Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01424644
Other study ID # V59_40
Secondary ID 2011-000476-34
Status Completed
Phase Phase 4
First received August 23, 2011
Last updated January 21, 2014
Start date September 2011
Est. completion date December 2012

Study information

Verified date January 2014
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationItaly: The Italian Medicines Agency
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 801
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Years to 18 Years
Eligibility Inclusion Criteria:

Individuals eligible for enrollment in this study were female and male individuals who had been shown to be healthy and who were:

1. 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

- Clinical judgment of the investigator

2. Had been properly vaccinated against diphtheria, tetanus, and pertussis per local regulations;

3. 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.

4. For female subjects, who had a negative urine pregnancy test.

5. Any female subject who is sexually active committed to practice appropriate birth control.

Exclusion Criteria:

Individuals not eligible to be enrolled in the study were those:

1. Who were unwilling to give their written assent / consent

2. Who were breastfeeding

3. Who was, and/or whose parents or legal guardians were perceived to be unreliable or unavailable for the duration of the study period

4. Who had previous confirmed or suspected disease caused by N. meningitidis

5. Who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment

6. 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)

7. Who had received prior human papillomavirus (HPV) vaccine

8. 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

9. 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)

10. 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

11. 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)

12. Who had epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome

13. Who had a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including latex allergy

14. 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

15. Who were known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;

16. Who have Down's syndrome or other known cytogenic disorders;

17. Who and/or whose families were planning to leave the area of the study site before the end of the study period;

18. Who had any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

19. Who were relatives of the study personnel.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Intervention

Biological:
Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine
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 Vaccine
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®.

Locations

Country Name City State
Italy Hospital "Maggiore della Carità". Pediatric Clinic Corso Mazzini, 18 Novara
Italy HOSPITAL"SAN MARTINO". Department of Health Sciences University of Genoa Via Pastore, 1 Genoa
Italy Hospital of Taranto- Unit of Hygiene and Publich Health Vaccination Center Viale Magna Grecia, 173 Taranto
United States Bellevue Family Practice, 2206 Longo Suite 201 Bellevue Nebraska
United States Birmingham Pediatrics, 806 Saint Vincent's Drive, Suite 615 Birmingham Alabama
United States Roslindale Pediatrics Associates, 1153 Centre Street, Suite 31 Boston Massachusetts
United States Clinical Research Advantage / Colorado Springs Health Partners, 6340 Barnes Road Colorado Springs Colorado
United States Columbia Medical Practice, 5450 Knoll North Drive, Suite 215 Columbia Maryland
United States Clinical Research Advantage / Ridge Family Physicians, 201 Ridge Street, Suite 201 Council Bluffs Iowa
United States Dayton Clinical Research, 1100 Salem Ave Dayton Florida
United States Prairie Fields Family Medicine, 350 W. 23rd Street, Suite A Fremont California
United States Ohio Pediatric Research Association, 7371 Brandt Pike Suite C Huber Heights Ohio
United States Altamonte Pediatric Associates, 101 N. Country Club Rd. #113 Lake Mary Florida
United States Complete Children's Health, 8201 Northwoods Drive Lincoln Nebraska
United States Madera Family Medical Group, 1111 W. Fourth Street Madera California
United States Pediatrics and Adolescent Medicine, 2155 Post Oak Tritt Road, Suite 100 Marietta Georgia
United States Meridian Clinical Research, 3319 North, 107th Street Omaha Nebraska
United States Capitol Pediatrics and Adolescent Center, 3801 Computer Drive Suite 200 Raleigh North Carolina
United States Omega Medical Research, 400 Bald Hill Road Warwick Rhode Island
United States Pediatrics and Adolescent Medicine, 120 Stonebridge Parkway, Suite 410 Woodstock New York

Sponsors (2)

Lead Sponsor Collaborator
Novartis Novartis Vaccines

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 month post Tdap vaccination. No
Primary 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. 1 month post Tdap vaccination. No
Secondary 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. 1 month post MenACWY-CRM vaccination. No
Secondary 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. Day 1-7 after any vaccination. Yes
Secondary 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.
Throughout the study (Day 1 to Day 211). Yes
See also
  Status Clinical Trial Phase
Completed NCT01434680 - Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers Phase 2
Completed NCT00384397 - A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers Phase 3
Completed NCT01453348 - Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine Phase 3
Completed NCT01214837 - Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life Phase 3
Completed NCT00874549 - Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years Phase 1/Phase 2
Completed NCT00355121 - Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL® Phase 2
Completed NCT02591290 - Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects Phase 4
Completed NCT01717638 - Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1 Phase 3
Completed NCT01482052 - Safety Study of Group A, C, Y & W-135 Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine for Meningitis Phase 1
Completed NCT01466387 - A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults Phase 3
Completed NCT01239043 - Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination Phase 2
Completed NCT00994695 - Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Vaccine Phase 2
Completed NCT01732627 - Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older Phase 2
Completed NCT01478347 - A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults Phase 3
Completed NCT00474487 - A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults Phase 3
Completed NCT00483574 - Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers Phase 3
Completed NCT03205358 - Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Toddlers Phase 2
Not yet recruiting NCT06226714 - A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in 18-59 Year Olds Phase 3
Completed NCT00667602 - Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers Phase 3
Completed NCT00450437 - A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults Phase 3