Neisseria MeningitidisPhase 3NCT01839175
Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster Vaccination
A Phase 3 study testing Hexavalent vaccine, NeisVac-C and Prevenar 13 in people with Neisseria Meningitidis and Bacterial Infections, run by Sanofi Pasteur, a Sanofi Company at 11 sites in Finland.
Trial summary
Primary Series Primary objectives To demonstrate that the concomitant administration of the hexavalent vaccine with a meningococcal serogroup C conjugate vaccine is non inferior to the administration of the hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate for hepatitis B one month… Read more about this study
- Who is it for?
- Ages 46 to 76 daysHealthy volunteers can take part
- Conditions the study is for
- Neisseria Meningitidis, Bacterial Infections, Virus Diseases
- What is being tested?
- Hexavalent vaccine, NeisVac-C and Prevenar 13
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 11 sitesFinland
- Study dates
- Apr 2013to Feb 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 46 to 76 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infant 46 to 74 days of age (both inclusive)
- Born at full term of pregnancy (≥37 weeks) and/or with a birth weight≥2.5 kg
- Subject's parent(s) or legal representative able to comply with the study procedures
Who cannot join
- Participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding each study vaccination
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, meningococcal, pneumococcal, rotavirus infection
- Know or suspected congenital, hereditary or acquired immunodeficiency
- History of seizures or encephalopathy
- Known thrombocytopenia
Show all 14Show fewer
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
- Chronic illness that could interfere with trial conduct or completion
- Known or suspected hypersensitivity to any of the study vaccines' active substance or excipients or history of a life-threatening reaction to a vaccine(s) containing the same substances as the study vaccines
- Contraindication to any of the study vaccines
- Known personal or maternal history of hepatitis B or hepatitis C seropositivity
- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b or meningococcal serogroup C infection
- Receipt of immune globulin, blood or blood-derived products, immunosuppressive drugs, systemic corticosteroid since birth
- Identified as a natural or adopted child of the investigator or employee with direct involvement in the current study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Finland11 sites
Sanofi Pasteur MSD Investigational Site 003
Espoo
Sanofi Pasteur MSD Investigational Site 001
Helsinki
Sanofi Pasteur MSD Investigational Site 002
Helsinki
Sanofi Pasteur MSD Investigational Site 011
Jarvenpaa
Sanofi Pasteur MSD Investigational Site 010
Kokkola
Sanofi Pasteur MSD Investigational Site 004
Oulu
Sanofi Pasteur MSD Investigational Site 005
Pori
Sanofi Pasteur MSD Investigational Site 009
Seinäjoki
Sanofi Pasteur MSD Investigational Site 006
Tampere
Sanofi Pasteur MSD Investigational Site 007
Turku
Sanofi Pasteur MSD Investigational Site 008
Vantaa
About this study
Official title: A Phase III Open-label Randomised Study to Evaluate the Immunogenicity and Safety of the Concomitant Administration of a New Hexavalent DTaP-IPV-HepB-PRP-T Combined Vaccine (Hexavalent Vaccine) Given at 2, 3, and 4 Months of Age With a Meningococcal Serogroup C Conjugate (MenC) Vaccine Given at 2 and 4 Months of Age
Primary Series Primary objectives
- To demonstrate that the concomitant administration of the hexavalent vaccine with a meningococcal serogroup C conjugate vaccine is non inferior to the administration of the hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate for hepatitis B one month after the third dose of the hexavalent vaccine
- To demonstrate that the concomitant administration of a MenC vaccine with the hexavalent vaccine induces an acceptable response for MenC in term of seroprotection rate (SPR) one month after the second dose of MenC
Read more
Booster Primary objectives
- To describe the immunogenicity of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of age or given separately.
Read the detailed description
Primary Series Secondary objectives
- To describe the antibody response to all the hexavalent vaccine antigens one month after the third dose of the hexavalent vaccine when given concomitantly or not to MenC
- To describe the antibody response to MenC vaccine when a MenC vaccine is given concomitantly with the hexavalent vaccine, one month after the first and the second dose of MenC vaccine
- To describe the safety profile of the hexavalent vaccine after each and any injection when given concomitantly or not with a MenC vaccine
Booster Secondary objectives
- To describe the antibody (Ab) persistence at 12 months of age for the hexavalent valences following a 3-dose primary vaccination at 2, 3 and 4 months of age (prior to administration of a booster dose)
- To describe the safety of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of age or given separately.
- Conditions
- Neisseria Meningitidis, Bacterial Infections, Virus Diseases
- Being tested
- Hexavalent vaccine, NeisVac-C, Prevenar 13, RotaTeq, Nimenrix
- Medical subject headings
- Bacterial Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hexavalent vaccineBiological
Also called Diphtheria, tetanus, pertussis, hepatitis B,, poliomyelitis and Haemophilus influenzae type b conjugate vaccine (adsorbed).
0.5 mL intramuscular injection at 2, 3 and 4 months of age (primary series) 0.5 mL intramuscular injection at 12 or 13 months of age (booster)
NeisVac-CBiological
Also called Meningococcal group C polysaccharide conjugate vaccine adsorbed
0.5 mL intramuscular injection at 2 and 4 months of age
Prevenar 13Biological
Also called Pneumococcal conjugate vaccine (13-valent, adsorbed)
0.5 mL intramuscular injection at 2 and 4 months of age (primary series) 0.5 mL intramuscular injection at 13 months of age (booster)
RotaTeqBiological
Also called Human-bovine rotavirus reassortants (live) vaccine
2 mL oral administration at 2, 3 and 4 months
NimenrixBiological
Also called Meningococcal group A, C, W-135 and Y conjugate vaccine
0.5 mL intramuscular injection at 12 months
M-M-RVAXPROBiological
Also called Measles, mumps and rubella vaccine (live)
0.5 mL intramuscular or subcutaneous injection at 13 months of age
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Biological: Hexavalent vaccine; Biological: NeisVac-C; Biological: Prevenar 13; Biological: RotaTeq; Biological: Nimenrix; Biological: M-M-RVAXPRO |
| Group 2 | Active comparator | Not described Receives: Biological: Hexavalent vaccine; Biological: Prevenar 13; Biological: RotaTeq; Biological: Nimenrix; Biological: M-M-RVAXPRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL
Measured: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
Proportion of subjects with an anti-MenC titre ≥1:8 dil
Measured: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
Secondary outcomes (15)
Proportion of subjects with an anti-polyribosylribitol phosphate concentration ≥0.15 µg/mL
Measured: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster)
Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL
Measured: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster)
Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL
Measured: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster)
Proportion of subjects with an anti-inactivated poliovirus 1, 2, 3 titre ≥1:8 dil
Measured: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster)
Proportion of subjects with pertussis vaccine response
Measured: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
Proportion of subjects with an anti-MenC titre ≥1:8 dil
Measured: Month 3 (One month after dose 1 of MenC vaccine)
Solicited injection-site and systemic reactions
Measured: Day 1 to Day 7 following vaccination
Unsolicited adverse events
Measured: Day 1 to Day 30 following vaccination
Serious adverse events
Measured: From signature of the informed consent to the last visit of the subject, an expected average of 11 months
Proportion of subjects with an anti-polyribosylribitol phosphate concentration ≥1 µg/mL
Measured: Month 12 (Pre-booster) and Month 13 (One month post-booster)
Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL
Measured: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster)
Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL
Measured: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster)
Proportion of subjects with an anti-MenA, anti-MenC, anti-MenW-135, anti-MenY titre ≥1:8 dil
Measured: Month 13 (One month after MenAWCY vaccine)
Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL
Measured: Month 12 (Pre-booster) and Month 13 (One month post-booster)
Proportion of subjects with pertussis booster response
Measured: Month 13 (One month post-booster)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Sanofi Pasteur, a Sanofi CompanyThe 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
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839175
- Sponsor's protocol ID
- HXM01C
- Other IDs
- 2012-005547-24
- Status last verified
- Sep 2017
- First submitted
- 19 Apr 2013
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Vesikari T, Borrow R, Da Costa X, Thomas S, Eymin C, Boisnard F, Lockhart S. Concomitant administration of a fully liquid ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal ACWY conjugate vaccine in toddlers. Vaccine. 2018 Dec 18;36(52):8019-8027. doi: 10.1016/j.vaccine.2018.10.100. Epub 2018 Nov 22.
PubMed 30471953Vesikari T, Borrow R, Da Costa X, Richard P, Eymin C, Boisnard F, Lockhart S. Concomitant administration of a fully liquid, ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal serogroup C conjugate vaccine in infants. Vaccine. 2017 Jan 11;35(3):452-458. doi: 10.1016/j.vaccine.2016.11.053. Epub 2016 Dec 9.
PubMed 27939054
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Open-label Randomised Study to Evaluate the Immunogenicity and Safety of the Concomitant Administration of a New Hexavalent DTaP-IPV-HepB-PRP-T Combined Vaccine (Hexavalent Vaccine) Given at 2, 3, and 4 Months of Age With a Meningococcal Serogroup C Conjugate (MenC) Vaccine Given at 2 and 4 Months of Age
- ClinicalTrials.gov ID
- NCT01839175
- Acronym / sponsor ID
- HXM01C
- Conditions
- Neisseria Meningitidis, Bacterial Infections, Virus Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2013 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Series Primary objectives
- To demonstrate that the concomitant administration of the hexavalent vaccine with a meningococcal serogroup C conjugate vaccine is non inferior to the administration of the hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate for hepatitis B one month after the third dose of the hexavalent vaccine
- To demonstrate that the concomitant administration of a MenC vaccine with the hexavalent vaccine induces an acceptable response for MenC in term of seroprotection rate (SPR) one month after the second dose of MenC
Booster Primary objectives
- To describe the immunogenicity of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of age or given separately.
Detailed description
Primary Series Secondary objectives
- To describe the antibody response to all the hexavalent vaccine antigens one month after the third dose of the hexavalent vaccine when given concomitantly or not to MenC
- To describe the antibody response to MenC vaccine when a MenC vaccine is given concomitantly with the hexavalent vaccine, one month after the first and the second dose of MenC vaccine
- To describe the safety profile of the hexavalent vaccine after each and any injection when given concomitantly or not with a MenC vaccine
Booster Secondary objectives
- To describe the antibody (Ab) persistence at 12 months of age for the hexavalent valences following a 3-dose primary vaccination at 2, 3 and 4 months of age (prior to administration of a booster dose)
- To describe the safety of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of age or given separately.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Hexavalent vaccine, Biological: NeisVac-C, Biological: Prevenar 13, Biological: RotaTeq, Biological: Nimenrix, Biological: M-M-RVAXPRO |
| Group 2 | Active comparator | Biological: Hexavalent vaccine, Biological: Prevenar 13, Biological: RotaTeq, Biological: Nimenrix, Biological: M-M-RVAXPRO |
Who may qualify
- Ages
- 46 to 76 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infant 46 to 74 days of age (both inclusive)
- Born at full term of pregnancy (≥37 weeks) and/or with a birth weight≥2.5 kg
- Subject's parent(s) or legal representative able to comply with the study procedures
Key exclusion criteria (14 listed)
- Participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding each study vaccination
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, meningococcal, pneumococcal, rotavirus infection
- Know or suspected congenital, hereditary or acquired immunodeficiency
- History of seizures or encephalopathy
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 |
|---|---|---|
| Hexavalent vaccineAlso: Diphtheria, tetanus, pertussis, hepatitis B,, poliomyelitis and Haemophilus influenzae type b conjugate vaccine (adsorbed).0.5 mL intramuscular injection at 2, 3 and 4 months of age (primary series) 0.5 mL intramuscular injection at 12 or 13 months of age (booster) | Biological | Group 1, Group 2 |
| NeisVac-CAlso: Meningococcal group C polysaccharide conjugate vaccine adsorbed0.5 mL intramuscular injection at 2 and 4 months of age | Biological | Group 1 |
| Prevenar 13Also: Pneumococcal conjugate vaccine (13-valent, adsorbed)0.5 mL intramuscular injection at 2 and 4 months of age (primary series) 0.5 mL intramuscular injection at 13 months of age (booster) | Biological | Group 1, Group 2 |
| RotaTeqAlso: Human-bovine rotavirus reassortants (live) vaccine2 mL oral administration at 2, 3 and 4 months | Biological | Group 1, Group 2 |
| NimenrixAlso: Meningococcal group A, C, W-135 and Y conjugate vaccine0.5 mL intramuscular injection at 12 months | Biological | Group 1, Group 2 |
| M-M-RVAXPROAlso: Measles, mumps and rubella vaccine (live)0.5 mL intramuscular or subcutaneous injection at 13 months of age | Biological | Group 1, Group 2 |
Primary outcome
Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL
Time frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
Proportion of subjects with an anti-MenC titre ≥1:8 dil
Time frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
15 secondary outcomes
Proportion of subjects with an anti-polyribosylribitol phosphate concentration ≥0.15 µg/mL
Time frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster)
Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL
Time frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster)
Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL
Time frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster)
Proportion of subjects with an anti-inactivated poliovirus 1, 2, 3 titre ≥1:8 dil
Time frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster)
Proportion of subjects with pertussis vaccine response
Time frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)
Proportion of subjects with an anti-MenC titre ≥1:8 dil
Time frame: Month 3 (One month after dose 1 of MenC vaccine)
Solicited injection-site and systemic reactions
Time frame: Day 1 to Day 7 following vaccination
Unsolicited adverse events
Time frame: Day 1 to Day 30 following vaccination
Serious adverse events
Time frame: From signature of the informed consent to the last visit of the subject, an expected average of 11 months
Proportion of subjects with an anti-polyribosylribitol phosphate concentration ≥1 µg/mL
Time frame: Month 12 (Pre-booster) and Month 13 (One month post-booster)
Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL
Time frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster)
Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL
Time frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine), Month 12 (Pre-booster) and Month 13 (One month post-booster)
Proportion of subjects with an anti-MenA, anti-MenC, anti-MenW-135, anti-MenY titre ≥1:8 dil
Time frame: Month 13 (One month after MenAWCY vaccine)
Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL
Time frame: Month 12 (Pre-booster) and Month 13 (One month post-booster)
Proportion of subjects with pertussis booster response
Time frame: Month 13 (One month post-booster)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Derived from this study: PubMed 30471953Vesikari T, Borrow R, Da Costa X, Thomas S, Eymin C, Boisnard F, Lockhart S. Concomitant administration of a fully liquid ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal ACWY conjugate vaccine in toddlers. Vaccine. 2018 Dec 18;36(52):8019-8027. doi: 10.1016/j.vaccine.2018.10.100. Epub 2018 Nov 22.
- Derived from this study: PubMed 27939054Vesikari T, Borrow R, Da Costa X, Richard P, Eymin C, Boisnard F, Lockhart S. Concomitant administration of a fully liquid, ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal serogroup C conjugate vaccine in infants. Vaccine. 2017 Jan 11;35(3):452-458. doi: 10.1016/j.vaccine.2016.11.053. Epub 2016 Dec 9.
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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.
Medical Director study director
Sanofi Pasteur, a Sanofi Company
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hexavalent vaccine, NeisVac-C and Prevenar 13 in people with Neisseria Meningitidis and Bacterial Infections, run by Sanofi Pasteur, a Sanofi Company at 11 sites in Finland.
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 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: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects with an anti-hepatitis B concentration ≥10 IU/mL (time frame: Month 5 (One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine)). 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 NCT01839175, which also lists 2 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 11 Sep 2017.