NCT01926015 - 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) | Crick

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

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.

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)

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.

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)

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.

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)

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.

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)

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