Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in Adolescents

Meningococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210885
• Other study ID #: V102_02
• Status: Completed
• Phase: Phase 2
• First received: September 27, 2010
• Last updated: October 21, 2011
• Start date: December 2010
• Est. completion date: July 2011

Study information

• Verified date: October 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis, Meningococcal
• Meningococcal Disease
• Meningococcal Infections
• Meningococcal Meningitis

Intervention

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

Locations

Country	Name	City	State
Chile	CESFAM Gabriela Mistral	Santiago
Chile	Liceo Carmela Carvajal de Prat	Santiago
Chile	Pontificia Universidad Católica de Chile	Santiago
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	Bogotá
Panama	Health Research International	Panama City
Panama	Indicasat	Panama City

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

Chile,  Colombia,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Bactericidal Assay (SBA) Geometric Mean Titers (GMTs)		3 months	Yes
Primary	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	Yes
Primary	Percentage of subjects with hSBA titer = 1:5 to N. meningitidis serogroup B strains		3 months	Yes
Primary	Number of participants with solicited local and systemic reactions		within 7 days after each vaccination	Yes
Primary	Number of participants with any adverse events (AEs)		6 months	Yes
Primary	Number of participants with Serious Adverse Events (SAEs)		3 months	Yes