Meningococcal DiseasePhase 2NCT01210885
Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents
A Phase 2 study testing Meningococcal Vaccine in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 8 sites in 3 countries.
Trial summary
The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity of two doses of 4 different investigational MenABCWY combination vaccine when administered to healthy adolescents aged 11-18 years. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease, Meningococcal Meningitis
- What is being tested?
- Meningococcal Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Dec 2010to Jul 2011
- Phase
- Phase 2
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
- Individuals eligible to be enrolled into this study are male and female subjects:
- 11-18 years at the time of enrollment;
- who have given their written consent/assent and whose parents or legal guardians have given written informed consent at the time of enrollment;
- who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
- in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Who cannot join
- History of any meningococcal vaccine administration;
- Current or previous, confirmed or suspected disease caused by N. meningitidis;
- Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
- Significant acute or chronic infection within the previous 7 days or fever (defined as temperature 38C) within the previous 3 days;
- Antibiotics within 7 days prior to enrollment;
- Pregnancy or nursing (breastfeeding) mothers;
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- Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods at least two months prior to study entry;
- Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition);
- Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; immunostimulants;
- Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
- History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
- Individuals who received any other vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines;
- Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study;
- Individuals who are part of study personnel or close family members conducting this study;
- Individuals with medical history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
- Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Chile3 sites
CESFAM Gabriela Mistral
Santiago
Liceo Carmela Carvajal de Prat
Santiago
Pontificia Universidad Católica de Chile
Santiago
Colombia3 sites
CafeSalud M P (Dir. de Investigación y Proyectos Especiales)
Bogotá
Centro de Atencion e Investigacion Medica - CAIMED
Bogotá
Centro de Investigaciones CAFAM
Bogotá
About this study
Official title: Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents, to Evaluate Safety, Tolerability and Immunogenicity of Four Different rMenB Plus MenACWY Formulations
The purpose of this phase 2 study is to evaluate the safety, tolerability and immunogenicity of two doses of 4 different investigational MenABCWY combination vaccine when administered to healthy adolescents aged 11-18 years.
- Conditions
- Meningococcal Disease, Meningococcal Meningitis
- Being tested
- Meningococcal Vaccine
- Keywords
- Meningococcal Disease, Vaccines, Adolescents
- Medical subject headings
- Meningococcal Infections, Meningitis, Meningococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal VaccineBiological
MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Group I: Investigational MenABCWY Formulation 1 | Experimental | Not described Receives: Biological: Meningococcal Vaccine |
| Group II: Investigational MenABCWY Formulation 2 | Experimental | Not described Receives: Biological: Meningococcal Vaccine |
| Group III: Investigational MenABCWY Formulation 3 | Experimental | Not described Receives: Biological: Meningococcal Vaccine |
| Group IV: Investigational MenABCWY Formulation 4 | Experimental | Not described Receives: Biological: Meningococcal Vaccine |
| Group V: Active comparator investigational MenB | Active comparator | Not described Receives: Biological: Meningococcal Vaccine |
| Group VI: Active comparator MenACWY | Active comparator | Not described Receives: Biological: Meningococcal Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs)
Measured: 3 months
Percentage of subjects with seroresponse, and human Serum Bactericidal Activity (hSBA) titer ≥ 1:8 and hSBA titer ≥ 1:4 to Neisseria meningitidis serogroups A, C, W-135 and Y
Measured: 3 months
Percentage of subjects with hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains
Measured: 3 months
Number of participants with solicited local and systemic reactions
Measured: within 7 days after each vaccination
Number of participants with any adverse events (AEs)
Measured: 6 months
Number of participants with Serious Adverse Events (SAEs)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningococcal DiseaseStudies 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
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210885
- Sponsor's protocol ID
- V102_02
- Status last verified
- Oct 2011
- First submitted
- 27 Sep 2010
- Last updated
- 24 Oct 2011
- Results posted
- No
Publications
Saez-Llorens X, Aguilera Vaca DC, Abarca K, Maho E, Grana MG, Heijnen E, Smolenov I, Dull PM. Immunogenicity and safety of investigational vaccine formulations against meningococcal serogroups A, B, C, W, and Y in healthy adolescents. Hum Vaccin Immunother. 2015;11(6):1507-17. doi: 10.1080/21645515.2015.1029686.
PubMed 25969894