Neisseria Meningitidis, Haemophilus Influenzae Type b
Conditions
Keywords
Invasive Hib & N. meningitidis diseases
Brief summary
This study is evaluating the safety and immunogenicity of Hib-MenCY-TT vaccine compared to control groups receiving licensed Hib or MenC conjugate vaccines, each administered at 2, 4, 6, and 12 to 15 months of age. Co-administration with live, attenuated measles, mumps, and rubella combination vaccine; and with live, attenuated varicella vaccine will be assessed with administration of the booster dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Detailed description
The study will be conducted in 2 stages: a 3-dose primary vaccination at 2, 4 and 6 months of age and a booster vaccination at 12 to 15 months of age. All subjects will have 3 blood samples taken. Half of the subjects of each group will have a blood sample taken just prior to the administration of the third dose of the primary vaccination and the other half of the subjects of each group will have a blood sample taken at one month after the third vaccine dose of the primary vaccination phase. In addition, all subjects of all groups will have a blood sample taken before and 42 days after administration of the booster dose.
Interventions
BIOLOGICALMenHibrix (Hib-MenCY-TT)
One intramuscular dose at 2, 4 and 6 months of age ( group A) and one intramuscular dose at 12 to 15 months of age (groups A and B)
BIOLOGICALInfanrix® Penta
One intramuscular dose at 2, 4 and 6 months of age
BIOLOGICALPrevenar®
One intramuscular dose at 2, 4 and 6 months of age
BIOLOGICALActHIB®
One intramuscular dose at 2, 4 and 6 months of age
BIOLOGICALMeningitec®
One intramuscular dose at 2, 4 and 6 months of age
BIOLOGICALM-M-R®II
One subcutaneous dose at 12-15 months of age
BIOLOGICALVarivax®
One subcutaneous dose at 12 to 15 months of age
BIOLOGICALPedvaxHIB®
One intramuscular dose at 12 to 15 months of age
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Born after a gestation period between 36 and 42 weeks.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s). * Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine. Vaccination with hepatitis B at birth is accepted (although not mandatory). Influenza vaccination is allowed 30 days after administration of the third vaccine dose to 30 days preceding the booster dose. * History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, Streptococcus pneumoniae and/or varicella invasive disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including dry natural latex rubber, tetanus toxoid, diphtheria toxoid, neomycin, polymyxin. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Additional specific criteria for the booster part of the study * History of or previous vaccination against measles, mumps, rubella or varicella. * Previous booster vaccination with Hib or meningococcal serogroup C vaccine since the last visit of the primary phase.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL) | One month after the 3-dose primary vaccination course | The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure. |
| Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128 | One month after the 3-dose primary vaccination course | The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB + Meningitec groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure. |
| Number of Subjects Seroconverted for Anti-measles Antibodies | 42 days after the fourth dose vaccination | The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-measles seroconversion is defined as the appearance of antibodies (i.e. concentration greater than or equal to the cut-off value of 150 milli-international units per milliliter (mIU/mL)) in the serum of subjects seronegative (below 150 mIU/mL) before vaccination. |
| Number of Subjects Seroconverted for Anti-mumps Antibodies | 42 days after the fourth dose vaccination | The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-mumps seroconversion is defined as titer greater than or equal to 28 ED50 in subjects seronegative (\<28 ED50) before vaccination. ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. |
| Number of Subjects With an Anti-rubella Seroresponse | 42 days after the fourth dose vaccination | The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-rubella seroresponse is defined as post-vaccination concentration greater than or equal to 10 IU/mL (ELISA, Enzygnost) in subjects seronegative (concentration below 4 IU/mL) before vaccination. |
| Number of Subjects Seroconverted for Anti-varicella Antibodies | 42 days after the fourth dose vaccination | The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-varicella seroconversion is defined as post-vaccination titers greater than or equal to 1:5, in subjects seronegative (titers below 1:5) before vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) | The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8. |
| hSBA-MenY Titers | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) | The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers. |
| Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL. |
| Anti-PSC Concentrations | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations. |
| Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL. |
| Anti-PSY Concentrations | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations. |
| Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.15 µg/mL and 1.0 µg/mL. |
| Anti-PRP Concentrations | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) | The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations. |
| Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL | Just prior to the fourth dose and 42 days after the fourth dose | The cut-off value assessed was 150 mIU/mL. |
| Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50 | Just prior to the fourth dose and 42 days after the fourth dose | ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. |
| Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL | Just prior to the fourth dose and 42 days after the fourth dose | The cut-off value assessed was 4 IU/mL. |
| Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5 | Just prior to the fourth dose and 42 days after the fourth dose | The cut-off value assessed was a titer of 1:5. |
| Number of Subjects With a Fourth Dose Response for hSBA-MenC | 42 days after the fourth dose | Fourth dose response for hSBA-MenC is defined as: •For initially seronegative subjects (i.e., subjects with pre fourth dose hSBA antibody titer below 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:16; •For initially seropositive subjects (i.e., subjects with pre fourth dose antibody titer greater than or equal to 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:128. |
| Number of Subjects With a Fourth Dose Response for hSBA-MenY | 42 days after the fourth dose | Fourth dose response for hSBA-MenY defined as: •For initially seronegative subjects (i.e., pre fourth dose hSBA antibody titer \< 1:4), post fourth dose hSBA antibody titer greater than or equal to (≥) 1:16; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:4 and \< 1:64, post fourth dose hSBA antibody titer at least 4-fold higher than the pre fourth dose hSBA antibody titer; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:64, post fourth dose hSBA antibody titer at least 2-fold higher than the pre fourth dose hSBA antibody titer. |
| Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | 42 days after the fourth dose | The pre-defined cut-off values were 150 mIU/mL and 200 mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL. |
| Anti-measles Concentrations in Initially Seronegative Subjects | 42 days after the fourth dose | Concentrations are presented as Geometric Mean Concentrations expressed as mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL. |
| Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | 42 days after the fourth dose | The pre-defined cut-off values were 4 IU/mL and 10 IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 4 IU/mL. |
| Anti-rubella Concentrations in Initially Seronegative Subjects | 42 days after the fourth dose | Concentrations are presented as Geometric Mean Concentrations expressed as IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-rubella concentration below 4 IU/mL. |
| Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination | 42 days after the fourth dose | ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. |
| Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) | The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128. |
| Anti-mumps Titers in Initially Seronegative Subjects | 42 days after the fourth dose | Titers are presented as Geometric Mean Titers expressed as ED50, the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50. |
| Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | 42 days after the fourth dose | The pre-defined cut-off values were 1:5 and 1:40. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5. |
| Anti-varicella Titers in Initially Seronegative Subjects | 42 days after the fourth dose | Titers are presented as Geometric Mean Titers. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5. |
| Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite. |
| Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | During a 4-day period (Day 0-3) after the fourth dose vaccination phase | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite. |
| Number of Subjects Reporting Unsolicited Adverse Events | During the 31-day (Day 0-30) post-primary and post-fourth dose vaccination period | Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | During a 43-day (Day 0-42) after the fourth dose | Specific solicited general symptoms assessed include fever (temperature greater than or equal to 38 degrees Celcius), meningismus/ febrile convulsion, parotid / salivary gland swelling and rash. |
| Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | From enrolment through the day preceding the fourth dose | SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis. |
| Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 months of age | SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis. |
| Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | 42 days after the fourth dose | The pre-defined cut-off values were 28 ED50 and 51 ED50. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50. |
| rSBA-MenC Titers | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) | The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers. |
| Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) | The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128. |
| rSBA-MenY Titers | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) | The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers. |
| Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) | The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8. |
| hSBA-MenC Titers | After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4) | The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers. |
Countries
Australia
Participant flow
Recruitment details
Subjects were randomised at the beginning of the primary vaccination phase and kept their group assignment during the fourth dose vaccination phase. Not all subjects who completed the primary vaccination phase returned for participation in the fourth dose vaccination phase.
Pre-assignment details
One subject who had a subject number allocated, was not vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| MenHibrix Group Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. | 661 |
| ActHIB + Meningitec Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371. | 221 |
| ActHIB/PedvaxHIB Group Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371. | 221 |
| Total | 1,103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Fourth Dose Vaccination Phase | Lost to Follow-up | 1 | 3 | 1 |
| Fourth Dose Vaccination Phase | Mother just delivered a new baby | 1 | 0 | 0 |
| Primary Vaccination Phase | Adverse Event | 4 | 0 | 0 |
| Primary Vaccination Phase | Lost to Follow-up | 7 | 3 | 3 |
| Primary Vaccination Phase | Protocol Violation | 1 | 0 | 0 |
| Primary Vaccination Phase | Withdrawal by Subject | 2 | 3 | 2 |
Baseline characteristics
| Characteristic | MenHibrix Group | ActHIB + Meningitec Group | ActHIB/PedvaxHIB Group | Total |
|---|---|---|---|---|
| Age, Continuous | 61.0 Days STANDARD_DEVIATION 7.38 | 61.5 Days STANDARD_DEVIATION 7.22 | 61.5 Days STANDARD_DEVIATION 7.95 | 61.2 Days STANDARD_DEVIATION 7.46 |
| Sex: Female, Male Female | 328 Participants | 118 Participants | 103 Participants | 549 Participants |
| Sex: Female, Male Male | 333 Participants | 103 Participants | 118 Participants | 554 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 657 / 661 | 220 / 221 | 220 / 221 |
| serious Total, serious adverse events | 55 / 661 | 21 / 221 | 15 / 221 |
Outcome results
Primary
Number of Subjects Seroconverted for Anti-measles Antibodies
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-measles seroconversion is defined as the appearance of antibodies (i.e. concentration greater than or equal to the cut-off value of 150 milli-international units per milliliter (mIU/mL)) in the serum of subjects seronegative (below 150 mIU/mL) before vaccination.
Time frame: 42 days after the fourth dose vaccination
Population: Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Seroconverted for Anti-measles Antibodies | 815 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Seroconverted for Anti-measles Antibodies | 274 Participants |
Primary
Number of Subjects Seroconverted for Anti-mumps Antibodies
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-mumps seroconversion is defined as titer greater than or equal to 28 ED50 in subjects seronegative (\<28 ED50) before vaccination. ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.
Time frame: 42 days after the fourth dose vaccination
Population: Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Seroconverted for Anti-mumps Antibodies | 595 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Seroconverted for Anti-mumps Antibodies | 191 Participants |
Primary
Number of Subjects Seroconverted for Anti-varicella Antibodies
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-varicella seroconversion is defined as post-vaccination titers greater than or equal to 1:5, in subjects seronegative (titers below 1:5) before vaccination.
Time frame: 42 days after the fourth dose vaccination
Population: Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Seroconverted for Anti-varicella Antibodies | 722 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Seroconverted for Anti-varicella Antibodies | 223 Participants |
Primary
Number of Subjects With an Anti-rubella Seroresponse
The analysis was performed on blood samples taken from the subjects in the MenHibrix and ActHIB groups only. Anti-rubella seroresponse is defined as post-vaccination concentration greater than or equal to 10 IU/mL (ELISA, Enzygnost) in subjects seronegative (concentration below 4 IU/mL) before vaccination.
Time frame: 42 days after the fourth dose vaccination
Population: Analysis was performed on initially seronegative subjects in the MenHibrix and ActHIB groups only, on the Fourth dose According-to-Protocol cohort for immunogenicity, including all evaluable subjects with assay result available for the blood sample taken at 42 days after the administration of the fourth vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects With an Anti-rubella Seroresponse | 848 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With an Anti-rubella Seroresponse | 284 Participants |
Primary
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL)
The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.
Time frame: One month after the 3-dose primary vaccination course
Population: Analysis was performed on half of the subjects in the MenHibrix and ActHIB/PedvaxHib groups only, on the Primary According-to-Protocol (ATP) Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL) | 255 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL) | 76 Participants |
Primary
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128
The analysis was performed on blood samples taken from half of the subjects in the MenHibrix and ActHIB + Meningitec groups only. The other half of the subjects in these study groups donated a blood sample after the second vaccine dose for analysis of the corresponding secondary outcome measure.
Time frame: One month after the 3-dose primary vaccination course
Population: Analysis was performed on subjects in the MenHibrix and ActHIB + Meningitec groups only, on the Primary According-to-Protocol Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128 | 271 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128 | 95 Participants |
Secondary
Anti-measles Concentrations in Initially Seronegative Subjects
Concentrations are presented as Geometric Mean Concentrations expressed as mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.
Time frame: 42 days after the fourth dose
Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MenHibrix Group | Anti-measles Concentrations in Initially Seronegative Subjects | 1627.494 Milli-International Units per Milliliter |
| ActHIB + Meningitec Group | Anti-measles Concentrations in Initially Seronegative Subjects | 1773.293 Milli-International Units per Milliliter |
| ActHIB/PedvaxHIB Group | Anti-measles Concentrations in Initially Seronegative Subjects | 1786.404 Milli-International Units per Milliliter |
Secondary
Anti-mumps Titers in Initially Seronegative Subjects
Titers are presented as Geometric Mean Titers expressed as ED50, the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.
Time frame: 42 days after the fourth dose
Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MenHibrix Group | Anti-mumps Titers in Initially Seronegative Subjects | 120.777 Titer |
| ActHIB + Meningitec Group | Anti-mumps Titers in Initially Seronegative Subjects | 145.405 Titer |
| ActHIB/PedvaxHIB Group | Anti-mumps Titers in Initially Seronegative Subjects | 115.279 Titer |
Secondary
Anti-PRP Concentrations
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti-PRP Concentrations | Post-dose 2 | 1.320 Microgram per milliliter (µg/mL) |
| MenHibrix Group | Anti-PRP Concentrations | Post-dose 3 | 8.551 Microgram per milliliter (µg/mL) |
| MenHibrix Group | Anti-PRP Concentrations | Pre-dose 4 | 1.175 Microgram per milliliter (µg/mL) |
| MenHibrix Group | Anti-PRP Concentrations | Post-dose 4 | 34.890 Microgram per milliliter (µg/mL) |
| ActHIB + Meningitec Group | Anti-PRP Concentrations | Post-dose 4 | 13.442 Microgram per milliliter (µg/mL) |
| ActHIB + Meningitec Group | Anti-PRP Concentrations | Post-dose 2 | 0.788 Microgram per milliliter (µg/mL) |
| ActHIB + Meningitec Group | Anti-PRP Concentrations | Pre-dose 4 | 0.668 Microgram per milliliter (µg/mL) |
| ActHIB + Meningitec Group | Anti-PRP Concentrations | Post-dose 3 | 3.692 Microgram per milliliter (µg/mL) |
| ActHIB/PedvaxHIB Group | Anti-PRP Concentrations | Post-dose 4 | 20.975 Microgram per milliliter (µg/mL) |
| ActHIB/PedvaxHIB Group | Anti-PRP Concentrations | Post-dose 3 | 5.014 Microgram per milliliter (µg/mL) |
| ActHIB/PedvaxHIB Group | Anti-PRP Concentrations | Pre-dose 4 | 0.748 Microgram per milliliter (µg/mL) |
| ActHIB/PedvaxHIB Group | Anti-PRP Concentrations | Post-dose 2 | 0.861 Microgram per milliliter (µg/mL) |
Secondary
Anti-PSC Concentrations
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti-PSC Concentrations | Post-dose 2 | 4.32 Microgram per milliliter (µg/mL) |
| MenHibrix Group | Anti-PSC Concentrations | Post-dose 3 | 4.15 Microgram per milliliter (µg/mL) |
| MenHibrix Group | Anti-PSC Concentrations | Pre-dose 4 | 0.77 Microgram per milliliter (µg/mL) |
| MenHibrix Group | Anti-PSC Concentrations | Post-dose 4 | 4.78 Microgram per milliliter (µg/mL) |
| ActHIB + Meningitec Group | Anti-PSC Concentrations | Post-dose 4 | 2.65 Microgram per milliliter (µg/mL) |
| ActHIB + Meningitec Group | Anti-PSC Concentrations | Post-dose 2 | 3.54 Microgram per milliliter (µg/mL) |
| ActHIB + Meningitec Group | Anti-PSC Concentrations | Pre-dose 4 | 0.86 Microgram per milliliter (µg/mL) |
| ActHIB + Meningitec Group | Anti-PSC Concentrations | Post-dose 3 | 3.94 Microgram per milliliter (µg/mL) |
| ActHIB/PedvaxHIB Group | Anti-PSC Concentrations | Post-dose 4 | 0.15 Microgram per milliliter (µg/mL) |
| ActHIB/PedvaxHIB Group | Anti-PSC Concentrations | Post-dose 3 | 0.16 Microgram per milliliter (µg/mL) |
| ActHIB/PedvaxHIB Group | Anti-PSC Concentrations | Pre-dose 4 | 0.15 Microgram per milliliter (µg/mL) |
| ActHIB/PedvaxHIB Group | Anti-PSC Concentrations | Post-dose 2 | 0.17 Microgram per milliliter (µg/mL) |
Secondary
Anti-PSY Concentrations
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. Concentrations are given as Geometric Mean Concentrations.
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti-PSY Concentrations | Post-dose 2 | 7.81 Microgram per milliliter (µg/mL) |
| MenHibrix Group | Anti-PSY Concentrations | Post-dose 3 | 12.92 Microgram per milliliter (µg/mL) |
| MenHibrix Group | Anti-PSY Concentrations | Pre-dose 4 | 2.44 Microgram per milliliter (µg/mL) |
| MenHibrix Group | Anti-PSY Concentrations | Post-dose 4 | 16.92 Microgram per milliliter (µg/mL) |
| ActHIB + Meningitec Group | Anti-PSY Concentrations | Post-dose 4 | 7.09 Microgram per milliliter (µg/mL) |
| ActHIB + Meningitec Group | Anti-PSY Concentrations | Post-dose 2 | 0.16 Microgram per milliliter (µg/mL) |
| ActHIB + Meningitec Group | Anti-PSY Concentrations | Pre-dose 4 | 0.16 Microgram per milliliter (µg/mL) |
| ActHIB + Meningitec Group | Anti-PSY Concentrations | Post-dose 3 | 0.15 Microgram per milliliter (µg/mL) |
| ActHIB/PedvaxHIB Group | Anti-PSY Concentrations | Post-dose 4 | 0.16 Microgram per milliliter (µg/mL) |
| ActHIB/PedvaxHIB Group | Anti-PSY Concentrations | Post-dose 3 | 0.16 Microgram per milliliter (µg/mL) |
| ActHIB/PedvaxHIB Group | Anti-PSY Concentrations | Pre-dose 4 | 0.16 Microgram per milliliter (µg/mL) |
| ActHIB/PedvaxHIB Group | Anti-PSY Concentrations | Post-dose 2 | 0.17 Microgram per milliliter (µg/mL) |
Secondary
Anti-rubella Concentrations in Initially Seronegative Subjects
Concentrations are presented as Geometric Mean Concentrations expressed as IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-rubella concentration below 4 IU/mL.
Time frame: 42 days after the fourth dose
Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MenHibrix Group | Anti-rubella Concentrations in Initially Seronegative Subjects | 78.779 International Units per Milliliter |
| ActHIB + Meningitec Group | Anti-rubella Concentrations in Initially Seronegative Subjects | 83.168 International Units per Milliliter |
| ActHIB/PedvaxHIB Group | Anti-rubella Concentrations in Initially Seronegative Subjects | 76.691 International Units per Milliliter |
Secondary
Anti-varicella Titers in Initially Seronegative Subjects
Titers are presented as Geometric Mean Titers. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.
Time frame: 42 days after the fourth dose
Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| MenHibrix Group | Anti-varicella Titers in Initially Seronegative Subjects | 414.633 Titer |
| ActHIB + Meningitec Group | Anti-varicella Titers in Initially Seronegative Subjects | 468.985 Titer |
| ActHIB/PedvaxHIB Group | Anti-varicella Titers in Initially Seronegative Subjects | 438.280 Titer |
Secondary
hSBA-MenC Titers
The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | hSBA-MenC Titers | Post-dose 2 | 179.4 Titer |
| MenHibrix Group | hSBA-MenC Titers | Post-dose 3 | 379.4 Titer |
| MenHibrix Group | hSBA-MenC Titers | Pre-dose 4 | 97.7 Titer |
| MenHibrix Group | hSBA-MenC Titers | Post-dose 4 | 1807.6 Titer |
| ActHIB + Meningitec Group | hSBA-MenC Titers | Post-dose 4 | 171.5 Titer |
| ActHIB + Meningitec Group | hSBA-MenC Titers | Post-dose 2 | 319.0 Titer |
| ActHIB + Meningitec Group | hSBA-MenC Titers | Pre-dose 4 | 34.6 Titer |
| ActHIB + Meningitec Group | hSBA-MenC Titers | Post-dose 3 | 254.2 Titer |
| ActHIB/PedvaxHIB Group | hSBA-MenC Titers | Post-dose 4 | 2.2 Titer |
| ActHIB/PedvaxHIB Group | hSBA-MenC Titers | Post-dose 3 | 2.0 Titer |
| ActHIB/PedvaxHIB Group | hSBA-MenC Titers | Pre-dose 4 | 2.6 Titer |
| ActHIB/PedvaxHIB Group | hSBA-MenC Titers | Post-dose 2 | 2.0 Titer |
Secondary
hSBA-MenY Titers
The analysis for was performed on the first 30% of the blood samples taken at each time point. Titers are given as Geometric Mean Titers.
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | hSBA-MenY Titers | Post-dose 2 | 25.6 Titer |
| MenHibrix Group | hSBA-MenY Titers | Post-dose 3 | 86.4 Titer |
| MenHibrix Group | hSBA-MenY Titers | Pre-dose 4 | 81.2 Titer |
| MenHibrix Group | hSBA-MenY Titers | Post-dose 4 | 1002.2 Titer |
| ActHIB + Meningitec Group | hSBA-MenY Titers | Post-dose 4 | 8.8 Titer |
| ActHIB + Meningitec Group | hSBA-MenY Titers | Post-dose 2 | 2.0 Titer |
| ActHIB + Meningitec Group | hSBA-MenY Titers | Pre-dose 4 | 2.2 Titer |
| ActHIB + Meningitec Group | hSBA-MenY Titers | Post-dose 3 | 2.0 Titer |
| ActHIB/PedvaxHIB Group | hSBA-MenY Titers | Post-dose 4 | 18.3 Titer |
| ActHIB/PedvaxHIB Group | hSBA-MenY Titers | Post-dose 3 | 2.0 Titer |
| ActHIB/PedvaxHIB Group | hSBA-MenY Titers | Pre-dose 4 | 2.0 Titer |
| ActHIB/PedvaxHIB Group | hSBA-MenY Titers | Post-dose 2 | 2.0 Titer |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.
Time frame: From the day of administration of the fourth dose until the end of the extended safety follow-up period (last study contact at 18-21 months of age
Population: Analysis was performed on the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the ourth dose vaccination phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | Physician office visits | 220 Participants |
| MenHibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | Emergency room visits | 42 Participants |
| MenHibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | Rash | 52 Participants |
| MenHibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | New onset of chronic illnesses | 20 Participants |
| MenHibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | Serious adverse events | 40 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | Emergency room visits | 13 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | Rash | 15 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | New onset of chronic illnesses | 8 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | Physician office visits | 64 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | Serious adverse events | 12 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | Serious adverse events | 8 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | Physician office visits | 63 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | Rash | 13 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | Emergency room visits | 10 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Fourth Dose Vaccination Phase | New onset of chronic illnesses | 5 Participants |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. NOCI: e.g. autoimmune disorders, asthma, type I diabetes and allergies. Types of rash: hives, idiopathic thrombocytopenic purpura and petechiae. ER and PO visits assessed were not related to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infection, otitis media, pharyngitis and gastroenteritis.
Time frame: From enrolment through the day preceding the fourth dose
Population: Analysis was performed on the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | Physician office visits | 291 Participants |
| MenHibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | Emergency room visits | 81 Participants |
| MenHibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | Rash | 176 Participants |
| MenHibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | New onset of chronic illnesses | 124 Participants |
| MenHibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | Serious adverse events | 55 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | Emergency room visits | 22 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | Rash | 67 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | New onset of chronic illnesses | 39 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | Physician office visits | 90 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | Serious adverse events | 21 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | Serious adverse events | 15 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | Physician office visits | 88 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | Rash | 51 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | Emergency room visits | 14 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCI), Rash, Emergency Room Visits (ER), Physician Office Visits (PO) During the Primary Vaccination Phase | New onset of chronic illnesses | 36 Participants |
Secondary
Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.
Time frame: During a 4-day period (Day 0-3) after the fourth dose vaccination phase
Population: Analysis was performed on all subjects with an available symptom sheet in the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the fourth dose vaccination phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Redness | 379 Participants |
| MenHibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Fever | 60 Participants |
| MenHibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Drowsiness | 196 Participants |
| MenHibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Pain | 217 Participants |
| MenHibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Loss of appetite | 224 Participants |
| MenHibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Irritability | 361 Participants |
| MenHibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Swelling | 225 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Drowsiness | 63 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Pain | 60 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Redness | 102 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Swelling | 63 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Fever | 14 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Irritability | 120 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Loss of appetite | 76 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Fever | 31 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Redness | 157 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Loss of appetite | 62 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Irritability | 117 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Drowsiness | 71 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Swelling | 123 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Fourth Dose Vaccination Phase | Pain | 100 Participants |
Secondary
Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever (rectal temperature greater than or equal to 38 degrees Celcius), irritability and loss of appetite.
Time frame: During a 4-day period (Day 0-3) after any vaccine dose in the primary vaccination phase
Population: Analysis was performed on all subjects with an available symptom sheet in the Primary Total Vaccinated Cohort, including all subjects vaccinated during the primary vaccination phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Redness | 556 Participants |
| MenHibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Fever | 196 Participants |
| MenHibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Drowsiness | 530 Participants |
| MenHibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Pain | 432 Participants |
| MenHibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Loss of appetite | 410 Participants |
| MenHibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Irritability | 616 Participants |
| MenHibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Swelling | 492 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Drowsiness | 193 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Pain | 171 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Redness | 189 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Swelling | 163 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Fever | 83 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Irritability | 211 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Loss of appetite | 153 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Fever | 80 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Redness | 189 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Loss of appetite | 135 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Irritability | 212 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Drowsiness | 176 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Swelling | 167 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms During the Primary Vaccination Phase | Pain | 152 Participants |
Secondary
Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine
Specific solicited general symptoms assessed include fever (temperature greater than or equal to 38 degrees Celcius), meningismus/ febrile convulsion, parotid / salivary gland swelling and rash.
Time frame: During a 43-day (Day 0-42) after the fourth dose
Population: Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | Parotid / salivary gland swelling | 4 Participants |
| MenHibrix Group | Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | Fever | 324 Participants |
| MenHibrix Group | Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | Rash | 232 Participants |
| MenHibrix Group | Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | Meningismus/ febrile convulsion | 0 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | Parotid / salivary gland swelling | 1 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | Meningismus/ febrile convulsion | 0 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | Rash | 86 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | Fever | 107 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | Rash | 66 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | Fever | 112 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | Meningismus/ febrile convulsion | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Specific Solicited General AEs Related to Measles, Mumps, Rubella Vaccine and Varicella Vaccine | Parotid / salivary gland swelling | 0 Participants |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events
Unsolicited adverse event covers any adverse event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 31-day (Day 0-30) post-primary and post-fourth dose vaccination period
Population: Analysis was performed on the Primary Total Vaccinated Cohort and the Fourth Dose Total Vaccinated Cohort, including all subjects vaccinated during the primary and fourth dose vaccination phases, respectively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Unsolicited Adverse Events | Post-primary vaccination period | 490 Participants |
| MenHibrix Group | Number of Subjects Reporting Unsolicited Adverse Events | Post-fourth dose vaccination period | 429 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Unsolicited Adverse Events | Post-primary vaccination period | 166 Participants |
| ActHIB + Meningitec Group | Number of Subjects Reporting Unsolicited Adverse Events | Post-fourth dose vaccination period | 139 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Unsolicited Adverse Events | Post-primary vaccination period | 158 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects Reporting Unsolicited Adverse Events | Post-fourth dose vaccination period | 147 Participants |
Secondary
Number of Subjects With a Fourth Dose Response for hSBA-MenC
Fourth dose response for hSBA-MenC is defined as: •For initially seronegative subjects (i.e., subjects with pre fourth dose hSBA antibody titer below 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:16; •For initially seropositive subjects (i.e., subjects with pre fourth dose antibody titer greater than or equal to 1:4), post fourth dose hSBA antibody titer greater than or equal to 1:128.
Time frame: 42 days after the fourth dose
Population: Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects With a Fourth Dose Response for hSBA-MenC | 100 Participants |
| ActHIB + Meningitec Group | Number of Subjects With a Fourth Dose Response for hSBA-MenC | 23 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With a Fourth Dose Response for hSBA-MenC | 1 Participants |
Secondary
Number of Subjects With a Fourth Dose Response for hSBA-MenY
Fourth dose response for hSBA-MenY defined as: •For initially seronegative subjects (i.e., pre fourth dose hSBA antibody titer \< 1:4), post fourth dose hSBA antibody titer greater than or equal to (≥) 1:16; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:4 and \< 1:64, post fourth dose hSBA antibody titer at least 4-fold higher than the pre fourth dose hSBA antibody titer; •For initially seropositive subjects with pre fourth dose hSBA antibody titer ≥ 1:64, post fourth dose hSBA antibody titer at least 2-fold higher than the pre fourth dose hSBA antibody titer.
Time frame: 42 days after the fourth dose
Population: Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects With a Fourth Dose Response for hSBA-MenY | 75 Participants |
| ActHIB + Meningitec Group | Number of Subjects With a Fourth Dose Response for hSBA-MenY | 6 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With a Fourth Dose Response for hSBA-MenY | 16 Participants |
Secondary
Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL
The cut-off value assessed was 150 mIU/mL.
Time frame: Just prior to the fourth dose and 42 days after the fourth dose
Population: Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL | Just prior to the fourth dose | 0 Participants |
| MenHibrix Group | Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL | 42 days after the fourth dose | 510 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL | Just prior to the fourth dose | 1 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL | 42 days after the fourth dose | 173 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL | Just prior to the fourth dose | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-measles Concentration Greater Than or Equal to 150 mIU/mL | 42 days after the fourth dose | 170 Participants |
Secondary
Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
The pre-defined cut-off values were 150 mIU/mL and 200 mIU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 150 mIU/mL.
Time frame: 42 days after the fourth dose
Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Greater than or equal to 150 mIU/mL | 469 Participants |
| MenHibrix Group | Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Greater than or equal to 200 mIU/mL | 466 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Greater than or equal to 150 mIU/mL | 164 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Greater than or equal to 200 mIU/mL | 163 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Greater than or equal to 150 mIU/mL | 163 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-measles Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Greater than or equal to 200 mIU/mL | 162 Participants |
Secondary
Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50
ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.
Time frame: Just prior to the fourth dose and 42 days after the fourth dose
Population: Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50 | Just prior to the fourth dose | 179 Participants |
| MenHibrix Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50 | 42 days after the fourth dose | 505 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50 | Just prior to the fourth dose | 59 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50 | 42 days after the fourth dose | 169 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50 | Just prior to the fourth dose | 52 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to 24 ED50 | 42 days after the fourth dose | 163 Participants |
Secondary
Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination
ED50 is defined as the reciprocal of the sample dilution in the neutralising assay reducing the number of viral plaques by fifty percent.
Time frame: 42 days after the fourth dose
Population: Analysis was performed on subjects with a pre-vaccination anti-mumps titer below 28 ED50 in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination | 330 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination | 115 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to 28 ED50 in Subjects With Anti-mumps Titer Below 28 ED50 Before Vaccination | 110 Participants |
Secondary
Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
The pre-defined cut-off values were 28 ED50 and 51 ED50. Initially seronegative subjects are defined as subjects with pre-vaccination anti-mumps titer below 24 ED50.
Time frame: 42 days after the fourth dose
Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Greater than or equal to 28 ED50 | 293 Participants |
| MenHibrix Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Greater than or equal to 51 ED50 | 265 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Greater than or equal to 28 ED50 | 98 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Greater than or equal to 51 ED50 | 92 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Greater than or equal to 28 ED50 | 102 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-mumps Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Greater than or equal to 51 ED50 | 93 Participants |
Secondary
Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 concentration ≥0.3 µg/mL | 296 Participants |
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 concentration ≥0.3 µg/mL | 276 Participants |
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 concentration≥0.3 µg/mL | 417 Participants |
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 concentration≥0.3µg/mL | 489 Participants |
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 concentration ≥2.0 µg/mL | 248 Participants |
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 concentration ≥2.0 µg/mL | 241 Participants |
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 concentration≥2.0 µg/mL | 53 Participants |
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 concentration≥2.0µg/mL | 408 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 concentration≥0.3 µg/mL | 138 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 concentration≥2.0 µg/mL | 31 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 concentration≥0.3µg/mL | 158 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 concentration ≥2.0 µg/mL | 81 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 concentration ≥2.0 µg/mL | 79 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 concentration ≥0.3 µg/mL | 95 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 concentration ≥0.3 µg/mL | 95 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 concentration≥2.0µg/mL | 95 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 concentration≥0.3 µg/mL | 2 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 concentration ≥0.3 µg/mL | 3 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 concentration ≥0.3 µg/mL | 7 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 concentration≥0.3µg/mL | 1 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 concentration≥2.0 µg/mL | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 concentration ≥2.0 µg/mL | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 concentration ≥2.0 µg/mL | 1 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 concentration≥2.0µg/mL | 0 Participants |
Secondary
Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.3 µg/mL and 2 µg/mL.
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 concentration ≥0.3 µg/mL | 291 Participants |
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 concentration ≥0.3 µg/mL | 269 Participants |
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 concentration≥0.3 µg/mL | 469 Participants |
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 concentration≥0.3µg/mL | 502 Participants |
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 concentration ≥2.0 µg/mL | 268 Participants |
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 concentration ≥2.0 µg/mL | 266 Participants |
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 concentration≥2.0 µg/mL | 278 Participants |
| MenHibrix Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 concentration≥2.0µg/mL | 96 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 concentration≥0.3 µg/mL | 2 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 concentration≥2.0 µg/mL | 1 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 concentration≥0.3µg/mL | 160 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 concentration ≥2.0 µg/mL | 0 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 concentration ≥2.0 µg/mL | 0 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 concentration ≥0.3 µg/mL | 3 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 concentration ≥0.3 µg/mL | 3 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 concentration≥2.0µg/mL | 46 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 concentration≥0.3 µg/mL | 4 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 concentration ≥0.3 µg/mL | 4 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 concentration ≥0.3 µg/mL | 6 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 concentration≥0.3µg/mL | 3 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 concentration≥2.0 µg/mL | 2 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 concentration ≥2.0 µg/mL | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 concentration ≥2.0 µg/mL | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-Polysaccharide Y (Anti-PSY) Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 concentration≥2.0µg/mL | 1 Participants |
Secondary
Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values
The analysis for post-Dose 2 and post-Dose 3 data was performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were 0.15 µg/mL and 1.0 µg/mL.
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 ≥ 0.15 µg/mL | 255 Participants |
| MenHibrix Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 ≥ 0.15 µg/mL | 265 Participants |
| MenHibrix Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 ≥ 0.15 µg/mL | 541 Participants |
| MenHibrix Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 ≥ 0.15 µg/mL | 549 Participants |
| MenHibrix Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 ≥ 1.0 µg/mL | 151 Participants |
| MenHibrix Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 ≥ 1.0 µg/mL | 255 Participants |
| MenHibrix Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 ≥ 1.0 µg/mL | 314 Participants |
| MenHibrix Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 ≥ 1.0 µg/mL | 547 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 ≥ 0.15 µg/mL | 160 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 ≥ 1.0 µg/mL | 71 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 ≥ 0.15 µg/mL | 183 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 ≥ 1.0 µg/mL | 41 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 ≥ 1.0 µg/mL | 74 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 ≥ 0.15 µg/mL | 77 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 ≥ 0.15 µg/mL | 85 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 ≥ 1.0 µg/mL | 176 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 ≥ 0.15 µg/mL | 159 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 ≥ 0.15 µg/mL | 88 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 ≥ 0.15 µg/mL | 70 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 ≥ 0.15 µg/mL | 182 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 ≥ 1.0 µg/mL | 74 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 ≥ 1.0 µg/mL | 76 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 ≥ 1.0 µg/mL | 40 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-PRP Antibody Concentration Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 ≥ 1.0 µg/mL | 179 Participants |
Secondary
Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL
The cut-off value assessed was 4 IU/mL.
Time frame: Just prior to the fourth dose and 42 days after the fourth dose
Population: Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL | 42 days after the fourth dose | 540 Participants |
| MenHibrix Group | Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL | Just prior to the fourth dose | 2 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL | Just prior to the fourth dose | 1 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL | 42 days after the fourth dose | 184 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL | Just prior to the fourth dose | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-rubella Concentration Greater Than or Equal to 4 IU/mL | 42 days after the fourth dose | 177 Participants |
Secondary
Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
The pre-defined cut-off values were 4 IU/mL and 10 IU/mL. Initially seronegative subjects are defined as subjects with pre-vaccination anti-measles concentration below 4 IU/mL.
Time frame: 42 days after the fourth dose
Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | ≥ 4 International Units per Milliliter | 500 Participants |
| MenHibrix Group | Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | ≥ 10 International Units per Milliliter | 498 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | ≥ 4 International Units per Milliliter | 174 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | ≥ 10 International Units per Milliliter | 173 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | ≥ 4 International Units per Milliliter | 171 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-rubella Concentration Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | ≥ 10 International Units per Milliliter | 171 Participants |
Secondary
Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5
The cut-off value assessed was a titer of 1:5.
Time frame: Just prior to the fourth dose and 42 days after the fourth dose
Population: Analysis was performed on the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5 | Just prior to the fourth dose | 126 Participants |
| MenHibrix Group | Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5 | 42 days after the fourth dose | 547 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5 | Just prior to the fourth dose | 44 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5 | 42 days after the fourth dose | 183 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5 | Just prior to the fourth dose | 56 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-varicella Titer Greater Than or Equal to 1:5 | 42 days after the fourth dose | 179 Participants |
Secondary
Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects
The pre-defined cut-off values were 1:5 and 1:40. Initially seronegative subjects are defined as subjects with pre-vaccination anti-varicella titer below 1:5.
Time frame: 42 days after the fourth dose
Population: Analysis was performed on initially seronegative subjects in the Fourth Dose ATP Cohort for Immunogenicity, including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Titer greater than or equal to 1:5 | 403 Participants |
| MenHibrix Group | Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Titer greater than or equal to 1:40 | 403 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Titer greater than or equal to 1:5 | 136 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Titer greater than or equal to 1:40 | 136 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Titer greater than or equal to 1:5 | 119 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Anti-varicella Titer Greater Than or Equal to Predefined Cut-off Values in Initially Seronegative Subjects | Titer greater than or equal to 1:40 | 119 Participants |
Secondary
Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values
The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:4 | 85 Participants |
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:4 | 83 Participants |
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:4 | 125 Participants |
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:4 | 131 Participants |
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:8 | 84 Participants |
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:8 | 83 Participants |
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:8 | 125 Participants |
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:8 | 131 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:4 | 46 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:8 | 46 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:4 | 41 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:8 | 29 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:8 | 28 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:4 | 29 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:4 | 28 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:8 | 41 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:4 | 5 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:4 | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:4 | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:4 | 1 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:8 | 5 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:8 | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:8 | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenC) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:8 | 1 Participants |
Secondary
Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values
The analysis for was performed on the first 30% of the blood samples taken at each time point. The cut-off values assessed were titers 1:4 and 1:8.
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:4 | 79 Participants |
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:4 | 85 Participants |
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:4 | 104 Participants |
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:4 | 119 Participants |
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:8 | 73 Participants |
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:8 | 85 Participants |
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:8 | 103 Participants |
| MenHibrix Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:8 | 119 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:4 | 1 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:8 | 1 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:4 | 15 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:8 | 0 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:8 | 0 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:4 | 0 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:4 | 0 Participants |
| ActHIB + Meningitec Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:8 | 13 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:4 | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:4 | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:4 | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:4 | 16 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:8 | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:8 | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:8 | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With Meningococcal Polysaccharide Y Serum Bactericidal Activity/Assay Using Human Complement (hSBA-MenY) Antibody Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:8 | 16 Participants |
Secondary
Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values
The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:8 | 282 Participants |
| MenHibrix Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:8 | 284 Participants |
| MenHibrix Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:8 | 449 Participants |
| MenHibrix Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:8 | 494 Participants |
| MenHibrix Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:128 | 239 Participants |
| MenHibrix Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:128 | 271 Participants |
| MenHibrix Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:128 | 241 Participants |
| MenHibrix Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:128 | 482 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:8 | 143 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:128 | 50 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:8 | 155 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:128 | 91 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:128 | 95 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:8 | 97 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:8 | 99 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:128 | 115 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:8 | 16 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:8 | 5 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:8 | 2 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:8 | 16 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:128 | 1 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:128 | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:128 | 0 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenC Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:128 | 5 Participants |
Secondary
Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values
The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. The cut-off values assessed were titers 1:8 and 1:128.
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:8 | 289 Participants |
| MenHibrix Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:8 | 287 Participants |
| MenHibrix Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:8 | 506 Participants |
| MenHibrix Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:8 | 496 Participants |
| MenHibrix Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:128 | 224 Participants |
| MenHibrix Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:128 | 264 Participants |
| MenHibrix Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:128 | 414 Participants |
| MenHibrix Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:128 | 493 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:8 | 65 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:128 | 35 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:8 | 162 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:128 | 2 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:128 | 9 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:8 | 10 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:8 | 16 Participants |
| ActHIB + Meningitec Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:128 | 152 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:8 | 42 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:8 | 22 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:8 | 13 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:8 | 90 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Pre-dose 4 titer ≥ 1:128 | 19 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 3 titer ≥ 1:128 | 5 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 2 titer ≥ 1:128 | 3 Participants |
| ActHIB/PedvaxHIB Group | Number of Subjects With rSBA-MenY Titer Greater Than or Equal to Pre-defined Cut-off Values | Post-dose 4 titer ≥ 1:128 | 59 Participants |
Secondary
rSBA-MenC Titers
The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | rSBA-MenC Titers | Post-dose 2 | 356.9 titer |
| MenHibrix Group | rSBA-MenC Titers | Post-dose 3 | 804.6 titer |
| MenHibrix Group | rSBA-MenC Titers | Pre-dose 4 | 102.8 titer |
| MenHibrix Group | rSBA-MenC Titers | Post-dose 4 | 1696.7 titer |
| ActHIB + Meningitec Group | rSBA-MenC Titers | Post-dose 4 | 261.9 titer |
| ActHIB + Meningitec Group | rSBA-MenC Titers | Post-dose 2 | 714.5 titer |
| ActHIB + Meningitec Group | rSBA-MenC Titers | Pre-dose 4 | 53.7 titer |
| ActHIB + Meningitec Group | rSBA-MenC Titers | Post-dose 3 | 790.1 titer |
| ActHIB/PedvaxHIB Group | rSBA-MenC Titers | Post-dose 4 | 5.4 titer |
| ActHIB/PedvaxHIB Group | rSBA-MenC Titers | Post-dose 3 | 4.5 titer |
| ActHIB/PedvaxHIB Group | rSBA-MenC Titers | Pre-dose 4 | 5.2 titer |
| ActHIB/PedvaxHIB Group | rSBA-MenC Titers | Post-dose 2 | 4.2 titer |
Secondary
rSBA-MenY Titers
The analyses for post-Dose 2 and post-Dose 3 data were performed on blood samples taken from the respective half of the subjects at both time points. Titers are given as Geometric Mean Titers.
Time frame: After the second vaccine dose (post-dose 2), one month after the 3-dose primary vaccination course (post-dose 3), just prior to (pre-dose 4) and 42 days after the fourth dose (post-dose 4)
Population: Analysis was performed on the Primary ATP Cohort for Immunogenicity (post-Dose 2 and post-Dose 3), the ATP Cohort for Persistence (pre-Dose 4) and the Fourth Dose ATP Cohort for Immunogenicity (post-Dose 4), including all evaluable subjects with assay result available for the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | rSBA-MenY Titers | Post-dose 3 | 728.3 Titer |
| MenHibrix Group | rSBA-MenY Titers | Pre-dose 4 | 264.4 Titer |
| MenHibrix Group | rSBA-MenY Titers | Post-dose 2 | 315.6 Titer |
| MenHibrix Group | rSBA-MenY Titers | Post-dose 4 | 1986.5 Titer |
| ActHIB + Meningitec Group | rSBA-MenY Titers | Post-dose 3 | 7.1 Titer |
| ActHIB + Meningitec Group | rSBA-MenY Titers | Post-dose 2 | 5.4 Titer |
| ActHIB + Meningitec Group | rSBA-MenY Titers | Pre-dose 4 | 16.0 Titer |
| ActHIB + Meningitec Group | rSBA-MenY Titers | Post-dose 4 | 797.7 Titer |
| ActHIB/PedvaxHIB Group | rSBA-MenY Titers | Pre-dose 4 | 10.5 Titer |
| ActHIB/PedvaxHIB Group | rSBA-MenY Titers | Post-dose 2 | 5.9 Titer |
| ActHIB/PedvaxHIB Group | rSBA-MenY Titers | Post-dose 3 | 7.7 Titer |
| ActHIB/PedvaxHIB Group | rSBA-MenY Titers | Post-dose 4 | 34.4 Titer |