Neisseria MeningitidisPhase 3NCT00359983

Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB

A Phase 3 study testing MenHibrix (Hib-MenCY-TT) and Hib conjugate vaccine (ActHIB) in people with Neisseria Meningitidis and Haemophilus Influenzae Type b, run by GlaxoSmithKline at 21 sites in United States.

Completed

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

Official record

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Trial summary

This study is evaluating antibody persistence at 1, 3 \& 5 years post-fourth dose (i.e., at 2, 4 \& 6 years of age, respectively) in subjects vaccinated in a previous study. This protocol posting deals with objectives \& outcome measures of the extension phase at years 1, 3 and 5. Read more about this study

Who is it for?: Ages 22 to 60 monthsHealthy volunteers can take part
Conditions the study is for: Neisseria Meningitidis, Haemophilus Influenzae Type b
What is being tested?: MenHibrix (Hib-MenCY-TT) and Hib conjugate vaccine (ActHIB)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 270 participants
Where: 21 sitesUnited States
Study dates: Sep 2006to May 2011
Phase: Phase 3
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 22 to 60 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy male and female children who completed the previous four dose vaccination series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines are as follows:
Year 1: 22 to 36 months of age.
Year 3: 44 to 60 months of age.
Year 5: 5 years post-dose 4 +/- 8 weeks
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study
Having completed the fourth dose vaccination of study Hib-MenCY-TT-005/006

Who cannot join

Children should not have:
received more than 4 doses of Hib or meningococcal serogroup C and Y vaccine
had a history of H. influenzae type b, meningococcal serogroup C and Y diseases

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Boardman, Ohio, 44512
GSK Investigational Site
Bossier City, Louisiana, 71111
GSK Investigational Site
Boston, Massachusetts, 02118
GSK Investigational Site
Cleveland, Ohio, 44121
GSK Investigational Site
Erie, Pennsylvania, 16505
GSK Investigational Site
Fall River, Massachusetts, 02724
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Greenville, Pennsylvania, 16125
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Louisville, Kentucky, 40272
GSK Investigational Site
Marietta, Georgia, 30062
GSK Investigational Site
Norwich, Connecticut, 06360
GSK Investigational Site
Pittsburgh, Pennsylvania, 15217
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Pittsford, New York, 14534
GSK Investigational Site
Rochester, New York, 14620
GSK Investigational Site
Waukee, Iowa, 50263
GSK Investigational Site
Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: A Study to Evaluate the Long-term Antibody Persistence at 1, 3 & 5 Years After the Administration of a Fourth Dose of Hib-MenCY-TT Vaccine Compared to ActHIB in Subjects Boosted in a Previous Study.

This study is evaluating antibody persistence at 1, 3 \& 5 years post-fourth dose (i.e., at 2, 4 \& 6 years of age, respectively) in subjects vaccinated in a previous study.

This protocol posting deals with objectives \& outcome measures of the extension phase at years 1, 3 and 5. The objectives \& outcome measures of the first four doses are presented in a separate protocol posting (NCT00129129).

This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.

Read the detailed description

In this long-term follow-up study, no new subjects will be recruited. All subjects participating in this long-term follow-up study should have already participated in a previous study. No vaccine will be administered during the persistence phase of the study.

This Protocol Posting has been updated following Protocol amendment 3, September 2009.

Conditions: Neisseria Meningitidis, Haemophilus Influenzae Type b
Being tested: MenHibrix (Hib-MenCY-TT), Hib conjugate vaccine (ActHIB)
Keywords: Humans, Meningococcal vaccines, Immunogenicity, Vaccines, H. influenzae type b vaccine, Conjugate, Toddlers, Comparative study, Neisseria meningitidis
Medical subject headings: Haemophilus Infections

What participants receive

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

MenHibrix (Hib-MenCY-TT)Biological
Also called GSK biologicals' Hib-MenCY-TT
First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
Hib conjugate vaccine (ActHIB)Biological
Also called ActHIB
First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose

Study groups in NCT00359983
Study group	Role	What they receive
MenHibrix 4-dose group	Experimental	Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study. Receives: Biological: MenHibrix (Hib-MenCY-TT)
ActHIB 4-dose group	Active comparator	Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study. Receives: Biological: Hib conjugate vaccine (ActHIB)
ActHIB 3-dose + MenHibrix 4th-dose group	Experimental	Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study. Receives: Biological: MenHibrix (Hib-MenCY-TT); Biological: Hib conjugate vaccine (ActHIB)

What is being measured

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

Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter
Results up to 5 years after the fourth dose are presented.
Measured: One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Results up to 5 years after the fourth dose are presented.
Measured: One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Results up to 5 years after the fourth dose are presented.
Measured: One year, three years, and five years after the fourth dose vaccination.

Secondary outcomes (6)

Anti-PRP Geometric Mean Concentrations (GMCs)
Concentration were measured as Geometric Mean Concentrations expressed as microgram per milliliter (µg/mL).
Results up to 5 years after the fourth dose are presented.
Measured: One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter
Results up to 5 years after the fourth dose are presented.
Measured: One year, three years, and five years after the fourth dose vaccination.
hSBA-MenC Geometric Mean Titers (GMTs)
Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition.
Results up to 5 years after the fourth dose are presented.
Measured: One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4
Results up to 5 years after the fourth dose are presented.
Measured: One year, three years, and five years after the fourth dose vaccination.
hSBA-MenY Geometric Mean Titers (GMTs)
Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition.
Results up to 5 years after the fourth dose are presented.
Measured: One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4
Results up to 5 years after the fourth dose are presented.
Measured: One year, three years, and five years after the fourth dose vaccination.

Timeline

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

Sep 2006May 2011

First posted3 Aug 2006 (estimated)
Study startSep 2006
Primary completionNov 2007
Study completionMay 2011

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 (5)Papers the sponsor has linked to this study.
Other trials for Neisseria MeningitidisStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 270 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00359983
Sponsor's protocol ID: 107824
Other IDs: 107826, 107829
Status last verified: Nov 2016
First submitted: 31 Jul 2006
Last updated: 16 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
PubMed 21806393
Marshall GS, Marchant CD, Blatter M, Aris E, Boutriau D, Poolman JT, Friedland LR, Miller JM. Immune response and one-year antibody persistence after a fourth dose of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age. Pediatr Infect Dis J. 2010 May;29(5):469-71. doi: 10.1097/INF.0b013e3181cdd379.
PubMed 20072077
Marshall GS et al. Antibody persistence 5 years after the fourth dose of a US-licensed Heamophilus influenzae type B and Neisseria meningitidis serogroups C and Y tetanus toxoid (HIBMENCY-TT) conjugate vaccine. Abstract presented at the 50th Annual Meeting of the Infectious Diseases Society of America - (IDSA-IDWeek), San Diego, 17-21 October 2012.
Marshall GS et al. Persistence of Immunity three years after an Investigational Haemophilus influenzae type b and Neisseria meningitidis Serogroups C and Y Tetanus Toxoid (HibMenCY-TT) Conjugate Vaccine. Abstract presented at the 45th National Immunization Conference (NIC). Washington, D.C, USA, 28-31 March 2011.
Marshall GS, Blatter M, Marchant C, Aris E, Mesaros N, Miller JM. Antibody persistence for up to 5 years after a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY-TT) given at 12-15 months of age. Pediatr Infect Dis J. 2013 Jun;32(6):662-8. doi: 10.1097/INF.0b013e3182840e35.
PubMed 23340564

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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Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Long-term Antibody Persistence at 1, 3 & 5 Years After the Administration of a Fourth Dose of Hib-MenCY-TT Vaccine Compared to ActHIB in Subjects Boosted in a Previous Study.
ClinicalTrials.gov ID: NCT00359983
Acronym / sponsor ID: 107824
Conditions: Neisseria Meningitidis, Haemophilus Influenzae Type b
Keywords: Humans, Meningococcal vaccines, Immunogenicity, Vaccines, H. influenzae type b vaccine, Conjugate, Toddlers, Comparative study
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 270 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Nov 2007 (actual)
Study completion: May 2011 (actual)
First posted: 3 Aug 2006 (estimated)
Results: Posted 20 Jul 2012

Clinical summary

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

This study is evaluating antibody persistence at 1, 3 \& 5 years post-fourth dose (i.e., at 2, 4 \& 6 years of age, respectively) in subjects vaccinated in a previous study.

This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.

Detailed description

This Protocol Posting has been updated following Protocol amendment 3, September 2009.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
MenHibrix 4-dose group	Experimental	Biological: MenHibrix (Hib-MenCY-TT)Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
ActHIB 4-dose group	Active comparator	Biological: Hib conjugate vaccine (ActHIB)Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
ActHIB 3-dose + MenHibrix 4th-dose group	Experimental	Biological: MenHibrix (Hib-MenCY-TT), Biological: Hib conjugate vaccine (ActHIB)Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.

Who may qualify

Ages: 22 to 60 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

Healthy male and female children who completed the previous four dose vaccination series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines are as follows:
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study
Having completed the fourth dose vaccination of study Hib-MenCY-TT-005/006

Key exclusion criteria (3 listed)

received more than 4 doses of Hib or meningococcal serogroup C and Y vaccine
had a history of H. influenzae type b, meningococcal serogroup C and Y diseases

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
MenHibrix (Hib-MenCY-TT)Also: GSK biologicals' Hib-MenCY-TTFirst three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose	Biological	ActHIB 3-dose + MenHibrix 4th-dose group, MenHibrix 4-dose group
Hib conjugate vaccine (ActHIB)Also: ActHIBFirst three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose	Biological	ActHIB 3-dose + MenHibrix 4th-dose group, ActHIB 4-dose group

Primary outcome

Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter
Time frame: One year, three years, and five years after the fourth dose vaccination.
Results up to 5 years after the fourth dose are presented.
Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Time frame: One year, three years, and five years after the fourth dose vaccination.
Results up to 5 years after the fourth dose are presented.
Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Time frame: One year, three years, and five years after the fourth dose vaccination.
Results up to 5 years after the fourth dose are presented.

6 secondary outcomes

Anti-PRP Geometric Mean Concentrations (GMCs)
Time frame: One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter
Time frame: One year, three years, and five years after the fourth dose vaccination.
hSBA-MenC Geometric Mean Titers (GMTs)
Time frame: One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4
Time frame: One year, three years, and five years after the fourth dose vaccination.
hSBA-MenY Geometric Mean Titers (GMTs)
Time frame: One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4
Time frame: One year, three years, and five years after the fourth dose vaccination.

Results and safety

Results posted to the registry on 20 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MenHibrix 4-dose Group	138	138
ActHIB 4-dose Group	70	70
ActHIB 3-dose + MenHibrix 4th-dose Group	62	62

Primary outcome: Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter

Time frame: One year, three years, and five years after the fourth dose vaccination.. Number. Unit: Subjects

Measure	MenHibrix 4-dose Group n = 116	ActHIB 4-dose Group n = 51	ActHIB 3-dose + MenHibrix 4th-dose Group n = 46
Year 1 (N=116; 51; 46)	116	49	46
Year 3 (N=61; 28; 36)	60	26	36
Year 5 (N=84; 39; 37)	83	36	36

Population analysed: Analysis was done on the ATP cohort for persistence of each respective timepoint in all evaluable subjects who had assay results available for at least one tested antigen and who had a blood sample taken between 309 and 645 days (Year 1 data), 1039 and 1375 days (Year 3 data) and 1770 and 1882 days (Year 5 data) after administration of fourth dose.

Primary outcome: Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)

Time frame: One year, three years, and five years after the fourth dose vaccination.. Number. Unit: Subjects

Measure	MenHibrix 4-dose Group n = 116	ActHIB 4-dose Group n = 52	ActHIB 3-dose + MenHibrix 4th-dose Group n = 48
Year 1 (N=116; 52; 48)	112	12	34
Year 3 (N=59; 27; 35)	48	3	20
Year 5 (N=76; 38; 34)	63	8	25

Primary outcome: Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)

Time frame: One year, three years, and five years after the fourth dose vaccination.. Number. Unit: Subjects

Measure	MenHibrix 4-dose Group n = 105	ActHIB 4-dose Group n = 50	ActHIB 3-dose + MenHibrix 4th-dose Group n = 47
Year 1 (N=105; 50; 47)	88	0	31
Year 3 (N=58; 26; 34)	39	4	19
Year 5 (N=82; 38; 35)	57	7	19

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were assessed in subjects for Year 1, Year 3 and Year 5 respectively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MenHibrix 4-dose Group	0 of 138 (0%)	0 of 0	Not reported
ActHIB 4-dose Group	0 of 70 (0%)	0 of 0	Not reported
ActHIB 3-dose + MenHibrix 4th-dose Group	0 of 62 (0%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21806393Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
Background: PubMed 20072077Marshall GS, Marchant CD, Blatter M, Aris E, Boutriau D, Poolman JT, Friedland LR, Miller JM. Immune response and one-year antibody persistence after a fourth dose of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age. Pediatr Infect Dis J. 2010 May;29(5):469-71. doi: 10.1097/INF.0b013e3181cdd379.
BackgroundMarshall GS et al. Antibody persistence 5 years after the fourth dose of a US-licensed Heamophilus influenzae type B and Neisseria meningitidis serogroups C and Y tetanus toxoid (HIBMENCY-TT) conjugate vaccine. Abstract presented at the 50th Annual Meeting of the Infectious Diseases Society of America - (IDSA-IDWeek), San Diego, 17-21 October 2012.
BackgroundMarshall GS et al. Persistence of Immunity three years after an Investigational Haemophilus influenzae type b and Neisseria meningitidis Serogroups C and Y Tetanus Toxoid (HibMenCY-TT) Conjugate Vaccine. Abstract presented at the 45th National Immunization Conference (NIC). Washington, D.C, USA, 28-31 March 2011.
Derived from this study: PubMed 23340564Marshall GS, Blatter M, Marchant C, Aris E, Mesaros N, Miller JM. Antibody persistence for up to 5 years after a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY-TT) given at 12-15 months of age. Pediatr Infect Dis J. 2013 Jun;32(6):662-8. doi: 10.1097/INF.0b013e3182840e35.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

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

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 3 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 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 20 Jul 2012). 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?

Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter (time frame: One year, three years, and five years after the fourth dose vaccination.). 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 NCT00359983, which also lists 5 linked publications.

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 16 Dec 2016.