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Immunogenicity and Safety of a Meningococcal Conjugate Vaccine Given Concomitantly With Other Vaccines in Toddlers

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ClinicalTrials.gov Identifier: NCT03205371
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

This Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study was conducted to assess the immunogenicity and safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine when administered alone and in combination with other pediatric vaccines in healthy toddlers in South Korea, Thailand, the Russian Federation, and Mexico.

Primary Objective:

  • To describe the immunogenicity profile of MenACYW Conjugate vaccine administered alone or concomitantly with licensed pediatric vaccine(s) (measles-mumps-rubella vaccine [MMR] + Varicella, diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type-b Conjugate vaccine [DTaP-IPV-HB-Hib], or pneumococcal Conjugate vaccine [PCV13]).

Secondary Objective:

  • To describe the immunogenicity profile of licensed pediatric vaccine(s) (MMR + Varicella, DTaP-IPV-HB-Hib, or PCV13) when administered alone or concomitantly with MenACYW Conjugate vaccine.

Condition or disease Intervention/treatment Phase
Meningitis, Meningococcal Biological: MenACYW conjugate vaccine Biological: MMR Biological: Varicella Biological: DTaP-IPV-HB-Hib Biological: PCV13 Phase 3

Detailed Description:
Healthy, meningococcal-vaccine naïve toddlers aged 12 to 23 months were randomized either to a single dose of MenACYW Conjugate vaccine alone or in combination with other pediatric vaccines in healthy toddlers in South Korea and Thailand (MMR + varicella vaccine), the Russian Federation (PCV13), and Mexico (DTaP-IPV-HB-Hib). Immunogenicity (pre- and 30 days post-vaccination) and safety was assessed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study
Masking: Single (Outcomes Assessor)
Masking Description: The study had an open-label design; however, as per the protocol, the laboratory technicians who were responsible for performing the serological testing remained blinded to the participants' group allocations throughout the study to avoid any bias.
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Other Pediatric Vaccines in Healthy Toddlers
Actual Study Start Date : November 7, 2016
Actual Primary Completion Date : July 19, 2018
Actual Study Completion Date : July 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis

Arm Intervention/treatment
Experimental: South Korea(Group1):MenACYW Conjugate + MMR+ Varicella Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
Biological: MenACYW conjugate vaccine
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular

Biological: MMR
Measles, Mumps, and Rubella Virus Vaccine Live; 0.5 mL, Subcutaneous

Biological: Varicella
Varicella Virus Vaccine Live; 0.5 mL, Subcutaneous

Experimental: South Korea (Group 2): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
Biological: MenACYW conjugate vaccine
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular

Active Comparator: South Korea (Group 3): MMR + Varicella Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
Biological: MMR
Measles, Mumps, and Rubella Virus Vaccine Live; 0.5 mL, Subcutaneous

Biological: Varicella
Varicella Virus Vaccine Live; 0.5 mL, Subcutaneous

Experimental: Thailand (Group 10):MenACYW Conjugate +MMR+Varicella Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
Biological: MenACYW conjugate vaccine
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular

Biological: MMR
Measles, Mumps, and Rubella Virus Vaccine Live; 0.5 mL, Subcutaneous

Biological: Varicella
Varicella Virus Vaccine Live; 0.5 mL, Subcutaneous

Experimental: Thailand (Group 11):MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
Biological: MenACYW conjugate vaccine
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular

Active Comparator: Thailand (Group 12): MMR + Varicella Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
Biological: MMR
Measles, Mumps, and Rubella Virus Vaccine Live; 0.5 mL, Subcutaneous

Biological: Varicella
Varicella Virus Vaccine Live; 0.5 mL, Subcutaneous

Experimental: Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type-b (DTaP-IPV-HB-Hib) vaccine on Day 0.
Biological: MenACYW conjugate vaccine
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular

Biological: DTaP-IPV-HB-Hib
Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B, Poliomyelitis (inactivated), and Haemophilus influenzae type-b conjugate vaccine (adsorbed); 0.5 mL, Intramuscular

Experimental: Mexico (Group 5): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
Biological: MenACYW conjugate vaccine
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular

Active Comparator: Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib vaccine on Day 0.
Biological: DTaP-IPV-HB-Hib
Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B, Poliomyelitis (inactivated), and Haemophilus influenzae type-b conjugate vaccine (adsorbed); 0.5 mL, Intramuscular

Experimental: Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and pneumococcal Conjugate vaccine (PCV13) on Day 0.
Biological: MenACYW conjugate vaccine
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular

Biological: PCV13
Pneumococcal 13-valent Conjugate Vaccine; 0.5 mL, Intramuscular

Experimental: Russian Federation (Group 8): MenACYW Conjugate Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
Biological: MenACYW conjugate vaccine
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular

Active Comparator: Russian Federation (Group 9): PCV13 Vaccine
Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.
Biological: PCV13
Pneumococcal 13-valent Conjugate Vaccine; 0.5 mL, Intramuscular




Primary Outcome Measures :
  1. Antibody titers against meningococcal serogroups A, C, Y, and W measured by serum bactericidal assay using human complement in participants receiving MenACYW conjugate vaccine alone or in combination with other pediatric vaccines. [ Time Frame: Day 0 and Day 30 post-vaccination ]
    Antibody titers against meningococcal serogroups A, C, Y, and W are assessed on Day 0 and Day 30 post vaccination with either MenACYW conjugate vaccine alone in combination with other pediatric vaccines.


Secondary Outcome Measures :
  1. Antibody responses to antigens in the MMR (measles, mumps, and rubella) vaccine [ Time Frame: Day 0 and Day 30 post-vaccination ]
    Antibodies to antigens in the MMR vaccine are assessed on Day 0 and Day 30 post-vaccination with either MenACYW conjugate vaccine alone in combination with MMR vaccine.

  2. Anti-Varicella antibody concentrations following vaccination with the Varicella vaccine [ Time Frame: Day 0 and Day 30 post-vaccination ]
    Anti-Varicella antibody concentrations are assessed on Day 0 and Day 30 post-vaccination with either MenACYW conjugate vaccine alone in combination with Varicella vaccine.

  3. Antibody responses to antigens (tetanus and acellular pertussis [pertussis toxoid {PT} and filamentous hemagglutinin {FHA}) in the DTaP-IPV-HB-Hib vaccine [ Time Frame: Day 0 and Day 30 post-vaccination ]
    Antibody responses to antigens (tetanus and acellular pertussis) are assessed on Day 0 and Day 30 post-vaccination with either MenACYW conjugate vaccine alone in combination with DTaP-IPV-HB-HiB vaccine.

  4. Antibody responses to diphtheria, inactivated poliomyelitis, hepatitis B, and Haemophilus influenzae antigens in the DTaP-IPV-HB-Hib vaccine [ Time Frame: Day 0 and Day 30 post-vaccination ]
    Antibody responses to diphtheria, inactivated poliomyelitis, hepatitis B, and Haemophilus influenzae antigens are assessed on Day 0 and Day 30 post-vaccination with either MenACYW conjugate vaccine alone in combination with DTaP-IPV-HB-Hib vaccine.

  5. Anti-pneumococcal antibody concentrations for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F in the PCV13 vaccine [ Time Frame: Day 0 and Day 30 post-vaccination ]
    Anti-pneumococcal antibody concentrations for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F are assessed on Day 0 and Day 30 post-vaccination with either MenACYW conjugate vaccine alone in combination with PCV13 vaccine.

  6. Solicited injection site and systemic reactions, unsolicited adverse events, and serious events in participants receiving MenACYW conjugate vaccine alone or in combination with other pediatric vaccines [ Time Frame: Day 0 up to Day 30 post-vaccination ]
    Solicited injection site and systemic reactions (Day 0 up to Day 7), unsolicited adverse events and serious adverse events (Day 0 up to Day 30 post-vaccination) are reported.


Other Outcome Measures:
  1. Antibody titers against meningococcal serogroups A, C, Y, and W measured by serum bactericidal assay using baby rabbit complement in participants receiving MenACYW conjugate vaccine alone or in combination with other pediatric vaccines [ Time Frame: Day 0 and Day 30 post-vaccination ]
    Antibody titers against meningococcal serogroups A, C, Y, and W are assessed on Day 0 and Day 30 post vaccination with either MenACYW conjugate vaccine alone in combination with other pediatric vaccines.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For South Korea: Korean males and females aged 12 to 23 months on the day of the first study visit.
  • For Mexico: Males and females aged 12 to 23 months on the day of the first study visit.
  • For the Russian Federation: Males and females aged 12 to 14 months or 16 to 23 months on the day of the first study visit (eligible for enrollment to MenACYW conjugate vaccine group) or 15 to 23 months on the day of the first study visit (eligible for enrollment to the MenACYW conjugate vaccine positive(+) PCV13 group or the PCV13 group).
  • For Thailand: Thai males and females aged 12 to 23 months on the day of the first study visit
  • Participants had received all recommended standard of care vaccinations according to their age as per local regulations*.
  • For the Russian Federation only, participants aged 15 to 23 months on the day of the first study visit (eligible for enrollment to MenACYW conjugate vaccine+PCV13 group or the PCV13 group) must not had received the third PCV13 vaccination corresponding to his or her age as per the country's National Immunization Program (NIP). The 2nd dose of PCV13 must had been administered at least 4 weeks before the 3rd dose of PCV13 was administered in the study.
  • For South Korea, participants must not had received the MMR or Varicella vaccination corresponding to his or her age at inclusion.
  • For Mexico, participants must not had received the DTaP-IPV-HB-Hib vaccination corresponding to his or her age at inclusion.
  • For Thailand, participants must not have received the any dose of MMR or V vaccination.
  • Informed consent form was signed and dated by the parent(s) or guardian if allowed by local regulations (and by independent witnesses if required by local regulations)†.
  • Participant and parent/guardian were able to attend all scheduled visits and to comply with all trial procedures.
  • *Participants must had received the total number of doses expected for each vaccine recommended for his/her age in the respective NIPs, but inclusion of participants with variations in the vaccine administration timeframes is considered acceptable if the total number of doses for the corresponding vaccines had been completed (e.g., in Mexico, 3 infant doses of the pentavalent vaccine must had been administered but the 4th dose due in the 2nd year of life should not had been administered for participants to be included in the trial). For the Russian Federation only, participants that had not received a seasonal flu vaccination from 6 months of age according to the Russian NIP were still eligible to participate in this study. For Thailand only, participants who had received a vaccine ahead of the schedule can still be included in the study provided the first doses of MMR and Varicella vaccines have not been administered prior to inclusion.
  • †In the Russian Federation, as per local regulations, only the participant's parent(s) are entitled to sign an informed consent form. A child under the responsibility of a guardian were not included in the study.

Exclusion Criteria:

  • Participation in the 4 weeks preceding the first trial vaccination 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 (28 days) preceding the first trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after the study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
  • Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine).
  • For participants enrolled at sites in the Russian Federation: previous vaccination with the third dose of PCV13 in participants 15 to 23 months of age (eligible for MenACYW conjugate vaccine+PCV13 group or the PCV13).
  • For participants enrolled at sites in Mexico: known history of seizures, or uncontrolled neurologic disorder (including epilepsy); or encephalopathy of unknown etiology occurring within 7 days following previous vaccination with pertussis containing vaccine; previous vaccination with DTaP-IPV-HB-Hib or DTaP-containing vaccine at 12 to 23 months of age.
  • For participants enrolled at sites in South Korea and Thailand: known history of seizures, cerebral injury, or encephalopathy; previous vaccination with MMR or Varicella at 12 to 23 months of age.
  • 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, according to the Investigator's judgment (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling 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 vaccine(s) used in the trial or to a vaccine containing any of the same substances.
  • Verbal report of thrombocytopenia, as reported by the parent/guardian, contraindicating intramuscular (IM) vaccination by the Investigator's judgment.
  • Known bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination by the Investigator's judgment.
  • Personal history of Guillain-Barré syndrome (GBS).
  • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
  • For participants enrolled at sites in South Korea or Mexico and Thailand: Moderate or severe acute illness/infection (according to investigator's judgment) on the day of vaccination or febrile illness (temperature >= 38.0 degree Celsius [°C]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
  • For participants enrolled at sites in the Russian Federation: Acute disease of any severity on the day of vaccination or febrile illness (axillary temperature >= 37.0°C). A prospective participant should not be included in the study until the condition has 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 a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205371


Locations
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Korea, Republic of
Ansan, Korea, Republic of, 425-707
Anyang, Korea, Republic of, 431-070
Daegu, Korea, Republic of, 41931
Daejeon, Korea, Republic of
Gwangju, Korea, Republic of, 61469
Ilsan, Korea, Republic of, 10444
Incheon, Korea, Republic of, 400-700
Jeju City, Korea, Republic of, 63241
Seoul, Korea, Republic of, 02053
Seoul, Korea, Republic of, 05278
Seoul, Korea, Republic of, 100-380
Seoul, Korea, Republic of, 130-702
Seoul, Korea, Republic of, 132-703
Seoul, Korea, Republic of, 139-709
Seoul, Korea, Republic of, 158-710
Suwon-si, Korea, Republic of, 442-723
Wŏnju, Korea, Republic of, 162
Yangsan, Korea, Republic of, 626-770
Mexico
Acapulco, Mexico, 39670
Mexico City, Mexico, 04530
Tlaltizapan, Mexico, 62770
Russian Federation
Barnaul, Russian Federation, 656054
Kazan', Russian Federation, 420012
Krasnodar, Russian Federation, 350015
Moscow, Russian Federation, 119296
Murmansk, Russian Federation, 183031
Novosibirsk, Russian Federation, 630102
Perm, Russian Federation, 614066
Saint Petersburg, Russian Federation, 191025
Saint Petersburg, Russian Federation, 197022
Saint Petersburg, Russian Federation, 197101
Samara, Russian Federation, 443079
Smolensk, Russian Federation, 214014
Tomsk, Russian Federation, 634050
Yekaterinburg, Russian Federation, 620028
Thailand
Pathum Wan, Bangkok, Thailand, 10330
Rajthevi, Bangkok, Thailand, 10400
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur, a Sanofi Company

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03205371     History of Changes
Other Study ID Numbers: MET57
U1111-1161-2787 ( Other Identifier: WHO Universal Trial Number (UTN) )
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcal Meningitis
Meningococcal Infections
MenACYW Conjugate vaccine
Additional relevant MeSH terms:
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Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs