Trial · NCT03197376
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serotype-specific Geometric Mean Concentration of IgG Antibody | 4 weeks after the third dose | Serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA |
| Primary | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | 4 weeks after the third dose | Number and Percentage of subjects with serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL |
| Primary | Serotype-specific Geometric Mean Concentration of IgG Antibody | 4 weeks after the third dose | Serotype-specific immunoglobulin G (IgG) geometric mean concentration (GMC) 4 weeks after the primary series of PNEUMOSIL/Synflorix co-administered with pentavalent, RV and polio vaccines. |
| Primary | Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus) | 4 weeks after the third dose | Subjects with 1) anti-diphtheria toxoid (DT) and anti-tetanus toxoid (DT) IgG concentration ≥ 0.1 IU/mL; 2) anti-Hepatitis B surface antigen (HBsAg) IgG concentration ≥ 10 mIU/mL; 3) anti-Hib (polyribosylribitol phosphate \[PRP\]) IgG concentration ≥ 0.15 µg/mL; 4) anti-poliovirus types 1, 2 and 3 neutralizing antibody titers ≥ 1:8; 5) anti-rotavirus IgA concentration ≥ 20 U/mL. |
| Primary | Anti-pertussis Toxoid GMCs for the Pertussis Antigen | 4 weeks after the third dose | Anti-pertussis toxoid GMCs for the pertussis antigen |
| Primary | Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen | 4 weeks after the third dose | Anti fimbriae 2/3 IgG GMCs for the pertussis antigen |
| Primary | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | 7 days (including day of vaccination) | In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\]. |
| Primary | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | 7 days (including day of vaccination) | In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\]. |
| Primary | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | 7 days (including day of vaccination) | In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\]. |
| Primary | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | 7 days (including day of vaccination) | In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\]. |
| Primary | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | 4 weeks post last vaccination | All subjects were followed up for AEs till 4 weeks post vaccination dose 3 and subjects in the booster cohort were followed up for AEs till 4 weeks post booster vaccination |
| Primary | Number and Percentage of All SAEs by Severity and Relatedness | 4 weeks post last vaccination | All subjects were followed up for SAEs till 4 weeks post vaccination dose 3 and subjects in the booster cohort were followed up for SAEs till 4 weeks post booster vaccination |
| Secondary | Number and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody | 4 weeks after the third dose | Subjects with 6A and 19A serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA |
| Secondary | 6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody | 4 weeks after the third dose | 6A and 19A Serotype Specific Immune Responses in terms of IgG GMCs measured by ELISA |
| Secondary | Number and Percentage of Subjects With Functional Antibody Responses | 4 weeks after the third dose | Serotype-specific functional antibody titer measured by OPA |
| Secondary | Serotype-specific OPA Geometric Mean Titer | 4 weeks after the third dose | Serotype-specific functional antibody titer measured by OPA and expressed as OPA GMT in a subset |
| Secondary | Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | 4 weeks post booster vaccination | Comparison of Serotype-specific booster responses (antibody concentrations) measured by ELISA from 4 weeks after a 3-dose primary series to 4 weeks after a booster dose |
| Secondary | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose | 4 weeks post booster vaccination | Comparison of Serotype-specific booster responses (antibody concentrations) to PNEUMOSIL in comparison to Synflorix 4 weeks after a booster dose |
| Secondary | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | 4 weeks post booster vaccination | Comparison of Serotype-specific booster responses (functional response-OPA) from 4 weeks after a 3-dose primary series to 4 weeks after a booster dose |
| Secondary | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | 4 weeks post booster vaccination | Comparison of Serotype-specific booster responses (functional response) to PNEUMOSIL in comparison to Synflorix 4 weeks after a booster dose |
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/NCT03197376/registered