Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents

NCT ID: NCT02199691

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1715 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-22
• Study Completion Date: 2015-10-02

Brief Summary

The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed vaccine MENVEO® in adolescents 10 to 17 years of age in the United States (US). This study also evaluated the immunogenicity and safety of MenACYW Conjugate vaccine when given alone compared to when given concomitantly with tetanus, diphtheria, acellular pertussis (Tdap) vaccine and human papilloma virus (HPV) vaccine.

Primary objective:

• To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine when MenACYW Conjugate vaccine was given alone compared to those when MENVEO vaccine was given alone.

Secondary objective:

• To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine, when MenACYW Conjugate vaccine was given concomitantly with Tdap and HPV vaccines, compared to those when it was given alone.
• To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap vaccine was given concomitantly with MenACYW Conjugate vaccine and HPV vaccine, compared to those when Tdap vaccine was given with HPV vaccine only.
• To evaluate the antibody responses to the antigens present in HPV vaccine after the 3-dose series, when the first dose of HPV vaccine is given concomitantly with MenACYW Conjugate vaccine and Tdap vaccine, compared to those when the first dose of HPV vaccine is given with Tdap 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 was given with Tdap and HPV vaccines.

Detailed Description

Healthy adolescents were randomized and received a single dose of their assigned vaccines. They were assessed for immunogenicity at baseline (pre-vaccination) and at 30 days post-vaccination. Safety information were collected post-vaccination and throughout the entire study.

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1: MenACYW Conjugate Vaccine

Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine on Day 0.

Group Type: EXPERIMENTAL

Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5 milliliter (mL), Intramuscular (IM)

Group 2: MENVEO® Vaccine

Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MENVEO® vaccine on Day 0.

Group Type: ACTIVE_COMPARATOR

Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, IM

Group 3: MenACYW Conjugate Vaccine+Tdap+HPV

Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.

Group Type: EXPERIMENTAL

Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

Intervention Type: BIOLOGICAL

0.5 mL, IM

GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant

Intervention Type: BIOLOGICAL

0.5 mL, IM

Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular (IM)

Group 4: Tdap+HPV

Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0.

Group Type: ACTIVE_COMPARATOR

Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

Intervention Type: BIOLOGICAL

0.5 mL, IM

GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant

Intervention Type: BIOLOGICAL

0.5 mL, IM

Interventions

Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine

0.5 milliliter (mL), Intramuscular (IM)

Intervention Type: BIOLOGICAL

Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

0.5 mL, IM

Intervention Type: BIOLOGICAL

Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

0.5 mL, IM

Intervention Type: BIOLOGICAL

GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant

0.5 mL, IM

Intervention Type: BIOLOGICAL

Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine

0.5 mL, Intramuscular (IM)

Intervention Type: BIOLOGICAL

Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

0.5 mL, IM

Intervention Type: BIOLOGICAL

GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant

0.5 mL, IM

Intervention Type: BIOLOGICAL

Other Intervention Names

MenACYW Conjugate vaccine; MENVEO®; Adacel® (Tdap); GARDASIL® (HPV); MenACYW Conjugate vaccine; Adacel® (Tdap); GARDASIL® (HPV)

Eligibility Criteria

Inclusion Criteria

• Aged 10 to 17 years on the day of inclusion.
• Informed consent form was signed and dated by the parent(s) or another legally acceptable representative.
• Assent form was signed and dated by the participant.
• Participant and parent legally acceptable representative were able to attend all scheduled visits and comply with all trial procedures.

Exclusion Criteria

• Participant was 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 included 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 human papilloma virus (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., participants with persistent complement deficiency, with anatomic or functional asplenia, or participants 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., human immunodeficiency virus [HIV] hepatitis B, hepatitis C) that, in the opinion of the investigator, was 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 degree fahrenheit [°F]). A prospective participant was not included in the study until the condition had resolved or the febrile event had 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Downey, California, United States

San Diego, California, United States

Miami Beach, Florida, United States

Wichita, Kansas, United States

Bardstown, Kentucky, United States

Nicholasville, Kentucky, United States

Columbia, Maryland, United States

Lincoln, Nebraska, United States

Lincoln, Nebraska, United States

Lincoln, Nebraska, United States

Cleveland, Ohio, United States

Dayton, Ohio, United States

Norman, Oklahoma, United States

Erie, Pennsylvania, United States

Charleston, South Carolina, United States

Kingsport, Tennessee, United States

Tullahoma, Tennessee, United States

Layton, Utah, United States

Orem, Utah, United States

Payson, Utah, United States

Provo, Utah, United States

Roy, Utah, United States

Salt Lake City, Utah, United States

Salt Lake City, Utah, United States

South Jordan, Utah, United States

Spanish Fork, Utah, United States

Syracuse, Utah, United States

West Haven, Utah, United States

West Jordan, Utah, United States

Charlottesville, Virginia, United States

Midlothian, Virginia, United States

Spokane, Washington, United States

Spokane, Washington, United States

San Juan, PR, Puerto Rico

Countries

United States; Puerto Rico

References

Chang LJ, Hedrick J, Christensen S, Pan J, Jordanov E, Dhingra MS. A Phase II, randomized, immunogenicity and safety study of a quadrivalent meningococcal conjugate vaccine, MenACYW-TT, in healthy adolescents in the United States. Vaccine. 2020 Apr 23;38(19):3560-3569. doi: 10.1016/j.vaccine.2020.03.017. Epub 2020 Mar 21.

Reference Type: RESULT

PMID: 32209248 (View on PubMed)

Other Identifiers

U1111-1143-8537

Identifier Type: OTHER

Identifier Source: secondary_id

MET50

Identifier Type: -

Identifier Source: org_study_id