- Picornaviridae Infections
- Spinal Cord Diseases
- Myelitis
- Gastroenteritis
- Poliomyelitis
Other Study ID Numbers
- V260-074 (Other Identifier: Merck Protocol Number)
- 2020-003329-49 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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