Trial · NCT03207750
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Analysis was performed on the Per protocol set (PPS) for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Immunogenicity in Terms of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | IU/mL | GEOMETRIC_MEAN |
| PRIMARY | Immunogenicity in Terms of Anti-pneumococcal Serotypes (Anti-PnPS) Antibody Concentrations. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | µg/mL | GEOMETRIC_MEAN |
| PRIMARY | Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 0.15 µg/mL. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 1.0 µg/mL. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Seroresponse to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seropositive Subjects With Anti-Rota Virus Immunoglobulin A (Anti-RV IgA) Antibody Concentrations Above or Equal to Cut-off Value of 20 Units/Milliliter (U/mL). | At Month 5 (Three months after Dose 2 of HRV vaccine) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seropositive Subjects With Anti-RV IgA Antibody Concentrations Above or Equal to Cut-off Value of 90 U/mL. | At Month 5 (Three months after Dose 2 of HRV vaccine) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seropositive Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above or Equal to Cut-off Value. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seropositive Subjects With Anti-PnPS Antibody Concentrations Above or Equal to Cut-off Value. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | IU/mL | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity in Terms of Anti-PRP Antibody Concentrations. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity in Terms of Anti-HBs Antibody Concentrations. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | mIU/mL | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity in Terms of Anti-poliovirus Types 1, 2 and 3 Antibody Titers. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Any Solicited General Adverse Events (AEs). | During the 8-day (Days 1-8) follow-up period after each HRV vaccination. | Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Unsolicited AEs. | During the 31-day (Days 1-31) follow-up period after each HRV vaccination. | Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Serious Adverse Events (SAEs). | During the entire study period (Day 1 to Month 10) | Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03207750/outcomes