Trial · NCT02692859
A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine
NCT02692859, Phase 3, Completed, Jiangsu Province Centers for Disease Control and Prevention; results first posted 2017-08-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine. Trials, record NCT02692859. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02692859
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine
- NCT number
- NCT02692859
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,992 participants, actual
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Conditions
- Haemophilus Influenza
- Interventions
- Hib conjugate vaccine
- First posted
- 2016-02-26
- Last updated
- 2017-09-20
- Results first posted
- 2017-08-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Solicited Adverse Reactions | 0-7 days after each dose | Number of Participants with Solicited Adverse Reactions |
| Primary | Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥1.0μg/ml | 28 days after full course of vaccination | |
| Secondary | Incidence of Unsolicited Adverse Reactions | 0-28 days after each dose | |
| Secondary | Incidence of Serious Adverse Event (SAE) During the Whole Study Period | 0-84 days for children aged 3-5 months, 0-56 days for children aged 6-11 months and 0-28 days for children aged 1-5 y | |
| Secondary | Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥0.15μg/ml | 28 days after full course of vaccination | |
| Secondary | the Anti-PRP Geometric Mean Concentrations (GMCs) | 28 days after full course of vaccination | |
| Secondary | the Anti-PRP Geometric Mean Fold Increase (GMFI) | 28 days after full course of vaccination |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Solicited Adverse Reactions | 0-7 days after each dose | A total of participants in aged 3-5 months,6-11months and 1-5years | Count of Participants | NUMBER |
| PRIMARY | Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥1.0μg/ml | 28 days after full course of vaccination | |||
| SECONDARY | Incidence of Unsolicited Adverse Reactions | 0-28 days after each dose | |||
| SECONDARY | Incidence of Serious Adverse Event (SAE) During the Whole Study Period | 0-84 days for children aged 3-5 months, 0-56 days for children aged 6-11 months and 0-28 days for children aged 1-5 y | |||
| SECONDARY | Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥0.15μg/ml | 28 days after full course of vaccination | |||
| SECONDARY | the Anti-PRP Geometric Mean Concentrations (GMCs) | 28 days after full course of vaccination | |||
| SECONDARY | the Anti-PRP Geometric Mean Fold Increase (GMFI) | 28 days after full course of vaccination |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Solicited Adverse Reactions | Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | 507 | Count of Participants | ||
| Number of Participants With Solicited Adverse Reactions | Vaccine (Walvax Biotechnology Co., LTD.) | 480 | Count of Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | 996 | |
| Overall Study | STARTED | Vaccine (Walvax Biotechnology Co., LTD.) | 996 | |
| Overall Study | COMPLETED | Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | 912 | |
| Overall Study | COMPLETED | Vaccine (Walvax Biotechnology Co., LTD.) | 901 | |
| Overall Study | NOT COMPLETED | Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | 84 | |
| Overall Study | NOT COMPLETED | Vaccine (Walvax Biotechnology Co., LTD.) | 95 |
Source ClinicalTrials.gov
Adverse events10
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 |
|---|---|---|---|---|---|---|
| serious | bronchopneumonia | Infections and infestations | Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | 6 | 996 | 6 |
| serious | bronchopneumonia | Infections and infestations | Vaccine (Walvax Biotechnology Co., LTD.) | 12 | 996 | 12 |
| serious | upper respiratory tract infection | Infections and infestations | Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | 1 | 996 | 1 |
| serious | upper respiratory tract infection | Infections and infestations | Vaccine (Walvax Biotechnology Co., LTD.) | 0 | 996 | 0 |
| serious | hand-foot-and-mouth disease | Gastrointestinal disorders | Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | 1 | 996 | 1 |
| serious | hand-foot-and-mouth disease | Gastrointestinal disorders | Vaccine (Walvax Biotechnology Co., LTD.) | 1 | 996 | 1 |
| serious | pneumonia | Infections and infestations | Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | 1 | 996 | 1 |
| serious | pneumonia | Infections and infestations | Vaccine (Walvax Biotechnology Co., LTD.) | 1 | 996 | 1 |
| serious | viral enteritis | Gastrointestinal disorders | Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | 1 | 996 | 1 |
| serious | viral enteritis | Gastrointestinal disorders | Vaccine (Walvax Biotechnology Co., LTD.) | 1 | 996 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | ||
| Total, all-cause mortality | Vaccine (Walvax Biotechnology Co., LTD.) | ||
| Total, other adverse events | Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | 0 | 996 |
| Total, other adverse events | Vaccine (Walvax Biotechnology Co., LTD.) | 0 | 996 |
| Total, serious adverse events | Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) | 10 | 996 |
| Total, serious adverse events | Vaccine (Walvax Biotechnology Co., LTD.) | 15 | 996 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.) vs Vaccine (Walvax Biotechnology Co., LTD.): serious adverse events |
Source 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/NCT02692859
GET https://conductscience.org/api/trials/v1/NCT02692859/registered