Meningitis, MeningococcalPhase 2NCT00798304
Study Evaluating Safety, Tolerability, and Immunogenicity of Meningococcal B Vaccine in Healthy Infants
A Phase 2 study testing meningococcal B rLP2086 vaccine and Routine age appropriate childhood vaccines in people with Meningitis, Meningococcal, run by Pfizer at 7 sites in Spain.
Trial summary
The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants. Read more about this study
- Who is it for?
- Ages 42 to 98 days
- Conditions the study is for
- Meningitis, Meningococcal
- What is being tested?
- meningococcal B rLP2086 vaccine and Routine age appropriate childhood vaccines
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 7 sitesSpain
- Study dates
- Jan 2009to Sep 2009
- 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 42 to 98 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Investigators should always use good clinical judgment in considering a subject's overall fitness for trial participation. In addition, any condition that in the opinion of the investigator may interfere with the evaluation of study objectives should be carefully considered prior to enrolling subjects.
- Male or female subjects aged 2 months (42 to 98 days of age) at the time of enrollment.
- Available for the entire consented period and whose parent/legal guardian can be reached by telephone.
- Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
- Parent/legal guardian must be able to complete all relevant study procedures during study participation.
Who cannot join
- Previous vaccination with licensed or investigational vaccines: meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, poliovirus, rotavirus, varicella, measles, mumps, or rubella.
- Any of the following illnesses/conditions that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study:
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), poliovirus, rotavirus, varicella, measles, mumps, or rubella.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Known or suspected immune deficiency or suppression.
Show all 14Show fewer
- History of culture-proven invasive disease caused by N meningitidis or Neisseria gonorrhoea.
- Major known congenital malformation or serious chronic disorder.
- Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder.
- Does not include resolving syndromes due to birth trauma such as Erb palsy.
- Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies).
- Received any investigational drugs, vaccines or devices (aside from those specified in the protocol) within 4 weeks before administration of the first dose of test article or at any time throughout the study.
- Participation in purely observational studies is acceptable.
- Infant who is a direct descendant (child, grandchild) of the study site personnel.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Clínica Mediterráneo
Almería, Almeria, 4007
Hospital Gral. Gregorio Maranon
Madrid, Madrid, 28007
Hospital 12 de Octubre Materno-Infantil Unidad de Lactantes
Madrid, Madrid, 28041
Hospital Universitario de Mostóles
Mostóles, Madrid, 28935
Hospital Virgen del Camino
Pamplona, Navarre, 31008
Hospital Clinico Universitario de Santiago
Santiado de Compostela, La Coruña, 15706
Hospital Xeral de Vigo
Vigo, 36024
About this study
Official title: An Open Label, Randomized, Phase 1/2 Trial Of The Safety, Tolerability, And Immunogenicity Of Meningococcal Group B Rlp2086 Vaccine In Healthy Infants
The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.
- Conditions
- Meningitis, Meningococcal
- Being tested
- meningococcal B rLP2086 vaccine, Routine age appropriate childhood vaccines
- Keywords
- Meningococcal B vaccine, infants, safety, immunogenicity
- Medical subject headings
- Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meningococcal B rLP2086 vaccineBiological
vaccination
Routine age appropriate childhood vaccinesBiological
vaccination
meningococcal B rLP2086 vaccineBiological
vaccination
Routine age appropriate childhood vaccinesBiological
vaccination
Routine age appropriate childhood vaccinesBiological
vaccination
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines Receives: Biological: meningococcal B rLP2086 vaccine; Biological: Routine age appropriate childhood vaccines |
| 2 | Experimental | Dose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines Receives: Biological: meningococcal B rLP2086 vaccine; Biological: Routine age appropriate childhood vaccines |
| 3 | Experimental | Control group Receives: Biological: Routine age appropriate childhood vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain
Measured: 1 month after Dose 3
Percentage of Participants With at Least One Adverse Event (AE)
Measured: From signing of informed consent form to completion of study (up to 2 years)
Secondary outcomes (2)
Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain
Measured: 1 month after Dose 2, Dose 3; before Dose 4
Percentage of Participants Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain
Measured: 1 month after Dose 2, Dose 3; before Dose 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionSep 2009
Why it stopped: Following program review within Pfizer, decision was made not to go ahead with this study. This study is cancelled
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningitis, MeningococcalStudies 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
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798304
- Sponsor's protocol ID
- 6108K2-2000
- Other IDs
- B1971008, 2008-001457-18, 2008
- Status last verified
- Nov 2014
- First submitted
- 25 Nov 2008
- Last updated
- 26 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Martinon-Torres F, Gimenez-Sanchez F, Bernaola-Iturbe E, Diez-Domingo J, Jiang Q, Perez JL. A randomized, phase 1/2 trial of the safety, tolerability, and immunogenicity of bivalent rLP2086 meningococcal B vaccine in healthy infants. Vaccine. 2014 Sep 8;32(40):5206-11. doi: 10.1016/j.vaccine.2014.07.049. Epub 2014 Jul 29.
PubMed 25077420
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Phase 1/2 Trial Of The Safety, Tolerability, And Immunogenicity Of Meningococcal Group B Rlp2086 Vaccine In Healthy Infants
- ClinicalTrials.gov ID
- NCT00798304
- Acronym / sponsor ID
- 6108K2-2000
- Conditions
- Meningitis, Meningococcal
- Keywords
- Meningococcal B vaccine, infants, safety, immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following program review within Pfizer, decision was made not to go ahead with this study. This study is cancelled
- Enrolment
- 46 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Posted 26 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the safety and immunogenicity of an investigational meningococcal B vaccine in healthy infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: meningococcal B rLP2086 vaccine, Biological: Routine age appropriate childhood vaccinesDose level 1 of meningococcal B rLP2086 vaccine and routine childhood vaccines |
| 2 | Experimental | Biological: meningococcal B rLP2086 vaccine, Biological: Routine age appropriate childhood vaccinesDose level 2 of meningococcal B rLP2086 vaccine and routine childhood vaccines |
| 3 | Experimental | Biological: Routine age appropriate childhood vaccinesControl group |
Who may qualify
- Ages
- 42 to 98 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Investigators should always use good clinical judgment in considering a subject's overall fitness for trial participation. In addition, any condition that in the opinion of the investigator may interfere with the evaluation of study objectives should be carefully considered prior to enrolling subjects.
- Male or female subjects aged 2 months (42 to 98 days of age) at the time of enrollment.
- Available for the entire consented period and whose parent/legal guardian can be reached by telephone.
- Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
- Parent/legal guardian must be able to complete all relevant study procedures during study participation.
Key exclusion criteria (14 listed)
- Previous vaccination with licensed or investigational vaccines: meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, poliovirus, rotavirus, varicella, measles, mumps, or rubella.
- Any of the following illnesses/conditions that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study:
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with meningococcal B, meningococcal C, pneumococcal, Hib, diphtheria, tetanus, acellular pertussis, Hepatitis B (HBV), poliovirus, rotavirus, varicella, measles, mumps, or rubella.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
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 |
|---|---|---|
| meningococcal B rLP2086 vaccinevaccination | Biological | 1 |
| Routine age appropriate childhood vaccinesvaccination | Biological | 1 |
| meningococcal B rLP2086 vaccinevaccination | Biological | 2 |
| Routine age appropriate childhood vaccinesvaccination | Biological | 2 |
| Routine age appropriate childhood vaccinesvaccination | Biological | 3 |
Primary outcome
Percentage of Participants Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain
Time frame: 1 month after Dose 3
Percentage of Participants With at Least One Adverse Event (AE)
Time frame: From signing of informed consent form to completion of study (up to 2 years)
2 secondary outcomes
Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs) for 1 Subfamily A Strain and 1 Subfamily B Strain
Time frame: 1 month after Dose 2, Dose 3; before Dose 4
Percentage of Participants Achieving at Least 1:4, 1:8, 1:16, 1:32, 1:64, 1:128 rLP2086-specific SBA Titer to 1 Subfamily A Strain and 1 Subfamily B Strain
Time frame: 1 month after Dose 2, Dose 3; before Dose 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25077420Martinon-Torres F, Gimenez-Sanchez F, Bernaola-Iturbe E, Diez-Domingo J, Jiang Q, Perez JL. A randomized, phase 1/2 trial of the safety, tolerability, and immunogenicity of bivalent rLP2086 meningococcal B vaccine in healthy infants. Vaccine. 2014 Sep 8;32(40):5206-11. doi: 10.1016/j.vaccine.2014.07.049. Epub 2014 Jul 29.
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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
7 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 meningococcal B rLP2086 vaccine and Routine age appropriate childhood vaccines in people with Meningitis, Meningococcal, run by Pfizer at 7 sites in Spain.
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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 26 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 7 sites in Spain. 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 26 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 Achieving at Least 1:4 rLP2086-specific Serum Bactericidal Assay (SBA) Titer to 1 Subfamily A Strain and 1 Subfamily B Strain (time frame: 1 month after Dose 3). The study lists 2 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 NCT00798304, which also lists 1 linked publication.
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 26 Nov 2014.