Meningococcal MeningitisPhase 4NCT01424644

A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents

A Phase 4 study testing MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine in people with Meningococcal Meningitis, run by Novartis at 20 sites in 2 countries.

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

The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline, Boostrix®) and HPV vaccine (Merck \& Co., Inc., Gardasil®) when administered concomitantly with MenACWY are comparable to responses elicited by these vaccines when given alone. Read more about this study

Who is it for?: Ages 11 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Meningitis
What is being tested?: MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 801 participants
Where: 20 sitesin 2 countries
Study dates: Sep 2011to Dec 2012
Phase: Phase 4
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 for enrollment in this study were female and male individuals who had been shown to be healthy and who were:
11-18 years of age inclusive who had given their written consent/assent and if applicable, whose parents or legal guardians had given written informed consent at the time of enrollment;
Available for all visits and telephone calls scheduled for the study;
In good health as determined by:
Medical history
Physical assessment

Show all 11Show fewer

Clinical judgment of the investigator
Had been properly vaccinated against diphtheria, tetanus, and pertussis per local regulations;
Subjects who were current with childhood DTP-containing vaccinations per local guidelines. Any previous vaccinations containing DTP must have been received at least 5 years before study enrollment and no prior adolescent vaccinations (11-18 years of age) containing DTP vaccines were allowed.
For female subjects, who had a negative urine pregnancy test.
Any female subject who is sexually active committed to practice appropriate birth control.

Who cannot join

Individuals not eligible to be enrolled in the study were those:
Who were unwilling to give their written assent / consent
Who were breastfeeding
Who was, and/or whose parents or legal guardians were perceived to be unreliable or unavailable for the duration of the study period
Who had previous confirmed or suspected disease caused by N. meningitidis
Who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment

Show all 33Show fewer

Who had previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational). (Exception: Receipt of OMP-containing Hib vaccines was permitted)
Who had received prior human papillomavirus (HPV) vaccine
Who had received investigational agents or vaccines within 30 days prior to enrollment or who expected to receive an investigational agent or vaccine prior to completion of the study
Who had received live licensed vaccines within 30 days and inactive vaccine within 15 days prior to enrollment or for whom receipt of a licensed vaccine is anticipated during the study period.
(Exception: Influenza vaccine could be administered up to 15 days prior to each study immunization and no less than 15 days after each study vaccination)
Who had experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to enrollment
Who had any serious acute, chronic or progressive disease such as
History of cancer
Complicated diabetes mellitus
Advanced arteriosclerotic disease
Autoimmune disease
HIV infection or AIDS
Blood dyscrasias
Congestive heart failure
Renal failure
Severe malnutrition (Note: Subjects with mild asthma were eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids were not eligible for enrollment)
Who had epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome
Who had a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including latex allergy
Who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
Receipt of immunosuppressive therapy within 30 days prior to enrollment (systemic corticosteroids administered for more than 5 days, or in a daily dose > 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy)
Receipt of immunostimulants
Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study
Who were known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
Who have Down's syndrome or other known cytogenic disorders;
Who and/or whose families were planning to leave the area of the study site before the end of the study period;
Who had any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Who were relatives of the study personnel.

Trial locations and contacts

20 sites in 2 countries.

Country

City, postcode or hospital

20 sites in 2 countries

United States17 sites

Bellevue Family Practice, 2206 Longo Suite 201
Bellevue, Nebraska, 68005
Birmingham Pediatrics, 806 Saint Vincent's Drive, Suite 615
Birmingham, Alabama, 35205
Roslindale Pediatrics Associates, 1153 Centre Street, Suite 31
Boston, Massachusetts, 02130
Clinical Research Advantage / Colorado Springs Health Partners, 6340 Barnes Road
Colorado Springs, Colorado, 80922
Columbia Medical Practice, 5450 Knoll North Drive, Suite 215
Columbia, Maryland, 21045
Clinical Research Advantage / Ridge Family Physicians, 201 Ridge Street, Suite 201
Council Bluffs, Iowa, 51503
Dayton Clinical Research, 1100 Salem Ave
Dayton, Florida, 45406
Prairie Fields Family Medicine, 350 W. 23rd Street, Suite A
Fremont, California, 68025
Ohio Pediatric Research Association, 7371 Brandt Pike Suite C
Huber Heights, Ohio, 45424
Altamonte Pediatric Associates, 101 N. Country Club Rd. #113
Lake Mary, Florida, 32746
Complete Children's Health, 8201 Northwoods Drive
Lincoln, Nebraska, 68505
Madera Family Medical Group, 1111 W. Fourth Street
Madera, California, 93637
Pediatrics and Adolescent Medicine, 2155 Post Oak Tritt Road, Suite 100
Marietta, Georgia, 30062
Meridian Clinical Research, 3319 North, 107th Street
Omaha, Nebraska, 68134
Capitol Pediatrics and Adolescent Center, 3801 Computer Drive Suite 200
Raleigh, North Carolina, 27609
Omega Medical Research, 400 Bald Hill Road
Warwick, Rhode Island, 02886
Pediatrics and Adolescent Medicine, 120 Stonebridge Parkway, Suite 410
Woodstock, New York, 30189

Other trials in United States

Italy3 sites

Hospital "Maggiore della Carità". Pediatric Clinic
Corso Mazzini, 18, Novara, 28100
HOSPITAL"SAN MARTINO". Department of Health Sciences University of Genoa
Via Pastore, 1, Genoa, 16132
Hospital of Taranto- Unit of Hygiene and Publich Health Vaccination Center
Viale Magna Grecia, 173, Taranto, 74016

Other trials in Italy

About this study

Official title: A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine (Tdap, Boostrix®) and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine (Gardasil®) in Healthy Adolescents When Administered With MenACWY Conjugate Vaccine

Conditions: Meningococcal Meningitis
Being tested: Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine, MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine
Keywords: meningitis, human papillomavirus, tetanus, diptheria, pertussis
Medical subject headings: Meningitis, Meningococcal, Meningitis, Tetanus, Whooping Cough

What participants receive

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

Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus VaccineBiological
All three vaccines were administered concomitantly. Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine is GARDASIL®.
Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine(Tdap) is Boostrix®.
MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus VaccineBiological
All three vaccines were administered concomitantly. MenACWY-CRM contains diphtheria-like toxoid as carrier for the capsular polysaccharides. Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine is GARDASIL®.
Reduced Diphtheria Toxoid,Acellular Pertussis Vaccine(Tdap) is Boostrix®.

Study groups in NCT01424644
Study group	Role	What they receive
Placebo + Tdap + HPV	Placebo comparator	This group will receive Tdap, HPV and placebo concomitantly for the first vaccination. The second and third doses of HPV vaccine will be administered to all subjects 2 and 6 months after the first dose. All subjects will have serum samples collected at Visit 1 (baseline), Visit 2 (31 days) and Visit 5 (7 months after visit 1) for serology testing. Receives: Biological: Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine
MenACWY-CRM + Tdap + HPV	Experimental	This group will receive Tdap, HPV and MenACWY-CRM concomitantly. The second and third doses of HPV vaccine will be administered to this group 2 and 6 months after the first dose. All subjects will have serum samples collected at Visit 1 (baseline), Visit 2 (31 days) and Visit 5 (7 months after visit 1) for serology testing. Receives: Biological: MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine

What is being measured

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

Percentages of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With HPV and MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With HPV and Placebo
The percentages of subjects with anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap with HPV and MenACWY-CRM vaccine as compared to concomitant administration of Tdap with HPV and placebo.
Measured: 1 month post Tdap vaccination.
Geometric Mean Concentrations of Antibodies Against Pertussis Antigens After Concomitant Administration of Tdap With HPV and MenACWY-CRM Compared to Concomitant Administration of Tdap With HPV and Placebo
The geometric mean concentrations (GMCs) of antibodies against pertussis antigens (PT, FHA and PRN), as measured by ELISA, following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.
Measured: 1 month post Tdap vaccination.

Secondary outcomes (3)

Geometric Mean hSBA Titers Against N. Meningitidis Serogroups A,C,W and Y at 1 Month After Men ACWY Vaccination.
The immunogenicity was assessed in terms of geometric mean hSBA titers of MenACWY when administered concomitantly with Tdap and HPV at 1 month after 1 dose of MenACWY vaccination.
Measured: 1 month post MenACWY-CRM vaccination.
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine, Tdap and HPV vaccine as compared to concomitant administration of placebo with Tdap and HPV.
Measured: Day 1-7 after any vaccination.
Number of Subjects With Unsolicited Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
The number of subjects reporting any unsolicited adverse reactions (AEs) when Tdap and HPV are concomitantly administered with MenACWY-CRM as compared to when Tdap and HPV vaccine are concomitantly administered with placebo.
Note: A total of 2 MenACWY-CRM+Tdap+HPV subjects reported AEs leading to premature withdrawal - one subject due to treatment emergent AE and another subject prior to study vaccination on day 1.
Measured: Throughout the study (Day 1 to Day 211).

Timeline

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

Sep 2011Dec 2012

First posted29 Aug 2011 (estimated)
Study startSep 2011
Primary completionDec 2012
Study completionDec 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 MeningitisStudies 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 801 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01424644
Sponsor's protocol ID: V59_40
Other IDs: 2011-000476-34
Status last verified: Jan 2014
First submitted: 23 Aug 2011
Last updated: 14 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Miao Y, Mzolo T, Pellegrini M. Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine When Co-Administered with Tetanus-Reduced Diphtheria-Acellular Pertussis and Quadrivalent Meningococcal Conjugate Vaccines in Healthy Adolescents: Results from a Randomized, Observer-Blind, Controlled Trial. Infect Dis Ther. 2019 Sep;8(3):335-341. doi: 10.1007/s40121-019-00258-5. Epub 2019 Aug 3.
PubMed 31377946

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
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 6-11 Months
Epidemic Meningitis, Meningococcal Vaccines
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 Months
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All Meningococcal Meningitis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine (Tdap, Boostrix®) and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine (Gardasil®) in Healthy Adolescents When Administered With MenACWY Conjugate Vaccine
ClinicalTrials.gov ID: NCT01424644
Acronym / sponsor ID: V59_40
Conditions: Meningococcal Meningitis
Keywords: meningitis, human papillomavirus, tetanus, diptheria, pertussis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 801 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Collaborators: Novartis Vaccines
Study start: Sep 2011
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 29 Aug 2011 (estimated)
Results: Posted 14 Feb 2014

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo + Tdap + HPV	Placebo comparator	Biological: Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus VaccineThis group will receive Tdap, HPV and placebo concomitantly for the first vaccination. The second and third doses of HPV vaccine will be administered to all subjects 2 and 6 months after the first dose. All subjects will have serum samples collected at Visit 1 (baseline), Visit 2 (31 days) and Visit 5 (7 months after visit 1) for serology testing.
MenACWY-CRM + Tdap + HPV	Experimental	Biological: MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus VaccineThis group will receive Tdap, HPV and MenACWY-CRM concomitantly. The second and third doses of HPV vaccine will be administered to this group 2 and 6 months after the first dose. All subjects will have serum samples collected at Visit 1 (baseline), Visit 2 (31 days) and Visit 5 (7 months after visit 1) for serology testing.

Who may qualify

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

Key inclusion criteria (11 listed)

Individuals eligible for enrollment in this study were female and male individuals who had been shown to be healthy and who were:
11-18 years of age inclusive who had given their written consent/assent and if applicable, whose parents or legal guardians had given written informed consent at the time of enrollment;
Had been properly vaccinated against diphtheria, tetanus, and pertussis per local regulations;
Subjects who were current with childhood DTP-containing vaccinations per local guidelines. Any previous vaccinations containing DTP must have been received at least 5 years before study enrollment and no prior adolescent vaccinations (11-18 years of age) containing DTP vaccines were allowed.
For female subjects, who had a negative urine pregnancy test.

Key exclusion criteria (33 listed)

Who were unwilling to give their written assent / consent
Who were breastfeeding
Who was, and/or whose parents or legal guardians were perceived to be unreliable or unavailable for the duration of the study period
Who had previous confirmed or suspected disease caused by N. meningitidis
Who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment

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
Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus VaccineAll three vaccines were administered concomitantly. Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine is GARDASIL®. Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine(Tdap) is Boostrix®.	Biological	Placebo + Tdap + HPV
MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus VaccineAll three vaccines were administered concomitantly. MenACWY-CRM contains diphtheria-like toxoid as carrier for the capsular polysaccharides. Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine is GARDASIL®. Reduced Diphtheria Toxoid,Acellular Pertussis Vaccine(Tdap) is Boostrix®.	Biological	MenACWY-CRM + Tdap + HPV

Primary outcome

Percentages of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With HPV and MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With HPV and Placebo
Time frame: 1 month post Tdap vaccination.
The percentages of subjects with anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap with HPV and MenACWY-CRM vaccine as compared to concomitant administration of Tdap with HPV and placebo.
Geometric Mean Concentrations of Antibodies Against Pertussis Antigens After Concomitant Administration of Tdap With HPV and MenACWY-CRM Compared to Concomitant Administration of Tdap With HPV and Placebo
Time frame: 1 month post Tdap vaccination.
The geometric mean concentrations (GMCs) of antibodies against pertussis antigens (PT, FHA and PRN), as measured by ELISA, following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.

3 secondary outcomes

Geometric Mean hSBA Titers Against N. Meningitidis Serogroups A,C,W and Y at 1 Month After Men ACWY Vaccination.
Time frame: 1 month post MenACWY-CRM vaccination.
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Time frame: Day 1-7 after any vaccination.
Number of Subjects With Unsolicited Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo
Time frame: Throughout the study (Day 1 to Day 211).

Results and safety

Results posted to the registry on 14 Feb 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
MenACWY-CRM+Tdap+HPV	402	369
Placebo+Tdap+HPV	399	372

Primary outcome: Percentages of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With HPV and MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With HPV and Placebo

Time frame: 1 month post Tdap vaccination.. Number (95% Confidence Interval). Unit: percentages of subjects

Measure	MenACWY-CRM+Tdap+HPV n = 376	Placebo+Tdap+HPV n = 382
Day 1 (diphtheria) (N=375, 380)	5 (3 to 8)	3 (2 to 5)
One month post dose (diphtheria)	95 (93 to 97)	82 (78 to 86)
Day 1 (tetanus ) (N=375, 380)	28 (24 to 33)	28 (23 to 32)
One month post dose (tetanus )	99 (97 to 100)	98 (97 to 99)

MenACWY-CRM+Tdap+HPV vs Placebo+Tdap+HPV: Vaccine group difference: 13 (95% CI 9 to 17), Miettinen and Nurminen
MenACWY-CRM+Tdap+HPV vs Placebo+Tdap+HPV: Vaccine group difference: 0 (95% CI -2 to 2), Miettinen and Nurminen

Population analysed: Analysis was done on the Tdap per-protocol population, i.e., all subjects who received all the relevant doses of vaccine correctly, and provided serology results at one month postvaccination, and had no major protocol violation as defined prior to unblinding.

Primary outcome: Geometric Mean Concentrations of Antibodies Against Pertussis Antigens After Concomitant Administration of Tdap With HPV and MenACWY-CRM Compared to Concomitant Administration of Tdap With HPV and Placebo

Time frame: 1 month post Tdap vaccination.. Geometric mean (95% Confidence Interval). Unit: EU/mL

Measure	MenACWY-CRM+Tdap+HPV n = 376	Placebo+Tdap+HPV n = 382
PT (Day 1) (N= 375, 380)	4.77 (4.11 to 5.53)	4.16 (3.59 to 4.82)
PT(One month post dose)	44 (40 to 48)	44 (40 to 48)
FHA (Day 1) (N= 375, 380)	24 (21 to 27)	21 (18 to 23)
FHA (One month post dose)	202 (187 to 218)	240 (222 to 259)
PRN (Day 1) (N= 375, 380)	20 (18 to 23)	21 (18 to 24)
PRN (One month post dose)	330 (300 to 363)	403 (367 to 443)

MenACWY-CRM+Tdap+HPV vs Placebo+Tdap+HPV: Vaccine group ratio-Geometric mean conc: 1.01 (95% CI 0.89 to 1.14), ANOVA
MenACWY-CRM+Tdap+HPV vs Placebo+Tdap+HPV: Vaccine group ratio- Geometric mean conc: 0.84 (95% CI 0.76 to 0.93), ANOVA
MenACWY-CRM+Tdap+HPV vs Placebo+Tdap+HPV: Vaccine group ratio-Geometric mean conc: 0.82 (95% CI 0.72 to 0.93), ANOVA

Population analysed: Analysis was done on the Tdap per-protocol population.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From day 1 through day 211.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MenACWY-CRM+Tdap+HPV	4 of 396 (1%)	288 of 396 (72.7%)	Not reported
Placebo+Tdap+HPV	3 of 397 (0.8%)	248 of 397 (62.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31377946Miao Y, Mzolo T, Pellegrini M. Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine When Co-Administered with Tetanus-Reduced Diphtheria-Acellular Pertussis and Quadrivalent Meningococcal Conjugate Vaccines in Healthy Adolescents: Results from a Randomized, Observer-Blind, Controlled Trial. Infect Dis Ther. 2019 Sep;8(3):335-341. doi: 10.1007/s40121-019-00258-5. Epub 2019 Aug 3.

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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

20 sites in 2 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 11 inclusion and 33 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 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 14 Feb 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 Anti-diphtheria and Anti-tetanus Antibody Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With HPV and MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With HPV and Placebo (time frame: 1 month post Tdap vaccination.). 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 NCT01424644, 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 14 Feb 2014.