Meningococcal MeningitisPhase 2NCT00310817
Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.
A Phase 2 study testing MenACWY-CRM conjugate vaccine, adjuvanted, MenACWY polysaccharide vaccine and MenACWY-CRM conjugate vaccine, unadjuvanted in people with Meningococcal Meningitis, run by Novartis Vaccines at 2 sites in 2 countries.
Trial summary
To compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine Read more about this study
- Who is it for?
- Ages 12 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Meningitis
- What is being tested?
- MenACWY-CRM conjugate vaccine, adjuvanted, MenACWY polysaccharide vaccine and MenACWY-CRM conjugate vaccine, unadjuvanted
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 623 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2005to May 2006
- 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 12 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy 12-<60 month old children;
Who cannot join
- subjects who have previously received any meningococcal vaccine
- subjects with any serious acute or chronic progressive disease
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Poland1 site
Oddz. Neuroinfekcji, Szpital Jana Pawla II, Krakow
Samodzielny ZOZ, Lubartów
About this study
Official title: A Phase II, Randomized, Observer Blind, Multi-Center, Active Controlled Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.
To compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine
- Conditions
- Meningococcal Meningitis
- Being tested
- MenACWY-CRM conjugate vaccine, adjuvanted, MenACWY polysaccharide vaccine, MenACWY-CRM conjugate vaccine, unadjuvanted
- Keywords
- meningitis, children, vaccine
- Medical subject headings
- Meningitis, Meningococcal, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenACWY-CRM conjugate vaccine, adjuvantedBiological
MenACWY polysaccharide vaccineBiological
MenACWY-CRM conjugate vaccine, unadjuvantedBiological
| Study group | Role | What they receive |
|---|---|---|
| MenACWY-CRM(Ad+) 12 to 35 Months | Experimental | Subjects received one dose of MenACWY-CRM conjugate vaccine with adjuvant (Ad+) on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination. Receives: Biological: MenACWY-CRM conjugate vaccine, adjuvanted |
| MenACWY-CRM(Ad-) 12 to 35 Months | Experimental | Subjects received one dose of MenACWY-CRM conjugate vaccine without adjuvant (Ad-) on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination. Receives: Biological: MenACWY-CRM conjugate vaccine, unadjuvanted |
| MenACWY-CRM(Ad-) 36 to 59 Months | Experimental | Subjects received one dose of MenACWY-CRM conjugate vaccine without adjuvant on day 1 and second dose on day 169 or day 337. Receives: Biological: MenACWY-CRM conjugate vaccine, unadjuvanted |
| MenACWY-PS (36 to 59 Months) | Active comparator | Subjects received one dose of MenACWY polysaccharide (PS) vaccine on day 1 and second dose of MenACWY-CRM conjugate vaccine without adjuvant on day 169 or day 337. Receives: Biological: MenACWY polysaccharide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Measured: 28 days after first vaccination.
Secondary outcomes (25)
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Immune response of one dose of MenACWY-CRM(Ad-) compared to that of a MenACWY-PS vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentages of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Measured: 28 days after first vaccination
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Immune response of one dose of MenACWY-CRM(Ad-) vaccine compared with that of one dose of MenACWY-PS vaccine, 28 days after administration in subjects 36-59 months of age, as measured by hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, and Y.
Measured: 28 days after first vaccination
hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
Measured: 6 months after first vaccination and 12 months after first vaccination
Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Measured: 6 months after first vaccination and 12 months after first vaccination
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Measured: 6 months after first vaccination and 12 months after first vaccination
hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age
Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured 21 days after the booster dose by hSBA GMT against N. meningitidis serogroups A, C, W, and Y.
Measured: 21 days after second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age
Booster effect of a second dose of MenACWY-CRM(-Ad) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Measured: 21 days after second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age
Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Measured: 21 days after the second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Measured: 28 days after first vaccination.
hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Immune response of one dose of MenACWY-CRM vaccine with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
Measured: 28 days after first vaccination
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with human complement serum bactericidal antibody (hSBA) titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Measured: 28 days after first vaccination.
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Measured: 21 days after second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Immune response to a second dose of either MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Measured: 21 days after second vaccination
hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
Measured: 21 days after second vaccination
hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age
Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
Measured: 6 months after first vaccination and 12 months after first vaccination
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Measured: 6 months after first vaccination and 12 months after first vaccination
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age
Persistence of immune response at 6 or 12 months after one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Measured: 6 months after first vaccination and 12 months after first vaccination
hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
Measured: 21 days after the second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Measured: 21 days after second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age
Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered either at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Measured: 21 days after second vaccination
hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age
Persistence of immune response at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
Measured: 12 months after second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Measured: 12 months after second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age
Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Measured: 12 months after second vaccination
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Safety was assessed as the number of subjects 12 to 59 months of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the first or second vaccination(s) with MenACWY-CRM vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.
Measured: From day 1 through day 7 after first or second vaccination(s)
Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination
Safety was assessed as the number of subjects 12 to 59 months of age who reported serious adverse events (SAE), AEs necessitating a physician's visit and/or resulting in premature withdrawal from the study, AEs were to be collected between day 7 and the subsequent visit (approximately 1 month later) after the first or second vaccination(s) of MenACWY-CRM vaccine, with or without adjuvant, or MenACWY-PS vaccine. Any SAE were to be collected throughout the study.
Measured: 28 days after first vaccination and 21 days after second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startMar 2005
- Primary completionMay 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meningococcal MeningitisStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines - Drug Information Services, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310817
- Sponsor's protocol ID
- V59P7
- Other IDs
- EUDRACT NUMBER: 2004-001896-21
- Status last verified
- Oct 2015
- First submitted
- 3 Apr 2006
- Last updated
- 6 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Observer Blind, Multi-Center, Active Controlled Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.
- ClinicalTrials.gov ID
- NCT00310817
- Acronym / sponsor ID
- V59P7
- Conditions
- Meningococcal Meningitis
- Keywords
- meningitis, children, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- Mar 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 5 Apr 2006 (estimated)
- Results
- Posted 6 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MenACWY-CRM(Ad+) 12 to 35 Months | Experimental | Biological: MenACWY-CRM conjugate vaccine, adjuvantedSubjects received one dose of MenACWY-CRM conjugate vaccine with adjuvant (Ad+) on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination. |
| MenACWY-CRM(Ad-) 12 to 35 Months | Experimental | Biological: MenACWY-CRM conjugate vaccine, unadjuvantedSubjects received one dose of MenACWY-CRM conjugate vaccine without adjuvant (Ad-) on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination. |
| MenACWY-CRM(Ad-) 36 to 59 Months | Experimental | Biological: MenACWY-CRM conjugate vaccine, unadjuvantedSubjects received one dose of MenACWY-CRM conjugate vaccine without adjuvant on day 1 and second dose on day 169 or day 337. |
| MenACWY-PS (36 to 59 Months) | Active comparator | Biological: MenACWY polysaccharide vaccineSubjects received one dose of MenACWY polysaccharide (PS) vaccine on day 1 and second dose of MenACWY-CRM conjugate vaccine without adjuvant on day 169 or day 337. |
Who may qualify
- Ages
- 12 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy 12-<60 month old children;
Key exclusion criteria (2 listed)
- subjects who have previously received any meningococcal vaccine
- subjects with any serious acute or chronic progressive disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MenACWY-CRM conjugate vaccine, adjuvanted | Biological | MenACWY-CRM(Ad+) 12 to 35 Months |
| MenACWY polysaccharide vaccine | Biological | MenACWY-PS (36 to 59 Months) |
| MenACWY-CRM conjugate vaccine, unadjuvanted | Biological | MenACWY-CRM(Ad-) 12 to 35 Months, MenACWY-CRM(Ad-) 36 to 59 Months |
Primary outcome
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Time frame: 28 days after first vaccination.
Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
25 secondary outcomes
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Time frame: 28 days after first vaccination
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Time frame: 28 days after first vaccination
hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Time frame: 6 months after first vaccination and 12 months after first vaccination
Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Time frame: 6 months after first vaccination and 12 months after first vaccination
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Time frame: 6 months after first vaccination and 12 months after first vaccination
hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age
Time frame: 21 days after second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age
Time frame: 21 days after second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age
Time frame: 21 days after the second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Time frame: 28 days after first vaccination.
hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Time frame: 28 days after first vaccination
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Time frame: 28 days after first vaccination.
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Time frame: 21 days after second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Time frame: 21 days after second vaccination
hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Time frame: 21 days after second vaccination
hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age
Time frame: 6 months after first vaccination and 12 months after first vaccination
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Time frame: 6 months after first vaccination and 12 months after first vaccination
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age
Time frame: 6 months after first vaccination and 12 months after first vaccination
hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Time frame: 21 days after the second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Time frame: 21 days after second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age
Time frame: 21 days after second vaccination
hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age
Time frame: 12 months after second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Time frame: 12 months after second vaccination
Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age
Time frame: 12 months after second vaccination
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Time frame: From day 1 through day 7 after first or second vaccination(s)
Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination
Time frame: 28 days after first vaccination and 21 days after second vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Vaccines - Drug Information Services study chair
Novartis
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MenACWY-CRM conjugate vaccine, adjuvanted, MenACWY polysaccharide vaccine and MenACWY-CRM conjugate vaccine, unadjuvanted in people with Meningococcal Meningitis, run by Novartis Vaccines at 2 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 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Poland. 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 6 Nov 2015). 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?
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age (time frame: 28 days after first vaccination.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2015.