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:
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
  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:

  1. 11 - 18 years inclusive at the time of enrollment;
  2. Who have given their written informed consent at the time of enrollment;
  3. 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);
  4. In good health as determined by the outcome of medical history, physical examination screening/baseline labs and clinical judgment of the Investigator.

Exclusion Criteria:

  1. History of any meningococcal vaccine administration;
  2. Current or previous, confirmed or suspected disease caused by N. meningitidis;
  3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
  4. Significant acute or chronic infection within the previous 7 days or fever (defined as temperature >38°C) within the previous 3 days;
  5. Antibiotics within 7 days prior to enrollment;
  6. Pregnant or nursing (breastfeeding) mothers;
  7. 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;
  8. 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).
  9. 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
  10. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
  11. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
  12. 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.
  13. 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.
  14. Individuals who are part of study personnel or close family members conducting this study.
  15. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningitis, Bacterial
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on October 23, 2014