Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico

Phase 3

Completed

Conditions: Healthy Volunteers (Meningococcal Infection)

Interventions: Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Biological: Pneumococcal 13-valent Conjugate Vaccine
Biological: Rotavirus Vaccine, Live, Pentavalent
Biological: Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine
Biological: Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine
Biological: Hepatitis B Vaccine

Registration Number: NCT03630705

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary: Primary Objective:

1. To describe the vaccine seroprotection (antibody titer greater than or equal to \[\>=\] 1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine or Menveo® measured by serum bactericidal assay using human complement (hSBA), for Groups 1 and 2 when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico.

2. To describe the vaccine seroprotection (antibody titer \>=1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine measured by hSBA, for Group 3, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation.

Secondary Objective:

1. To describe hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) 30 days after the last vaccination of the infant series, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico and Russian Federation (RF).

2. To describe immunogenicity profile of routine pediatric vaccines when administered concomitantly with MenACYW Conjugate vaccine or Menveo®; or when administered alone.

3. To describe hSBA antibody responses against meningococcal serogroups A, C, Y, and W when MenACYW Conjugate vaccine and Menveo® are administered concomitantly with routine pediatric vaccines in Mexico and RF.

4. To describe antibody titers to the antigens present in MenACYW Conjugate vaccine and Menveo®, before the first vaccination and 30 days after the last vaccination of the infant series and in the second year of life, when administered concomitantly with routine pediatric vaccines in a subset of participants in Mexico and RF.

Detailed Description: Study duration per participant was approximately 12 months.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 525

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: MenACYW Conjugate Vaccine (Mexico)	Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine	Participants aged 2 months (at the time of enrollment) received Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus toxoid (MenACYW) Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and measles, mumps, rubella (MMR®II) vaccine at the age of Month 12.
Group 1: MenACYW Conjugate Vaccine (Mexico)	Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine	Participants aged 2 months (at the time of enrollment) received Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus toxoid (MenACYW) Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and measles, mumps, rubella (MMR®II) vaccine at the age of Month 12.
Group 3: MenACYW Conjugate Vaccine (Russian Federation)	Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine	Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
Group 3: MenACYW Conjugate Vaccine (Russian Federation)	Measles, Mumps, and Rubella Virus Vaccine Live	Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
Group 3: MenACYW Conjugate Vaccine (Russian Federation)	Pneumococcal 13-valent Conjugate Vaccine	Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
Group 1: MenACYW Conjugate Vaccine (Mexico)	Pneumococcal 13-valent Conjugate Vaccine	Participants aged 2 months (at the time of enrollment) received Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus toxoid (MenACYW) Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and measles, mumps, rubella (MMR®II) vaccine at the age of Month 12.
Group 1: MenACYW Conjugate Vaccine (Mexico)	Rotavirus Vaccine, Live, Pentavalent	Participants aged 2 months (at the time of enrollment) received Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus toxoid (MenACYW) Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and measles, mumps, rubella (MMR®II) vaccine at the age of Month 12.
Group 2: Menveo® (Mexico)	Measles, Mumps, and Rubella Virus Vaccine Live	Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
Group 2: Menveo® (Mexico)	Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine	Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
Group 2: Menveo® (Mexico)	Pneumococcal 13-valent Conjugate Vaccine	Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
Group 2: Menveo® (Mexico)	Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine	Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
Group 3: MenACYW Conjugate Vaccine (Russian Federation)	Hepatitis B Vaccine	Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
Group 4: Routine Pediatric Vaccines (Russian Federation)	Pneumococcal 13-valent Conjugate Vaccine	Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
Group 1: MenACYW Conjugate Vaccine (Mexico)	Measles, Mumps, and Rubella Virus Vaccine Live	Participants aged 2 months (at the time of enrollment) received Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus toxoid (MenACYW) Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and measles, mumps, rubella (MMR®II) vaccine at the age of Month 12.
Group 2: Menveo® (Mexico)	Rotavirus Vaccine, Live, Pentavalent	Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
Group 4: Routine Pediatric Vaccines (Russian Federation)	Measles, Mumps, and Rubella Virus Vaccine Live	Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
Group 3: MenACYW Conjugate Vaccine (Russian Federation)	Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine	Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
Group 4: Routine Pediatric Vaccines (Russian Federation)	Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine	Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
Group 4: Routine Pediatric Vaccines (Russian Federation)	Hepatitis B Vaccine	Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3	30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay.
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2	30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Group 3 data were presented separately.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)	30 days after the last vaccination at the age of 6 months of the infant series (i.e., at the age of 7 months)	Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>=1:16 for participants with pre-vaccination hSBA titers \<1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Geometric Mean Concentration of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Before Vaccination With Hexacima® Vaccine Administered Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)	Day 0 (before the first vaccination with Hexacima® vaccine) of the infant series (i.e., at the age of 2 months)	Geometric mean concentration (GMCs) for PT and FHA were measured by electrochemiluminescent (ECL) assay. Concentration was expressed in terms of titers (1/dilution). Infant series here denotes the vaccines administered at the age of 6 months of participants.
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)	30 days after the last vaccination at the age of 6 months of the infant series (i.e., at the age of 7 months)	The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titers less than (\<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8. Group 3 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Geometric Mean Concentrations of Anti-rotavirus Serum Immunoglobulin A (IgA) Antibodies Before and After RotaTeq® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)	Day 0 (before the first vaccination with RotaTeq® vaccine at the age of 2 months) and 30 days after the vaccination with RotaTeq® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)	GMCs of Anti-rotavirus serum IgA antibodies were assessed using enzyme-linked immunosorbent assay (ELISA). Concentrations were measured in terms of units/milliliter (U/mL). Infant series here denotes the vaccines administered at the age of 6 months of participants.
Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)	30 days after the vaccination with Prevnar 13® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)	GMCs of anti-pneumococcal antibodies was assessed by electrochemiluminscent (ECL) assay. GMCs of Prevnar 13 serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were reported. Concentration was expressed in terms of titers (1/dilution). Infant series here denotes the vaccines administered at the age of 6 months of participants.
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)	30 days after the vaccination with Prevnar 13® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)	Percentage of participants with anti-pneumococcal antibody concentrations \>=0.35 micrograms per milliliter (mcg/mL) and \>=1.0 mcg/mL for Prevnar 13 serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F was reported in this outcome measure. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Geometric Mean Titers (GMTs) of MMR Antibodies Following Vaccination With M-M-R®II Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2	30 days after the vaccination with M-M-R®II vaccine at the age of 12 months (i.e., at the age of 13 months)	GMTs against anti-measles and anti-rubella antibodies were measured by Bulk Measles immunoglobulin G (IgG) Enzyme Immunoassay (EIA) and anti-mumps antibodies were assessed by ELISA. Titers were expressed in terms of 1/dilution.
Percentage of Participants With >=3-fold and >=4-fold Rise in Anti-rotavirus Serum IgA Antibody Concentrations After RotaTeq® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 & 2 (up to the Infant Age of 6 Months)	From Day 0 (before the first vaccination with RotaTeq® vaccine at the age of 2 months), 30 days after the vaccination with RotaTeq® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)	Anti-rotavirus IgA antibodies in human serum was measured by ELISA. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days after 6-months vaccination) to pre-dose titer at age of 2 months (i.e., Day 0). Infant series here denotes the vaccines administered at the age of 6 months of participants.
Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2	30 days after the vaccination with Prevnar13® vaccine at the age of 12 months (i.e., at the age of 13 months)	GMCs against Streptococcus pneumoniae polysaccharide (PS) serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were measured by ECL assay. Concentration was expressed in terms of titers (1/dilution).
Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2	30 days after the vaccination with Prevnar 13® vaccine at the age of 12 months (i.e., at the age of 13 months)	Percentage of participants with anti-pneumococcal antibody concentrations \>=0.35 mcg/mL and \>=1.0 mcg/mL for Prevnar 13 serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F was reported in this outcome measure.
Percentage of Participants With Anti-MMR Antibodies (Ab) Concentrations Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2	30 days after the vaccination with M-M-R®II vaccine at the age of 12 months (i.e., at the age of 13 months)	Percentage of participants with anti-measles Ab concentrations \>=255 milli-international unit per milliliter (mIU/mL), anti-mumps Ab concentrations: \>=10 Ab units/mL, and anti-rubella Ab concentrations \>=10 international unit per milliliter (IU/mL) was reported in this outcome measure.
Percentage of Participants With Antibodies Concentrations Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 1 and 2	30 days after the vaccination with Hexacima® vaccine at the age of 12 months (i.e., at the age of 13 months)	Percentage of participants with anti-diphtheria Ab concentrations: \>= 0.1 and 1 IU/mL, and anti-tetanus Ab concentrations: \>= 0.1 and 1 IU/mL, anti-poliovirus types 1, 2, and 3 Ab titers \>= 8 (1/dilution), anti-hepatitis B surface (HBs) antigen Ab concentrations: \>= 10 and \>= 100 mIU/mL and anti-polyribosyl-ribitol phosphate (anti-PRP) Ab concentrations: \>= 0.15 and 1.0 microgram per milliliter (mcg/mL) was reported in this outcome measure.
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3 (up to the Infant Age of 6 Months)	From Day 0 (before the first vaccination, at the age of 2 months), 30 days after vaccination with MenACYW Conjugate vaccine at the age of 6 months of infant series (i.e., at the age of 7 months)	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days after the 6-months vaccination) to pre-dose titer at 2 months of age (i.e., Day 0). Group 2 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 3	30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)	The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8. Group 2 data were presented separately.
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)	Day 0 (before the first vaccination, at the age of Month 2), 30 days after the vaccination of MenACYW Conjugate vaccine at the age of 6 months (i.e., at the age of 7 months)	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using rabbit complement (rSBA). Titers were expressed in terms of 1/dilution. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Percentage of Participants With Vaccine Response for Pertussis (PT) and FHA Antibodies Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2	30 days after the vaccination with Hexacima® vaccine at the age of 12 months (i.e., at the age of 13 months)	Pertussis and FHA vaccine response was defined as: if the pre-vaccination concentration was \>=4\lower limit of quantification (LLOQ), then the post-vaccination concentration was \>=pre-vaccination concentration and if the pre-vaccination concentration was \<4\LLOQ, then the post-booster vaccination concentration was \>= 4\*LLOQ. The LLOQ was equal to 2.00 Endotoxin units per milliliter (EU/mL).
Geometric Mean Concentration of PT and FHA Antibodies Before Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)	Day 0 (before first vaccination with Pentaxim® vaccine) of the infant series (i.e., at the age of 2 months)	GMCs for PT and FHA were measured by ECL assay. Concentration was expressed in terms of titers (1/dilution). Infant series here denotes the vaccines administered at the age of 6 months of participants.
Percentage of Participants With Vaccine Response for PT and FHA Antibodies Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)	30 days after the vaccination with Pentaxim® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)	Pertussis and FHA vaccine response was defined as: if the pre-vaccination concentration was \>=4\LLOQ, then the post-vaccination concentration was \>= pre-vaccination concentration and if the pre-vaccination concentration was \<4\LLOQ, then the post-booster vaccination concentration was \>= 4\*LLOQ. The LLOQ was equal to 2.00 EU/mL. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Geometric Mean Concentrations of MMR Antibodies Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4	30 days after the vaccination with MMR vaccine at the age of 12 months (i.e., at the age of 13 months)	GMCs against anti-measles and anti-rubella antibodies were measured by Bulk Measles IgG EIA, and anti-mumps antibodies were assessed by ELISA. Concentrations were expressed in terms of titers (1/dilution).
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Before Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to the Infant Age of 6 Months)	Day 0 (before the first vaccination with MenACYW Conjugate or Menveo® Vaccine) of the infant series (i.e., at the age of 2 months)	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following MenACYW Conjugate Vaccine: Groups 1 and 3 (up to the Infant Age of 6 Months)	30 days after the vaccination with MenACYW Conjugate vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Group 2 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Percentage of Participants With Antibodies Concentrations Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)	30 days after the vaccination with Pentaxim® vaccine at the age of 6 months of the infant series (i.e., at the age of Month 7)	Percentage of participants with anti-diphtheria Ab concentrations: \>= 0.1 and 1 IU/mL, anti-tetanus Ab concentrations: \>= 0.1 and 1 IU/mL, anti-poliovirus types 1, 2, and 3 Ab titers \>= 8 (1/dilution), and anti-PRP Ab concentrations: \>= 0.15 and 1.0 mcg/mL were reported in this outcome measure. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)	30 days after the vaccination with Menveo® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by Serum Bactericidal Assay Using Baby Rabbit Complement Following MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)	Day 0 (before the first vaccination, at the age of 2 months), 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 6 months (i.e., at the age of 7 months)	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using rabbit complement (rSBA). Titers were expressed in terms of 1/dilution. Group 3 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination	Within 7 days after any vaccination and each vaccination (i.e., at the age 2 months, 3 months, 4 months, 4.5 months, 6 months and 12 months)	SR: expected AR (sign/symptom) observed \& reported under conditions (nature \& onset) prelisted (i.e., solicited) in protocol \& CRF. Injection site reactions were tenderness, erythema \& swelling. Assessment of injection site reactions after MenACYW Conjugate vaccine, Menveo, Prevnar 13, Hexacima, MMR, Pentaxim \& ENGERIX-B allowed local reactogenicity assessment \& helped to identify injection site reaction per vaccine received. Here, for Groups (Gps) 2 \& 4: "0" in number analyzed for MenACYW vaccine (Vac.) categories signifies that no participant were evaluable; for Gps 1, 3 \& 4: "0" in number analyzed for Menveo Vac. categories signifies that no participant were evaluable; for Gps 3 and 4: '0' in number analyzed field of Hexacima Vac. categories signifies that no participant were evaluable; for Gps 1 and 2: '0' in number analyzed field of Pentaxim and ENGERIX-B Vac. categories signifies that no participant were evaluable, as specified vaccines were not administered in specified groups.
Percentage of Participants With Anti-Hepatitis (HBs) Concentrations Following Vaccination With ENGERIX-B® (Hepatitis B) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)	30 days after the vaccination with ENGERIX-B® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)	Percentage of participants with anti-hepatitis B surface (HBs) antigen Ab concentrations: \>=10 and \>=100 mIU/mL was presented in this outcome measure. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Percentage of Participants With Anti-MMR Concentrations Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Vaccine or Routine Pediatric Vaccines: Groups 3 and 4	30 days after the vaccination with MMR vaccine at the age of 12 months (i.e., at the age of 13 months)	Percentage of participants with anti-measles Ab concentrations \>=255 mIU/mL, anti-mumps Ab concentrations: \>=10 Ab units/mL, and anti-rubella Ab concentrations \>=10 IU/mL was reported in this outcome measure.
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3	30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Group 2 data were presented separately.
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Antibodies Following Last Vaccination With Menveo® Vaccine: Group 2	30 days after the vaccination with Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2	Day 0 (before the first vaccination, at the age of Month 2), 30 days after the vaccination with Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days after the vaccination at the age of 12 months) to pre-dose titer at Day 0 (i.e., before first vaccination, at the age of 2 months).
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccines: Groups 1 and 3 (up to the Infant Age of 6 Months)	30 days after the vaccination with MenACYW Conjugate vaccine at the age of 6 months of the infant series (i.e., at the age of Month 7)	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Group 2 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccinations With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)	Day 0 (before the first vaccination, at the age of 2 months), 30 days after vaccination with Menveo® vaccines at the age of 6 months of the infant series (i.e., at the age of 7 months)	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days after the vaccination at the age of 6 months) to pre-dose titer at Day 0 (i.e., before the first vaccination, at 2 months of age). Infant series here denotes the vaccines administered at the age of 6 months of participants.
Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3	Day 0 (before the first vaccination, at the age of 2 months), 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days after the vaccination at the age of 6 months) to pre-dose titer at Day 0 (i.e., before the first vaccination, at the age of 2 months). Group 2 data were presented separately.
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)	30 days after the vaccination with Menveo® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Antibodies Following Last Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3	30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Group 2 data were presented separately.
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following Last Vaccination With MenACYW Conjugate Vaccine or Menveo® Vaccine: Groups 1 and 2	30 days after the vaccination with MenACYW Conjugate or Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution. Group 3 data were presented separately.
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following Last Vaccination With MenACYW Conjugate Vaccine or Menveo® Vaccine: Group 3	30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)	GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.
Number of Participants With Unsolicited Adverse Events After Any and Each Vaccination	Within 30 days after any vaccination and each vaccination (i.e., at the age 2 months, 3 months, 4 months, 4.5 months, 6 months and 12 months)	An AE was any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol.
Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2	30 days after the vaccination with Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay.
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With Menveo® Vaccine: Group 2	30 days after the vaccination with Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)	The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.
Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination	Within 7 days after any vaccination and each vaccination (i.e., at the age of 2 months, 3 months, 4 months, 4.5 months, 6 months and 12 months)	A solicited reaction (SR) was an expected adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the case report form (CRF) and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability. Reported AEs for each arm were presented as pre-specified in the study protocol.
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)	From Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each Group (i.e., up to the age of 13 months)	A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was an event for which ongoing monitoring and rapid communication by the Investigator to the Sponsor must be done. Such an event might warrant further investigation in order to characterize and understand it. Depending on the nature of the event, rapid communication by the study Sponsor to other parties (e.g, regulators) might also be warranted. Reported AEs for each arm were presented as pre-specified in the study protocol.
Percentage of Participants With hSBA Titers Distribution Less Than (<) 1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to Infant Age of 6 Months)	30 days after the vaccination at the age of 6 months of the infant series (i.e., at the age of 7 months)	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA Titers distribution \< 1:4, 1:4 and 1:8 is reported in this outcome measure. Infant series here denotes the vaccines administered at the age of 6 months of participants.
Percentage of Participants With hSBA Titers Distribution <1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3	30 days after the vaccination at the age of 12 months (i.e., at the age of 13 months)	Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA Titers distribution \< 1:4, 1:4 and 1:8 is reported in this outcome measure.

Trial Locations

Locations (11): Investigational Site Number :6431008
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Krasnodar, Russian Federation
Investigational Site Number :6431004
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Perm, Russian Federation
Investigational Site Number :4840002
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Mexico City, Ciudad De Mexico, Mexico
Investigational Site Number :6431018
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Gatchina, Leningrad Region, Russian Federation
Investigational Site Number :4840003
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Tlaltizapan, Morelos, Mexico
Investigational Site Number :4840001
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Acapulco, Guerrero, Mexico
Investigational Site Number :6431002
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Ekaterinburg, Russian Federation
Investigational Site Number :6431010
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Saint-Petersburg, Russian Federation
Investigational Site Number :6431006
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Samara, Russian Federation
Investigational Site Number :6431007
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St Petersburg, Russian Federation
Investigational Site Number :6431001
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St Petersburg, Russian Federation