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

Novartis

Status and phase

Completed

Phase 2

Conditions

Meningococcal Meningitis

Meningococcal Disease

Treatments

Biological: Tdap

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01367158

V102_02E1

Details and patient eligibility

About

This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a meningococcal vaccine formulation in adolescents.

Enrollment

440 patients

Sex

All

Ages

11 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Individuals eligible to be enrolled into this study were male or female who completed study V102_02 (primary study), and:

who were 11 to 18 years at the time of enrollment in primary study;
who had given their written consent at the time of enrollment;
who were available for all the visits scheduled in the study (ie, not planning to leave the area before the end of the study period);
who were in good health as determined by the outcome of medical history, physical examination 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 or blood draw;
Pregnancy or nursing (breastfeeding) mothers;
Females of childbearing age who had not used or did 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 was 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 (eg, neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, human immunodeficiency virus infection or acquired immunodeficiency syndrome, 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 (ie, eczema on knees or face or elbows) of the body was 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 were 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 had intent to participate in another clinical study at any time during the conduct of this study.
Individuals who were 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 posed additional risk to the subjects due to participation in the study.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

440 participants in 11 patient groups

3ABCWY

Experimental group

Description:

Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study

Treatment:

Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine

2ABCWY

Experimental group

Description:

Treatment:

Biological: Tdap

3ABx2CWY

Experimental group

Description:

two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study

Treatment:

Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine

2ABx2CWY

Experimental group

Description:

two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study

Treatment:

Biological: Tdap

3ABCWY+OMV

Experimental group

Description:

Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study

Treatment:

Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine

2ABCWY+OMV

Experimental group

Description:

Treatment:

Biological: Tdap

3ABCWYqOMV

Experimental group

Description:

Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study

Treatment:

Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine

2ABCWYqOMV

Experimental group

Description:

Treatment:

Biological: Tdap

Active Comparator group

Description:

Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study

Treatment:

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Active Comparator group

Description:

Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study

Treatment:

Biological: Tdap

1ACWY

Active Comparator group

Description:

One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study

Treatment:

Biological: Tdap

Trial contacts and locations

Data sourced from clinicaltrials.gov

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