Trial · NCT03197376
Outcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
21 to 27 of 27
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever) | 4 weeks post booster vaccination | Evaluated in a subset who got 3 primary doses and a booster dose, had postdose immunogenicity data with no major protocol deviations. Non-inferiority shown if 2-sided 95% CI for difference in response proportions (PNEUMOSIL-Synflorix) had lower limit \>-0.10. For this, pooled PNUEMOSIL data was used as specified in SAP. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | One Year Post Booster Vaccination | In a subset of subjects who got 3 primary and a booster dose of study vaccines, had postdose immunogenicity measurement(s) one year post booster with no major protocol deviations, serotype-specific IgG responders and treatment group comparisons (with corresponding 95% CIs) were evaluated. Pooled PNEUMOSIL data was used for this analysis as per SAP | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster | One year post booster vaccination | Subset of subjects who got 3 primary and a booster dose of study vaccines, had postdose immunogenicity measurement(s) one year post booster with no major protocol deviations, serotype-specific GMC of IgG Antibody and treatment group ratios of IgG GMCs (with corresponding 95% CIs) evaluated. Pooled PNEUMOSIL data was used for this analysis | µg/mL | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose | One year post booster vaccination | Subset who got 3 primary series+booster dose of study vaccines, had postdose immunogenicity measurements post booster, no major PDs, comparisons based on ratios of IgG GMC one year post booster to IgG GMC four weeks post booster. Comparison done using ratios of the ratios for the 2 treatment groups \& corresponding 95% CIs. | µg/mL | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | One year post booster vaccination | Subset of subjects who got 3 primary doses + booster dose, had postdose immunogenicity measurement one year after booster, no major protocol deviations, functional immune responses induced by PNEUMOSIL were compared to Synflorix for 10 serotypes OPA Type 1\[OPA seroresponse rate (titer≥1:8)\] differences.Pooled PNEUMOSIL data was used. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | One year post booster vaccination | In a subset of subjects who got 3 primary + booster dose of study vaccines, had postdose immunogenicity measurement one year post booster and no major protocol deviations, functional immune responses induced by PNEUMOSIL were compared to Synflorix for 10 serotypes, i.e., ratio of OPA GMTs (and corresponding 95% CIs).Pooled PNEUMOSIL data was used. | Titer | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | One year post booster vaccination | In a subset who got 3 primary series+booster dose of study vaccines, had postdose immunogenicity measurements \& no major PDs, comparisons based on ratios of OPA GMT one year post booster to OPA GMT 4 weeks post booster. Comparison done using ratios of the ratios for the 2 treatment groups (PNEUMOSIL ratio/Synflorix ratio), \& corresponding 95% CIs. | Titer | GEOMETRIC_MEAN |
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.
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GET https://conductscience.org/api/trials/v1/NCT03197376/outcomes?page=2