Meningitis, MeningococcalPhase 3NCT03205371

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

A Phase 3 study testing MenACYW conjugate vaccine, MMR and Varicella in people with Meningitis, Meningococcal, run by Sanofi Pasteur, a Sanofi Company at 37 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 12 to 23 monthsHealthy volunteers can take part
Conditions the study is for: Meningitis, Meningococcal
What is being tested?: MenACYW conjugate vaccine, MMR and Varicella
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,183 participants
Where: 37 sitesin 4 countries
Study dates: 7 Nov 2016to 19 Jul 2018
Phase: Phase 3
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 12 to 23 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

37 sites in 4 countries.

Country

City, postcode or hospital

37 sites in 4 countries

South Korea18 sites

Study site
Ansan, 425-707
Study site
Anyang, 431-070
Study site
Daegu, 41931
Study site
Daejeon
Study site
Gwangju, 61469
Study site
Ilsan, 10444
Study site
Incheon, 400-700
Study site
Jeju City, 63241
Study site
Seoul, 02053
Study site
Seoul, 05278
Study site
Seoul, 100-380
Study site
Seoul, 130-702
Study site
Seoul, 132-703
Study site
Seoul, 139-709
Study site
Seoul, 158-710
Study site
Suwon, 442-723
Study site
Wŏnju, 162
Study site
Yangsan, 626-770

Other trials in South Korea

Russia14 sites

Study site
Barnaul, 656054
Study site
Kazan', 420012
Study site
Krasnodar, 350015
Study site
Moscow, 119296
Study site
Murmansk, 183031
Study site
Novosibirsk, 630102
Study site
Perm, 614066
Study site
Saint Petersburg, 191025
Study site
Saint Petersburg, 197022
Study site
Saint Petersburg, 197101
Study site
Samara, 443079
Study site
Smolensk, 214014
Study site
Tomsk, 634050
Study site
Yekaterinburg, 620028

Other trials in Russia

Mexico3 sites

Study site
Acapulco, 39670
Study site
Mexico City, 04530
Study site
Tlaltizapán, 62770

Other trials in Mexico

Thailand2 sites

Study site
Pathum Wan, Bangkok, 10330
Study site
Rajthevi, Bangkok, 10400

Other trials in Thailand

About this study

Official title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Other Pediatric Vaccines in Healthy Toddlers

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.

Read the 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.

Conditions: Meningitis, Meningococcal
Being tested: MenACYW conjugate vaccine, MMR, Varicella, DTaP-IPV-HB-Hib, PCV13
Keywords: Meningitis, Meningococcal Meningitis, Meningococcal Infections, MenACYW Conjugate vaccine
Medical subject headings: Meningitis, Meningococcal, Meningitis, Meningococcal Infections

What participants receive

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

MenACYW conjugate vaccineBiological
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular
MMRBiological
Measles, Mumps, and Rubella Virus Vaccine Live; 0.5 mL, Subcutaneous
VaricellaBiological
Varicella Virus Vaccine Live; 0.5 mL, Subcutaneous
DTaP-IPV-HB-HibBiological
Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B, Poliomyelitis (inactivated), and Haemophilus influenzae type-b conjugate vaccine (adsorbed); 0.5 mL, Intramuscular
PCV13Biological
Pneumococcal 13-valent Conjugate Vaccine; 0.5 mL, Intramuscular

Study groups in NCT03205371
Study group	Role	What they receive
South Korea(Group1):MenACYW Conjugate + MMR+ Varicella Vaccine	Experimental	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. Receives: Biological: MenACYW conjugate vaccine; Biological: MMR; Biological: Varicella
South Korea (Group 2): MenACYW Conjugate Vaccine	Experimental	Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. Receives: Biological: MenACYW conjugate vaccine
South Korea (Group 3): MMR + Varicella Vaccine	Active comparator	Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0. Receives: Biological: MMR; Biological: Varicella
Thailand (Group 10):MenACYW Conjugate +MMR+Varicella Vaccine	Experimental	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. Receives: Biological: MenACYW conjugate vaccine; Biological: MMR; Biological: Varicella
Thailand (Group 11):MenACYW Conjugate Vaccine	Experimental	Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. Receives: Biological: MenACYW conjugate vaccine
Thailand (Group 12): MMR + Varicella Vaccine	Active comparator	Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0. Receives: Biological: MMR; Biological: Varicella
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine	Experimental	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. Receives: Biological: MenACYW conjugate vaccine; Biological: DTaP-IPV-HB-Hib
Mexico (Group 5): MenACYW Conjugate Vaccine	Experimental	Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. Receives: Biological: MenACYW conjugate vaccine
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine	Active comparator	Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib vaccine on Day 0. Receives: Biological: DTaP-IPV-HB-Hib
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine	Experimental	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. Receives: Biological: MenACYW conjugate vaccine; Biological: PCV13
Russian Federation (Group 8): MenACYW Conjugate Vaccine	Experimental	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. Receives: Biological: MenACYW conjugate vaccine
Russian Federation (Group 9): PCV13 Vaccine	Active comparator	Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0. Receives: Biological: PCV13

What is being measured

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

Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Data for this outcome measure was planned to reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Measured: Day 0 and Day 30 post-vaccination
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Measured: Day 0 and Day 30 post-vaccination
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Measured: Day 0 up to Day 30 post-vaccination
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >=1:16 for participants with pre-vaccination titers <1:8 or at least a 4-fold increase in post-vaccination hSBA titers from pre- to post-vaccination, for participants with pre-vaccination titers >=1:8. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Measured: Day 30 post-vaccination

Secondary outcomes (12)

Geometric Mean Titers of MMR-Varicella Antibodies Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Antibodies titers of Measles and Rubella were measured by enzyme immunoassay (EIA). Antibodies titers for mumps and varicella were measured by enzyme-linked immunosorbent assay (ELISA). Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 3 and 12.
Measured: Day 0 and Day 30 post-vaccination
Percentage of Participants With Immune Response Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Immune response for MMR-Varicella vaccine was defined as: anti-measles Antibody (Ab) concentrations >=255 milli-international unit per milliliter (mIU/mL), anti-mumps Ab concentrations: >=10 Ab units/mL, anti-rubella Ab concentrations >=10 international unit per milliliter (IU/mL),anti-varicella Ab concentrations >=5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) Ab units/mL. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 3 and 12.
Measured: Day 0 and Day 30 post-vaccination
Geometric Mean Titers of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Antibodies titers of PT and FHA were measured by electrochemiluminescent (ECL) assay.
Measured: Day 0 and Day 30 post-vaccination
Geometric Mean Titers of DTaP-IPV-HB-Hib Antibodies Following Injection With DTaP-IPV-HB-Hib Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Antibodies titers of Diphtheria, Tetanus and Pertussis were measured by ECL assay. Antibodies titers of poliovirus types 1, 2, and 3 were measured by neutralization assay. Antibodies titers of Hepatitis B were measured by an immunodiagnostic system using chemiluminescence detection. Antibodies titers of Polyribosyl-ribitol phosphate (PRP) were measured by Farr-type radioimmunoassay (RIA).
Measured: Day 0 (for tetanus only) and Day 30 post-vaccination
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Immune response for DTaP-IPV-HB-Hib vaccine was defined as: anti-tetanus Ab concentrations: >= 0.01 and 0.1 IU/mL at Day 0 and >= 0.1 and 1.0 IU/mL at Day 30, anti-diphtheria Ab concentrations: >= 0.1 and 1.0 IU/mL, anti-PRP Ab concentrations >= 0.15 and 1.0 microgram per milliliter (mcg/mL), anti-poliovirus types 1, 2, and 3 Ab titers >= 1:8, anti-hepatitis B surface antigen Ab concentrations >= 10 mIU/mL, >= 100 mIU/mL.
Measured: Day 0 (tetanus only) and Day 30 post-vaccination
Percentage of Participants With Vaccine Response of PT and FHA Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Pertussis and FHA vaccine response was defined as: if the pre-vaccination concentration is < 4 * lower limit of quantification (LLOQ is equal to 2), then the post-vaccination concentration is >=4 * pre-vaccination concentration and if the pre-vaccination concentration is >= 4 * LLOQ, then the post-vaccination concentration is >= 2 * pre-vaccination concentration.
Measured: Day 0 and Day 30 post-vaccination
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Antibodies of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were measured by ECL assay.
Measured: Day 0 and Day 30 post-vaccination
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Immune response for PCV13 for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F was defined as: antibodies concentrations >=0.35 mcg/mL or >=1.0 mcg/mL.
Measured: Day 0 and Day 30 post-vaccination
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
Solicited Reaction (SR) was defined as an adverse event (AE) that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions: tenderness, erythema, and swelling. Tenderness: Grade 3: cries when injected limb moved or the movement of the injected limb reduced, Erythema and swelling: Grade 3: >= 50 millimeter (mm). Participants with any of the Grade and Grade 3 solicited injection-site reactions were reported.
Measured: Within 7 days post vaccination
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6
SR was defined as an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions: tenderness, erythema, and swelling. Tenderness: Grade 3: cries when injected limb moved or the movement of the injected limb reduced, Erythema and swelling: Grade 3: >= 50 mm. Participants with any of the Grade and Grade 3 solicited injection-site reactions were reported.
Measured: Within 7 days post vaccination
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9
SR was defined as an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions: tenderness, erythema, and swelling. Tenderness: Grade 3: cries when injected limb moved, or the movement of the injected limb reduced, Erythema and swelling: Grade 3: >= 50 mm. Participants with any of the Grade and Grade 3 solicited injection-site reactions were reported.
Measured: Within 7 days post vaccination
Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability)
SR was defined as an AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). Solicited systemic reaction: Fever: Grade 3: > 39.5 degree Celsius, Vomiting: Grade 3: >= 6 episodes per 24 hours or requiring parenteral hydration, Crying abnormal: Grade 3: > 3 hours, Drowsiness: Grade 3: sleeping most of the time or difficult to wake up, Appetite lost: Grade 3: refuses >= 3 feeds/meals or refuses most feeds/meals, Irritability: Grade 3: inconsolable. Participants with any of the Grade and Grade 3 solicited systemic reactions were reported.
Measured: Within 7 days post vaccination

Timeline

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

7 Nov 201619 Jul 2018

First posted2 Jul 2017
Study start7 Nov 2016
Primary completion19 Jul 2018
Study completion19 Jul 2018

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 Meningitis, MeningococcalStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,183 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03205371
Sponsor's protocol ID: MET57
Other IDs: U1111-1161-2787
Status last verified: Mar 2022
First submitted: 28 Jun 2017
Last updated: 5 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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://vivli.org

Publications

Dhingra MS, Namazova-Baranova L, Arredondo-Garcia JL, Kim KH, Limkittikul K, Jantarabenjakul W, Perminova O, Kobashi IAR, Bae CW, Ojeda J, Park J, Chansinghakul D, B'Chir S, Neveu D, Bonaparte M, Jordanov E. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers: a phase III randomised study. Epidemiol Infect. 2021 Apr 5;149:e90. doi: 10.1017/S0950268821000698.
PubMed 33814028

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?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Other Pediatric Vaccines in Healthy Toddlers
ClinicalTrials.gov ID: NCT03205371
Acronym / sponsor ID: MET57
Conditions: Meningitis, Meningococcal
Keywords: Meningitis, Meningococcal Meningitis, Meningococcal Infections, MenACYW Conjugate vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,183 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 7 Nov 2016 (actual)
Primary completion: 19 Jul 2018 (actual)
Study completion: 19 Jul 2018 (actual)
First posted: 2 Jul 2017 (actual)
Results: Posted 9 Jun 2020

Clinical summary

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

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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 12
Model description: Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study

Arm	Type	Receives
South Korea(Group1):MenACYW Conjugate + MMR+ Varicella Vaccine	Experimental	Biological: MenACYW conjugate vaccine, Biological: MMR, Biological: VaricellaHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
South Korea (Group 2): MenACYW Conjugate Vaccine	Experimental	Biological: MenACYW conjugate vaccineHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
South Korea (Group 3): MMR + Varicella Vaccine	Active comparator	Biological: MMR, Biological: VaricellaHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
Thailand (Group 10):MenACYW Conjugate +MMR+Varicella Vaccine	Experimental	Biological: MenACYW conjugate vaccine, Biological: MMR, Biological: VaricellaHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0.
Thailand (Group 11):MenACYW Conjugate Vaccine	Experimental	Biological: MenACYW conjugate vaccineHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
Thailand (Group 12): MMR + Varicella Vaccine	Active comparator	Biological: MMR, Biological: VaricellaHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0.
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine	Experimental	Biological: MenACYW conjugate vaccine, Biological: DTaP-IPV-HB-HibHealthy, 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.
Mexico (Group 5): MenACYW Conjugate Vaccine	Experimental	Biological: MenACYW conjugate vaccineHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine	Active comparator	Biological: DTaP-IPV-HB-HibHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib vaccine on Day 0.
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine	Experimental	Biological: MenACYW conjugate vaccine, Biological: PCV13Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and pneumococcal Conjugate vaccine (PCV13) on Day 0.
Russian Federation (Group 8): MenACYW Conjugate Vaccine	Experimental	Biological: MenACYW conjugate vaccineHealthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0.
Russian Federation (Group 9): PCV13 Vaccine	Active comparator	Biological: PCV13Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0.

Who may qualify

Ages: 12 to 23 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (13 listed)

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*.

Key exclusion criteria (20 listed)

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.

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
MenACYW conjugate vaccineMeningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular	Biological	Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine, Mexico (Group 5): MenACYW Conjugate Vaccine, Russian Federation (Group 8): MenACYW Conjugate Vaccine, Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine, South Korea (Group 2): MenACYW Conjugate Vaccine, South Korea(Group1):MenACYW Conjugate + MMR+ Varicella Vaccine, Thailand (Group 10):MenACYW Conjugate +MMR+Varicella Vaccine, Thailand (Group 11):MenACYW Conjugate Vaccine
MMRMeasles, Mumps, and Rubella Virus Vaccine Live; 0.5 mL, Subcutaneous	Biological	South Korea (Group 3): MMR + Varicella Vaccine, South Korea(Group1):MenACYW Conjugate + MMR+ Varicella Vaccine, Thailand (Group 10):MenACYW Conjugate +MMR+Varicella Vaccine, Thailand (Group 12): MMR + Varicella Vaccine
VaricellaVaricella Virus Vaccine Live; 0.5 mL, Subcutaneous	Biological	South Korea (Group 3): MMR + Varicella Vaccine, South Korea(Group1):MenACYW Conjugate + MMR+ Varicella Vaccine, Thailand (Group 10):MenACYW Conjugate +MMR+Varicella Vaccine, Thailand (Group 12): MMR + Varicella Vaccine
DTaP-IPV-HB-HibDiphtheria, Tetanus, Pertussis (acellular component), Hepatitis B, Poliomyelitis (inactivated), and Haemophilus influenzae type-b conjugate vaccine (adsorbed); 0.5 mL, Intramuscular	Biological	Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine, Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine
PCV13Pneumococcal 13-valent Conjugate Vaccine; 0.5 mL, Intramuscular	Biological	Russian Federation (Group 9): PCV13 Vaccine, Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine

Primary outcome

Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Time frame: Day 0 and Day 30 post-vaccination
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Data for this outcome measure was planned to reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Time frame: Day 0 and Day 30 post-vaccination
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Time frame: Day 0 up to Day 30 post-vaccination
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11
Time frame: Day 30 post-vaccination
The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >=1:16 for participants with pre-vaccination titers <1:8 or at least a 4-fold increase in post-vaccination hSBA titers from pre- to post-vaccination, for participants with pre-vaccination titers >=1:8. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.

12 secondary outcomes

Geometric Mean Titers of MMR-Varicella Antibodies Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Time frame: Day 0 and Day 30 post-vaccination
Percentage of Participants With Immune Response Following Injection With MMR-Varicella Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 1, 3, 10, and 12
Time frame: Day 0 and Day 30 post-vaccination
Geometric Mean Titers of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Time frame: Day 0 and Day 30 post-vaccination
Geometric Mean Titers of DTaP-IPV-HB-Hib Antibodies Following Injection With DTaP-IPV-HB-Hib Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Time frame: Day 0 (for tetanus only) and Day 30 post-vaccination
Percentage of Participants With Immune Response Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Time frame: Day 0 (tetanus only) and Day 30 post-vaccination
Percentage of Participants With Vaccine Response of PT and FHA Antibodies Following Injection With DTaP-IPV-HB-Hib Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 4 and 6
Time frame: Day 0 and Day 30 post-vaccination
Geometric Mean Titers of PCV13 Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Antibodies Following Injection With PCV13 Vaccine Administrated Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Time frame: Day 0 and Day 30 post-vaccination
Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9
Time frame: Day 0 and Day 30 post-vaccination
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12
Time frame: Within 7 days post vaccination
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6
Time frame: Within 7 days post vaccination
Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9
Time frame: Within 7 days post vaccination
Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability)
Time frame: Within 7 days post vaccination

Results and safety

Results posted to the registry on 9 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
South Korea(Group1):MenACYW Conjugate +MMR +Varicella Vaccine	107	103
South Korea (Group 2): MenACYW Conjugate Vaccine	53	52
South Korea (Group 3): MMR + Varicella Vaccine	53	53
Thailand (Group 10):MenACYW Conjugate + MMR+ Varicella Vaccine	86	86
Thailand (Group 11): MenACYW Conjugate Vaccine	42	42
Thailand (Group 12): MMR + Varicella Vaccine	42	42
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine	200	190
Mexico (Group 5): MenACYW Conjugate Vaccine	100	97
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine	100	95
Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine	200	200
Russian Federation (Group 8): MenACYW Conjugate Vaccine	100	100
Russian Federation (Group 9): PCV13 Vaccine	100	99

Primary outcome: Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11

Time frame: Day 0 and Day 30 post-vaccination. Geometric mean (95% Confidence Interval). Unit: titers (1/dilution)

Measure	Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine n = 177	Groups 2 and 11: MenACYW Conjugate Vaccine n = 87	Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine n = 155	Mexico (Group 5): MenACYW Conjugate Vaccine n = 79	Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine n = 196	Russian Federation (Group 8): MenACYW Conjugate Vaccine n = 96
Serogroup A: Day 0	5.20 (4.56 to 5.93)	6.10 (5.00 to 7.44)	5.35 (4.82 to 5.94)	5.49 (4.66 to 6.45)	5.99 (5.30 to 6.76)	8.54 (6.47 to 11.3)
Serogroup A: Day 30	43.9 (37.4 to 51.6)	30.0 (23.1 to 39.0)	31.4 (25.9 to 38.1)	37.8 (28.5 to 50.2)	24.6 (20.2 to 30.1)	49.0 (36.8 to 65.3)
Serogroup C: Day 0	2.37 (2.11 to 2.65)	2.58 (2.15 to 3.10)	2.21 (2.11 to 2.31)	2.16 (2.00 to 2.34)	2.77 (2.43 to 3.16)	3.69 (2.84 to 4.81)
Serogroup C: Day 30	876 (725 to 1057)	600 (456 to 790)	749 (633 to 886)	666 (538 to 825)	205 (156 to 269)	309 (218 to 437)
Serogroup Y: Day 0	3.14 (2.78 to 3.54)	3.12 (2.58 to 3.78)	2.63 (2.37 to 2.92)	2.94 (2.45 to 3.53)	2.90 (2.56 to 3.28)	3.49 (2.68 to 4.53)
Serogroup Y: Day 30	88.9 (75.1 to 105)	60.0 (47.3 to 76.3)	79.7 (65.7 to 96.6)	90.9 (66.8 to 124)	139 (111 to 173)	172 (130 to 229)
Serogroup W: Day 0	2.15 (2.00 to 2.30)	2.31 (2.02 to 2.64)	2.41 (2.22 to 2.62)	2.16 (2.04 to 2.30)	2.93 (2.54 to 3.38)	3.62 (2.73 to 4.79)
Serogroup W: Day 30	46.8 (39.1 to 56.0)	35.5 (27.6 to 45.7)	40.0 (32.5 to 49.3)	50.9 (37.2 to 69.8)	57.4 (47.9 to 68.6)	57.0 (44.3 to 73.5)

Population analysed: Analysis was performed on PPAS which included participants who received at least one dose of the study vaccine(s), had a valid post-vaccination blood sample result and no protocol deviations. Data for this outcome measure were not planned to be collected and analyzed for Groups 3, 6, 9, and 12.

Primary outcome: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11

Time frame: Day 0 and Day 30 post-vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Groups 1and 10:MenACYW Conjugate Vaccine+MMR+Varicella Vaccine n = 177	Groups 2 and 11: MenACYW Conjugate Vaccine n = 87	Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine n = 155	Mexico (Group 5): MenACYW Conjugate Vaccine n = 79	Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine n = 196	Russian Federation (Group 8): MenACYW Conjugate Vaccine n = 96
Serogroup A: Day 0 (>=1:4)	75.1 (68.1 to 81.3)	82.8 (73.2 to 90.0)	82.6 (75.7 to 88.2)	82.3 (72.1 to 90.0)	82.1 (76.1 to 87.2)	85.4 (76.7 to 91.8)
Serogroup A: Day 0 (>=1:8)	37.9 (30.7 to 45.4)	44.8 (34.1 to 55.9)	45.8 (37.8 to 54.0)	46.8 (35.5 to 58.4)	49.0 (41.8 to 56.2)	54.2 (43.7 to 64.4)
Serogroup A: Day 30 (>=1:4)	98.9 (96.0 to 99.9)	95.4 (88.6 to 98.7)	98.1 (94.4 to 99.6)	97.5 (91.2 to 99.7)	94.9 (90.8 to 97.5)	97.9 (92.7 to 99.7)
Serogroup A: Day 30 (>=1:8)	97.7 (94.3 to 99.4)	92.0 (84.1 to 96.7)	92.9 (87.7 to 96.4)	89.9 (81.0 to 95.5)	83.7 (77.7 to 88.6)	90.6 (82.9 to 95.6)
Serogroup C: Day 0 (>=1:4)	9.6 (5.7 to 14.9)	16.1 (9.1 to 25.5)	12.3 (7.5 to 18.5)	7.6 (2.8 to 15.8)	19.9 (14.5 to 26.2)	36.5 (26.9 to 46.9)
Serogroup C: Day 0 (>=1:8)	4.0 (1.6 to 8.0)	6.9 (2.6 to 14.4)	1.9 (0.4 to 5.6)	1.3 (0.0 to 6.9)	8.7 (5.1 to 13.5)	17.7 (10.7 to 26.8)
Serogroup C: Day 30 (>=1:4)	100.0 (97.9 to 100.0)	100.0 (95.8 to 100.0)	100.0 (97.6 to 100.0)

Primary outcome: Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11

Time frame: Day 0 up to Day 30 post-vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Groups 1 and10:MenACYW Conjugate Vaccine+MMR+Varicella Vaccine n = 177	Groups 2 and 11: MenACYW Conjugate Vaccine n = 87	Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine n = 155	Mexico (Group 5): MenACYW Conjugate Vaccine n = 79	Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine n = 196	Russian Federation (Group 8): MenACYW Conjugate Vaccine n = 96
Serogroup A	82.5 (76.1 to 87.8)	64.4 (53.4 to 74.4)	69.0 (61.1 to 76.2)	70.9 (59.6 to 80.6)	58.2 (50.9 to 65.2)	72.9 (62.9 to 81.5)
Serogroup C	98.3 (95.1 to 99.6)	98.9 (93.8 to 100.0)	100.0 (97.6 to 100.0)	98.7 (93.1 to 100.0)	92.3 (87.7 to 95.7)	91.7 (84.2 to 96.3)
Serogroup Y	95.5 (91.3 to 98.0)	89.7 (81.3 to 95.2)	96.8 (92.6 to 98.9)	94.9 (87.5 to 98.6)	94.4 (90.2 to 97.2)	93.8 (86.9 to 97.7)
Serogroup W	94.9 (90.6 to 97.6)	89.7 (81.3 to 95.2)	86.5 (80.0 to 91.4)	92.4 (84.2 to 97.2)	88.8 (83.5 to 92.8)	90.6 (82.9 to 95.6)

Population analysed: Analysis was performed on PPAS. Data for this outcome measure were not planned to be collected and analyzed for Groups 3, 6, 9, and 12.

Primary outcome: Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11

Time frame: Day 30 post-vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Groups 1 and10:MenACYW Conjugate Vaccine+MMR+Varicella Vaccine n = 177	Groups 2 and 11: MenACYW Conjugate Vaccine n = 87	Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine n = 155	Mexico (Group 5): MenACYW Conjugate Vaccine n = 79	Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine n = 196	Russian Federation (Group 8): MenACYW Conjugate Vaccine n = 96
Serogroup A	78.5 (71.7 to 84.3)	63.2 (52.2 to 73.3)	67.1 (59.1 to 74.4)	69.6 (58.2 to 79.5)	56.1 (48.9 to 63.2)	71.9 (61.8 to 80.6)
Serogroup C	97.7 (94.3 to 99.4)	98.9 (93.8 to 100.0)	100.0 (97.6 to 100)	98.7 (93.1 to 100.0)	90.8 (85.9 to 94.5)	91.7 (84.2 to 96.3)
Serogroup Y	93.2 (88.5 to 96.4)	88.5 (79.9 to 94.3)	92.3 (86.9 to 95.9)	87.3 (78.0 to 93.8)	92.9 (88.3 to 96.0)	92.7 (85.6 to 97.0)
Serogroup W	86.4 (80.5 to 91.1)	83.9 (74.5 to 90.9)	82.6 (75.7 to 88.2)	82.3 (72.1 to 90.0)	82.1 (76.1 to 87.2)	90.6 (82.9 to 95.6)

Population analysed: Analysis was performed on PPAS. Data for this outcome measure were not planned to be collected and analyzed for Groups 3, 6, 9 and 12.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: AE data were collected from Day 0 up to Day 30 post-vaccination. SR data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study period (up to Day 30 post-vaccination).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
South Korea(Group1):MenACYW Conjugate +MMR +Varicella Vaccine	6 of 103 (5.8%)	85 of 103 (82.5%)	0 of 103
South Korea (Group 2): MenACYW Conjugate Vaccine	4 of 52 (7.7%)	43 of 52 (82.7%)	0 of 52
South Korea (Group 3): MMR + Varicella Vaccine	2 of 53 (3.8%)	37 of 53 (69.8%)	0 of 53
Thailand (Group 10):MenACYW Conjugate + MMR +Varicella Vaccine	0 of 86 (0%)	58 of 86 (67.4%)	0 of 86
Thailand (Group 11): MenACYW Conjugate Vaccine	1 of 42 (2.4%)	37 of 42 (88.1%)	0 of 42
Thailand (Group 12): MMR + Varicella Vaccine	0 of 42 (0%)	37 of 42 (88.1%)	0 of 42
Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine	0 of 200 (0%)	142 of 200 (71%)	0 of 200
Mexico (Group 5): MenACYW Conjugate Vaccine	0 of 100 (0%)	65 of 100 (65%)	0 of 100
Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine	1 of 100 (1%)	85 of 100 (85%)	0 of 100
Russian Federation (Group 7):MenACYW Conjugate + PCV13 Vaccine	0 of 200 (0%)	75 of 200 (37.5%)	0 of 200
Russian Federation (Group 8): MenACYW Conjugate Vaccine	0 of 100 (0%)	30 of 100 (30%)	0 of 100
Russian Federation (Group 9): PCV13 Vaccine	0 of 99 (0%)	17 of 99 (17.2%)	0 of 99

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33814028Dhingra MS, Namazova-Baranova L, Arredondo-Garcia JL, Kim KH, Limkittikul K, Jantarabenjakul W, Perminova O, Kobashi IAR, Bae CW, Ojeda J, Park J, Chansinghakul D, B'Chir S, Neveu D, Bonaparte M, Jordanov E. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers: a phase III randomised study. Epidemiol Infect. 2021 Apr 5;149:e90. doi: 10.1017/S0950268821000698.
Related infoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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://vivli.org

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Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines
Active, not recruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years
Epidemic Meningitis, Meningococcal Vaccines
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 Months
Epidemic Meningitis, Meningococcal Vaccines

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.

Medical Director study director

Sanofi Pasteur, a Sanofi Company

37 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MenACYW conjugate vaccine, MMR and Varicella in people with Meningitis, Meningococcal, run by Sanofi Pasteur, a Sanofi Company at 37 sites in 4 countries.

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 13 inclusion and 20 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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in South Korea, Russia, Mexico, Thailand. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 9 Jun 2020). 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?

Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W Antibodies Following Injection With MenACYW Conjugate Vaccine Administered Alone or Concomitantly With Other Pediatric Vaccines: Groups 1, 2, 4, 5, 7, 8, 10, and 11 (time frame: Day 0 and Day 30 post-vaccination). The study lists 4 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 NCT03205371, 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 5 Apr 2022.