This Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study was conducted to assess the immunogenicity and safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine when administered alone and in combination with other pediatric vaccines in healthy toddlers in South Korea, Thailand, the Russian Federation, and Mexico. Primary Objective: * To describe the immunogenicity profile of MenACYW Conjugate vaccine administered alone or concomitantly with licensed pediatric vaccine(s) (measles-mumps-rubella vaccine \[MMR\] + Varicella, diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type-b Conjugate vaccine \[DTaP-IPV-HB-Hib\], or pneumococcal Conjugate vaccine \[PCV13\]). Secondary Objective: * To describe the immunogenicity profile of licensed pediatric vaccine(s) (MMR + Varicella, DTaP-IPV-HB-Hib, or PCV13) when administered alone or concomitantly with MenACYW Conjugate vaccine.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,183
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular
Measles, Mumps, and Rubella Virus Vaccine Live; 0.5 mL, Subcutaneous
Varicella Virus Vaccine Live; 0.5 mL, Subcutaneous
Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B, Poliomyelitis (inactivated), and Haemophilus influenzae type-b conjugate vaccine (adsorbed); 0.5 mL, Intramuscular
Pneumococcal 13-valent Conjugate Vaccine; 0.5 mL, Intramuscular
Unnamed facility
Acapulco, Mexico
Unnamed facility
Mexico City, Mexico
Unnamed facility
Tlaltizapán, Mexico
Unnamed facility
Barnaul, Russia
Unnamed facility
Kazan', Russia
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Krasnodar, Russia
Unnamed facility
Moscow, Russia
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Murmansk, Russia
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Novosibirsk, Russia
Unnamed facility
Perm, Russia
...and 27 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 30 post-vaccination
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.
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
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.
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
Antibodies titers of PT and FHA were measured by electrochemiluminescent (ECL) assay.
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
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).
Time frame: Day 0 (for tetanus only) and Day 30 post-vaccination
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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.
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
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.
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
Antibodies of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were measured by ECL assay.
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
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.
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
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.
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
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.
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
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.
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)
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.
Time frame: Within 7 days post vaccination