NCT01299480|CompletedPhase 2ResultsDMC

A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years

A Phase 2, Randomized, Placebo-controlled, Single-blind Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered In Either 2- Or 3-dose Regimens In Healthy Subjects Aged Greater Than Or Equal To 11 To <19 Years

Pfizer ClinicalTrials.gov

Compare

3 other identifiers

B19710126108A1-20032009-014493-18

Study Type

interventional

Target

1,714

Locations

7 countries

Sites

Timeline

RegisteredFeb 2011

StartedMar 2011

CompletionSep 2012

Brief Summary

This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how well it is tolerated. This study will also look at this vaccine being given 2 or 3 times. This study will be done in healthy adolescents.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,714

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Mar 2011

Geographic Reach

7 countries

63 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

February 15, 2011

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed

13 days until next milestone

Study Start

First participant enrolled

March 3, 2011

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2012

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2012

Completed

2.7 years until next milestone

Results Posted

Study results publicly available

June 4, 2015

Completed

Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

February 15, 2011

Results QC Date

November 21, 2014

Last Update Submit

October 26, 2022

Conditions

Meningococcal Vaccine

Keywords

Healthy adolescents

Outcome Measures

Primary Outcomes (2)

Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation: Group 1 and 2 Participants
1 month after Injection 4
Percentage of Participants Reporting At Least 1 Adverse Event (AE)
Injection 1 up to 1 month after Injection 4

Secondary Outcomes (4)

Percentage of Participants Achieving hSBA Titer >=LLOQ: Group 3 Participants
1 month after Injection 4
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs)
Before Injection (Inj) 1, 1 Month (M) after (aft) Injection 2, 3, 4
Percentage of Participants Achieving hSBA Titer >=LLOQ
Before Injection 1, 1 Month after Injection 2, 3, 4
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Before Injection 1, 1 Month after Injection 2, 3, 4

Other Outcomes (1)

Percentage of Participants Achieving At Least 4-fold Increase in hSBA Titer
1 month after Injection 2, 3, 4

Study Arms (5)

Group 1

EXPERIMENTAL

rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3

Biological: Vaccine

Group 2

EXPERIMENTAL

rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2

Biological: Vaccine

Group 3

EXPERIMENTAL

rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3

Biological: Vaccine

Group 4

EXPERIMENTAL

rLP2086 at visits 1 and 3, saline at visits 2 and 5

Biological: Vaccine

Group 5

EXPERIMENTAL

rLP2086 at visits 3 and 5, saline at visits 1 and 2

Biological: Vaccine

Interventions

VaccineBIOLOGICAL

rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3

Also known as: Group 1

Group 1

Eligibility Criteria

Age11 Years - 18 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Evidence of a personally signed and dated informed consent document indicating that the parent/legally acceptable representative and/or subject has been informed of all pertinent aspects of the study.
Parent/legally acceptable representative and/or subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Male or female subject aged ≥11 and \<19 years at the time of enrollment.
Available for the entire study period and can be reached by telephone.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
All male and female subjects must agree to practice a form of effective contraception, such as barrier contraception (ie, condom plus spermicide, a female condom, diaphragm, cervical cap or intrauterine device), implants, injectables, combined oral contraceptives or sexual abstinence prior to entering into the study, for the duration of the vaccination period and for 28 days after the last study vaccination.For Germany: The phrase sexual abstinence is not applicable, with the understanding that all male and all female subjects of childbearing potential must practice an effective form of contraception during the study.
Negative urine pregnancy test for female subjects.

You may not qualify if:

Previous vaccination with any meningococcal serogroup B vaccine.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
A known or suspected disease of the immune system or those receiving immunosuppressive therapy.
History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
Significant neurological disorder or history of seizure (excluding simple febrile seizure).
Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
Current chronic use of systemic antibiotics.
Participation in other studies during study participation. Participation in purely observational studies is acceptable.
Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination.
Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
Subject is pregnant or breastfeeding.
Subject is a direct descendant of study site or Pfizer personnel

Contact the study team to confirm eligibility.