Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)

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.

Time frame: 4 to 6 weeks after the third dose of DTP-IPV

Population: 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

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

Time frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV

Population: 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

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

Time frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV

Population: 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

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

Time frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV

Population: 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

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.

Time frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV

Population: 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

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.

Time frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV

Population: 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

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.

Time frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV

Population: 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

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

Time frame: Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV

Population: 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

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.

Time frame: 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)

Population: 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.

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.

Time frame: 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)

Population: 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.

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.

Time frame: 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)

Population: 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.

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.

Time frame: 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)

Population: 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.

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.

Time frame: Up to 14 days after any of the 6 study visits

Population: 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.