Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents

NCT01210885 | Completed Phase 2

• 1 other identifier: V102_02
• Study Type: interventional
• Target: 495
• Locations: 3 countries
• Sites: 8

Brief 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.

Conditions

Meningococcal Disease; Meningococcal Meningitis

Keywords

Meningococcal Disease; Vaccines; Adolescents

Outcome Measures

Primary Outcomes (6)

• Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs)

  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

  3 months

• Percentage of subjects with hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains

  3 months

• Number of participants with solicited local and systemic reactions

  within 7 days after each vaccination

• Number of participants with any adverse events (AEs)

  6 months

• Number of participants with Serious Adverse Events (SAEs)

  3 months

Study Arms (6)

Group I: Investigational MenABCWY Formulation 1

EXPERIMENTAL

Biological: Meningococcal Vaccine

Group II: Investigational MenABCWY Formulation 2

EXPERIMENTAL

Biological: Meningococcal Vaccine

Group III: Investigational MenABCWY Formulation 3

EXPERIMENTAL

Biological: Meningococcal Vaccine

Group IV: Investigational MenABCWY Formulation 4

EXPERIMENTAL

Biological: Meningococcal Vaccine

Group V: Active comparator investigational MenB

ACTIVE COMPARATOR

Biological: Meningococcal Vaccine

Group VI: Active comparator MenACWY

ACTIVE COMPARATOR

Biological: Meningococcal Vaccine

Interventions

Meningococcal Vaccine BIOLOGICAL

MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.

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: Active comparator investigational MenB; Group VI: Active comparator MenACWY

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals eligible to be enrolled into this study are male and female subjects:
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (8)

CESFAM Gabriela Mistral

Santiago, Chile

Location

Liceo Carmela Carvajal de Prat

Santiago, Chile

Location

Pontificia Universidad Católica de Chile

Santiago, Chile

Location

CafeSalud M P (Dir. de Investigación y Proyectos Especiales)

Bogotá, Colombia

Location

Centro de Atencion e Investigacion Medica - CAIMED

Bogotá, Colombia

Location

Centro de Investigaciones CAFAM

Bogotá, Colombia

Location

Health Research International

Panama City, Panama

Location

Indicasat

Panama City, Panama

Location

Related Publications (1)

• 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.

  PMID: 25969894 DERIVED

MeSH Terms

Conditions

Meningococcal Infections; Meningitis, Meningococcal

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2010
• First Posted: September 29, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 24, 2011

Record last verified: 2011-10

Locations

PA (2); CL (3); CO (3)