Meningococcal MeningitisPhase 3NCT00518180
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
A Phase 3 study testing Novartis Meningococcal ACWY Conjugate Vaccine and Tdap Vaccine in people with Meningococcal Meningitis and Human Papillomavirus Infection, run by Novartis Vaccines at 1 site in Costa Rica.
Trial summary
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Meningitis, Human Papillomavirus Infection, Pertussis
- What is being tested?
- Novartis Meningococcal ACWY Conjugate Vaccine and Tdap Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,620 participants
- Where
- 1 siteCosta Rica
- Study dates
- Jul 2007to Oct 2008
- Phase
- Phase 3
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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy adolescents 11-18 years of age
- virgins (both male and female) with no intention of becoming sexually active during the study period
- who have been properly vaccinated against diphtheria, tetanus, pertussis
Who cannot join
- who had a previous confirmed or suspected disease caused by N. meningitidis;
- who have previously been immunized with a meningococcal vaccine
- who have received prior human papillomavirus (HPV) vaccine;
- who have any serious acute, chronic or progressive disease
- who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
- who have a known or suspected impairment/alteration of immune function, either congenital or acquired
- who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
- who have Down's syndrome or other known cytogenic disorders;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents
- Being tested
- Novartis Meningococcal ACWY Conjugate Vaccine, Tdap Vaccine
- Keywords
- Meningococcal, meningitis, vaccine, adolescents
- Medical subject headings
- Meningitis, Meningococcal, Papillomavirus Infections, Whooping Cough, Tetanus, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novartis Meningococcal ACWY Conjugate VaccineBiological
One dose of vaccine administered intramuscularly
Tdap VaccineBiological
One dose of vaccine administered intramuscularly
Novartis Meningococcal ACWY Conjugate VaccineBiological
One dose of vaccine administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| MenACWY + Tdap + HPV | Experimental | Subjects received MenACWY concomitantly with Tdap and HPV at study month 0 followed by two injections of HPV at month 2 and 6 Receives: Biological: Novartis Meningococcal ACWY Conjugate Vaccine |
| MenACWY →Tdap → HPV | Experimental | Subjects received MenACWY at study month 0 followed by one injection of Tdap at month 1, followed by three injections of HPV at months 2, 4, and 8 Receives: Biological: Novartis Meningococcal ACWY Conjugate Vaccine |
| Tdap →MenACWY → HPV | Experimental | Subjects received Tdap at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2, 4, and 8 Receives: Biological: Tdap Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine.
Seroresponse to MenACWY: For a subject with baseline hSBA titer <1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Measured: 1 month post MenACWY vaccination
Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL
To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone
Measured: 1 month post Tdap vaccination
Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)
To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone
Measured: 1 month post Tdap vaccination
Secondary outcomes (10)
Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
The immune responses to the MenACWY conjugate vaccine, as measured by the hSBA Geometric Mean Titers (GMTs) when given: (a) alone, (b) concomitantly with the Tdap vaccine and the HPV vaccine, and (c) when given one month after the Tdap vaccine.
Measured: 1 month post MenACWY vaccination
Percentage of Subjects With Anti-HPV Seroconversion
To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccination.) Anti-HPV Seroconversion (SC): SC was defined as negative (baseline HPV titer < type-specific cut-off) for anti-HPV and anti-HPV ≥ an HPV type-specific cut-off at one month after the third HPV injection.
Measured: 1 month post third HPV vaccination
Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay
To compare the immune response of HPV vaccine given concomitantly with MenACWY and Tdap to the response when HPV vaccine is given alone. (Immune response against HPV virus-like particles (VLPs) for types 6, 11, 16, and 18 was measured at one month after the third HPV vaccine vaccination.)
Measured: 1 month post third HPV vaccination
Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
The immune responses to MenACWY, as measured by the percentage of subjects with hSBA titer ≥ 1:8, hSBA titer ≥ 1:4, when given: (a) alone, (b) concomitantly with Tdap and HPV vaccine; and (c) when given one month after Tdap.
Measured: 1 month post MenACWY vaccination
The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus
The immune response to the Tdap vaccine, as measured by the percentage of subjects with antidiphtheria and antitetanus toxin ≥1.0 IU/mL.
Measured: 1 month post Tdap vaccination
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus
To compare the immune response of Tdap, as measured by the antidiphtheria and antitetanus GMCs, when administered one month after the MenACWY vaccine with the immune response of the Tdap vaccine when administered alone.
Measured: 1 month post Tdap vaccination
Geometric Mean Titers (GMT) of Pertussis Antigens
To compare the immune response to Tdap administered one month after MenACWY with the immune response to Tdap administered alone.
Measured: 1 month post Tdap vaccination
Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN
To compare the immune response of Tdap, defined by the percentage of subjects with a 4-fold rise in antibody titer over baseline against PT, FHA, PRN, when administered one month after the MenACWY with the immune response of Tdap when administered alone.
Measured: 1 month post Tdap vaccination
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
Number of subjects with specified local and systemic reactions were assessed when MenACWY was given alone, one month after Tdap, and concomitantly with Tdap and HPV vaccine.
Measured: Days 1 to 7
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
Number of subjects with specified local and systemic reactions were solicited for 7 days after the HPV vaccination.
Measured: Days 1 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2008
- Study completionOct 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 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines and Diagnostics, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518180
- Sponsor's protocol ID
- V59P18
- Status last verified
- Apr 2016
- First submitted
- 17 Aug 2007
- Last updated
- 18 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Arguedas A, Soley C, Loaiza C, Rincon G, Guevara S, Perez A, Porras W, Alvarado O, Aguilar L, Abdelnour A, Grunwald U, Bedell L, Anemona A, Dull PM. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine. 2010 Apr 19;28(18):3171-9. doi: 10.1016/j.vaccine.2010.02.045. Epub 2010 Feb 26.
PubMed 20189491