| Primary | 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. | Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included. | Posted | | Number | | Percentage of Participants | | Baseline and 1 month postdose 3 of IPV (Month ~3.5) | | | | ID | Title | Description |
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| OG000 | Concomitant RotaTeq and IPV | Participants received 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). | | OG001 | Staggered RotaTeq and IPV | Participants received 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). |
| | | Title | Denominators | Categories |
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| Poliovirus Type 1 | | | | Poliovirus Type 2 | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Difference indicates Concomitant-use Group % - Staggered-use Group % | Unstratified Miettinen & Nurminen method | | < 0.001 | | Mean Difference (Final Values) | -1.1 | | | 2-Sided | 95 | -4.0 | 0.9 | | | | | Non-Inferiority | Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being > -10 percentage points (one-sided p-value < 0.025). | |
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| Secondary | 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. | Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 1 month postdose 3 of IPV (Month ~3.5) | | | | ID | Title | Description |
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| OG000 | Concomitant RotaTeq and IPV | Participants received 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). | | OG001 | Staggered RotaTeq and IPV | Participants received 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). |
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| Secondary | 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. | Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 1 month post dose 3 of IPV (Month ~3.5) | | | | ID | Title | Description |
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| OG000 | Concomitant RotaTeq and IPV | Participants received 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). | | OG001 | Staggered RotaTeq and IPV | Participants received 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). |
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| Secondary | 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. | Participants who received the 3 scheduled doses of study vaccination, adhered to guidelines for vaccine administration, provided baseline and post-vaccination blood samples within the acceptable day range, and did not have important protocol deviations are included. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 1 month postdose 3 of IPV (Month ~3.5) | | | | ID | Title | Description |
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| OG000 | Concomitant RotaTeq and IPV | Participants received 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). | | OG001 | Staggered RotaTeq and IPV | Participants received 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). |
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| Secondary | 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. | All participants who received ≥1 dose of study treatment are included. | Posted | | Number | | Percentage of Participants | | Up to 7 days following each IPV vaccination | | | | ID | Title | Description |
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| OG000 | Concomitant RotaTeq and IPV | Participants received 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). | | OG001 | Staggered RotaTeq and IPV | Participants received 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). |
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| Secondary | Percentage of Participants With Solicited Systemic Adverse Events | Solicited systemic AEs included diarrhea, vomiting, and elevated temperature (axillary temperature ≥37.5º C). | All participants who received ≥1 dose of study treatment and have data available are included. | Posted | | Number | | Percentage of Participants | | Up to 7 days following each RotaTeq and/or IPV vaccination | | | | ID | Title | Description |
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| OG000 | Concomitant RotaTeq and IPV | Participants received 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). | | OG001 | Staggered RotaTeq and IPV | Participants received 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). |
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| Secondary | 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. | All participants who received ≥1 dose of study treatment are included. | Posted | | Number | | Percentage of Participants | | Up to approximately 3.5 months | | | | ID | Title | Description |
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| OG000 | Concomitant RotaTeq and IPV | Participants received 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). | | OG001 | Staggered RotaTeq and IPV | Participants received 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). |
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