Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines
This study has been completed.
Sponsor:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01367158
First received: June 3, 2011
Last updated: August 13, 2012
Last verified: August 2012
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Purpose
This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a meningococcal vaccine formulation in adolescents.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal Disease Meningococcal Meningitis |
Biological: Meningococcal ABCWY Vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Prevention |
| Official Title: | Phase 2, Observer-Blind, Controlled, Randomized, Multi-Center Extension Study to Evaluate Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY in Adolescents Who Previously Received the Same Study Vaccines |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Percentage of subjects with hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W-135 and Y and with hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains. [ Time Frame: Throughout individual subject participation (7 months) ] [ Designated as safety issue: No ]
- Seroresponse to N. meningitidis serogroups A, C, W-135 and Y as hSBA titer ≥ 1:8 or four fold increase pre vaccination hSBA titer for subjects with pre-vaccination hSBA titer < 1:4 or ≥ 1:4 respectively) one month after vaccination. [ Time Frame: Throughout individual subject participation (7 months) ] [ Designated as safety issue: No ]
- Percentage of subjects with pre-vaccination hSBA titer <1:4 and post-vaccination hSBA titer ≥ 1:8 to N. meningitidis serogroups A, C, W-135 and Y one month after vaccination. [ Time Frame: Throughout individual subject participation (7 months) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Solicited local and systemic reactions, fever, AE and SAE within 7 days after vaccination [ Time Frame: Throughout individual subject participation (7 months) ] [ Designated as safety issue: Yes ]
- Medically attended AEs, SAEs, and AEs leading to withdrawal from the study collected throughout the study [ Time Frame: Throughout individual subject participation (7 months) ] [ Designated as safety issue: Yes ]
| Enrollment: | 440 |
| Study Start Date: | July 2011 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group I |
Biological: Meningococcal ABCWY Vaccine
Group I: Investigational MenABCWY Formulation 1 Group II: Investigational MenABCWY Formulation 2 Group III: Investigational MenABCWY Formulation 3 Group IV: Investigational MenABCWY Formulation 4 Group V: Investigational rMenB Group VI: Other Vaccination (Routine Vaccine)
|
| Experimental: Group II |
Biological: Meningococcal ABCWY Vaccine
Group I: Investigational MenABCWY Formulation 1 Group II: Investigational MenABCWY Formulation 2 Group III: Investigational MenABCWY Formulation 3 Group IV: Investigational MenABCWY Formulation 4 Group V: Investigational rMenB Group VI: Other Vaccination (Routine Vaccine)
|
| Experimental: Group III |
Biological: Meningococcal ABCWY Vaccine
Group I: Investigational MenABCWY Formulation 1 Group II: Investigational MenABCWY Formulation 2 Group III: Investigational MenABCWY Formulation 3 Group IV: Investigational MenABCWY Formulation 4 Group V: Investigational rMenB Group VI: Other Vaccination (Routine Vaccine)
|
| Experimental: Group IV |
Biological: Meningococcal ABCWY Vaccine
Group I: Investigational MenABCWY Formulation 1 Group II: Investigational MenABCWY Formulation 2 Group III: Investigational MenABCWY Formulation 3 Group IV: Investigational MenABCWY Formulation 4 Group V: Investigational rMenB Group VI: Other Vaccination (Routine Vaccine)
|
| Experimental: Group V |
Biological: Meningococcal ABCWY Vaccine
Group I: Investigational MenABCWY Formulation 1 Group II: Investigational MenABCWY Formulation 2 Group III: Investigational MenABCWY Formulation 3 Group IV: Investigational MenABCWY Formulation 4 Group V: Investigational rMenB Group VI: Other Vaccination (Routine Vaccine)
|
| Experimental: Group VI |
Biological: Meningococcal ABCWY Vaccine
Group I: Investigational MenABCWY Formulation 1 Group II: Investigational MenABCWY Formulation 2 Group III: Investigational MenABCWY Formulation 3 Group IV: Investigational MenABCWY Formulation 4 Group V: Investigational rMenB Group VI: Other Vaccination (Routine Vaccine)
|
Eligibility| Ages Eligible for Study: | 11 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 11 - 18 years inclusive at the time of enrollment;
- Who have given their 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 screening/baseline labs and clinical judgment of the Investigator.
Exclusion Criteria:
- 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 >38°C) within the previous 3 days;
- Antibiotics within 7 days prior to enrollment;
- Pregnant or nursing (breastfeeding) mothers;
- 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, HIV infection or AIDS, blood dyscrasias, bleeding 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 or immunostimulants 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
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367158
Locations
| Chile | |
| CESFAM Gabriela Mistral: | |
| Aurora de Chile 9872 - San Ramón, Saniago, Chile | |
| Pontificia Universidad Catolica de Chile | |
| Marcoleta 350, Santiago, Chile | |
| Colombia | |
| CAFAM | |
| Avenida Carrera 68# 90-88 Piso 4, Bogota, Colombia | |
| Centro de Investigacion CafeSalud Medicina Prepagada | |
| Carrera 14 No. 94-49 PisoSexto, Bogota, Colombia | |
| CAIMED | |
| Carrera, Bogotá, Colombia, 42A # 17-50 | |
| Panama | |
| Indicasat: | |
| Clayton, ciudad del Saber Edificio 219, Panama City, Panama | |
| Health Research International: Centro Especializado san Fernando | |
| Piso numero 5, Consultorio 12; Via Espana, las Sabanas,, Panama city, Panama | |
Sponsors and Collaborators
Novartis Vaccines
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT01367158 History of Changes |
| Other Study ID Numbers: | V102_02E1 |
| Study First Received: | June 3, 2011 |
| Last Updated: | August 13, 2012 |
| Health Authority: | Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Panama: Instituto Conmemorativo Gorgas de Estudios de la Salud (ICGES), Chile: Instituto de Salud Pública de Chile (ISP) |
Keywords provided by Novartis:
|
Meningococcal disease vaccines adolescents prevention Meningitis |
Additional relevant MeSH terms:
|
Meningitis Meningitis, Meningococcal Meningococcal Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases |
Meningitis, Bacterial Central Nervous System Bacterial Infections Bacterial Infections Neisseriaceae Infections Gram-Negative Bacterial Infections |
ClinicalTrials.gov processed this record on May 23, 2013