Meningococcal DiseasePhase 3NCT00329901

Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

A Phase 3 study testing Meningococcal ACWY conjugate vaccine (MenACWY-CRM) and Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap) in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 14 sites in Italy.

Completed

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

Official record

Search all trials

Trial summary

Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years Read more about this study

Who is it for?: Ages 11 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease, Meningococcal Meningitis
What is being tested?: Meningococcal ACWY conjugate vaccine (MenACWY-CRM) and Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,072 participants
Where: 14 sitesItaly
Study dates: Apr 2006to Dec 2007
Phase: Phase 3
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 25 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Male and female 11-25 years old healthy subjects;
who had received the primary immunization with a vaccine containing DT or Tdap antigens and a T, Td, or Tdap booster injection at least 5 years prior to study entry

Who cannot join

previous ascertained or suspected disease caused by N. meningitidis
previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
serious acute, chronic or progressive disease
history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component
known or suspected impairment/alteration of immune function, either congenital or acquired

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Italy14 sites

Study site
Andria
Study site
Catania
Study site
Chieti
Study site
Ferrara
Study site
Genova
Study site
Lanciano
Study site
Massafra
Study site
Modena
Study site
Novara
Study site
Palermo
Study site
Pieve Di Soligo (TV)
Study site
Roma
Study site
Sassari
Study site
Taranto

Other trials in Italy

About this study

Official title: A Phase 3, Multi-Center, Observer Blind, Controlled, Randomized Study to Compare the Immunogenicity and Safety of the Concomitant Administration of a Combined Tetanus, Reduced Diphtheria, and Acellular Pertussis (Tdap) Vaccine and Chiron (Now Novartis) Meningococcal ACWY Conjugate Vaccine, With Either One Dose of Acellular Pertussis (Tdap) Vaccine, or One Dose of Chiron (Now Novartis) Meningococcal ACWY Conjugate Vaccine, in Healthy Subjects Aged 11-25 Years

Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

Conditions: Meningococcal Disease, Meningococcal Meningitis
Being tested: Meningococcal ACWY conjugate vaccine (MenACWY-CRM), Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap), saline placebo
Keywords: Meningitis, healthy subject, vaccine
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 ACWY conjugate vaccine (MenACWY-CRM)Biological
Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)Biological
saline placeboBiological
4.5 mg sodium chloride per 0.5 ml dose

Study groups in NCT00329901
Study group	Role	What they receive
Tdap + MenACWY-CRM	Experimental	Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms Receives: Biological: Meningococcal ACWY conjugate vaccine (MenACWY-CRM); Biological: Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)
Tdap + saline	Experimental	Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms Receives: Biological: Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap); Biological: saline placebo
MenACWY-CRM + saline	Experimental	Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms Receives: Biological: Meningococcal ACWY conjugate vaccine (MenACWY-CRM); Biological: saline placebo

What is being measured

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

Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of
1. the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and
2. the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA).
Measured: 1 month after vaccination (Day 29)

Secondary outcomes (10)

Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
The percentage of subjects with anti-diphtheria and anti-tetanus concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.
Measured: 1 month after vaccination (Day 29)
Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
The geometric mean concentrations of antibodies ≥ 0.1 IU/mL against diphtheria, tetanus and pertussis (PT, FHA and PRN) antigens in subjects, as measured by ELISA, following concomitant administration of Tdap with MenACWY-CRM as compared to when Tdap given concomitantly with saline placebo.
Measured: 1 month after vaccination (Day 29)
Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
The geometric mean ratios (GMRs- day 29/day 1) of post-vaccination versus pre- vaccination antibody concentrations against diptheria, tetanus and pertussis (PT, FHA and PRN) antigens following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.
Measured: 1 month after vaccination (Day 29)
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
The percentage of subjects with serum bactericidal antibody titers(hSBA) ≥ 1:4 and ≥ 1:8 against Neisseria meningitidis serogroups A,C,W and Y,following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.
The serum bactericidal antibodies directed against N.meningitidis serogroup A, C, W and Y, are measured by human complement Serum Bactericidal Assay (hSBA).
Measured: 1 month after vaccination (Day 29)
The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
The hSBA geometric mean titers (GMTs) against N.meningitidis serogroups A,C,W and Y, at baseline and at one month, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine, as compared to when MenACWY-CRM was given concomitantly with saline placebo.
Measured: 1 month after vaccination (Day 29)
Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
The geometric mean ratios (GMRs-day 29/day1)of post-vaccination versus pre- vaccination hSBA titers against N.meningitidis serogroups A,C,W and Y, when MenACWY-CRM vaccine is concomitantly administered with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.
Measured: 1 month after vaccination (Day 29)
Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
The percentage of subjects showing an hSBA seroresponse against N.meningitidis serogroups A,C,W and Y, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.
Seroresponse to MenACWY-CRM is defined as a pre-vaccination hSBA titer < 1:4 to a post-vaccination hSBA titer of ≥ 1:8 or a pre-vaccination hSBA titer ≥ 1:4 to a post-vaccination titer of at least four times the baseline hSBA titer.
Measured: 1 month after vaccination (Day 29)
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when MenACWY-CRM vaccine was concomitantly administered with saline placebo.
Measured: Day 1-7 after any vaccination
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when Tdap was concomitantly administered with saline placebo
Measured: Day 1-7 after any vaccination
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
The number of subjects reporting any unsolicited adverse events (AEs) when Tdap is concomitantly administered with MenACWY-CRM as compared to when MenACWY-CRM vaccine or Tdap vaccine was concomitantly administered with saline placebo.
Measured: Throughout the study (Day 1 to Day 181)

Timeline

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

Apr 2006Dec 2007

First posted25 May 2006 (estimated)
Study startApr 2006
Primary completionMay 2007
Study completionDec 2007

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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,072 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00329901
Sponsor's protocol ID: V59P11
Other IDs: 2005-005519-12, 2005
Status last verified: Jun 2014
First submitted: 23 May 2006
Last updated: 18 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Gasparini R, Conversano M, Bona G, Gabutti G, Anemona A, Dull PM, Ceddia F. Randomized trial on the safety, tolerability, and immunogenicity of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, administered concomitantly with a combined tetanus, reduced diphtheria, and acellular pertussis vaccine in adolescents and young adults. Clin Vaccine Immunol. 2010 Apr;17(4):537-44. doi: 10.1128/CVI.00436-09. Epub 2010 Feb 17.
PubMed 20164251

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

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines

All Meningococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multi-Center, Observer Blind, Controlled, Randomized Study to Compare the Immunogenicity and Safety of the Concomitant Administration of a Combined Tetanus, Reduced Diphtheria, and Acellular Pertussis (Tdap) Vaccine and Chiron (Now Novartis) Meningococcal ACWY Conjugate Vaccine, With Either One Dose of Acellular Pertussis (Tdap) Vaccine, or One Dose of Chiron (Now Novartis) Meningococcal ACWY Conjugate Vaccine, in Healthy Subjects Aged 11-25 Years
ClinicalTrials.gov ID: NCT00329901
Acronym / sponsor ID: V59P11
Conditions: Meningococcal Disease, Meningococcal Meningitis
Keywords: Meningitis, healthy subject, vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,072 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: May 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 25 May 2006 (estimated)
Results: Posted 18 Jun 2014

Clinical summary

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

Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Tdap + MenACWY-CRM	Experimental	Biological: Meningococcal ACWY conjugate vaccine (MenACWY-CRM), Biological: Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms
Tdap + saline	Experimental	Biological: Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap), Biological: saline placeboSubjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
MenACWY-CRM + saline	Experimental	Biological: Meningococcal ACWY conjugate vaccine (MenACWY-CRM), Biological: saline placeboSubjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms

Who may qualify

Ages: 11 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

Male and female 11-25 years old healthy subjects;
who had received the primary immunization with a vaccine containing DT or Tdap antigens and a T, Td, or Tdap booster injection at least 5 years prior to study entry

Key exclusion criteria (5 listed)

previous ascertained or suspected disease caused by N. meningitidis
previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
serious acute, chronic or progressive disease
history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component
known or suspected impairment/alteration of immune function, either congenital or acquired

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 ACWY conjugate vaccine (MenACWY-CRM)	Biological	MenACWY-CRM + saline, Tdap + MenACWY-CRM
Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)	Biological	Tdap + MenACWY-CRM, Tdap + saline
saline placebo4.5 mg sodium chloride per 0.5 ml dose	Biological	MenACWY-CRM + saline, Tdap + saline

Primary outcome

Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Time frame: 1 month after vaccination (Day 29)
To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of 1. the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and 2. the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA).

10 secondary outcomes

Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
Time frame: 1 month after vaccination (Day 29)
Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Time frame: 1 month after vaccination (Day 29)
Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
Time frame: 1 month after vaccination (Day 29)
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Time frame: 1 month after vaccination (Day 29)
The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Time frame: 1 month after vaccination (Day 29)
Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Time frame: 1 month after vaccination (Day 29)
Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Time frame: 1 month after vaccination (Day 29)
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Time frame: Day 1-7 after any vaccination
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Time frame: Day 1-7 after any vaccination
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
Time frame: Throughout the study (Day 1 to Day 181)

Results and safety

Results posted to the registry on 18 Jun 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
Tdap + MenACWY-CRM	361	352
Tdap + Saline	354	349
MenACWY-CRM + Saline	357	353

Primary outcome: Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo

Time frame: 1 month after vaccination (Day 29). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	Tdap+MenACWY-CRM n = 350	Tdap+Saline n = 345
Day 1 (diphtheria)	4 (2 to 7)	5 (3 to 7)
Day 29 (diphtheria)	94 (91 to 96)	85 (80 to 88)
Day 1 (tetanus )	25 (20 to 30)	36 (31 to 42)
Day 29 (tetanus )	100 (99 to 100)	99 (98 to 100)
Day 29 (PT) 4-fold increase (N=286, 287)	76 (70 to 80)	81 (76 to 85)
Day 29 (FHA)4-fold increase (N=286, 287)	83 (78 to 87)	86 (82 to 90)
Day 29 (PRN) 4-fold increase (N=285, 287)	84 (79 to 88)	91 (87 to 94)

Tdap+MenACWY-CRM vs Tdap+Saline: Vaccine Group difference: 9 (95% CI 5 to 14)
Tdap+MenACWY-CRM vs Tdap+Saline: Vaccine Group Difference: 1 (95% CI -1 to 2)
Tdap+MenACWY-CRM vs Tdap+Saline: Vaccine Group difference: -5 (95% CI -12 to 1)

Population analysed: Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tdap + MenACWY-CRM	1 of 359 (0.3%)	297 of 359 (82.7%)	Not reported
Tdap + Saline	2 of 353 (0.6%)	309 of 353 (87.5%)	Not reported
MenACWY-CRM + Saline	0 of 357 (0%)	238 of 357 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20164251Gasparini R, Conversano M, Bona G, Gabutti G, Anemona A, Dull PM, Ceddia F. Randomized trial on the safety, tolerability, and immunogenicity of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, administered concomitantly with a combined tetanus, reduced diphtheria, and acellular pertussis vaccine in adolescents and young adults. Clin Vaccine Immunol. 2010 Apr;17(4):537-44. doi: 10.1128/CVI.00436-09. Epub 2010 Feb 17.

Related trials for Meningococcal Disease

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines

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 - Information Services study chair

Novartis Vaccines & Diagnostics

14 sites in 1 country: 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 2 inclusion and 5 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 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 18 Jun 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?

Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo (time frame: 1 month after vaccination (Day 29)). 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 NCT00329901, 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 18 Jun 2014.