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

NCT01367158 | Completed Phase 2 Results

• 1 other identifier: V102_02E1
• Study Type: interventional
• Target: 440
• Locations: 3 countries
• Sites: 7

Brief Summary

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

Conditions

Meningococcal Disease; Meningococcal Meningitis

Keywords

Meningococcal disease; vaccines; adolescents; prevention; Meningitis

Outcome Measures

Primary Outcomes (2)

• Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

  Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:8 and associated 95% CI, directed against to N meningitidis serogroups A, C, W, and Y at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).

  At month 6 and month 7

• Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

  Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and associated 95% CI, directed against to Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)

  At month 6 and month 7

Secondary Outcomes (17)

• Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

  At month 6 and month 7

• Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

  At month 7

• GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

  At month 6 and month 7

• GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

  At month 7

• Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo

  At month 7

Study Arms (11)

3ABCWY

EXPERIMENTAL

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

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

2ABCWY

EXPERIMENTAL

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

Biological: Tdap

3ABx2CWY

EXPERIMENTAL

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

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

2ABx2CWY

EXPERIMENTAL

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

Biological: Tdap

3ABCWY+OMV

EXPERIMENTAL

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

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

2ABCWY+OMV

EXPERIMENTAL

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

Biological: Tdap

3ABCWYqOMV

EXPERIMENTAL

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

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

2ABCWYqOMV

EXPERIMENTAL

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

Biological: Tdap

3B

ACTIVE COMPARATOR

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

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine

2B

ACTIVE COMPARATOR

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

Biological: Tdap

1ACWY

ACTIVE COMPARATOR

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

Biological: Tdap

Interventions

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

3ABCWY; 3ABCWY+OMV; 3ABCWYqOMV; 3ABx2CWY

Meningococcal (group B) multicomponent recombinant adsorbed vaccine BIOLOGICAL

Liquid Meningococcal (group B) multicomponent recombinant adsorbed vaccine

3B

Tdap BIOLOGICAL

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

1ACWY; 2ABCWY; 2ABCWY+OMV; 2ABCWYqOMV; 2ABx2CWY; 2B

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 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.

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 \>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.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (7)

CESFAM Gabriela Mistral:

Aurora de Chile 9872 - San Ramón, Saniago, Chile

Location

Pontificia Universidad Catolica de Chile

Marcoleta 350, Santiago Metropolitan, Chile

Location

CAFAM

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

Location

Centro de Investigacion CafeSalud Medicina Prepagada

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

Location

CAIMED

Carrera, Bogota D.C., 42A # 17-50, Colombia

Location

Indicasat:

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

Location

Health Research International: Centro Especializado san Fernando

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

Location

Related Publications (1)

• 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.

  PMID: 26135245 DERIVED

MeSH Terms

Conditions

Meningococcal Infections; Meningitis, Meningococcal; Meningitis

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; Neuroinflammatory Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines

RegistryContactVaccineUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 6, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 19, 2014
• Results First Posted: November 19, 2014

Record last verified: 2014-11

Locations

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