Trial · NCT03207750
This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine
NCT03207750, Phase 3, Completed, GlaxoSmithKline; results first posted 2019-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine. Trials, record NCT03207750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03207750
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine
- NCT number
- NCT03207750
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,280 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Rotavirus Infection, Rotavirus Vaccines
- Interventions
- Rotarix, Pediarix, Hiberix, Prevenar 13
- First posted
- 2017-07-05
- Last updated
- 2020-12-29
- Other registries' IDs
- eudract:2016-003210-27
- Results first posted
- 2019-10-31
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | Immunogenicity was assessed using Enzyme Linked Immunosorbent Assay (ELISA) in terms of seroprotection rates against diphtheria toxoid. A seroprotected subject is a subject whose antibody concentration is greater than or equal to (≥) the level defining clinical protection. The following seroprotection thresholds were applicable:anti-D antibody concentrations ≥ 0.1 International Units/milliliter (IU/mL), anti-T antibody concentrations ≥ 0.1 IU/mL. |
| 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) | Immunogenicity was assessed using ChemiLuminescence ImmunoAssay (CLIA) in terms of seroprotection rates against Hepatitis B. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-HB antibody concentrations ≥ 10 milli International Units/milliliter (mIU/mL). |
| 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) | Immunogenicity was assessed using virus micro-neutralization test in terms of seroprotection rates against polio virus types 1, 2 and 3. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-polio virus types 1, 2 and 3 types antibody titers ≥ 8 Estimated Dose 50% (ED50). |
| 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) | Antibody concentrations against PT, FHA and PRN were determined and expressed as Geometric Mean Concentrations (GMCs).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. |
| Primary | Immunogenicity in Terms of Anti-pneumococcal Serotypes (Anti-PnPS) Antibody Concentrations. | At Month 5 (One month after Dose 3 of co-administered vaccines) | Antibody concentrations against pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were determined and expressed as GMCs in micrograms per milliliter (µg/mL).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. |
| 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) | Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 0.15 µg/mL. |
| 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) | Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 1.0 µg/mL. |
| 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) | Seroresponse is defined as the percentage of subjects showing an antibody concentration above a threshold that leads to 95% seroresponse in the HRV lyophilized Group. The cut-offs used were as follows: anti-PT (18.566 IU/mL), anti-FHA (35.711 IU/mL) and anti-PRN (11.034 IU/mL). |
| 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) | Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 20 U/mL. |
| 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) | Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 90 U/mL. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group144
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value. | HRV Porcine Circovirus (PCV)-Free Liquid Group | Anti-D | 478 | Participants | |
| Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value. | HRV Lyophilized Group | Anti-D | 486 | Participants | |
| Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value. | HRV Porcine Circovirus (PCV)-Free Liquid Group | Anti-T | 486 | Participants | |
| Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value. | HRV Lyophilized Group | Anti-T | 495 | Participants | |
| Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value. | HRV Porcine Circovirus (PCV)-Free Liquid Group | 457 | Participants | ||
| Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value. | HRV Lyophilized Group | 471 | Participants | ||
| Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value. | HRV Porcine Circovirus (PCV)-Free Liquid Group | Anti-Polio 1 | 477 | Participants | |
| Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value. | HRV Lyophilized Group | Anti-Polio 1 | 486 | Participants | |
| Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value. | HRV Porcine Circovirus (PCV)-Free Liquid Group | Anti-Polio 2 | 463 | Participants | |
| Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value. | HRV Lyophilized Group | Anti-Polio 2 | 478 | Participants |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HRV Porcine Circovirus (PCV)-Free Liquid Group | 632 | |
| Overall Study | STARTED | HRV Lyophilized Group | 640 | |
| Overall Study | COMPLETED | HRV Porcine Circovirus (PCV)-Free Liquid Group | 574 | |
| Overall Study | COMPLETED | HRV Lyophilized Group | 574 | |
| Overall Study | NOT COMPLETED | HRV Porcine Circovirus (PCV)-Free Liquid Group | 58 | |
| Overall Study | NOT COMPLETED | HRV Lyophilized Group | 66 |
Source ClinicalTrials.gov
Adverse events500
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 | Anaemia | Blood and lymphatic system disorders | HRV Porcine Circovirus (PCV)-Free Liquid Group | 1 | 632 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | HRV Lyophilized Group | 0 | 640 | 0 |
| other | Ankyloglossia congenital | Congenital, familial and genetic disorders | HRV Porcine Circovirus (PCV)-Free Liquid Group | 1 | 632 | 1 |
| other | Ankyloglossia congenital | Congenital, familial and genetic disorders | HRV Lyophilized Group | 0 | 640 | 0 |
| other | Atrial septal defect | Congenital, familial and genetic disorders | HRV Porcine Circovirus (PCV)-Free Liquid Group | 1 | 632 | 1 |
| other | Atrial septal defect | Congenital, familial and genetic disorders | HRV Lyophilized Group | 0 | 640 | 0 |
| other | Birth mark | Congenital, familial and genetic disorders | HRV Porcine Circovirus (PCV)-Free Liquid Group | 0 | 632 | 0 |
| other | Birth mark | Congenital, familial and genetic disorders | HRV Lyophilized Group | 1 | 640 | 1 |
| other | Congenital musculoskeletal anomaly | Congenital, familial and genetic disorders | HRV Porcine Circovirus (PCV)-Free Liquid Group | 0 | 632 | 0 |
| other | Congenital musculoskeletal anomaly | Congenital, familial and genetic disorders | HRV Lyophilized Group | 1 | 640 | 1 |
1 to 10 of 500Source ClinicalTrials.gov
See all 500 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HRV Porcine Circovirus (PCV)-Free Liquid Group | 1 | 632 |
| Total, all-cause mortality | HRV Lyophilized Group | 0 | 640 |
| Total, other adverse events | HRV Porcine Circovirus (PCV)-Free Liquid Group | 571 | 632 |
| Total, other adverse events | HRV Lyophilized Group | 589 | 640 |
| Total, serious adverse events | HRV Porcine Circovirus (PCV)-Free Liquid Group | 20 | 632 |
| Total, serious adverse events | HRV Lyophilized Group | 19 | 640 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: Number of Subjects With Any Serious Adverse Events (SAEs). | Trial comparisons |
HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: 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). | Trial comparisons |
| HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value. | Trial comparisons |
| HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: Number of Seropositive Subjects With Anti-RV IgA Antibody Concentrations Above or Equal to Cut-off Value of 90 U/mL. | Trial comparisons |
HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: 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. | Trial comparisons |
| HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: deaths from any cause | Trial comparisons |
| HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: Number of Subjects With Any Unsolicited AEs. | Trial comparisons |
HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: 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. | Trial comparisons |
| HRV Porcine Circovirus (PCV)-Free Liquid Group vs HRV Lyophilized Group: 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.
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GET https://conductscience.org/api/trials/v1/NCT03207750/results?page=2