Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Meningococcal Disease; Meningococcal Meningitis
• Intervention / Treatment: Biological: Meningococcal Vaccine

• Study Type: Interventional
• Enrollment (Actual): 495
• Phase: Phase 2

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Pontificia Universidad Catolica de Chile
  • Santiago, Chile
    • CESFAM Gabriela Mistral
  • Santiago, Chile
    • Liceo Carmela Carvajal de Prat
• Colombia
  • Bogotá, Colombia
    • CafeSalud M P (Dir. de Investigación y Proyectos Especiales)
  • Bogotá, Colombia
    • Centro de Atencion e Investigacion Medica - CAIMED
  • Bogotá, Colombia
    • Centro de Investigaciones CAFAM
• Panama
  • Panama City, Panama
    • Health Research International
  • Panama City, Panama
    • Indicasat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

1. 11-18 years at the time of enrollment;
2. who have given their written consent/assent and whose parents or legal guardians have given 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 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 38C) within the previous 3 days;
5. Antibiotics within 7 days prior to enrollment;
6. Pregnancy 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, human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or blood dyscrasias or 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 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;
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;
16. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I: Investigational MenABCWY Formulation 1	Biological: Meningococcal Vaccine; MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.
Experimental: Group II: Investigational MenABCWY Formulation 2	Biological: Meningococcal Vaccine; MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.
Experimental: Group III: Investigational MenABCWY Formulation 3	Biological: Meningococcal Vaccine; MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.
Experimental: Group IV: Investigational MenABCWY Formulation 4	Biological: Meningococcal Vaccine; MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.
Active Comparator: Group V: Active comparator investigational MenB	Biological: Meningococcal Vaccine; MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.
Active Comparator: Group VI: Active comparator MenACWY	Biological: Meningococcal Vaccine; MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: September 27, 2010
• First Submitted That Met QC Criteria: September 28, 2010
• First Posted (Estimate): September 29, 2010

Study Record Updates

• Last Update Posted (Estimate): October 24, 2011
• Last Update Submitted That Met QC Criteria: October 21, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Adolescents; Vaccines; Meningococcal Disease
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Neisseriaceae Infections; Meningitis, Meningococcal; Meningitis; Meningococcal Infections
• Other Study ID Numbers: V102_02