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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

NCT ID: NCT01367158

Last Updated: 2014-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-07-31

Brief Summary

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

Detailed Description

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Conditions

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Meningococcal Disease Meningococcal Meningitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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3ABCWY

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

The lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine reconstituted with one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

2ABCWY

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

Group Type EXPERIMENTAL

Tdap

Intervention Type BIOLOGICAL

Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection

3ABx2CWY

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

The lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine reconstituted with one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

2ABx2CWY

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

Group Type EXPERIMENTAL

Tdap

Intervention Type BIOLOGICAL

Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection

3ABCWY+OMV

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

The lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine reconstituted with one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

2ABCWY+OMV

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 Tdap in current study

Group Type EXPERIMENTAL

Tdap

Intervention Type BIOLOGICAL

Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection

3ABCWYqOMV

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

The lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine reconstituted with one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

2ABCWYqOMV

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 Tdap in current study

Group Type EXPERIMENTAL

Tdap

Intervention Type BIOLOGICAL

Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection

3B

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

Group Type ACTIVE_COMPARATOR

Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Intervention Type BIOLOGICAL

Liquid Meningococcal (group B) multicomponent recombinant adsorbed vaccine

2B

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

Group Type ACTIVE_COMPARATOR

Tdap

Intervention Type BIOLOGICAL

Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection

1ACWY

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

Group Type ACTIVE_COMPARATOR

Tdap

Intervention Type BIOLOGICAL

Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection

Interventions

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

The lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine reconstituted with one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Intervention Type BIOLOGICAL

Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Liquid Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Intervention Type BIOLOGICAL

Tdap

Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Individuals eligible to be enrolled into this study were male or female who completed study V102\_02 (primary study), and:

1. who were 11 to 18 years at the time of enrollment in primary study;
2. who had given their written consent at the time of enrollment;
3. 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);
4. who were 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 \>38°C) within the previous 3 days;
5. Antibiotics within 7 days prior to enrollment or blood draw;
6. Pregnancy or nursing (breastfeeding) mothers;
7. 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;
8. 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).
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 (ie, eczema on knees or face or elbows) of the body was 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 were 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 had intent to participate in another clinical study at any time during the conduct of this study.
14. Individuals who were 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 posed additional risk to the subjects due to participation in the study.
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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CESFAM Gabriela Mistral:

Aurora de Chile 9872 - San Ramón, Saniago, Chile

Site Status

Pontificia Universidad Catolica de Chile

Marcoleta 350, Santiago Metropolitan, Chile

Site Status

CAFAM

Avenida Carrera 68# 90-88 Piso 4, Bogota D.C., Colombia

Site Status

Centro de Investigacion CafeSalud Medicina Prepagada

Carrera 14 No. 94-49 PisoSexto, Bogota D.C., Colombia

Site Status

CAIMED

Carrera, Bogota D.C., Colombia

Site Status

Indicasat:

Clayton, Ciudad Del Saber Edificio 219, Panama City, Panama

Site Status

Health Research International: Centro Especializado san Fernando

Piso Numero 5, Consultorio 12; Via Espana, Las Sabanas,, Panama City, Panama

Site Status

Countries

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Chile Colombia Panama

References

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Saez-Llorens X, Aguilera Vaca DC, Abarca K, Maho E, Han L, Smolenov I, Dull P. Persistence of Meningococcal Antibodies and Response to a Third Dose After a Two-dose Vaccination Series with Investigational MenABCWY Vaccine Formulations in Adolescents. Pediatr Infect Dis J. 2015 Oct;34(10):e264-78. doi: 10.1097/INF.0000000000000822.

Reference Type DERIVED
PMID: 26135245 (View on PubMed)

Other Identifiers

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V102_02E1

Identifier Type: -

Identifier Source: org_study_id