Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9

Intervention / Treatment
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* Biological: RotaTeq (V260)
* Biological: IPV


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 48 Days
Maximum Age: 63 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concomitant RotaTeq and IPV<br>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). | Biological: RotaTeq (V260)<br>* Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution<br>* Other names: V260;Biological: IPV<br>* 0.5 mL dose IPV (Sabin strain based), administered via IM injection<br>|
| Active Comparator: Staggered RotaTeq and IPV<br>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). | Biological: RotaTeq (V260)<br>* Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution<br>* Other names: V260;Biological: IPV<br>* 0.5 mL dose IPV (Sabin strain based), administered via IM injection<br>|

What is the study measuring?
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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 | 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. | Baseline and 1 month postdose 3 of IPV (Month  3.5) | 

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 | The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China. | 1 month postdose 3 of IPV (Month  3.5) | 
| Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV | The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China. | 1 month post dose 3 of IPV (Month  3.5) | 
| Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV | The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China. | 1 month postdose 3 of IPV (Month  3.5) | 
| Percentage of Participants With Solicited Injection-Site Adverse Events | Solicited injection-site adverse events (AEs) included erythema, swelling, induration, and pain at the IPV injection-site. | Up to 7 days following each IPV vaccination | 
| Percentage of Participants With Solicited Systemic Adverse Events | Solicited systemic AEs included diarrhea, vomiting, and elevated temperature (axillary temperature ≥37.5º C). | Up to 7 days following each RotaTeq and/or IPV vaccination | 
| Percentage of Participants With Serious Adverse Events (SAEs) | 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. | Up to approximately 3.5 months |