Overview

This trial has been completed.

Conditions meningitis, meningococcal meningitis, meningococcal infections
Treatments meningococcal polysaccharide (serogroups a, c, y, and w135) tetanus toxoid conjugate vaccine, meningococcal (groups a, c, y and w135) oligosaccharide diphtheria crm197conjugate vaccine, adacel®: tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, gardasil®: human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant
Phase phase 2
Sponsor Sanofi Pasteur, a Sanofi Company
Start date July 2014
End date October 2015
Trial size 1692 participants
Trial identifier NCT02199691, MET50, U1111-1143-8537

Summary

The purpose of this trial is to evaluate the immunogenicity and safety of MenACYW conjugate vaccine compared to those of a licensed product, MENVEO vaccine and also evaluate MenACYW conjugate vaccine when given alone compared to when given with Tdap vaccine and HPV vaccine.

Primary objective:

- To evaluate the antibody responses to the antigens present in MenACYW conjugate vaccine when MenACYW conjugate vaccine is given alone compared to those when MENVEO vaccine is given alone.

Secondary objective:

- To evaluate the antibody responses to the antigens present in MenACYW conjugate vaccine, when MenACYW conjugate vaccine is given concomitantly with Tdap and HPV vaccines, compared to those when it is given alone

- To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap vaccine is given concomitantly with MenACYW conjugate vaccine and HPV vaccine, compared to those when Tdap vaccine is given with HPV vaccine only

Observational objective:

- To describe the safety profile of MenACYW conjugate vaccine, compared to that of the licensed vaccine MENVEO®, and when MenACYW conjugate vaccine is given with Tdap and HPV vaccines.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Participants will receive MenACYW conjugate vaccine
meningococcal polysaccharide (serogroups a, c, y, and w135) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine
0.5 mL, Intramuscular (IM)
(Active Comparator)
Participants will receive MENVEO® vaccine
meningococcal (groups a, c, y and w135) oligosaccharide diphtheria crm197conjugate vaccine MENVEO®
0.5 mL, IM
(Experimental)
Participants will receive MenACYW conjugate vaccine, Tdap and HPV
adacel®: tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed Adacel® (Tdap)
0.5 mL, IM
gardasil®: human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant GARDASIL® (HPV)
0.5 mL, IM
meningococcal polysaccharide (serogroups a, c, y, and w135) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine
0.5 mL, Intramuscular (IM)
(Active Comparator)
Participants will receive Tdap and HPV
adacel®: tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed Adacel® (Tdap)
0.5 mL, IM
gardasil®: human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant GARDASIL® (HPV)
0.5 mL, IM

Primary Outcomes

Measure
Levels of Antibody titers against meningococcal serogroups A, C, Y, and W135 measured by serum bactericidal assay using human complement (hSBA) for Group 1 and Group 3
time frame: Day 0 (pre-vaccination) and 30 days post-vaccination

Secondary Outcomes

Measure
Levels of Antibody titers against meningococcal serogroups A, C, Y, and W135 measured by serum bactericidal assay using human complement (hSBA) for Group 1 and Group 2
time frame: Day 0 (pre-vaccination) and 30 days post-vaccination
Levels of Anti-pertussis antibody concentrations for Participants in Group 3 and Group 4
time frame: 30 days post-vaccination
Levels of Anti-tetanus and anti-diphtheria antibody concentrations for Participants in Group 3 and Group 4
time frame: 30 days post-vaccination
Levels of Anti-Human Papillomavirus (HPV) antibody concentrations (types 6, 11, 16, and 18) for Group 3 and Group 4
time frame: Day 0 and 30 days after the third dose of HPV vaccine
Percentage of participants reporting solicited reactions, unsolicited adverse events, and serious adverse events occurring throughout the trial
time frame: Day 0 up to Day 210 post-vaccination

Eligibility Criteria

Male or female participants from 10 years up to 17 years old.

Inclusion Criteria: - Aged 10 to 17 years on the day of inclusion - Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative - Assent form has been signed and dated by the subject - Subject and parent legally acceptable representative are able to attend all scheduled visits and comply with all trial procedures. Exclusion Criteria: - Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination) - Participation in the 4 weeks preceding the first trial vaccination(s) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure - Receipt of any vaccine in the 4 weeks preceding the first trial vaccination(s) or planned receipt of any vaccine in the 4 weeks prior to or following any trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after any study vaccines. This exception includes monovalent influenza vaccines and multivalent influenza vaccines. - Previous vaccination against meningococcal disease with either the trial vaccine or any mono- or polyvalent polysaccharide or conjugate meningococcal vaccine containing A, C, W, or Y antigens - History of vaccination with any tetanus, diphtheria, or pertussis vaccine within the previous 4 years - Previous HPV vaccination - Receipt of immune globulins, blood or blood-derived products in the past 3 months - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) - History of meningococcal infection, confirmed either clinically, serologically, or microbiologically - At high risk for meningococcal infection during the trial (i.e., subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease) - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances, including encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine - Personal history of Guillain-Barré syndrome - Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination - Verbal report of thrombocytopenia, contraindicating intramuscular vaccination - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily - Current alcohol abuse or drug addiction - Chronic illness (e.g., HIV hepatitis B, hepatitis C) that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion - Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided - Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw - Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

Additional Information

Official title A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
Description Participants will receive their assigned vaccine and will be evaluated for immunogenicity and safety. The duration of participation in the trial will be approximately 180 to 210 days.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sanofi.