Trial · NCT01352845
A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.
NCT01352845, Phase 3, Completed, Pfizer; results first posted 2016-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years. Trials, record NCT01352845. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01352845
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.
- NCT number
- NCT01352845
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,301 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Healthy
- Interventions
- rLP2086, Placebo
- First posted
- 2011-05-12
- Last updated
- 2016-02-23
- Other registries' IDs
- eudract:2009-014492-46
- Results first posted
- 2016-02-23
Source ClinicalTrials.gov
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1 | One month after third bivalent rLP2086 vaccination | Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only. |
| Primary | Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination | Within 7 days after first vaccination | |
| Primary | Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination | Within 7 days after second vaccination | |
| Primary | Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination | Within 7 days after third vaccination | |
| Primary | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Within 7 days after first vaccination | |
| Primary | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Within 7 days after second vaccination | |
| Primary | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Within 7 days after third vaccination | |
| Primary | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination | Within 30 days after first vaccination | |
| Primary | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination | Within 30 days after second vaccination | |
| Primary | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination | Within 30 days after third vaccination |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 registered outcomesOutcomes47
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1 | One month after third bivalent rLP2086 vaccination | Evaluable immunogenicity population: all eligible participants randomized, who received correct investigational product, had pre/post vaccination blood drawn at pre-specified time points, had valid and determinate assay results for proposed analysis, received no prohibited treatment or prohibited vaccines, and had no major protocol violations. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination | Within 7 days after first vaccination | Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination | Within 7 days after second vaccination | Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination | Within 7 days after third vaccination | Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination | Within 7 days after first vaccination | Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination. Here, 'N' signifies participants with known values reporting specific characteristic. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination | Within 7 days after second vaccination | Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination. Here, 'N' signifies participants with known values reporting specific characteristic. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination | Within 7 days after third vaccination | Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw. Here, 'N' signifies participants with known values reporting specific characteristic. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination | Within 30 days after first vaccination | Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination | Within 30 days after second vaccination | Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination | Within 30 days after third vaccination | Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw. | Percentage of participants | NUMBER |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 outcomesResults by group595
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1 | Group 1 rLP2086 | Composite hSBA response (N=1664) | 84.9 | 95% Confidence Interval 83.1 to 86.6 | Percentage of participants |
Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1 | Group 1 rLP2086 | PMB80 [A22] (N=1695) | 80.5 | 95% Confidence Interval 78.6 to 82.4 | Percentage of participants |
Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1 | Group 1 rLP2086 | PMB2001 [A56] (N=1642) | 90.0 | 95% Confidence Interval 88.4 to 91.4 | Percentage of participants |
Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1 | Group 1 rLP2086 | PMB2948 [B24] (N=1675) | 79.3 | 95% Confidence Interval 77.3 to 81.2 | Percentage of participants |
Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1 | Group 1 rLP2086 | PMB2707 [B44] (N=1696) | 79.6 | 95% Confidence Interval 77.6 to 81.5 | Percentage of participants |
| Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination | Group 1 rLP2086 | Pain at injection site: Any | 84.2 | 95% Confidence Interval 82.7 to 85.6 | Percentage of participants |
| Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination | Group 2 Saline | Pain at injection site: Any | 11.8 | 95% Confidence Interval 9.6 to 14.2 | Percentage of participants |
| Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination | Group 1 rLP2086 | Pain at injection site: Mild | 42.3 | 95% Confidence Interval 40.3 to 44.3 | Percentage of participants |
| Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination | Group 2 Saline | Pain at injection site: Mild | 10.7 | 95% Confidence Interval 8.6 to 13.0 | Percentage of participants |
| Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination | Group 1 rLP2086 | Pain at injection site: Moderate | 37.1 | 95% Confidence Interval 35.1 to 39.0 | Percentage of participants |
1 to 10 of 595Source ClinicalTrials.gov
See all 595 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 rLP2086 | 2,471 | |
| Overall Study | STARTED | Group 2 Saline | 822 | |
| Overall Study | COMPLETED | Group 1 rLP2086 | 1,800 | |
| Overall Study | COMPLETED | Group 2 Saline | 619 | |
| Overall Study | NOT COMPLETED | Group 1 rLP2086 | 671 | |
| Overall Study | NOT COMPLETED | Group 2 Saline | 203 |
Source ClinicalTrials.gov
Adverse events114
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 | Injection site pain | General disorders | Group 1 rLP2086 | 46 | 2,471 | |
| other | Injection site pain | General disorders | Group 2 Saline | 6 | 822 | |
| other | Fatigue | General disorders | Group 1 rLP2086 | 12 | 2,471 | |
| other | Fatigue | General disorders | Group 2 Saline | 10 | 822 | |
| other | Upper respiratory tract infection | Infections and infestations | Group 1 rLP2086 | 98 | 2,471 | |
| other | Upper respiratory tract infection | Infections and infestations | Group 2 Saline | 29 | 822 | |
| other | Nasopharyngitis | Infections and infestations | Group 1 rLP2086 | 77 | 2,471 | |
| other | Nasopharyngitis | Infections and infestations | Group 2 Saline | 33 | 822 | |
| other | Urinary tract infection | Infections and infestations | Group 1 rLP2086 | 45 | 2,471 | |
| other | Urinary tract infection | Infections and infestations | Group 2 Saline | 10 | 822 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 rLP2086 | ||
| Total, all-cause mortality | Group 2 Saline | ||
| Total, other adverse events | Group 1 rLP2086 | 2,193 | 2,471 |
| Total, other adverse events | Group 2 Saline | 567 | 822 |
| Total, serious adverse events | Group 1 rLP2086 | 33 | 2,471 |
| Total, serious adverse events | Group 2 Saline | 11 | 822 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
| Group 1 rLP2086 vs Group 2 Saline: 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/NCT01352845
GET https://conductscience.org/api/trials/v1/NCT01352845/registered?page=2