Haemophilus Influenzae Type bPhase 3NCT00345683
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
A Phase 3 study testing GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014), PedvaxHIB and Prevnar in people with Haemophilus Influenzae Type b and Neisseria Meningitidis, run by GlaxoSmithKline at 57 sites in 2 countries.
Trial summary
The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age. This protocol posting deals with objectives \& outcome measures of the booster phase. Read more about this study
- Who is it for?
- Ages 12 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Haemophilus Influenzae Type b, Neisseria Meningitidis
- What is being tested?
- GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014), PedvaxHIB and Prevnar
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,021 participants
- Where
- 57 sitesin 2 countries
- Study dates
- Jul 2007to Nov 2008
- 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 12 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study
Who cannot join
- Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:
- History of measles, mumps, rubella or varicella.
- Previous vaccination against measles, mumps, rubella or varicella.
- Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
- Patients receiving immunosuppressive therapy.
- Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
Show all 10Show fewer
- Individuals with primary and acquired immunodeficiency states.
- Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- Individuals with active tuberculosis.
- Acute disease at time of booster vaccination
Trial locations and contacts
57 sites in 2 countries.
57 sites in 2 countries
United States55 sites
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Benton, Arkansas, 72015
GSK Investigational Site
Birmingham, Alabama, 35205
GSK Investigational Site
Birmingham, Alabama, 35244
GSK Investigational Site
Boardman, Ohio, 44512
GSK Investigational Site
Bossier City, Louisiana, 71111
GSK Investigational Site
Boston, Massachusetts, 02130
GSK Investigational Site
Boulder, Colorado, 80303
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Cleveland, Ohio, 44121
GSK Investigational Site
Erie, Pennsylvania, 16505
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Fresno, California, 93710
GSK Investigational Site
Fresno, California, 93726
GSK Investigational Site
Greenville, Pennsylvania, 16125
GSK Investigational Site
Ithaca, New York, 14850
GSK Investigational Site
Jonesboro, Arkansas, 72401
GSK Investigational Site
Kingsport, Tennessee, 37660
GSK Investigational Site
Las Vegas, Nevada, 89104
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Lexington, Kentucky, 40503
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Longmont, Colorado, 80501
GSK Investigational Site
Madera, California, 93637
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Marshfield, Wisconsin, 54449
GSK Investigational Site
Nampa, Idaho, 208 463 3126
GSK Investigational Site
New Hartford, New York, 13413
GSK Investigational Site
Nies, Michigan, 49120
GSK Investigational Site
North Canton, Ohio, 44720
GSK Investigational Site
Ogden, Utah, 84405
GSK Investigational Site
Orem, Utah, 84057
GSK Investigational Site
Pittsburgh, Pennsylvania, 15217
GSK Investigational Site
Pittsburgh, Pennsylvania, 15220
GSK Investigational Site
Pittsburgh, Pennsylvania, 15227
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Plantation, Florida, 33324
GSK Investigational Site
Pleasant Gorve, Utah, 84062
GSK Investigational Site
Portage, Michigan, 49024
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Saint Paul, Minnesota, 55108
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
Salt Lake City, Utah, 84121
GSK Investigational Site
Slinas, California, 93901
GSK Investigational Site
South Euclid, Ohio, 44121
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
Stevensville, Michigan, 49127
GSK Investigational Site
Syracuse, New York, 13210
GSK Investigational Site
Waukee, Iowa, 50263
GSK Investigational Site
West Covina, California, 91790
GSK Investigational Site
West Desmoines, Iowa, 50266
GSK Investigational Site
West Jordan, Utah, 84088
GSK Investigational Site
Wexford, Pennsylvania, 15090
Mexico2 sites
GSK Investigational Site
Mexico City, 04530
GSK Investigational Site
Mexico City, 06720
About this study
Official title: Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.
This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579).
No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Read the detailed description
Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine.
The study will be conducted in a single blind manner up to 30 days after administration of the booster dose; the extended safety follow-up after the booster dose will be conducted in an unblinded manner.
All subjects will receive Prevnar, M-M-R II and Varivax as study vaccines, preferencially co-administered with the booster dose of Hib-MenCY-TT/PedvaxHIB.
Note: This protocol posting deals with the objectives \& outcome measures for the booster phase of the study. The objectives \& outcome measures for the primary phase are presented in a separate protocol posting (NCT00345579)
- Being tested
- GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014), PedvaxHIB, Prevnar, M-M-R II, Varivax
- Keywords
- H. influenzae type B vaccine, Infants, Neisseria meningitidis, Vaccines, conjugate, Meningococcal vaccines, Prophylaxis, Comparative study, Safety, Humans
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)Biological
Booster dose by intramuscular injection
PedvaxHIBBiological
Also called Monovalent Hib conjugate vaccine.
Booster dose by intramuscular injection
PrevnarBiological
Booster dose by intramuscular injection
M-M-R IIBiological
Also called Measles, mumps and rubella vaccine.
Single dose by subcutaneous injection
VarivaxBiological
Also called Varicella vaccine
Single dose by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Menhibrix Group | Experimental | Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. Receives: Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014); Biological: Prevnar; Biological: M-M-R II; Biological: Varivax |
| ActHIB Group | Active comparator | Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. Receives: Biological: PedvaxHIB; Biological: Prevnar; Biological: M-M-R II; Biological: Varivax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Measured: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Measured: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Number of Subjects Reporting Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Measured: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Measured: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Measured: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Measured: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Number of Subjects With Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Measured: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits
Measured: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startJul 2007
- Primary completionSep 2008
- Study completionNov 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Haemophilus Influenzae Type bStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 4,021 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345683
- Sponsor's protocol ID
- 105988
- Status last verified
- Oct 2016
- First submitted
- 26 Jun 2006
- Last updated
- 29 Nov 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
Rinderknecht S, Bryant K, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, Cohen C, Aris E, Mesaros N, Miller JM. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 13.
PubMed 22327493
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
- ClinicalTrials.gov ID
- NCT00345683
- Acronym / sponsor ID
- 105988
- Keywords
- H. influenzae type B vaccine, Infants, Neisseria meningitidis, Vaccines, conjugate, Meningococcal vaccines, Prophylaxis, Comparative study, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,021 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 28 Jun 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.
The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.
This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579).
No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine.
The study will be conducted in a single blind manner up to 30 days after administration of the booster dose; the extended safety follow-up after the booster dose will be conducted in an unblinded manner.
All subjects will receive Prevnar, M-M-R II and Varivax as study vaccines, preferencially co-administered with the booster dose of Hib-MenCY-TT/PedvaxHIB.
Note: This protocol posting deals with the objectives \& outcome measures for the booster phase of the study. The objectives \& outcome measures for the primary phase are presented in a separate protocol posting (NCT00345579)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menhibrix Group | Experimental | Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014), Biological: Prevnar, Biological: M-M-R II, Biological: VarivaxSubjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. |
| ActHIB Group | Active comparator | Biological: PedvaxHIB, Biological: Prevnar, Biological: M-M-R II, Biological: VarivaxSubjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study
Key exclusion criteria (10 listed)
- History of measles, mumps, rubella or varicella.
- Previous vaccination against measles, mumps, rubella or varicella.
- Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
- Patients receiving immunosuppressive therapy.
- Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
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 |
|---|---|---|
| GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)Booster dose by intramuscular injection | Biological | Menhibrix Group |
| PedvaxHIBAlso: Monovalent Hib conjugate vaccine.Booster dose by intramuscular injection | Biological | ActHIB Group |
| PrevnarBooster dose by intramuscular injection | Biological | ActHIB Group, Menhibrix Group |
| M-M-R IIAlso: Measles, mumps and rubella vaccine.Single dose by subcutaneous injection | Biological | ActHIB Group, Menhibrix Group |
| VarivaxAlso: Varicella vaccineSingle dose by subcutaneous injection | Biological | ActHIB Group, Menhibrix Group |
Primary outcome
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
Time frame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects Reporting Rash
Time frame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Time frame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
Time frame: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects With Rash
Time frame: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits
Time frame: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22327493Rinderknecht S, Bryant K, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, Cohen C, Aris E, Mesaros N, Miller JM. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 13.
- Primary StudyLink 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
57 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014), PedvaxHIB and Prevnar in people with Haemophilus Influenzae Type b and Neisseria Meningitidis, run by GlaxoSmithKline at 57 sites in 2 countries.
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 1 inclusion and 10 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 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Mexico. 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 Reporting Serious Adverse Events (SAEs) (time frame: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)). The study lists 8 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 NCT00345683, 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 29 Nov 2016.