Trial · NCT01352793
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
NCT01352793, Phase 3, Completed, Pfizer; results first posted 2015-03-11
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years. Trials, record NCT01352793. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01352793
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
- NCT number
- NCT01352793
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,715 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Meningitis, Meningococcal
- Interventions
- rLP2086 vaccine, control
- First posted
- 2011-05-12
- Last updated
- 2015-03-11
- Other registries' IDs
- eudract:2009-015198-11
- Results first posted
- 2015-03-11
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study | Vaccination 1 up to 6 months after Vaccination 3 | An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. |
| Primary | Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1 | Within 30 days after Vaccination 1 | A medically attended AE was defined as a non-serious AE that required medical attention. |
| Primary | Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2 | Within 30 days after Vaccination 2 | A medically attended AE was defined as a non-serious AE that required medical attention. |
| Primary | Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3 | Within 30 days after Vaccination 3 | A medically attended AE was defined as a non-serious AE that required medical attention. |
| Secondary | Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3) | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. |
| Secondary | Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods | Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3) | A medically attended AE was defined as a non-serious AE that required medical attention. |
| Secondary | Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3) | A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. |
| Secondary | Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3) | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. |
| Secondary | Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination | Within 30 minutes after Vaccination 1, 2, 3 | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period. |
| Secondary | Number of Days Participant Missed School or Work Due to Adverse Events (AEs) | Vaccination 1 up to 1 month after Vaccination 3 |
Source ClinicalTrials.gov
Outcomes10
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 at Least One Serious Adverse Event (SAE) Throughout the Study | Vaccination 1 up to 6 months after Vaccination 3 | Safety population included all participants who received at least 1 dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1 | Within 30 days after Vaccination 1 | Vaccination 1 safety population included all participants who received the first dose of study vaccine (bivalent rLP2086 or HAV vaccine) and had safety information available from Vaccination 1 until prior to Vaccination 2. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2 | Within 30 days after Vaccination 2 | Vaccination 2 safety population included all participants who received the second dose of study vaccine (bivalent rLP2086 or saline) and had safety information available from Vaccination 2 until prior to Vaccination 3. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3 | Within 30 days after Vaccination 3 | Vaccination 3 safety population included all participants who received the third dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available from Vaccination 3 to post Vaccination 3 follow-up visit (1 month after Vaccination 3). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3) | Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods | Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3) | Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3) | Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods | Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3) | Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination | Within 30 minutes after Vaccination 1, 2, 3 | Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available. | percentage of participants | NUMBER |
| SECONDARY | Number of Days Participant Missed School or Work Due to Adverse Events (AEs) | Vaccination 1 up to 1 month after Vaccination 3 | Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group60
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 at Least One Serious Adverse Event (SAE) Throughout the Study | Group 1: rLP2086 | 1.55 | 95% Confidence Interval 1.2 to 2.0 | percentage of participants | |
| Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study | Group 2: HAV/Saline/HAV | 2.52 | 95% Confidence Interval 1.9 to 3.3 | percentage of participants | |
| Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1 | Group 1: rLP2086 | 7.03 | 95% Confidence Interval 6.2 to 7.9 | percentage of participants | |
| Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1 | Group 2: HAV/Saline/HAV | 6.13 | 95% Confidence Interval 5.1 to 7.3 | percentage of participants | |
| Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2 | Group 1: rLP2086 | 5.50 | 95% Confidence Interval 4.8 to 6.3 | percentage of participants | |
| Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2 | Group 2: HAV/Saline/HAV | 6.09 | 95% Confidence Interval 5.0 to 7.3 | percentage of participants | |
| Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3 | Group 1: rLP2086 | 5.34 | 95% Confidence Interval 4.6 to 6.2 | percentage of participants | |
| Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3 | Group 2: HAV/Saline/HAV | 5.50 | 95% Confidence Interval 4.50 to 6.7 | percentage of participants | |
| Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods | Group 1: rLP2086 | 30 days after Vaccination 1 (N=3796, 1908) | 0.18 | 95% Confidence Interval 0.1 to 0.4 | percentage of participants |
| Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods | Group 2: HAV/Saline/HAV | 30 days after Vaccination 1 (N=3796, 1908) | 0.42 | 95% Confidence Interval 0.2 to 0.8 | percentage of participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: rLP2086 | 3,804 | |
| Overall Study | STARTED | Group 2: HAV/Saline/HAV | 1,908 | |
| Overall Study | Vaccination 1 | Group 1: rLP2086 | 3,796 | |
| Overall Study | Vaccination 1 | Group 2: HAV/Saline/HAV | 1,908 | |
| Overall Study | Vaccination 2 | Group 1: rLP2086 | 3,530 | |
| Overall Study | Vaccination 2 | Group 2: HAV/Saline/HAV | 1,806 | |
| Overall Study | Vaccination 3 | Group 1: rLP2086 | 3,314 | |
| Overall Study | Vaccination 3 | Group 2: HAV/Saline/HAV | 1,710 | |
| Overall Study | COMPLETED | Group 1: rLP2086 | 3,219 | |
| Overall Study | COMPLETED | Group 2: HAV/Saline/HAV | 1,663 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events224
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 | Nausea | Gastrointestinal disorders | Group 1: rLP2086 | 89 | 3,796 | |
| other | Nausea | Gastrointestinal disorders | Group 2: HAV/Saline/HAV | 33 | 1,908 | |
| other | Vomiting | Gastrointestinal disorders | Group 1: rLP2086 | 60 | 3,796 | |
| other | Vomiting | Gastrointestinal disorders | Group 2: HAV/Saline/HAV | 27 | 1,908 | |
| other | Abdominal pain | Gastrointestinal disorders | Group 1: rLP2086 | 47 | 3,796 | |
| other | Abdominal pain | Gastrointestinal disorders | Group 2: HAV/Saline/HAV | 32 | 1,908 | |
| other | Diarrhoea | Gastrointestinal disorders | Group 1: rLP2086 | 42 | 3,796 | |
| other | Diarrhoea | Gastrointestinal disorders | Group 2: HAV/Saline/HAV | 17 | 1,908 | |
| other | Injection site pain | General disorders | Group 1: rLP2086 | 722 | 3,796 | |
| other | Injection site pain | General disorders | Group 2: HAV/Saline/HAV | 149 | 1,908 |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 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: HAV/Saline/HAV | ||
| Total, other adverse events | Group 1: rLP2086 | 1,671 | 3,796 |
| Total, other adverse events | Group 2: HAV/Saline/HAV | 640 | 1,908 |
| Total, serious adverse events | Group 1: rLP2086 | 59 | 3,796 |
| Total, serious adverse events | Group 2: HAV/Saline/HAV | 48 | 1,908 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35164991 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Group 1: rLP2086 vs Group 2: HAV/Saline/HAV: 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT01352793
GET https://conductscience.org/api/trials/v1/NCT01352793/results?page=2