Meningitis, Meningococcal
Conditions
Keywords
Meningitis, Meningococcal Meningitis, Meningococcal Infections, MenACYW Conjugate vaccine
Brief summary
This Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study was conducted to assess the immunogenicity and safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine when administered alone and in combination with other pediatric vaccines in healthy toddlers in South Korea, Thailand, the Russian Federation, and Mexico. Primary Objective: * To describe the immunogenicity profile of MenACYW Conjugate vaccine administered alone or concomitantly with licensed pediatric vaccine(s) (measles-mumps-rubella vaccine \[MMR\] + Varicella, diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type-b Conjugate vaccine \[DTaP-IPV-HB-Hib\], or pneumococcal Conjugate vaccine \[PCV13\]). Secondary Objective: * To describe the immunogenicity profile of licensed pediatric vaccine(s) (MMR + Varicella, DTaP-IPV-HB-Hib, or PCV13) when administered alone or concomitantly with MenACYW Conjugate vaccine.
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.
Interventions
BIOLOGICALMenACYW conjugate vaccine
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular
BIOLOGICALMMR
Measles, Mumps, and Rubella Virus Vaccine Live; 0.5 mL, Subcutaneous
BIOLOGICALVaricella
Varicella Virus Vaccine Live; 0.5 mL, Subcutaneous
BIOLOGICALDTaP-IPV-HB-Hib
Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B, Poliomyelitis (inactivated), and Haemophilus influenzae type-b conjugate vaccine (adsorbed); 0.5 mL, Intramuscular
BIOLOGICALPCV13
Pneumococcal 13-valent Conjugate Vaccine; 0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The study had an open-label design; however, as per the protocol, the laboratory technicians who were responsible for performing the serological testing remained blinded to the participants' group allocations throughout the study to avoid any bias.
Intervention model description
Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study
Eligibility
Sex/Gender
ALL
Age
12 Months to 23 Months
Healthy volunteers
Yes
Inclusion criteria
* For South Korea: Korean males and females aged 12 to 23 months on the day of the first study visit. * For Mexico: Males and females aged 12 to 23 months on the day of the first study visit. * For the Russian Federation: Males and females aged 12 to 14 months or 16 to 23 months on the day of the first study visit (eligible for enrollment to MenACYW Conjugate vaccine group) or 15 to 23 months on the day of the first study visit (eligible for enrollment to the MenACYW Conjugate vaccine positive(+) PCV13 group or the PCV13 group). * For Thailand: Thai males and females aged 12 to 23 months on the day of the first study visit * Participants had received all recommended standard of care vaccinations according to their age as per local regulations\*. * For the Russian Federation only, participants aged 15 to 23 months on the day of the first study visit (eligible for enrollment to MenACYW Conjugate vaccine+PCV13 group or the PCV13 group) must not had received the third PCV13 vaccination corresponding to his or her age as per the country's National Immunization Program (NIP). The 2nd dose of PCV13 must had been administered at least 4 weeks before the 3rd dose of PCV13 was administered in the study. * For South Korea, participants must not had received the MMR or Varicella vaccination corresponding to his or her age at inclusion. * For Mexico, participants must not had received the DTaP-IPV-HB-Hib vaccination corresponding to his or her age at inclusion. * For Thailand, participants must not have received the any dose of MMR or V vaccination. * Informed consent form was signed and dated by the parent(s) or guardian if allowed by local regulations (and by independent witnesses if required by local regulations)†. * Participant and parent/guardian were able to attend all scheduled visits and to comply with all trial procedures. * \*Participants must had received the total number of doses expected for each vaccine recommended for his/her age in the respective NIPs, but inclusion of participants with variations in the vaccine administration timeframes is considered acceptable if the total number of doses for the corresponding vaccines had been completed (e.g., in Mexico, 3 infant doses of the pentavalent vaccine must had been administered but the 4th dose due in the 2nd year of life should not had been administered for participants to be included in the trial). For the Russian Federation only, participants that had not received a seasonal flu vaccination from 6 months of age according to the Russian NIP were still eligible to participate in this study. For Thailand only, participants who had received a vaccine ahead of the schedule can still be included in the study provided the first doses of MMR and Varicella vaccines have not been administered prior to inclusion. * †In the Russian Federation, as per local regulations, only the participant's parent(s) are entitled to sign an informed consent form. A child under the responsibility of a guardian were not included in the study.
Exclusion criteria
* Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after the study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. * Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine). * For participants enrolled at sites in the Russian Federation: previous vaccination with the third dose of PCV13 in participants 15 to 23 months of age (eligible for MenACYW Conjugate vaccine+PCV13 group or the PCV13). * For participants enrolled at sites in Mexico: known history of seizures, or uncontrolled neurologic disorder (including epilepsy); or encephalopathy of unknown etiology occurring within 7 days following previous vaccination with pertussis containing vaccine; previous vaccination with DTaP-IPV-HB-Hib or DTaP-containing vaccine at 12 to 23 months of age. * For participants enrolled at sites in South Korea and Thailand: known history of seizures, cerebral injury, or encephalopathy; previous vaccination with MMR or Varicella at 12 to 23 months of age. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * History of meningococcal infection, confirmed either clinically, serologically, or microbiologically. * At high risk for meningococcal infection during the trial, according to the Investigator's judgment (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances. * Verbal report of thrombocytopenia, as reported by the parent/guardian, contraindicating intramuscular (IM) vaccination by the Investigator's judgment. * Known bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination by the Investigator's judgment. * Personal history of Guillain-Barré syndrome (GBS). * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine. * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion. * For participants enrolled at sites in South Korea or Mexico and Thailand: Moderate or severe acute illness/infection (according to investigator's judgment) on the day of vaccination or febrile illness (temperature \>= 38.0 degree Celsius \[°C\]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. * For participants enrolled at sites in the Russian Federation: Acute disease of any severity on the day of vaccination or febrile illness (axillary temperature \>= 37.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event had subsided. * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 0 (tetanus only) and Day 30 post-vaccination | 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. |
| 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 | Day 0 and Day 30 post-vaccination | 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. |
| 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 | Day 0 and Day 30 post-vaccination | Antibodies of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were measured by ECL assay. |
| Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Day 0 and Day 30 post-vaccination | 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. |
| 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 | Day 0 and Day 30 post-vaccination | 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. |
| Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | Within 7 days post vaccination | 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. |
| Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | Within 7 days post vaccination | 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. |
| Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Within 7 days post vaccination | 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. |
| Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Within 7 days post vaccination | 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. |
| 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 | Day 0 and Day 30 post-vaccination | 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. |
| 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 | Day 0 and Day 30 post-vaccination | Antibodies titers of PT and FHA were measured by electrochemiluminescent (ECL) assay. |
| 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 | Day 0 (for tetanus only) and Day 30 post-vaccination | 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). |
Countries
Mexico, Russia, South Korea, Thailand
Participant flow
Recruitment details
Study participants were enrolled in South Korea, Mexico, the Russian Federation, and Thailand from 07 November 2016 to 13 June 2018.
Pre-assignment details
A total of 1183 participants were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| South Korea(Group1):MenACYW Conjugate +MMR+ Varicella Vaccine Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0. | 107 |
| South Korea (Group 2): MenACYW Conjugate Vaccine Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. | 53 |
| South Korea (Group 3): MMR + Varicella Vaccine Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0. | 53 |
| Thailand (Group 10): MenACYW Conjugate + MMR+Varicella Vaccine Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0. | 86 |
| Thailand (Group 11): MenACYW Conjugate Vaccine Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. | 42 |
| Thailand (Group 12): MMR + Varicella Vaccine Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0. | 42 |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and DTaP-IPV-HB-Hib vaccine on Day 0. | 200 |
| Mexico (Group 5): MenACYW Conjugate Vaccine Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. | 100 |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib vaccine on Day 0. | 100 |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and pneumococcal Conjugate vaccine (PCV13) on Day 0. | 200 |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. | 100 |
| Russian Federation (Group 9): PCV13 Vaccine Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0. | 100 |
| Total | 1,183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 2 | 3 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 1 | 0 | 0 | 0 | 0 | 4 | 0 | 2 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | South Korea (Group 2): MenACYW Conjugate Vaccine | South Korea (Group 3): MMR + Varicella Vaccine | Thailand (Group 10): MenACYW Conjugate + MMR+Varicella Vaccine | Thailand (Group 11): MenACYW Conjugate Vaccine | South Korea(Group1):MenACYW Conjugate +MMR+ Varicella Vaccine | Thailand (Group 12): MMR + Varicella Vaccine | Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Mexico (Group 5): MenACYW Conjugate Vaccine | Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | Russian Federation (Group 8): MenACYW Conjugate Vaccine | Russian Federation (Group 9): PCV13 Vaccine | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 12.7 months STANDARD_DEVIATION 1.5 | 12.3 months STANDARD_DEVIATION 0.96 | 12.4 months STANDARD_DEVIATION 0.9 | 12.4 months STANDARD_DEVIATION 0.88 | 12.7 months STANDARD_DEVIATION 1.58 | 12.8 months STANDARD_DEVIATION 1.76 | 16.4 months STANDARD_DEVIATION 2.73 | 16.8 months STANDARD_DEVIATION 2.83 | 16.8 months STANDARD_DEVIATION 2.99 | 16.5 months STANDARD_DEVIATION 2.36 | 16.0 months STANDARD_DEVIATION 3.1 | 16.3 months STANDARD_DEVIATION 2.26 | 15.2 months STANDARD_DEVIATION 2.97 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 86 Participants | 42 Participants | 1 Participants | 42 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 4 Participants | 179 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 53 Participants | 53 Participants | 0 Participants | 0 Participants | 106 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 212 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 200 Participants | 100 Participants | 99 Participants | 198 Participants | 99 Participants | 96 Participants | 792 Participants |
| Region of Enrollment Mexico | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 200 Participants | 100 Participants | 100 Participants | 0 Participants | 0 Participants | 0 Participants | 400 Participants |
| Region of Enrollment Russia | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 200 Participants | 100 Participants | 100 Participants | 400 Participants |
| Region of Enrollment South Korea | 53 Participants | 53 Participants | 0 Participants | 0 Participants | 107 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 213 Participants |
| Region of Enrollment Thailand | 0 Participants | 0 Participants | 86 Participants | 42 Participants | 0 Participants | 42 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 170 Participants |
| Sex: Female, Male Female | 18 Participants | 29 Participants | 47 Participants | 23 Participants | 49 Participants | 23 Participants | 93 Participants | 46 Participants | 48 Participants | 78 Participants | 51 Participants | 45 Participants | 550 Participants |
| Sex: Female, Male Male | 35 Participants | 24 Participants | 39 Participants | 19 Participants | 58 Participants | 19 Participants | 107 Participants | 54 Participants | 52 Participants | 122 Participants | 49 Participants | 55 Participants | 633 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 52 | 0 / 53 | 0 / 86 | 0 / 42 | 0 / 42 | 0 / 200 | 0 / 100 | 0 / 100 | 0 / 200 | 0 / 100 | 0 / 99 |
| other Total, other adverse events | 85 / 103 | 43 / 52 | 37 / 53 | 58 / 86 | 37 / 42 | 37 / 42 | 142 / 200 | 65 / 100 | 85 / 100 | 75 / 200 | 30 / 100 | 17 / 99 |
| serious Total, serious adverse events | 6 / 103 | 4 / 52 | 2 / 53 | 0 / 86 | 1 / 42 | 0 / 42 | 0 / 200 | 0 / 100 | 1 / 100 | 0 / 200 | 0 / 100 | 0 / 99 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup C: Day 0 | 2.37 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup A: Day 30 | 43.9 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup A: Day 0 | 5.20 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup C: Day 30 | 876 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup Y: Day 0 | 3.14 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup Y: Day 30 | 88.9 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup W: Day 0 | 2.15 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup W: Day 30 | 46.8 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 30 | 600 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 30 | 35.5 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 0 | 6.10 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 0 | 2.31 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 30 | 60.0 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 0 | 2.58 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 30 | 30.0 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 0 | 3.12 titers (1/dilution) |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup A: Day 30 | 31.4 titers (1/dilution) |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup C: Day 0 | 2.21 titers (1/dilution) |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup C: Day 30 | 749 titers (1/dilution) |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup W: Day 30 | 40.0 titers (1/dilution) |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup Y: Day 0 | 2.63 titers (1/dilution) |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup Y: Day 30 | 79.7 titers (1/dilution) |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup W: Day 0 | 2.41 titers (1/dilution) |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup A: Day 0 | 5.35 titers (1/dilution) |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 0 | 2.16 titers (1/dilution) |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 30 | 90.9 titers (1/dilution) |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 0 | 2.94 titers (1/dilution) |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 0 | 5.49 titers (1/dilution) |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 0 | 2.16 titers (1/dilution) |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 30 | 666 titers (1/dilution) |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 30 | 50.9 titers (1/dilution) |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 30 | 37.8 titers (1/dilution) |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup W: Day 30 | 57.4 titers (1/dilution) |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup A: Day 0 | 5.99 titers (1/dilution) |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup Y: Day 0 | 2.90 titers (1/dilution) |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup Y: Day 30 | 139 titers (1/dilution) |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup W: Day 0 | 2.93 titers (1/dilution) |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup A: Day 30 | 24.6 titers (1/dilution) |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup C: Day 0 | 2.77 titers (1/dilution) |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup C: Day 30 | 205 titers (1/dilution) |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 30 | 57.0 titers (1/dilution) |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 0 | 3.49 titers (1/dilution) |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 0 | 3.69 titers (1/dilution) |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 30 | 309 titers (1/dilution) |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 30 | 172 titers (1/dilution) |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 30 | 49.0 titers (1/dilution) |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 0 | 3.62 titers (1/dilution) |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 0 | 8.54 titers (1/dilution) |
Primary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup A | 78.5 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup W | 86.4 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup Y | 93.2 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup C | 97.7 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup W | 83.9 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup C | 98.9 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup A | 63.2 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup Y | 88.5 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup Y | 92.3 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup C | 100.0 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup A | 67.1 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup W | 82.6 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup Y | 87.3 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup C | 98.7 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup A | 69.6 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup W | 82.3 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup W | 82.1 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup C | 90.8 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup A | 56.1 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup Y | 92.9 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup C | 91.7 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup A | 71.9 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup W | 90.6 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup Y | 92.7 percentage of participants |
Primary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup A | 82.5 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup C | 98.3 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup Y | 95.5 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup W | 94.9 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup Y | 89.7 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup C | 98.9 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup A | 64.4 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup W | 89.7 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup W | 86.5 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup Y | 96.8 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup C | 100.0 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup A | 69.0 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup A | 70.9 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup W | 92.4 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup C | 98.7 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup Y | 94.9 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup Y | 94.4 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup W | 88.8 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup C | 92.3 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup A | 58.2 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup C | 91.7 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup Y | 93.8 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup W | 90.6 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup A | 72.9 percentage of participants |
Primary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup C: Day 0 (>=1:4) | 9.6 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup A: Day 0 (>=1:8) | 37.9 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup A: Day 30 (>=1:4) | 98.9 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup A: Day 30 (>=1:8) | 97.7 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup A: Day 0 (>=1:4) | 75.1 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup C: Day 0 (>=1:8) | 4.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup C: Day 30 (>=1:4) | 100.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup C: Day 30 (>=1:8) | 100.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup Y: Day 0 (>=1:4) | 32.2 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup Y: Day 0 (>=1:8) | 18.6 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup Y: Day 30 (>=1:4) | 99.4 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup Y: Day 30 (>=1:8) | 99.4 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup W: Day 0 (>=1:4) | 5.1 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup W: Day 0 (>=1:8) | 1.1 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup W: Day 30 (>=1:4) | 98.9 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serogroup W: Day 30 (>=1:8) | 96.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 30 (>=1:8) | 92.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 0 (>=1:4) | 28.7 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 30 (>=1:8) | 100.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 30 (>=1:4) | 100.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 30 (>=1:4) | 95.4 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 0 (>=1:4) | 82.8 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 0 (>=1:8) | 2.3 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 0 (>=1:4) | 11.5 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 30 (>=1:8) | 95.4 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 0 (>=1:4) | 16.1 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 0 (>=1:8) | 44.8 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 30 (>=1:8) | 92.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 30 (>=1:4) | 96.6 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 0 (>=1:8) | 17.2 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 30 (>=1:4) | 96.6 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 0 (>=1:8) | 6.9 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup W: Day 30 (>=1:4) | 97.4 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup A: Day 30 (>=1:8) | 92.9 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup C: Day 0 (>=1:4) | 12.3 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup C: Day 0 (>=1:8) | 1.9 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup C: Day 30 (>=1:4) | 100.0 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup C: Day 30 (>=1:8) | 100.0 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup Y: Day 0 (>=1:4) | 19.4 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup Y: Day 0 (>=1:8) | 11.0 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup Y: Day 30 (>=1:4) | 98.7 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup Y: Day 30 (>=1:8) | 98.7 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup W: Day 30 (>=1:8) | 90.3 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup W: Day 0 (>=1:4) | 14.8 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup W: Day 0 (>=1:8) | 7.7 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup A: Day 0 (>=1:4) | 82.6 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup A: Day 0 (>=1:8) | 45.8 percentage of participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | 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 | Serogroup A: Day 30 (>=1:4) | 98.1 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 30 (>=1:8) | 89.9 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 0 (>=1:4) | 25.3 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 0 (>=1:4) | 7.6 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 30 (>=1:4) | 97.5 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 0 (>=1:8) | 46.8 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 30 (>=1:8) | 98.7 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 30 (>=1:4) | 96.2 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 0 (>=1:8) | 2.5 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 30 (>=1:4) | 100.0 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 0 (>=1:8) | 12.7 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 30 (>=1:8) | 100.0 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 0 (>=1:4) | 8.9 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 0 (>=1:4) | 82.3 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 0 (>=1:8) | 1.3 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 30 (>=1:8) | 92.4 percentage of participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 30 (>=1:4) | 100.0 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup A: Day 30 (>=1:8) | 83.7 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup A: Day 30 (>=1:4) | 94.9 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup C: Day 0 (>=1:4) | 19.9 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup A: Day 0 (>=1:4) | 82.1 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup C: Day 30 (>=1:4) | 98.5 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup C: Day 0 (>=1:8) | 8.7 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup C: Day 30 (>=1:8) | 93.9 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup W: Day 30 (>=1:4) | 95.9 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup Y: Day 30 (>=1:4) | 98.5 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup W: Day 30 (>=1:8) | 94.4 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup Y: Day 30 (>=1:8) | 97.4 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup Y: Day 0 (>=1:4) | 21.9 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup A: Day 0 (>=1:8) | 49.0 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup Y: Day 0 (>=1:8) | 14.3 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup W: Day 0 (>=1:4) | 16.8 percentage of participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | 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 | Serogroup W: Day 0 (>=1:8) | 12.8 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 30 (>=1:8) | 99.0 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 0 (>=1:4) | 32.3 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 30 (>=1:4) | 96.9 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 0 (>=1:4) | 36.5 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 0 (>=1:8) | 20.8 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 0 (>=1:8) | 15.6 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 30 (>=1:8) | 95.8 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 30 (>=1:4) | 99.0 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup Y: Day 30 (>=1:8) | 97.9 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 30 (>=1:8) | 90.6 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 0 (>=1:8) | 54.2 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup W: Day 0 (>=1:4) | 26.0 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 30 (>=1:4) | 97.9 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 0 (>=1:8) | 17.7 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup C: Day 30 (>=1:4) | 99.0 percentage of participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | 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 | Serogroup A: Day 0 (>=1:4) | 85.4 percentage of participants |
Secondary
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
Population: Analysis was performed on PPAS. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure were not planned to be collected and analyzed for Groups 1, 2, 3, 5, 7, 8, 9, 10, 11, and 12.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Diphtheria: Day 30 | 5.52 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Tetanus: Day 0 | 0.238 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Tetanus: Day 30 | 7.06 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Polio 1: Day 30 | 4560 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Polio 2: Day 30 | 7244 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Polio 3: Day 30 | 5977 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Hepatitis B: Day 30 | 5171 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | PRP: Day 30 | 46.6 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | PRP: Day 30 | 56.2 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Diphtheria: Day 30 | 6.34 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Polio 2: Day 30 | 5618 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Tetanus: Day 0 | 0.234 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Hepatitis B: Day 30 | 7308 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Tetanus: Day 30 | 7.11 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Polio 3: Day 30 | 5100 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Polio 1: Day 30 | 4034 titers (1/dilution) |
Secondary
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
Population: Analysis was performed on PPAS. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure were not planned to be collected and analyzed for Groups 2, 4, 5, 6, 7, 8, 9, and 11.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Mumps: Day 0 | 5.51 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Measles: Day 0 | 40.0 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Mumps: Day 30 | 85.9 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Varicella: Day 0 | 0.556 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Rubella: Day 0 | 5.94 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Measles: Day 30 | 2156 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Rubella: Day 30 | 87.6 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Varicella: Day 30 | 13.4 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Rubella: Day 30 | 104 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Varicella: Day 0 | 0.665 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Measles: Day 0 | 45.0 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Measles: Day 30 | 2840 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Mumps: Day 0 | 5.43 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Mumps: Day 30 | 97.6 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Rubella: Day 0 | 7.12 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Varicella: Day 30 | 17.4 titers (1/dilution) |
Secondary
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
Population: Analysis was performed on PPAS. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure were not planned to be collected and analyzed for Groups 1, 2, 3, 4, 5, 6, 8, 10, 11, and 12.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 5: Day 0 | 0.828 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 1: Day 30 | 2.33 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 3: Day 0 | 0.409 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 3: Day 30 | 0.802 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 4: Day 0 | 0.604 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 4: Day 30 | 1.97 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 1: Day 0 | 0.867 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 5: Day 30 | 1.99 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 6A: Day 0 | 1.61 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 6A: Day 30 | 5.96 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 6B: Day 0 | 0.895 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 6B: Day 30 | 3.66 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 7F: Day 0 | 1.32 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 7F: Day 30 | 3.05 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 9V: Day 0 | 0.841 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 9V: Day 30 | 2.34 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 14: Day 0 | 3.25 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 14: Day 30 | 7.62 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 18C: Day 0 | 0.737 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 18C: Day 30 | 2.19 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 19A: Day 0 | 1.65 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 19A: Day 30 | 5.75 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 19F: Day 0 | 1.78 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 19F: Day 30 | 5.58 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 23F: Day 0 | 0.631 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Serotype 23F: Day 30 | 2.42 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 18C: Day 30 | 2.21 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 1: Day 0 | 0.918 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 7F: Day 30 | 2.67 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 1: Day 30 | 2.14 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 23F: Day 0 | 0.733 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 3: Day 0 | 0.414 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 9V: Day 0 | 0.863 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 3: Day 30 | 0.773 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 19A: Day 0 | 1.96 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 4: Day 0 | 0.653 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 9V: Day 30 | 2.52 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 4: Day 30 | 1.49 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 19F: Day 30 | 5.53 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 5: Day 0 | 0.782 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 14: Day 0 | 3.00 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 5: Day 30 | 1.73 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 19A: Day 30 | 5.91 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 6A: Day 0 | 1.48 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 14: Day 30 | 6.30 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 6A: Day 30 | 6.13 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 23F: Day 30 | 2.58 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 6B: Day 0 | 0.691 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 18C: Day 0 | 0.995 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 6B: Day 30 | 2.57 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 19F: Day 0 | 1.74 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Serotype 7F: Day 0 | 1.39 titers (1/dilution) |
Secondary
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
Population: Analysis was performed on PPAS. Data for this outcome measure were not planned to be collected and analyzed for Groups 1, 2, 3, 5, 7, 8, 9, 10, 11, and 12.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | PT: Day 0 | 17.9 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | PT: Day 30 | 144 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | FHA: Day 0 | 45.5 titers (1/dilution) |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | FHA: Day 30 | 299 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | FHA: Day 30 | 391 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | PT: Day 0 | 20.4 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | FHA: Day 0 | 57.4 titers (1/dilution) |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | PT: Day 30 | 169 titers (1/dilution) |
Secondary
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
Population: Analysis was performed on Safety analysis set (SafAS) which included participants who received at least 1 dose of study vaccine(s) \& had any safety data available. Here '0' in the number analyzed field signifies that the vaccines mentioned in the respective categories were not administered to the specified group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Tenderness: Grade 3 | 1 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Swelling: Any Grade | 18 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Swelling: Any Grade | 7 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Erythema: Grade 3 | 0 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Swelling: Grade 3 | 0 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Erythema: Any Grade | 13 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Tenderness: Any Grade | 21 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Swelling: Grade 3 | 0 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Swelling: Any Grade | 10 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Tenderness: Grade 3 | 1 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Erythema: Grade 3 | 1 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Erythema: Any Grade | 19 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Erythema: Any Grade | 27 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Tenderness: Grade 3 | 0 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Tenderness: Any Grade | 23 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Erythema: Grade 3 | 0 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Tenderness: Any Grade | 28 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Swelling: Grade 3 | 0 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Tenderness: Any Grade | 15 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Swelling: Grade 3 | 0 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Swelling: Any Grade | 14 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Erythema: Any Grade | 20 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Tenderness: Grade 3 | 0 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Erythema: Grade 3 | 2 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Swelling: Grade 3 | 0 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Tenderness: Any Grade | 10 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Tenderness: Grade 3 | 0 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Erythema: Any Grade | 6 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Erythema: Grade 3 | 0 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Swelling: Any Grade | 1 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Tenderness: Any Grade | 11 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Tenderness: Grade 3 | 0 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Erythema: Any Grade | 4 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Erythema: Grade 3 | 0 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Swelling: Any Grade | 2 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Swelling: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Tenderness: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Tenderness: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Swelling: Any Grade | 15 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Tenderness: Any Grade | 29 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Erythema: Any Grade | 18 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Swelling: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Swelling: Any Grade | 11 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Swelling: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Erythema: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Erythema: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Swelling: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Tenderness: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Erythema: Any Grade | 24 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Swelling: Any Grade | 12 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Tenderness: Any Grade | 17 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Erythema: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Erythema: Any Grade | 29 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Tenderness: Any Grade | 17 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Swelling: Any Grade | 7 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Tenderness: Any Grade | 17 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Erythema: Grade 3 | 0 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Erythema: Any Grade | 13 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Tenderness: Grade 3 | 1 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MenACYW: Swelling: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Tenderness: Grade 3 | 1 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Swelling: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Swelling: Any Grade | 5 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Tenderness: Any Grade | 18 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Erythema: Any Grade | 10 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Tenderness: Any Grade | 14 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Swelling: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Tenderness: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Swelling: Any Grade | 4 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Erythema: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | MMR: Erythema: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 1, 2, 3, 10, 11, and 12 | Varicella: Erythema: Any Grade | 13 Participants |
Secondary
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
Population: Analysis was performed on SafAS. Here, 'Number analyzed' = participants with available data for each specified category and '0' in the number analyzed field signifies that the vaccines mentioned in the respective categories were not administered to the specified group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | MenACYW: Tenderness: Any Grade | 68 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | MenACYW: Tenderness: Grade 3 | 6 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | MenACYW: Erythema: Any Grade | 40 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | MenACYW: Erythema: Grade 3 | 3 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | MenACYW: Swelling: Any Grade | 23 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | MenACYW: Swelling: Grade 3 | 2 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | DTaP-IPV-HB-Hib: Tenderness: Any Grade | 80 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | DTaP-IPV-HB-Hib: Tenderness: Grade 3 | 6 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | DTaP-IPV-HB-Hib: Erythema: Any Grade | 56 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | DTaP-IPV-HB-Hib: Erythema: Grade 3 | 8 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | DTaP-IPV-HB-Hib: Swelling: Any Grade | 45 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | DTaP-IPV-HB-Hib: Swelling: Grade 3 | 8 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | MenACYW: Tenderness: Grade 3 | 1 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | MenACYW: Erythema: Grade 3 | 3 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | MenACYW: Tenderness: Any Grade | 27 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | MenACYW: Swelling: Any Grade | 8 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | MenACYW: Erythema: Any Grade | 15 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | MenACYW: Swelling: Grade 3 | 2 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | DTaP-IPV-HB-Hib: Tenderness: Grade 3 | 10 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | DTaP-IPV-HB-Hib: Tenderness: Any Grade | 54 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | DTaP-IPV-HB-Hib: Erythema: Grade 3 | 5 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | DTaP-IPV-HB-Hib: Swelling: Any Grade | 30 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | DTaP-IPV-HB-Hib: Swelling: Grade 3 | 4 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 4, 5, and 6 | DTaP-IPV-HB-Hib: Erythema: Any Grade | 37 Participants |
Secondary
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
Population: Analysis was performed on SafAS. Here, '0' in the number analyzed field signifies that the vaccines mentioned in the respective categories were not administered to the specified group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | MenACYW: Tenderness: Any Grade | 28 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | MenACYW: Tenderness: Grade 3 | 4 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | MenACYW: Erythema: Any Grade | 43 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | MenACYW: Erythema: Grade 3 | 0 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | MenACYW: Swelling: Any Grade | 8 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | MenACYW: Swelling: Grade 3 | 0 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | PCV13: Tenderness: Any Grade | 34 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | PCV13: Tenderness: Grade 3 | 5 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | PCV13: Erythema: Any Grade | 48 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | PCV13: Erythema: Grade 3 | 0 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | PCV13: Swelling: Any Grade | 19 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | PCV13: Swelling: Grade 3 | 0 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | MenACYW: Tenderness: Grade 3 | 0 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | MenACYW: Erythema: Grade 3 | 0 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | MenACYW: Tenderness: Any Grade | 8 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | MenACYW: Swelling: Any Grade | 7 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | MenACYW: Erythema: Any Grade | 17 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | MenACYW: Swelling: Grade 3 | 0 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | PCV13: Tenderness: Grade 3 | 1 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | PCV13: Tenderness: Any Grade | 9 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | PCV13: Erythema: Grade 3 | 0 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | PCV13: Swelling: Any Grade | 2 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | PCV13: Swelling: Grade 3 | 0 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Injection Site Reactions (Tenderness, Erythema, and Swelling): Groups 7, 8, and 9 | PCV13: Erythema: Any Grade | 8 Participants |
Secondary
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
Population: Analysis was performed on Safety analysis set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Any Grade | 17 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Grade 3 | 0 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Any Grade | 31 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Grade 3 | 0 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Grade 3 | 0 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Any Grade | 17 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Grade 3 | 1 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Any Grade | 29 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Grade 3 | 0 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Any Grade | 21 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Grade 3 | 1 Participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Any Grade | 6 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Any Grade | 9 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Any Grade | 3 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Grade 3 | 0 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Grade 3 | 0 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Grade 3 | 2 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Grade 3 | 0 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Any Grade | 12 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Grade 3 | 0 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Any Grade | 10 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Any Grade | 9 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Any Grade | 8 Participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Grade 3 | 0 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Grade 3 | 0 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Any Grade | 9 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Grade 3 | 0 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Grade 3 | 1 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Any Grade | 5 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Any Grade | 11 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Any Grade | 2 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Grade 3 | 0 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Grade 3 | 0 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Any Grade | 6 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Any Grade | 8 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Any Grade | 14 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Any Grade | 8 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Any Grade | 11 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Any Grade | 14 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Any Grade | 5 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Any Grade | 6 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Any Grade | 4 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Grade 3 | 0 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Any Grade | 1 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Grade 3 | 0 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Any Grade | 11 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Any Grade | 12 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Any Grade | 17 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Grade 3 | 1 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Grade 3 | 1 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Grade 3 | 0 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Any Grade | 7 Participants |
| Russian Federation (Group 7): MenACYW Conjugate +PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Any Grade | 5 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Any Grade | 7 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Any Grade | 5 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Grade 3 | 2 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Grade 3 | 1 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Any Grade | 3 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Any Grade | 12 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Grade 3 | 1 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Any Grade | 14 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Grade 3 | 1 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Any Grade | 32 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Grade 3 | 4 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Any Grade | 15 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Grade 3 | 0 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Any Grade | 46 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Grade 3 | 1 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Any Grade | 31 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Any Grade | 51 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Grade 3 | 8 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Any Grade | 64 Participants |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Grade 3 | 4 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Any Grade | 6 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Grade 3 | 1 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Any Grade | 7 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Grade 3 | 0 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Grade 3 | 2 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Grade 3 | 1 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Grade 3 | 1 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Any Grade | 15 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Any Grade | 25 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Any Grade | 34 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Any Grade | 25 Participants |
| Mexico (Group 5): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Grade 3 | 1 Participants |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Grade 3 | 0 Participants |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Grade 3 | 0 Participants |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Any Grade | 17 Participants |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Any Grade | 9 Participants |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Grade 3 | 3 Participants |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Any Grade | 26 Participants |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Any Grade | 20 Participants |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Any Grade | 33 Participants |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Grade 3 | 2 Participants |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Grade 3 | 1 Participants |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Any Grade | 16 Participants |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Grade 3 | 3 Participants |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Any Grade | 26 Participants |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Grade 3 | 2 Participants |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Grade 3 | 1 Participants |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Any Grade | 8 Participants |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Any Grade | 19 Participants |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Grade 3 | 0 Participants |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Any Grade | 0 Participants |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Grade 3 | 4 Participants |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Grade 3 | 1 Participants |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Grade 3 | 0 Participants |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Any Grade | 12 Participants |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Any Grade | 25 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Any Grade | 3 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Any Grade | 6 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Any Grade | 4 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Any Grade | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Any Grade | 16 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Grade 3 | 0 Participants |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Any Grade | 12 Participants |
| Russian Federation (Group 9): PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Grade 3 | 0 Participants |
| Russian Federation (Group 9): PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Appetite Lost: Any Grade | 7 Participants |
| Russian Federation (Group 9): PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Grade 3 | 0 Participants |
| Russian Federation (Group 9): PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Any Grade | 4 Participants |
| Russian Federation (Group 9): PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Grade 3 | 0 Participants |
| Russian Federation (Group 9): PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Any Grade | 9 Participants |
| Russian Federation (Group 9): PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Drowsiness: Grade 3 | 0 Participants |
| Russian Federation (Group 9): PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Fever: Any Grade | 2 Participants |
| Russian Federation (Group 9): PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Any Grade | 2 Participants |
| Russian Federation (Group 9): PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Irritability: Grade 3 | 0 Participants |
| Russian Federation (Group 9): PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Abnormal crying: Grade 3 | 0 Participants |
| Russian Federation (Group 9): PCV13 Vaccine | Number of Participants Reporting at Least One Solicited Systemic Reactions (Fever, Vomiting, Abnormal Crying, Drowsiness, Appetite Loss, and Irritability) | Vomiting: Any Grade | 0 Participants |
Secondary
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
Population: Analysis was performed on PPAS. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure were not planned to be collected and analyzed for Groups 1, 2, 3, 5, 7, 8, 9, 10, 11 and 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | PRP: Day 30 (>=0.15 mcg/mL) | 100.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | PRP: Day 30 (>=1.0 mcg/mL) | 100.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Diphtheria: Day 30 (>=1 IU/mL) | 98.7 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Tetanus: Day 0 (>=0.01 IU/mL) | 100.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Tetanus: Day 0 (>=0.1 IU/mL) | 81.3 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Tetanus: Day 30 (>=0.1 IU/mL) | 100.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Tetanus: Day 30 (>=1 IU/mL) | 98.1 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Polio 1: Day 30 (>=8 [1/dilution]) | 100.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Polio 2: Day 30 (>=8 [1/dilution]) | 100.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Polio 3: Day 30 (>=8 [1/dilution]) | 100.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Hepatitis B: Day 30 (>=10 mIU/mL) | 100.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Hepatitis B: Day 30 (>=100 mIU/mL) | 98.7 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Diphtheria: Day 30 (>=0.1 IU/mL) | 100.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Hepatitis B: Day 30 (>=10 mIU/mL) | 100.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | PRP: Day 30 (>=0.15 mcg/mL) | 100.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Tetanus: Day 30 (>=1 IU/mL) | 98.5 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | PRP: Day 30 (>=1.0 mcg/mL) | 100.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Diphtheria: Day 30 (>=0.1 IU/mL) | 100.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Polio 3: Day 30 (>=8 [1/dilution]) | 100.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Diphtheria: Day 30 (>=1 IU/mL) | 100.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Polio 1: Day 30 (>=8 [1/dilution]) | 100.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Tetanus: Day 0 (>=0.01 IU/mL) | 100.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Hepatitis B: Day 30 (>=100 mIU/mL) | 100.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Tetanus: Day 0 (>=0.1 IU/mL) | 77.6 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Polio 2: Day 30 (>=8 [1/dilution]) | 100.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Tetanus: Day 30 (>=0.1 IU/mL) | 100.0 percentage of participants |
Secondary
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
Population: Analysis was performed on PPAS. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure were not planned to be collected and analyzed for Groups 2, 4, 5, 6, 7, 8, 9, and 11.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Measles: Day 0 | 0.6 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Measles: Day 30 | 96.6 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Mumps: Day 0 | 7.4 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Mumps: Day 30 | 97.7 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Rubella: Day 0 | 27.3 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Rubella: Day 30 | 100.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Varicella: Day 0 | 4.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | Varicella: Day 30 | 93.2 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Varicella: Day 30 | 98.9 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Measles: Day 0 | 0.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Rubella: Day 0 | 31.5 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Measles: Day 30 | 97.8 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Varicella: Day 0 | 7.6 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Mumps: Day 0 | 6.5 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Rubella: Day 30 | 100.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | Mumps: Day 30 | 100.0 percentage of participants |
Secondary
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
Population: Analysis was performed on PPAS. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure were not planned to be collected and analyzed for Groups 1, 2, 3, 4, 5, 6, 8, 10, 11, and 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 7F: Day 30 (>=0.35 mcg/mL) | 98.4 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 3: Day 30 (>=1.0 mcg/mL) | 48.2 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 7F: Day 30 (>=1.0 mcg/mL) | 80.1 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 5: Day 30 (>=0.35 mcg/mL) | 94.8 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 9V: Day 0 (>=0.35 mcg/mL) | 77.2 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 3: Day 0 (>=0.35 mcg/mL) | 49.2 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 9V: Day 0 (>=1.0 mcg/mL) | 42.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 5: Day 30 (>=1.0 mcg/mL) | 71.2 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 9V: Day 30 (>=0.35 mcg/mL) | 95.3 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 4: Day 0 (>=0.35 mcg/mL) | 66.8 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 9V: Day 30 (>=1.0 microg/mL) | 74.3 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6A: Day 0 (>=0.35 mcg/mL) | 90.2 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 14: Day 0 (>=0.35 mcg/mL) | 95.8 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 1: Day 0 (>=1.0 mcg/mL) | 43.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 14: Day 0 (>=1.0 mcg/mL) | 83.3 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6A: Day 0 (>=1.0 mcg/mL) | 63.7 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 14: Day 30 (>=0.35 mcg/mL) | 99.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 4: Day 0 (>=1.0 mcg/mL) | 33.7 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 14: Day 30 (>=1.0 mcg/mL) | 97.4 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6A: Day 30 (>=0.35 mcg/mL) | 97.4 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 18C: Day 0 (>=0.35 mcg/mL) | 71.5 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 3: Day 0 (>=1.0 mcg/mL) | 22.3 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 18C: Day 0 (>=1.0 mcg/mL) | 40.9 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6A: Day 30 (>=1.0 mcg/mL) | 96.3 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 18C: Day 30 (>=0.35 mcg/mL) | 95.3 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 4: Day 30 (>=0.35 mcg/mL) | 92.7 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 18C: Day 30 (>=1.0 mcg/mL) | 79.1 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6B: Day 0 (>=0.35 mcg/mL) | 72.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19A: Day 0 (>=0.35 mcg/mL) | 87.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 1: Day 30 (>=1.0 mcg/mL) | 76.4 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19A: Day 0 (>=1.0 mcg/mL) | 62.7 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6B: Day 0 (>=1.0 mcg/mL) | 44.6 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19A: Day 30 (>=0.35 mcg/mL) | 96.3 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 4: Day 30 (>=1.0 mcg/mL) | 80.1 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19A: Day 30 (>=1.0 mcg/mL) | 92.7 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6B: Day 30 (>=0.35 mcg/mL) | 94.8 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19F: Day 0 (>=0.35 mcg/mL) | 87.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 3: Day 30 (>=0.35 mcg/mL) | 72.3 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19F: Day 0 (>=1.0 mcg/mL) | 64.2 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6B: Day 30 (>=1.0 mcg/mL) | 86.4 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19F: Day 30 (>=0.35 mcg/mL) | 96.9 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 5: Day 0 (>=0.35 mcg/mL) | 81.3 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19F: Day 30 (>=1.0 mcg/mL) | 88.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 7F: Day 0 (>=0.35 mcg/mL) | 87.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 23F: Day 0 (>=0.35 mcg/mL) | 68.2 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 1: Day 30 (>=0.35 mcg/mL) | 97.4 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 23F: Day 0 (>=1.0 mcg/mL) | 34.9 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 7F: Day 0 (>=1.0 mcg/mL) | 62.7 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 23F: Day 30 (>=0.35 mcg/mL) | 96.3 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 5: Day 0 (>=1.0 mcg/mL) | 41.5 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 23F: Day 30 (>=1.0 mcg/mL) | 72.3 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 1: Day 0 (>=0.35 mcg/mL) | 80.8 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 23F: Day 30 (>=1.0 mcg/mL) | 78.3 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 1: Day 0 (>=0.35 mcg/mL) | 79.3 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 1: Day 0 (>=1.0 mcg/mL) | 45.7 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 1: Day 30 (>=0.35 mcg/mL) | 94.6 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 1: Day 30 (>=1.0 mcg/mL) | 70.7 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 3: Day 0 (>=0.35 mcg/mL) | 53.3 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 3: Day 0 (>=1.0 mcg/mL) | 18.5 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 3: Day 30 (>=0.35 mcg/mL) | 76.1 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 3: Day 30 (>=1.0 mcg/mL) | 38.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 4: Day 0 (>=0.35 mcg/mL) | 68.5 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 4: Day 0 (>=1.0 mcg/mL) | 38.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 4: Day 30 (>=0.35 mcg/mL) | 90.2 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 4: Day 30 (>=1.0 mcg/mL) | 62.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 5: Day 0 (>=0.35 mcg/mL) | 76.1 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 5: Day 0 (>=1.0 mcg/mL) | 50.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 5: Day 30 (>=0.35 mcg/mL) | 90.2 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 5: Day 30 (>=1.0 mcg/mL) | 69.6 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6A: Day 0 (>=0.35 mcg/mL) | 82.6 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6A: Day 0 (>=1.0 mcg/mL) | 65.2 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6A: Day 30 (>=0.35 mcg/mL) | 96.7 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6A: Day 30 (>=1.0 mcg/mL) | 90.2 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6B: Day 0 (>=0.35 mcg/mL) | 68.5 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6B: Day 0 (>=1.0 mcg/mL) | 41.3 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6B: Day 30 (>=0.35 mcg/mL) | 92.4 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 6B: Day 30 (>=1.0 mcg/mL) | 75.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 7F: Day 0 (>=0.35 mcg/mL) | 88.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 7F: Day 0 (>=1.0 mcg/mL) | 65.2 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 7F: Day 30 (>=0.35 mcg/mL) | 94.6 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 7F: Day 30 (>=1.0 mcg/mL) | 83.7 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 9V: Day 0 (>=0.35 mcg/mL) | 79.3 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 9V: Day 0 (>=1.0 mcg/mL) | 43.5 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 9V: Day 30 (>=0.35 mcg/mL) | 92.4 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 9V: Day 30 (>=1.0 microg/mL) | 75.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 14: Day 0 (>=0.35 mcg/mL) | 92.4 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 14: Day 0 (>=1.0 mcg/mL) | 87.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 14: Day 30 (>=0.35 mcg/mL) | 98.9 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 14: Day 30 (>=1.0 mcg/mL) | 94.6 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 18C: Day 0 (>=0.35 mcg/mL) | 84.8 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 18C: Day 0 (>=1.0 mcg/mL) | 48.9 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 18C: Day 30 (>=0.35 mcg/mL) | 92.4 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 18C: Day 30 (>=1.0 mcg/mL) | 79.3 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19A: Day 0 (>=0.35 mcg/mL) | 87.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19A: Day 0 (>=1.0 mcg/mL) | 69.6 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19A: Day 30 (>=0.35 mcg/mL) | 98.9 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19A: Day 30 (>=1.0 mcg/mL) | 90.2 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19F: Day 0 (>=0.35 mcg/mL) | 89.1 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19F: Day 0 (>=1.0 mcg/mL) | 65.2 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19F: Day 30 (>=0.35 mcg/mL) | 97.8 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 19F: Day 30 (>=1.0 mcg/mL) | 85.9 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 23F: Day 0 (>=0.35 mcg/mL) | 64.1 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 23F: Day 0 (>=1.0 mcg/mL) | 44.6 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | Percentage of Participants With Immune Response Following Injection With PCV13 Vaccine Administered Alone or Concomitantly With the MenACYW Conjugate Vaccine: Groups 7 and 9 | Serotype 23F: Day 30 (>=0.35 mcg/mL) | 93.5 percentage of participants |
Secondary
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
Population: Analysis was performed on PPAS. Data for this outcome measure were not planned to be collected and analyzed for Groups 1, 2, 3, 5, 7, 8, 9, 10, 11, and 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | PT: Day 30/Day 0 | 91.0 percentage of participants |
| Groups 1and10: MenACYW Conjugate Vaccine+MMR+Varicella Vaccine | 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 | FHA: Day 30/Day 0 | 89.0 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | PT: Day 30/Day 0 | 92.6 percentage of participants |
| Groups 2 and 11: MenACYW Conjugate Vaccine | 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 | FHA: Day 30/Day 0 | 88.2 percentage of participants |