Trial · NCT04382326
Outcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Within 7 days after Dose 1 | Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any electronic diary (e-diary) data reported after Dose 1. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reaction Within 7 Days After Dose 2 | Within 7 Days After Dose 2 | Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any electronic diary (e-diary) data reported after Dose 2. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Within 7 days after Dose 3 | Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any electronic diary (e-diary) data reported after Dose 3. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Within 7 days after Dose 4 | Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants with any electronic diary (e-diary) data reported after Dose 4. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Within 7 days after Dose 1 | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any e-diary data reported after Dose 1. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Within 7 days after Dose 2 | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any e-diary data reported after Dose 2. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Within 7 days after Dose 3 | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any e-diary data reported after Dose 3. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Within 7 days after Dose 4 | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. 'Number of Participants Analyzed' = number of participants with any e-diary data reported after Dose 4. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 | From Dose 1 to 1 Month after Dose 3 | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants who received Dose 1. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 | From Dose 4 to 1 month after Dose 4 | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants who received Dose 4 and had safety follow up after Dose 4. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months Following Dose 4 | From Dose 1 to 6 months following Dose 4 | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants who received Dose 1. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months Following Dose 4 | From Dose 1 to 6 months following Dose 4 | Safety population included all the participants who received at least 1 dose of the IP with safety follow up after any dose. Here, 'Number of Participants Analyzed' = number of participants who received Dose 1. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Predefined Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3 | 1 month after Dose 3 | Dose 3 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received the first 3 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days post Dose 3, and had no major protocol deviations. Number of Participants Analyzed= participants in Dose 3 evaluable immunogenicity population, Number Analyzed = number of participants with valid IgG concentrations for the specified serotype reported at 1 month after Dose 3. | percentage of participants | NUMBER |
| PRIMARY | Serotype-specific IgG Geometric Mean Concentration (GMCs) and Geometric Mean Ratios (GMRs) at 1 Month After Dose 4 | From Dose 1 to 6 months following Dose 4 | Dose 4 evaluable immunogenicity population: aged 42-98 days on Dose 1, received the first 4 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days after Dose 4, had no major protocol deviations. Number of Participants Analyzed= participants in Dose 4 evaluable immunogenicity population, Number Analyzed = number of participants with valid IgG concentrations for the specified serotype reported at 1 month after Dose 4. | microgram per milliliter (μg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants With Prespecified Antibody Levels to Specific Concomitant Vaccine Antigens 1 Month After Dose 3 | 1 month after Dose 3 | Dose 3 evaluable population: eligible participants aged 42-98 days on Dose 1, received the first 3 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days post Dose 3, had no major protocol deviations. Number of Participants Analyzed=participants in Dose 3 evaluable immunogenicity population, Number Analyzed = number of participants with valid assay results for the specified antigen at 1 month after Dose 3. | percentage of participants | NUMBER |
| SECONDARY | Serotype-specific IgG GMCs and GMRs at 1 Month After Dose 3 | 1 month after Dose 3 | Dose 3 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received the first 3 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days post Dose 3, and had no major protocol deviations. Number of Participants Analyzed= participants in Dose 3 evaluable immunogenicity population, Number Analyzed = number of participants with valid IgG concentrations for the specified serotype reported at 1 month after Dose 3. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants With Predefined IgG Concentrations 1 Month After Dose 4 | 1 month after Dose 4 | Dose 4 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received all 4 doses as randomized, had at least 1 valid immunogenicity result within 27 to 56 days after Dose 4, and had no other major protocol deviations. Number of Participants Analyzed=participants in Dose 4 evaluable immunogenicity population, Number Analyzed = number of participants with valid IgG concentrations for the specified serotype reported at 1 month after Dose 4. | percentage of participants | NUMBER |
| SECONDARY | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Dose 3 | 1 month after Dose 3 | Dose 3 evaluable immunogenicity population: aged 42-98 days on Dose 1, received the first 3 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days after Dose 3, had no protocol deviations. Number of Participants Analyzed = Dose 3 evaluable immunogenicity populations. Number Analyzed = number of participants with valid OPA titers for the specified serotype reported at 1 month after Dose 3. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Serotype-specific OPA GMTs at 1 Month After Dose 4 | 1 month after Dose 4 | Dose 4 evaluable immunogenicity population: aged 42-98 days on Dose 1, received the first 4 doses randomized, had at least 1 valid immunogenicity result 27 to 56 days after Dose 4, had no major protocol deviations. Number of Participants Analyzed = Dose 4 evaluable immunogenicity populations. Number Analyzed = number of participants with valid OPA titers for the specified serotype reported at 1 month after Dose 4. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Serotype-specific IgG Geometric Mean Fold Rise (GMFRs) From 1 Month After Dose 3 to Before Dose 4 | 1 month after Dose 3 to before Dose 4 | Dose 3 evaluable immunogenicity population: eligible participants aged 42-98 days on Dose 1, received the first 3 doses as randomized, had at least 1 valid immunogenicity result 27 to 56 days after Dose 3, and had no major protocol deviations. Number of Participants Analyzed= participants in Dose 3 evaluable immunogenicity population; Number Analyzed= number of participants with valid IgG concentrations at both timepoints for the specified serotype. | Fold rise | 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
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GET https://conductscience.org/api/trials/v1/NCT04382326/outcomes