HealthyPhase 2NCT00387725

Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents

A Phase 2 study testing rLP2086 in people with Healthy, run by Pfizer at 9 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents Read more about this study

Who is it for?: Ages 8 to 14 years
Conditions the study is for: Healthy
What is being tested?: rLP2086
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 127 participants
Where: 9 sitesAustralia
Study dates: Nov 2006to Feb 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

Aged 8 to 14 years at the time of enrollment.
Healthy male or female subjects
Negative urine pregnancy test for female subjects

Who cannot join

Prior vaccination with a meningococcal B vaccine
Prior meningococcal disease

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Australia9 sites

Royal Children's Hospital
Herston, Queensland, 4006
Sir Albert Sakzewski Virus Research Centre (SASVRC)
Herston, QLD 4006
Women's & Children's Hospital
North Adelaide, SA 5006
Sydney Children's Hospital
Randwick, New South Wales, 2031
Princess Margaret Hospital for Children
Subiaco, Western Australia, 6008
The Telethon Institute for Child Health Research
Subiaco, WA 6008
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
National Centre for Immunisation
Westmead, NSW 2145
Department of Paediatrics and Child Health
Woden, ACT 2606

Other trials in Australia

About this study

Official title: A Randomized, Observer-blinded, Parallel-group, Active-control, Phase ½ Trial Of The Safety, Immunogenicity, And Tolerability Of 20 Mg, 60 Mg, And 200 Mg Of Meningococcal Group B Rlp2086 Vaccine In Healthy Children And Adolescents Aged 8 To 14 Years

Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents

Conditions: Healthy
Being tested: rLP2086
Keywords: Adolescent, Meningococcal, Safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rLP2086Biological
Vaccine administered at 0, 1, and 6 months
rLP2086Biological
Vaccine administered at 0, 1, and 6 months
rLP2086Biological
Vaccine administered at 0, 1, and 6 months
rLP2086Biological
Vaccine administered at 0, 1, and 6 months

Study groups in NCT00387725
Study group	Role	What they receive
Group A	Experimental	20ug Experimental Receives: Biological: rLP2086
Group 2	Experimental	60ug Experimental Receives: Biological: rLP2086
Group 3	Experimental	200ug Experimental Receives: Biological: rLP2086
Group 4	Active comparator	Active comparator Receives: Biological: rLP2086

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2
Measured: 1 month after Dose 2
Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3
Measured: 1 month after Dose 3
Percentage of Participants With at Least One Adverse Event (AE)
Measured: Dose 1 up to 1 month after Dose 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006Feb 2008

First posted13 Oct 2006 (estimated)
Study startNov 2006
Primary completionJan 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00387725
Sponsor's protocol ID: 6108A1-501
Other IDs: B1971006
Status last verified: Nov 2014
First submitted: 11 Oct 2006
Last updated: 21 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Observer-blinded, Parallel-group, Active-control, Phase ½ Trial Of The Safety, Immunogenicity, And Tolerability Of 20 Mg, 60 Mg, And 200 Mg Of Meningococcal Group B Rlp2086 Vaccine In Healthy Children And Adolescents Aged 8 To 14 Years
ClinicalTrials.gov ID: NCT00387725
Acronym / sponsor ID: 6108A1-501
Conditions: Healthy
Keywords: Adolescent, Meningococcal, Safety
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Jan 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 13 Oct 2006 (estimated)
Results: Posted 21 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study to evaluate the safety of an investigational meningitis vaccine and the immune response to it in adolescents

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group A	Experimental	Biological: rLP208620ug Experimental
Group 2	Experimental	Biological: rLP208660ug Experimental
Group 3	Experimental	Biological: rLP2086200ug Experimental
Group 4	Active comparator	Biological: rLP2086Active comparator

Who may qualify

Ages: 8 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Aged 8 to 14 years at the time of enrollment.
Healthy male or female subjects
Negative urine pregnancy test for female subjects

Key exclusion criteria (2 listed)

Prior vaccination with a meningococcal B vaccine
Prior meningococcal disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rLP2086Vaccine administered at 0, 1, and 6 months	Biological	Group 4
rLP2086Vaccine administered at 0, 1, and 6 months	Biological	Group 3
rLP2086Vaccine administered at 0, 1, and 6 months	Biological	Group 2
rLP2086Vaccine administered at 0, 1, and 6 months	Biological	Group A

Primary outcome

Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2
Time frame: 1 month after Dose 2
Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3
Time frame: 1 month after Dose 3
Percentage of Participants With at Least One Adverse Event (AE)
Time frame: Dose 1 up to 1 month after Dose 3

Results and safety

Results posted to the registry on 21 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Twinrix	21	20
Initial Formulation rLP2086 20 mcg	16	15
Initial Formulation rLP2086 60 mcg	45	43
Initial Formulation rLP2086 200 mcg	45	43

Primary outcome: Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2

Time frame: 1 month after Dose 2. Number. Unit: percentage of participants

Measure	Twinrix n = 21	Initial Formulation rLP2086 20 mcg n = 16	Initial Formulation rLP2086 60 mcg n = 45	Initial Formulation rLP2086 200 mcg n = 45
PMB1745 (N=19, 15, 44, 42)	0.0 (0.0 to 17.6)	33.3 (11.8 to 61.6)	63.6 (47.8 to 77.6)	83.3 (68.6 to 93.0)
PMB17 (N=18, 16, 44, 42)	0.0 (0.0 to 18.5)	18.8 (4.0 to 45.6)	52.3 (36.7 to 67.5)	61.9 (45.6 to 76.4)

Primary outcome: Percentage of Participants With Seroconversion in rLP2086 Specific SBA Titer 1 Month After Dose 3

Time frame: 1 month after Dose 3. Number. Unit: percentage of participants

Measure	Twinrix n = 21	Initial Formulation rLP2086 20 mcg n = 16	Initial Formulation rLP2086 60 mcg n = 45	Initial Formulation rLP2086 200 mcg n = 45
PMB1745 (N=19, 16, 41, 43)	0.0 (0.0 to 17.6)	68.8 (41.3 to 89.0)	70.7 (54.5 to 83.9)	90.7 (77.9 to 97.4)
PMB17 (N=18, 16, 41, 43)	0.0 (0.0 to 18.5)	87.5 (61.7 to 98.4)	82.9 (67.9 to 92.8)	95.3 (84.2 to 99.4)

Primary outcome: Percentage of Participants With at Least One Adverse Event (AE)

Time frame: Dose 1 up to 1 month after Dose 3. Number. Unit: percentage of participants

Measure	Twinrix n = 21	Initial Formulation rLP2086 20 mcg n = 16	Initial Formulation rLP2086 60 mcg n = 45	Initial Formulation rLP2086 200 mcg n = 45
Value	90.5	93.8	93.3	97.8

Adverse events

Time frame: Dose 1 up to 1 month after Dose 3. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Twinrix	0 of 21 (0%)	19 of 21 (90.5%)	Not reported
Initial Formulation rLP2086 20 mcg	2 of 16 (12.5%)	15 of 16 (93.8%)	Not reported
Initial Formulation rLP2086 60 mcg	3 of 45 (6.7%)	42 of 45 (93.3%)	Not reported
Initial Formulation rLP2086 200 mcg	3 of 45 (6.7%)	44 of 45 (97.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rLP2086 in people with Healthy, run by Pfizer at 9 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Seroconversion in rLP2086 Specific Serum Bactericidal Assay (SBA) Titer 1 Month After Dose 2 (time frame: 1 month after Dose 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00387725.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.