Meningococcal DiseasePhase 2NCT01367158

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

A Phase 2 study testing Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine, Meningococcal (group B) multicomponent recombinant adsorbed vaccine and Tdap in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 11 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease, Meningococcal Meningitis
What is being tested?: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine, Meningococcal (group B) multicomponent recombinant adsorbed vaccine and Tdap
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 440 participants
Where: 7 sitesin 3 countries
Study dates: Jul 2011to Jul 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 11 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Individuals eligible to be enrolled into this study were male or female who completed study V10202 (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.

Who cannot join

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;

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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 locations and contacts

7 sites in 3 countries.

Country

City, postcode or hospital

7 sites in 3 countries

Colombia3 sites

CAFAM
Avenida Carrera 68# 90-88 Piso 4, Bogota D.C.
CAIMED
Carrera, Bogota D.C., 42A # 17-50
Centro de Investigacion CafeSalud Medicina Prepagada
Carrera 14 No. 94-49 PisoSexto, Bogota D.C.

Other trials in Colombia

Chile2 sites

CESFAM Gabriela Mistral:
Aurora de Chile 9872 - San Ramón, Saniago
Pontificia Universidad Catolica de Chile
Marcoleta 350, Santiago Metropolitan

Other trials in Chile

Panama2 sites

Indicasat:
Clayton, Ciudad Del Saber Edificio 219, Panama City
Health Research International: Centro Especializado san Fernando
Piso Numero 5, Consultorio 12; Via Espana, Las Sabanas,, Panama City

Other trials in Panama

About this study

Official title: Phase 2, Observer-Blind, Controlled, Randomized, Multi-Center Extension Study to Evaluate Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY in Adolescents Who Previously Received the Same Study Vaccines

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

Conditions: Meningococcal Disease, Meningococcal Meningitis
Being tested: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine, Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Tdap
Keywords: Meningococcal disease, vaccines, adolescents, prevention, Meningitis
Medical subject headings: Meningococcal Infections, Meningitis, Meningococcal, Meningitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccineBiological
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
Meningococcal (group B) multicomponent recombinant adsorbed vaccineBiological
Liquid Meningococcal (group B) multicomponent recombinant adsorbed vaccine
TdapBiological
Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection

Study groups in NCT01367158
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Biological: Tdap

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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)
Measured: 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
Antibody response was measured as Geometric Mean hSBA Titers against N meningitidis Serogroups A, C, W and Y at One of Four MenABCWY Formulations or rMenB at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)
Measured: 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
Antibody response was measured as Geometric Mean Ratio (95% CI), against N meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination (month 7) With One of Four MenABCWY Formulations or rMenB
Measured: 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
Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Measured: 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
Antibody response was measured as Geometric Mean Ratio (95% CI), against Serogroup B Test Strains at One Month After the Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Measured: 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
Antibody response was measured as the percentage of subjects with seroresponse Against N meningitidis Serogroups A, C, W and Y, after pre and post vaccination at month 6 and after the third vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo. Seroresponse to N meningitidis serogroups A, C, W and Y is defined as: For subjects with a prevaccination hSBA <1:4, a postvaccination hSBA ≥1:8;For subjects with a prevaccination hSBA ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Measured: At month 7
Percentages of Subjects With 4-fold Increase in hSBA Titers 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 4-fold Increase in human serum bactericidal assay (hSBA) titers and associated 95% CI, Against Serogroup B Test Strains at One Month After Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Measured: At month 7
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Antibody response was measured as Geometric Mean hSBA Titers Against N meningitidis Serogroups A, C, W and Y after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.
Measured: At month 1, 3, 6, 7 and 12
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Antibody response was measured as Geometric Mean Ratios (95%CI) Against N meningitidis Serogroups A, C, W and Y after after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Measured: At month 1, 3, 6, 7 and 12
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, After Third Vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Measured: At month 1, 3, 6, 7 and 12
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (month 6) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Measured: At month 1, 3, 6, 7 and 12
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Measured: At month 1, 3, 6, 7 and 12
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Measured: At month 1, 3, 6, 7 and 12
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Measured: At month 1, 3, 6, 7 and 12
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Measured: At month 1, 3, 6, 7 and 12
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
Unsolicited AEs were collected with onset from Day 1 through Day 7 After Vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
Measured: From Day 1 to Day 7 after vaccination
Numbers of Subjects With Other Unsolicited AEs
Unsolicited AEs were collected from Day 8 After vaccination Through Study Termination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
Measured: Day 8 After vaccination Through Study Termination, up to 6 months
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Solicited local and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.
Measured: From Day 1 to Day 7 after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Jul 2012

First posted6 Jun 2011 (estimated)
Study startJul 2011
Primary completionJan 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Meningococcal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Care provider
Enrolment: 440 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01367158
Sponsor's protocol ID: V102_02E1
Status last verified: Nov 2014
First submitted: 3 Jun 2011
Last updated: 19 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 26135245

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Meningococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2, Observer-Blind, Controlled, Randomized, Multi-Center Extension Study to Evaluate Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY in Adolescents Who Previously Received the Same Study Vaccines
ClinicalTrials.gov ID: NCT01367158
Acronym / sponsor ID: V102_02E1
Conditions: Meningococcal Disease, Meningococcal Meningitis
Keywords: Meningococcal disease, vaccines, adolescents, prevention, Meningitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 440 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Jan 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 6 Jun 2011 (estimated)
Results: Posted 19 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 11

Arm	Type	Receives
3ABCWY	Experimental	Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccineTwo 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
2ABCWY	Experimental	Biological: TdapTwo 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
3ABx2CWY	Experimental	Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccinetwo 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
2ABx2CWY	Experimental	Biological: Tdaptwo 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
3ABCWY+OMV	Experimental	Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccineTwo 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
2ABCWY+OMV	Experimental	Biological: TdapTwo 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
3ABCWYqOMV	Experimental	Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccineTwo 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
2ABCWYqOMV	Experimental	Biological: TdapTwo 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
3B	Active comparator	Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccineTwo doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
2B	Active comparator	Biological: TdapTwo doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
1ACWY	Active comparator	Biological: TdapOne 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

Who may qualify

Ages: 11 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Individuals eligible to be enrolled into this study were male or female who completed study V10202 (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.

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccineThe 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	Biological	3ABCWY, 3ABCWY+OMV, 3ABCWYqOMV, 3ABx2CWY
Meningococcal (group B) multicomponent recombinant adsorbed vaccineLiquid Meningococcal (group B) multicomponent recombinant adsorbed vaccine	Biological	3B
TdapSterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection	Biological	1ACWY, 2ABCWY, 2ABCWY+OMV, 2ABCWYqOMV, 2ABx2CWY, 2B

Primary outcome

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
Time frame: At month 6 and month 7
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).
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
Time frame: At month 6 and month 7
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)

17 secondary outcomes

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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At month 7
Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo
Time frame: At month 7
GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time frame: At month 1, 3, 6, 7 and 12
GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time frame: At month 1, 3, 6, 7 and 12
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time frame: At month 1, 3, 6, 7 and 12
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time frame: At month 1, 3, 6, 7 and 12
GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time frame: At month 1, 3, 6, 7 and 12
GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time frame: At month 1, 3, 6, 7 and 12
GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time frame: At month 1, 3, 6, 7 and 12
GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo
Time frame: At month 1, 3, 6, 7 and 12
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
Time frame: From Day 1 to Day 7 after vaccination
Numbers of Subjects With Other Unsolicited AEs
Time frame: Day 8 After vaccination Through Study Termination, up to 6 months
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination
Time frame: From Day 1 to Day 7 after vaccination

Results and safety

Results posted to the registry on 19 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3ABCWY	25	25
2ABCWY	49	46
3ABx2CWY	24	23
2ABx2CWY	49	48
3ABCWY+OMV	25	23
2ABCWY+OMV	48	46
3ABCWYqOMV	25	25
2ABCWYqOMV	49	47
3 B	23	23
2 B	50	50
1ACWY	73	72

Primary outcome: 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

Time frame: At month 6 and month 7. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	3ABCWY n = 25	3ABx2CWY n = 24	3ABCWY+OMV n = 25	3ABCWYqOMV n = 25	3 B n = 23	1ACWY n = 72
Ser. A - month 6 (n=23,24,24,25,23,69)	52 (31 to 73)	79 (58 to 93)	75 (53 to 90)	68 (46 to 85)	35 (16 to 57)	55 (43 to 67)
Ser. A - month 7 (n=24,24,21,25,22,71)	100 (86 to 100)	100 (86 to 100)	100 (84 to 100)	100 (86 to 100)	91 (71 to 99)	58 (45 to 69)
Ser. C - month 6 (n=22,24,24,24,21,70)	100 (85 to 100)	96 (79 to 100)	100 (86 to 100)	100 (86 to 100)	33 (15 to 57)	76 (64 to 85)
Ser. C - month 7 (n=23,24,23,25,22,72)	100 (85 to 100)	100 (86 to 100)	100 (85 to 100)	100 (86 to 100)	73 (50 to 89)	68 (56 to 79)
Ser. W - month 6 (n=24,24,25,24,22,69)	100 (86 to 100)	96 (79 to 100)	100 (86 to 100)	100 (86 to 100)	55 (32 to 76)	97 (90 to 100)
Ser. W - month 7 (n=23,24,21,25,21,72)	100 (85 to 100)	100 (86 to 100)	100 (84 to 100)	100 (86 to 100)	90 (70 to 99)	96 (88 to 99)
Ser. Y - month 6 (n=24,24,24,25,23,72)	96 (79 to 100)	100 (86 to 100)	96 (79 to 100)	92 (74 to 99)	4 (0 to 22)	85 (74 to 92)
Ser. Y - month 7 (n=25,24,24,25,22,72)	100 (86 to 100)	96 (79 to 100)	100 (86 to 100)	100 (86 to 100)	14 (3 to 35)	85 (74 to 92)

Population analysed: Analysis was done by Modified Intention-To-Treat (MITT) Month 7 Set. MITT is defined as all subjects in the enrolled set who received a study vaccination at Month 6 and provided one evaluable serum sample at Month 7.

Primary outcome: 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

Time frame: At month 6 and month 7. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	3ABCWY n = 25	3ABx2CWY n = 24	3ABCWY+OMV n = 25	3ABCWYqOMV n = 25	3 B n = 23	1ACWY n = 73
H44/76 (fHbp) - month 6 (n=25,24,25,24,23,72)	40 (21 to 61)	46 (26 to 67)	52 (31 to 72)	29 (13 to 51)	35 (16 to 57)	3 (0 to 10)
H44/76 (fHbp) - month 7 (n=25,24,24,24,25,22,73)	92 (74 to 99)	96 (79 to 100)	96 (79 to 100)	92 (74 to 99)	91 (71 to 99)	4 (1 to 12)
5/99 (NadA) - month 6 (n=25,24,24,25,23,72)	96 (80 to 100)	100 (86 to 100)	96 (79 to 100)	100 (86 to 100)	100 (85 to 100)	15 (8 to 26)
5/99 (NadA) - month 7 (n=25,24,24,25,23,73)	100 (86 to 100)	100 (86 to 100)	100 (86 to 100)	100 (86 to 100)	100 (85 to 100)	16 (9 to 27)
NZ98/254(PorA) - month 6 (n=25,24,24,25,23,72)	12 (3 to 31)	8 (1 to 27)	29 (13 to 51)	12 (3 to 31)	9 (1 to 28)	0 (0 to 5)
NZ98/254(PorA) - month 7 (n=25,24,24,25,23,73)	20 (7 to 41)	29 (13 to 51)	88 (68 to 97)	76 (55 to 91)	17 (5 to 39)	1 (0.035 to 7)
M14459(fHBP) - month 6 (n=25,24,25,25,23,71)	24 (9 to 45)	25 (10 to 47)	32 (15 to 54)	16 (5 to 36)	17 (5 to 39)	6 (2 to 14)
M14459(fHBP) - month 7 (n=25,24,23,25,22,73)	80 (59 to 93)	79 (58 to 93)	87 (66 to 97)	88 (69 to 97)	64 (41 to 83)	8 (3 to 17)

Population analysed: Analysis was done by MITT Month 7 Set.

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety was assessed up to 6 months after vaccination. Solicited local AEs and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. All unsolicited AEs including SAEs were collected for 7 days after the vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3ABCWY	0 of 24 (0%)	20 of 24 (83.3%)	Not reported
2ABCWY	0 of 49 (0%)	38 of 49 (77.6%)	Not reported
3ABx2CWY	1 of 24 (4.2%)	20 of 24 (83.3%)	Not reported
2ABx2CWY	1 of 49 (2%)	36 of 49 (73.5%)	Not reported
3ABCWY+OMV	0 of 25 (0%)	23 of 25 (92%)	Not reported
2ABCWY+OMV	0 of 48 (0%)	37 of 48 (77.1%)	Not reported
3ABCWYqOMV	1 of 24 (4.2%)	22 of 24 (91.7%)	Not reported
2ABCWYqOMV	1 of 50 (2%)	38 of 50 (76%)	Not reported
3 B	0 of 23 (0%)	19 of 23 (82.6%)	Not reported
2 B	1 of 50 (2%)	40 of 50 (80%)	Not reported
1ACWY	0 of 73 (0%)	56 of 73 (76.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26135245Saez-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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Vaccines study chair

Novartis Vaccines

7 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Colombia, Chile, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: At month 6 and month 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01367158, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.