Trial · NCT03197376
Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants
NCT03197376, Phase 3, Completed, PATH; results first posted 2019-09-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants. Trials, record NCT03197376. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03197376
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants
- NCT number
- NCT03197376
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,250 participants, actual
- Lead sponsor
- PATH
- Conditions
- Pneumonia, Pneumococcal
- Interventions
- Pneumosil, Synflorix
- First posted
- 2017-06-23
- Last updated
- 2020-07-14
- Results first posted
- 2019-09-11
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 \[life threatening\]. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Serotype-specific Geometric Mean Concentration of IgG Antibody | 4 weeks after the third dose | All subjects who received all primary series doses of study vaccines, had post-dose immunogenicity measurement(s) with no major protocol deviations | µg/mL | GEOMETRIC_MEAN |
| PRIMARY | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | 4 weeks after the third dose | Non-inferiority for each serotype is based on 2 non-inferiority criteria evaluation: for each serotype, non-inferiority was shown if a two-sided 97.5% CI for the absolute difference in proportions responding (PNEUMOSIL-Synflorix) had a lower limit \>-0.10, or if a two-sided 97.5% CI for the IgG GMC ratio (PNEUMOSIL/Synflorix) had a lower limit \>0.5. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Serotype-specific Geometric Mean Concentration of IgG Antibody | 4 weeks after the third dose | Non-inferiority for each serotype is based on 2 non-inferiority criteria evaluation: for each serotype, non-inferiority was shown if a two-sided 97.5% CI for the absolute difference in proportions responding (PNEUMOSIL-Synflorix) had a lower limit \>-0.10, or if a two-sided 97.5% CI for the IgG GMC ratio (PNEUMOSIL/Synflorix) had a lower limit \>0.5. | µg/mL | GEOMETRIC_MEAN |
| 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 | Evaluated in a subset who got 3 primary doses, had postdose immunogenicity data with no major protocol deviations.For each Ag in the pentavalent, RV, OPV vaccines, 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 |
| PRIMARY | Anti-pertussis Toxoid GMCs for the Pertussis Antigen | 4 weeks after the third dose | Evaluated in a subset who got 3 primary doses, had postdose immunogenicity data with no major protocol deviations.Non-inferiority was defined as 2-sided 95% CI for the GMC ratio (PNEUMOSIL/Synflorix) with lower limit\>0.5 for each of 2 separate antigens (pertussis toxoid and fimbriae).For this analysis, pooled PNUEMOSIL data used as specified in SAP | IU/mL | GEOMETRIC_MEAN |
| PRIMARY | Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen | 4 weeks after the third dose | Evaluated in a subset of subjects who received all primary series doses, had postdose immunogenicity results with no major protocol deviations. Non-inferiority was defined as a two-sided 95% CI for the GMC ratio (PNEUMOSIL/Synflorix) with lower limit \> 0.5 for each of 2 separate antigens (pertussis toxoid and fimbriae). | U/mL | GEOMETRIC_MEAN |
| PRIMARY | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | 7 days (including day of vaccination) | Sample size for evaluation of solicited local and systemic AEs was approx. 1,125. Evaluated in a subset of subjects who got a study vaccine and had some post-vaccination safety data. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | 7 days (including day of vaccination) | Sample size for evaluation of solicited local and systemic AEs was approx. 1,125. Evaluated in a subset of subjects who got a study vaccine and had some post-vaccination safety data. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | 7 days (including day of vaccination) | Sample size for evaluation of solicited local and systemic AEs was approx. 1,125. Evaluated in a subset of subjects who got a study vaccine and had some post-vaccination safety data. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | 7 days (including day of vaccination) | Reported in a subset of subjects who got 3 doses and booster dose of the study vaccine and had post-vaccination safety data.Treatment groups (PNUEMOSIL or Synflorix) were based on actual treatment received at Visit 1. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used (specified in SAP) | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group1,156
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Serotype-specific Geometric Mean Concentration of IgG Antibody | Lot 1 | Pn IgG Type 1 | 4.08 | 95% Confidence Interval 3.84 to 4.33 | µg/mL |
| Serotype-specific Geometric Mean Concentration of IgG Antibody | Lot 2 | Pn IgG Type 1 | 4.24 | 95% Confidence Interval 3.97 to 4.52 | µg/mL |
| Serotype-specific Geometric Mean Concentration of IgG Antibody | Lot 3 | Pn IgG Type 1 | 4.58 | 95% Confidence Interval 4.30 to 4.87 | µg/mL |
| Serotype-specific Geometric Mean Concentration of IgG Antibody | Lot 1 | Pn IgG Type 5 | 1.34 | 95% Confidence Interval 1.27 to 1.43 | µg/mL |
| Serotype-specific Geometric Mean Concentration of IgG Antibody | Lot 2 | Pn IgG Type 5 | 1.80 | 95% Confidence Interval 1.70 to 1.91 | µg/mL |
| Serotype-specific Geometric Mean Concentration of IgG Antibody | Lot 3 | Pn IgG Type 5 | 1.84 | 95% Confidence Interval 1.73 to 1.96 | µg/mL |
| Serotype-specific Geometric Mean Concentration of IgG Antibody | Lot 1 | Pn IgG Type 6A | 1.05 | 95% Confidence Interval 0.95 to 1.15 | µg/mL |
| Serotype-specific Geometric Mean Concentration of IgG Antibody | Lot 2 | Pn IgG Type 6A | 0.95 | 95% Confidence Interval 0.86 to 1.06 | µg/mL |
| Serotype-specific Geometric Mean Concentration of IgG Antibody | Lot 3 | Pn IgG Type 6A | 1.01 | 95% Confidence Interval 0.91 to 1.11 | µg/mL |
| Serotype-specific Geometric Mean Concentration of IgG Antibody | Lot 1 | Pn IgG Type 6B | 1.30 | 95% Confidence Interval 1.15 to 1.47 | µg/mL |
1 to 10 of 1,156Source ClinicalTrials.gov
See all 1,156 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Primary and Booster Phase | STARTED | Pneumosil Lot 1 | 502 | |
| Primary and Booster Phase | STARTED | Pneumosil Lot 2 | 501 | |
| Primary and Booster Phase | STARTED | Pneumosil Lot 3 | 500 | |
| Primary and Booster Phase | STARTED | Synflorix | 747 | |
| Primary and Booster Phase | Vaccinated-Dose 1 | Pneumosil Lot 1 | 502 | |
| Primary and Booster Phase | Vaccinated-Dose 1 | Pneumosil Lot 2 | 501 | |
| Primary and Booster Phase | Vaccinated-Dose 1 | Pneumosil Lot 3 | 500 | |
| Primary and Booster Phase | Vaccinated-Dose 1 | Synflorix | 747 | |
| Primary and Booster Phase | Vaccinated-Dose 2 | Pneumosil Lot 1 | 495 | |
| Primary and Booster Phase | Vaccinated-Dose 2 | Pneumosil Lot 2 | 495 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events104
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Pneumosil | 730 | 1,503 | 1,041 |
| other | Upper respiratory tract infection | Infections and infestations | Synflorix | 379 | 747 | 552 |
| other | Furuncle | Infections and infestations | Pneumosil | 150 | 1,503 | 183 |
| other | Furuncle | Infections and infestations | Synflorix | 65 | 747 | 77 |
| other | Gastroenteritis | Infections and infestations | Pneumosil | 154 | 1,503 | 169 |
| other | Gastroenteritis | Infections and infestations | Synflorix | 76 | 747 | 80 |
| other | Conjunctivitis | Infections and infestations | Pneumosil | 110 | 1,503 | 116 |
| other | Conjunctivitis | Infections and infestations | Synflorix | 64 | 747 | 67 |
| other | Bronchiolitis | Infections and infestations | Pneumosil | 59 | 1,503 | 65 |
| other | Bronchiolitis | Infections and infestations | Synflorix | 42 | 747 | 47 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pneumosil | 1 | 1,503 |
| Total, all-cause mortality | Synflorix | 2 | 747 |
| Total, other adverse events | Pneumosil | 1,131 | 1,503 |
| Total, other adverse events | Synflorix | 572 | 747 |
| Total, serious adverse events | Pneumosil | 51 | 1,503 |
| Total, serious adverse events | Synflorix | 26 | 747 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33516293 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pneumosil vs Synflorix: deaths from any cause | Trial comparisons |
| Pneumosil vs Synflorix: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03197376
GET https://conductscience.org/api/trials/v1/NCT03197376/registered?page=2