| Primary | Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3 | Participant serum was collected for determination of antibody responses. Threshold levels for seroresponse were the following: Diphtheria Toxin, >=0.1 International Units (IU)/mL; Tetanus Toxin, >=0.01 IU/mL; Pertussis Toxin and Pertussis FHA, >=10 Enzyme Units (EU)/mL; Poliovirus Types 1, 2, and 3, neutralizing antibody (NA) titer >=8. | The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint | Posted | | Number | | Percentage of participants | | 4 to 6 weeks after the third dose of DTP-IPV | | | | ID | Title | Description |
|---|
| OG000 | Concomitant RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) | | OG001 | Staggered RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) |
| | | Title | Denominators | Categories |
|---|
| Diphtheria Toxin >=0.1 IU/mL | | | | Tetanus Toxin >=0.01 IU/mL | | |
| | 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 |
|---|
| Diphtheria Toxin >=0.1 IU/mL | Miettinen and Nurminen | | <0.001 | | Difference in percentage | 0.0 | | | 2-Sided | 95 | -3.99 | 3.95 | | | | | Non-Inferiority or Equivalence | Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10 | | |
|
| Secondary | Percentage of Participants Reporting an Adverse Event With Incidence >=1% | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events with an incidence >=1% in either treatment group were recorded. | The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was were counted only once overall. | Posted | | Number | | Percentage of participants | | Up to 14 days after any of the 6 study visits | | | | ID | Title | Description |
|---|
| OG000 | Concomitant RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) | | OG001 | Staggered RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) |
| |
| Secondary | Percentage of Participants Reporting an Adverse Event of Special Interest: Fever | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events. | The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was counted only once within a study Period and only once Overall. | Posted | | Number | | Percentage of participants | | Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit) | | | | ID | Title | Description |
|---|
| OG000 | Concomitant RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) | | OG001 | Staggered RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) |
|
| Secondary | Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events. | The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall. | Posted | | Number | | Percentage of participants | | Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit) | | | | ID | Title | Description |
|---|
| OG000 | Concomitant RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) | | OG001 | Staggered RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) |
|
| Secondary | Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events. | The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall. | Posted | | Number | | Percentage of participants | | Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit) | | | | ID | Title | Description |
|---|
| OG000 | Concomitant RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) | | OG001 | Staggered RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) |
|
| Secondary | Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events. | The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall. | Posted | | Number | | Percentage of participants | | Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit) | | | | ID | Title | Description |
|---|
| OG000 | Concomitant RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) | | OG001 | Staggered RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) |
|
| Secondary | Geometric Mean Titers for Diphtheria Toxin Antibody | Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV | The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV | | | | ID | Title | Description |
|---|
| OG000 | Concomitant RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) | | OG001 | Staggered RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) |
| |
| Secondary | Geometric Mean Titers for Tetanus Toxin Antibody | Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV | The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV | | | | ID | Title | Description |
|---|
| OG000 | Concomitant RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) | | OG001 | Staggered RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) |
| |
| Secondary | Geometric Mean Titers for Pertussis Toxin Antibody | Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV | The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint | Posted | | Geometric Mean | 95% Confidence Interval | EU/mL | | Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV | | | | ID | Title | Description |
|---|
| OG000 | Concomitant RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) | | OG001 | Staggered RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) |
| |
| Secondary | Geometric Mean Titers for Pertussis FHA Antibody | Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV | The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint | Posted | | Geometric Mean | 95% Confidence Interval | EU/mL | | Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV | | | | ID | Title | Description |
|---|
| OG000 | Concomitant RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) | | OG001 | Staggered RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) |
| |
| Secondary | Geometric Mean Titers for Poliovirus Type 1 Antibody | Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers. | The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint | Posted | | Geometric Mean | 95% Confidence Interval | NA Titer | | Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV | | | | ID | Title | Description |
|---|
| OG000 | Concomitant RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) | | OG001 | Staggered RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) |
| |
| Secondary | Geometric Mean Titers for Poliovirus Type 2 Antibody | Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers. | The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint | Posted | | Geometric Mean | 95% Confidence Interval | NA Titer | | Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV | | | | ID | Title | Description |
|---|
| OG000 | Concomitant RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) | | OG001 | Staggered RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) |
| |
| Secondary | Geometric Mean Titers for Poliovirus Type 3 Antibody | Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers. | The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint | Posted | | Geometric Mean | 95% Confidence Interval | NA Titer | | Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV | | | | ID | Title | Description |
|---|
| OG000 | Concomitant RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) | | OG001 | Staggered RotaTeqâ„¢ and DTP-IPV | RotaTeqâ„¢ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4) |
| |