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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
400
Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution
0.5 mL dose IPV (Sabin strain based), administered via IM injection
Yangchun Center For Disease Prevention And Control ( Site 0001)
Yangchun, Guangdong, China
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.
Time frame: Baseline and 1 month postdose 3 of IPV (Month ~3.5)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Up to approximately 3.5 months
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