Haemophilus Influenzae Type b, Neisseria Meningitidis
Conditions
Keywords
Primary and booster vaccination, Neisseria meningitidis, Hib disease, Meningococcal vaccine, Meningococcal disease, Children, Immunogenicity, Safety, Infants
Brief summary
This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.
Detailed description
The subjects from this study will participate in one of three cohorts: * US Safety and Immunogenicity (Cohort 1): All immunogenicity analyses in the primary and booster phases will be evaluated in this cohort. These subjects will also contribute to the safety analyses in the primary and booster phases. * Safety Only (Cohort 2): Only safety objectives will be assessed in the primary and booster phases for this cohort. * Non-US Safety and Immunogenicity (Cohort 3): Only descriptive immunogenicity results in the primary and booster phases will be reported for this cohort. These subjects will also contribute to the safety analyses in the primary and booster phases. Treatment allocation: Primary phase: Subjects will be randomized with balanced allocation (1:1:1:1) to 1 of the 4 treatment groups and with a stratification according to the cohort. Assignment to a cohort will be based on study site. Booster phase: Subjects who received Hib-MenCY-TT vaccine in the primary phase will receive a booster dose of Hib-MenCY-TT vaccine. Subjects who received ActHIB in the primary phase will receive a booster dose of PedvaxHIB. During the 3-dose primary vaccination course, co-administration of Prevnar, Synagis, and/or rotavirus vaccine is permitted; co-administration of influenza vaccine is permitted at dose 3. During the booster vaccination, co-administration of Prevnar, hepatitis A vaccine and influenza vaccine is permitted for all subjects in Cohort 1, 2 and 3; and co-administration of measles, mumps, rubella and varicella vaccine is permitted for all subjects in Cohort 2 and 3. The study will be conducted in a double-blind fashion with regard to consistency of the 3 manufacturing lots of Hib-MenCY-TT vaccine and single-blind fashion for Hib-MenCY-TT vaccine versus monovalent Hib vaccine. The parents/guardians will be blinded up to collection of all data pertaining to the period up to one month after booster vaccination. Therefore, the extended safety follow-up after the booster dose will be conducted in an unblinded manner. The person administering the vaccines will ensure that the parent/guardian does not see the vaccine vial used in reconstituting the vaccine. Due to the differences in the presentations of the candidate Hib-MenCY-TT vaccine and control vaccines, it is not possible to blind study personnel who administer the vaccines.
Interventions
BIOLOGICALGSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine
3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.
BIOLOGICALActHIB
3-dose intramuscular injection at 2, 4 and 6 months of age.
BIOLOGICALPedvaxHIB
1 booster dose by intramuscular injection at 12 to 15 months of age.
BIOLOGICALPediarix
3-dose intramuscular injection at 2, 4 and 6 months of age.
BIOLOGICALPrevnar
3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.
BIOLOGICALM-M-R II
1 booster dose by subcutaneous injection at 12 to 15 months of age.
BIOLOGICALVarivax
1 booster dose by subcutaneous injection at 12 to 15 months of age
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 15 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol * 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. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Born after 36 weeks gestation. * Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment. * Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.
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 study vaccine(s). (Synagis® \[palivizumab, MedImmune\], Prevnar (Prevenar), rotavirus vaccine, and influenza vaccine are allowed. * Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine. * History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required). * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at time of enrollment. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). Additional specific criteria for the US subjects in Cohort 1. In addition, for Cohorts 2 and 3, subjects should not be administered M-M-R II and Varivax if any of these criteria apply: * History of measles, mumps, rubella or varicella. * Previous vaccination against measles, mumps, rubella or varicella. * Hypersensitivity to any component of the vaccines, including gelatin or neomycin. * Patients receiving immunosuppressive therapy. * Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. * Individuals with primary and acquired immunodeficiency states. * Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. * Individuals with active tuberculosis. * Acute disease at time of booster vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations | One month after primary vaccination | Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | One month after primary vaccination | Titers were expressed as Geometric Mean Titers (GMTs) This analysis occured on the cohort 1 : Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | One month after primary vaccination | Titers are expressen as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| hSBA-MenC Antibody Titers | Prior to the fourth dose vaccination and 42 days after the fourth dose | Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| hSBA-MenY Antibody Titers | Prior to the fourth dose vaccination and 42 days after the fourth dose | Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) | One month after primary vaccination | This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8 | 42 days after the fourth dose | This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8 | 42 days after the fourth dose | This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML) | 42 days after the fourth dose | The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. Co-administration with MMR-II vaccine |
| Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter | 42 days after the fourth dose | This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50) | 42 days after the fourth dose | The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 28 ED50 Co-administration with MMR-II vaccine. |
| Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL) | 42 days after the fourth dose | The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 4 IU/mL. Co-administration with MMR-II vaccine. |
| Number of Subjects With Anti-varicella Titer Equal to or Above 1:5 | 42 days after the fourth dose | The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titer below 1:5. Co-administration with Varivax vaccine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hSBA-MenC and hSBA-MenY Antibody Titers | One month after the primary vaccination course | Titres are expressed as Geometric Mean Titers (GMTs). The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis. |
| Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | One month after the primary vaccination course | Anti-PSC and anti-PSY antibody cut-off values assessed were \>=0.3 microgram per milliliter (µg/mL) and \>=2.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis. |
| Anti-PSC and Anti-PSY Antibodies Concentrations | One month after the primary vaccination course | Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL). The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis. |
| Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value | One month after the primary vaccination course | Anti-PRP antibody cut-off values assessed were \>=0.15 µg/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | One month after the primary vaccination course | hSBA-MenC and hSBA-MenY antibody cut-off values assessed were \>=1:4 and \>=1:8. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL) | Prior to the fourth dose vaccination and 42 days after fourth vaccination | This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4 | Prior to the fourth dose vaccination and 42 days after fourth vaccination | This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL) | 42 days after fourth vaccination | The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Anti-measles Antibody Concentrations | 42 days after fourth vaccination | Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-international units per milliliter (mIU/mL). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values | 42 days after fourth vaccination | Anti-mumps antibody cut-off values assessed were \>=28 estimated dose 50 (ED50) and \>=51 ED50. The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 24 ED50. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Anti-mumps Antibody Titers | 42 days after fourth vaccination | Titers are expressed as Geometric Mean Titers (GMTs). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titers below 24 ED50. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL) | 42 days after fourth vaccination | The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Anti-rubella Antibody Concentrations | 42 days after fourth vaccination | Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With Anti-varicella Titer Equal to or Above 1:40 | 42 days after fourth vaccination | The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 1:5 This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Anti-varicella Antibody Titers | 42 days after fourth vaccination | Titers are expressed as Geometric Mean Titers (GMTs) The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-varicella antibody titers below 1:5 This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Within 31 days (Day 0-30) following the primary vaccination course | Unsolicited AE covers any AE 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 With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40 | Prior to the fourth dose vaccination and one month after the fourth dose vaccination | anti-H1N1, anti-H3N2 and anti-influenza-B (anti B) antibody were measured by hemagglutination inhibition assay (HIA), in subjects who received 2 doses of influenza vaccine within the same influenza season of which at least one dose is concomitant with the study vaccine. For the purposes of this study, concomitant administration of influenza vaccine was defined as administration within 28 days before to 7 days after administration of study vaccines. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. |
| Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit | In the 4-day (Day 0-3) follow-up period after primary vaccination course | Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F). |
| Number of Subjects Reporting Solicited Local and General Symptoms | Within the 4 days (Day 0-3) following each dose of the primary vaccination course | Solicited local symptoms assessed were pain, redness and swelling. Solicited genral symptoms assessed were fever, irritability/fussiness, drowsiness and loss of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C. |
| Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s) | Within 4 days (Day 0 to Day 3) after fourth dose vaccination | Increased circumferential swelling defined as either swelling with a diameter of \>50 mm or a \>50 mm increase in the circumference of the mid-limb when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interferes with or prevents everyday activities (for example, active playing, eating, sleeping). |
| Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL) | One month after primary vaccination | This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | From Dose 0 through 6 months after the last primary dose or untill administration of the fourth dose | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. |
| Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs) | From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose | NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects Reporting Rash | From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose | Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae. |
| Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose | Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis. |
| Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits. | From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose | Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis. |
| Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits | From the fourth dose through the end of the 6-month safety follow-up | Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis. |
| Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL). | Prior to the fourth dose vaccination | This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8. | Prior to the fourth dose vaccination | This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination | Within 43 days (Day 0 through Day 42) after vaccination | Symptoms assessed were fever, rash/exanthem, parotid/salivary gland swelling, and any suspected signs of meningism including febrile convulsions. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C. |
| Anti-D and Anti-T Antibody Concentrations | One month after primary vaccination | Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL). This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL) | One month after primary vaccination | Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Anti-HBS Antibody Concentrations | One month after primary vaccination | Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-International units per milliliter (mIU/mL) Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL) | One month after primary vaccination | This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | One month after primary vaccination | This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50) | One month after primary vaccination | This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Anti-poliovirus Types 1, 2 and 3 Titers | One month after primary vaccination | Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values | One month after primary vaccination | Anti-PSC and anti-PSY antibody cut-off values assessed were \>=0.3 microgram per milliliter (µg/mL) and \>=2.0 µg/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Anti-PSC and Anti-PSY Antibody Concentrations | One month after primary vaccination | Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis. |
| Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | One month after the primary vaccination course | Anti-PRP antibody cut-off values assessed were \>=0.15 microgram per milliliter (µg/mL) and \>=1.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis. |
| Anti-PRP Antibody Concentrations | One month after the primary vaccination course | Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis. |
| Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | One month after the primary vaccination course | hSBA-MenC/Y antibody cut-off values assessed were \>=1:4 and \>=1:8 The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis. |
Countries
Australia, Mexico, United States
Participant flow
Recruitment details
Subjects were randomized at the beginning of the primary phase and kept their group assignment during the fourth dose vaccination phase. The study protocol identified 3 different study cohorts : United States (US) Safety and Immunogenicity (Cohort 1), Safety Only (Cohort 2: from all investigation sites), Non-US Safety and Immunogenicity (Cohort 3).
Pre-assignment details
The data for 261 subjects from one study center in the US were not included in the analyses as vaccine accountability could not be fully reconciled (i.e. treatment group assignment for the different subjects could not be verified).
Participants by arm
| Arm | Count |
|---|---|
| Menhibrix Group Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. | 3,136 |
| ActHIB Group Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm. | 1,044 |
| Total | 4,180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Fourth Dose Phase | Adverse Event | 1 | 0 |
| Fourth Dose Phase | Lost to Follow-up | 53 | 12 |
| Fourth Dose Phase | Migration from the study area | 1 | 1 |
| Fourth Dose Phase | Other | 22 | 10 |
| Fourth Dose Phase | Withdrawal by Subject | 10 | 1 |
| Primary Phase | Adverse Event | 10 | 1 |
| Primary Phase | Lost to Follow-up | 60 | 14 |
| Primary Phase | Migration from the study area | 26 | 10 |
| Primary Phase | Other | 32 | 12 |
| Primary Phase | Protocol Violation | 27 | 6 |
| Primary Phase | Withdrawal by Subject | 93 | 40 |
Baseline characteristics
| Characteristic | Menhibrix Group | ActHIB Group | Total |
|---|---|---|---|
| Age, Continuous | 2.11 Months STANDARD_DEVIATION 0.26 | 2.11 Months STANDARD_DEVIATION 0.27 | 2.11 Months STANDARD_DEVIATION 0.27 |
| Sex: Female, Male Female | 1523 Participants | 498 Participants | 2021 Participants |
| Sex: Female, Male Male | 1613 Participants | 546 Participants | 2159 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3,034 / 3,136 | 998 / 1,044 |
| serious Total, serious adverse events | 126 / 3,136 | 50 / 1,044 |
Outcome results
Primary
Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after primary vaccination
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menhibrix Group | Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations | 10.170 microgram per milliliter (µg/mL) |
| ActHIB Group | Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations | 11.424 microgram per milliliter (µg/mL) |
| Menhibrix C Group | Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations | 11.438 microgram per milliliter (µg/mL) |
| Menhibrix Group | Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations | 11.021 microgram per milliliter (µg/mL) |
| ActHIB Group | Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations | 6.463 microgram per milliliter (µg/mL) |
Comparison: To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.95% CI: [0.89, 1.42]
Comparison: To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.95% CI: [0.89, 1.42]
Comparison: To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.95% CI: [0.8, 1.26]
Primary
hSBA-MenC Antibody Titers
Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth dose vaccination and 42 days after the fourth dose
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | hSBA-MenC Antibody Titers | hSBA-MenC [post-dose 4] | 2039.8 Titers |
| Menhibrix Group | hSBA-MenC Antibody Titers | hSBA-MenC [pre-dose 4] | 180.3 Titers |
| ActHIB Group | hSBA-MenC Antibody Titers | hSBA-MenC [post-dose 4] | 4.3 Titers |
| ActHIB Group | hSBA-MenC Antibody Titers | hSBA-MenC [pre-dose 4] | 3.0 Titers |
Comparison: To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenC.95% CI: [10.4, 13.8]
Comparison: To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenC.95% CI: [1.4, 1.4]
Primary
hSBA-MenY Antibody Titers
Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth dose vaccination and 42 days after the fourth dose
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | hSBA-MenY Antibody Titers | hSBA-MenY [post-dose 4] | 1389.5 Titers |
| Menhibrix Group | hSBA-MenY Antibody Titers | hSBA-MenY [pre-dose 4] | 119.1 Titers |
| ActHIB Group | hSBA-MenY Antibody Titers | hSBA-MenY [post-dose 4] | 48.6 Titers |
| ActHIB Group | hSBA-MenY Antibody Titers | hSBA-MenY [pre-dose 4] | 2.5 Titers |
Comparison: To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenY.95% CI: [10.2, 13.8]
Comparison: To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenY.95% CI: [21.1, 21.1]
Primary
Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers
Titers were expressed as Geometric Mean Titers (GMTs) This analysis occured on the cohort 1 : Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after primary vaccination
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menhibrix Group | Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | 910.0 Titers |
| ActHIB Group | Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | 1118.0 Titers |
| Menhibrix C Group | Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | 885.7 Titers |
| Menhibrix Group | Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | 967.6 Titers |
| ActHIB Group | Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | 2.5 Titers |
Comparison: To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).95% CI: [0.93, 1.62]
Comparison: To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).95% CI: [0.74, 1.29]
Comparison: To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).95% CI: [0.6, 1.04]
Primary
Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers
Titers are expressen as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after primary vaccination
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menhibrix Group | Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | 178.9 Titers |
| ActHIB Group | Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | 288.1 Titers |
| Menhibrix C Group | Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | 249.6 Titers |
| Menhibrix Group | Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | 236.6 Titers |
| ActHIB Group | Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers | 2.2 Titers |
Comparison: To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).95% CI: [1.14, 2.27]
Comparison: To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).95% CI: [0.99, 1.97]
Comparison: To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).95% CI: [0.62, 1.21]
Primary
Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. Co-administration with MMR-II vaccine
Time frame: 42 days after the fourth dose
Population: The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML) | 815 Participants |
| ActHIB Group | Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML) | 274 Participants |
Comparison: To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M-M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.95% CI: [-2.56, 3.06]
Primary
Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 28 ED50 Co-administration with MMR-II vaccine.
Time frame: 42 days after the fourth dose
Population: The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50) | 595 Participants |
| ActHIB Group | Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50) | 191 Participants |
Comparison: To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M--M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.95% CI: [-2.16, 0.98]
Primary
Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: 42 days after the fourth dose
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter | 358 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter | 125 Participants |
Comparison: To demonstrate that, following a fourth dose, the immune response to Hib polysaccharide (PRP) in the group that received 3 primary vaccine doses of Menhibrix vaccine and a fourth dose of Menhibrix vaccine coadministered with M-M-R II and Varivax vaccines was non-inferior to the corresponding immune response in the group that received 3 primary vaccine doses of ActHIB vaccine and a fourth dose of PedvaxHIB vaccine co-administered with M-M-R II and Varivax vaccines.95% CI: [-1.78, 3.57]
Primary
Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after primary vaccination
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) | 158 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) | 175 Participants |
| Menhibrix C Group | Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) | 166 Participants |
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) | 499 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) | 156 Participants |
Primary
Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 4 IU/mL. Co-administration with MMR-II vaccine.
Time frame: 42 days after the fourth dose
Population: The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL) | 848 Participants |
| ActHIB Group | Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL) | 284 Participants |
Comparison: To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M-M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.95% CI: [-0.57, 1.73]
Primary
Number of Subjects With Anti-varicella Titer Equal to or Above 1:5
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titer below 1:5. Co-administration with Varivax vaccine.
Time frame: 42 days after the fourth dose
Population: The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-varicella Titer Equal to or Above 1:5 | 722 Participants |
| ActHIB Group | Number of Subjects With Anti-varicella Titer Equal to or Above 1:5 | 223 Participants |
Comparison: To demonstrate the non-inferiority of Varivax vaccine co-administered with a fourth dose of Menhibrix vaccine compared to Varivax vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with M-M-R II vaccine in terms of immunogenicity to varicella as measured by fluorescent antibody to membrane antigen (FAMA).95% CI: [-0.78, 1.56]
Primary
Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: 42 days after the fourth dose
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8 | 326 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8 | 26 Participants |
Primary
Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: 42 days after the fourth dose
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8 | 338 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8 | 87 Participants |
Secondary
Anti-D and Anti-T Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL). This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after primary vaccination
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 2.0 IU/mL |
| Menhibrix Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 3.9 IU/mL |
| ActHIB Group | Anti-D and Anti-T Antibody Concentrations | Anti-D | 2.2 IU/mL |
| ActHIB Group | Anti-D and Anti-T Antibody Concentrations | Anti-T | 1.9 IU/mL |
Secondary
Anti-HBS Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-International units per milliliter (mIU/mL) Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after primary vaccination
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | Anti-HBS Antibody Concentrations | Anti-HBs with Hepatitis B at birth | 1963.2 mIU/mL |
| Menhibrix Group | Anti-HBS Antibody Concentrations | Anti-HBs without Hepatitis B at birth | 1672.7 mIU/mL |
| ActHIB Group | Anti-HBS Antibody Concentrations | Anti-HBs with Hepatitis B at birth | 2187.6 mIU/mL |
| ActHIB Group | Anti-HBS Antibody Concentrations | Anti-HBs without Hepatitis B at birth | 3593.2 mIU/mL |
Secondary
Anti-measles Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-international units per milliliter (mIU/mL). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: 42 days after fourth vaccination
Population: The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menhibrix Group | Anti-measles Antibody Concentrations | 1990.0 mIU/mL |
| ActHIB Group | Anti-measles Antibody Concentrations | 1989.5 mIU/mL |
Secondary
Anti-mumps Antibody Titers
Titers are expressed as Geometric Mean Titers (GMTs). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titers below 24 ED50. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: 42 days after fourth vaccination
Population: The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menhibrix Group | Anti-mumps Antibody Titers | 123.9 Titers |
| ActHIB Group | Anti-mumps Antibody Titers | 114.3 Titers |
Secondary
Anti-poliovirus Types 1, 2 and 3 Titers
Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after primary vaccination
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | Anti-poliovirus Types 1, 2 and 3 Titers | Anti-Polio 1 | 591.8 Titers |
| Menhibrix Group | Anti-poliovirus Types 1, 2 and 3 Titers | Anti-Polio 2 | 496.7 Titers |
| Menhibrix Group | Anti-poliovirus Types 1, 2 and 3 Titers | Anti-Polio 3 | 1367.7 Titers |
| ActHIB Group | Anti-poliovirus Types 1, 2 and 3 Titers | Anti-Polio 1 | 590.7 Titers |
| ActHIB Group | Anti-poliovirus Types 1, 2 and 3 Titers | Anti-Polio 2 | 452.7 Titers |
| ActHIB Group | Anti-poliovirus Types 1, 2 and 3 Titers | Anti-Polio 3 | 1239.2 Titers |
Secondary
Anti-PRP Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL). This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after the primary vaccination course and prior to the fourth dose vaccination
Population: The Fourth dose ATP cohort for safety included eligible subjects, who met inclusion criteria, who received 3 vaccine doses in the primary vaccination course, who received the fourth vaccine dose, who did not receive a vaccine not specified or forbidden and who were not excluded from from the Primary ATP cohort for immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | Anti-PRP Antibody Concentrations | Anti-PRP post-primary | 10.802 µg/mL |
| Menhibrix Group | Anti-PRP Antibody Concentrations | Anti-PRP pre-dose 4 | 1.615 µg/mL |
| ActHIB Group | Anti-PRP Antibody Concentrations | Anti-PRP post-primary | 6.086 µg/mL |
| ActHIB Group | Anti-PRP Antibody Concentrations | Anti-PRP pre-dose 4 | 0.832 µg/mL |
Secondary
Anti-PRP Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Time frame: One month after the primary vaccination course
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menhibrix Group | Anti-PRP Antibody Concentrations | 24.984 µg/mL |
| ActHIB Group | Anti-PRP Antibody Concentrations | 24.050 µg/mL |
| Menhibrix C Group | Anti-PRP Antibody Concentrations | 20.489 µg/mL |
| Menhibrix Group | Anti-PRP Antibody Concentrations | 23.165 µg/mL |
| ActHIB Group | Anti-PRP Antibody Concentrations | 29.759 µg/mL |
Secondary
Anti-PRP Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | Anti-PRP Antibody Concentrations | Anti-PRP Pre-dose 4 | 3.340 µg/mL |
| Menhibrix Group | Anti-PRP Antibody Concentrations | Anti-PRP Post-dose 4 | 132.965 µg/mL |
| ActHIB Group | Anti-PRP Antibody Concentrations | Anti-PRP Pre-dose 4 | 4.123 µg/mL |
| ActHIB Group | Anti-PRP Antibody Concentrations | Anti-PRP Post-dose 4 | 92.800 µg/mL |
Secondary
Anti-PRP Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth vaccination and 42 days after fourth vaccination
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | Anti-PRP Antibody Concentrations | Anti-PRP [post-dose 4] | 34.851 µg/mL |
| Menhibrix Group | Anti-PRP Antibody Concentrations | Anti-PRP [pre-dose 4] | 1.617 µg/mL |
| ActHIB Group | Anti-PRP Antibody Concentrations | Anti-PRP [post-dose 4] | 20.200 µg/mL |
| ActHIB Group | Anti-PRP Antibody Concentrations | Anti-PRP [pre-dose 4] | 0.759 µg/mL |
Secondary
Anti-PSC and Anti-PSY Antibodies Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL). The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Time frame: One month after the primary vaccination course
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | Anti-PSC and Anti-PSY Antibodies Concentrations | Anti-PSC | 13.4 µg/mL |
| Menhibrix Group | Anti-PSC and Anti-PSY Antibodies Concentrations | Anti-PSY | 36.7 µg/mL |
| ActHIB Group | Anti-PSC and Anti-PSY Antibodies Concentrations | Anti-PSC | 0.2 µg/mL |
| ActHIB Group | Anti-PSC and Anti-PSY Antibodies Concentrations | Anti-PSY | 0.2 µg/mL |
Secondary
Anti-PSC and Anti-PSY Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after primary vaccination
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSC | 5.8 µg/mL |
| Menhibrix Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSY | 17.5 µg/mL |
| ActHIB Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSC | 0.2 µg/mL |
| ActHIB Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSY | 0.2 µg/mL |
Secondary
Anti-PSC and Anti-PSY Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL). This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth dose vaccination and 42 days after fourth dose vaccination
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSC pre-dose 4 | 1.04 µg/mL |
| Menhibrix Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSC post-dose 4 | 4.81 µg/mL |
| Menhibrix Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSY pre-dose 4 | 3.15 µg/mL |
| Menhibrix Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSY post-dose 4 | 18.26 µg/mL |
| ActHIB Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSY post-dose 4 | 0.18 µg/mL |
| ActHIB Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSC pre-dose 4 | 0.16 µg/mL |
| ActHIB Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSY pre-dose 4 | 0.15 µg/mL |
| ActHIB Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSC post-dose 4 | 0.19 µg/mL |
Secondary
Anti-PSC and Anti-PSY Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL). The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSC pre-dose 4 | 2.20 µg/mL |
| Menhibrix Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSC post-dose 4 | 15.63 µg/mL |
| Menhibrix Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSY pre-dose 4 | 5.70 µg/mL |
| Menhibrix Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSY post-dose 4 | 64.66 µg/mL |
| ActHIB Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSY post-dose 4 | 0.15 µg/mL |
| ActHIB Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSC pre-dose 4 | 0.15 µg/mL |
| ActHIB Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSY pre-dose 4 | 0.15 µg/mL |
| ActHIB Group | Anti-PSC and Anti-PSY Antibody Concentrations | Anti-PSC post-dose 4 | 0.15 µg/mL |
Secondary
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after primary vaccination
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 57.7 EL.U/mL |
| Menhibrix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 243.8 EL.U/mL |
| Menhibrix Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 98.6 EL.U/mL |
| ActHIB Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 65.6 EL.U/mL |
| ActHIB Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 293.6 EL.U/mL |
| ActHIB Group | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 103.1 EL.U/mL |
Secondary
Anti-rubella Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: 42 days after fourth vaccination
Population: The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menhibrix Group | Anti-rubella Antibody Concentrations | 81.4 IU/mL |
| ActHIB Group | Anti-rubella Antibody Concentrations | 74.9 IU/mL |
Secondary
Anti-varicella Antibody Titers
Titers are expressed as Geometric Mean Titers (GMTs) The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-varicella antibody titers below 1:5 This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: 42 days after fourth vaccination
Population: The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Menhibrix Group | Anti-varicella Antibody Titers | 407.1 Titers |
| ActHIB Group | Anti-varicella Antibody Titers | 394.1 Titers |
Secondary
hSBA-MenC and hSBA-MenY Antibody Titers
Titres are expressed as Geometric Mean Titers (GMTs). The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Time frame: One month after the primary vaccination course
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenC | 3055.8 Titers |
| Menhibrix Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenY | 666.5 Titers |
| ActHIB Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenC | 3370.7 Titers |
| ActHIB Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenY | 916.7 Titers |
| Menhibrix C Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenC | 3119.3 Titers |
| Menhibrix C Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenY | 989.6 Titers |
| Menhibrix Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenY | 837.2 Titers |
| Menhibrix Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenC | 3172.6 Titers |
| ActHIB Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenC | 2.4 Titers |
| ActHIB Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenY | 2.2 Titers |
Secondary
hSBA-MenC and hSBA-MenY Antibody Titers
Titers are expressed as Geometric Mean Titers (GMTs) The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenC pre-dose 4 | 504.7 Titers |
| Menhibrix Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenC post-dose 4 | 10132.9 Titers |
| Menhibrix Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenY pre-dose 4 | 446.5 Titers |
| Menhibrix Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenY post-dose 4 | 5775.8 Titers |
| ActHIB Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenY post-dose 4 | 27.4 Titers |
| ActHIB Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenC pre-dose 4 | 3.6 Titers |
| ActHIB Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenY pre-dose 4 | 5.3 Titers |
| ActHIB Group | hSBA-MenC and hSBA-MenY Antibody Titers | hSBA-MenC post-dose 4 | 2.5 Titers |
Secondary
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.
Time frame: From the fourth dose through the end of the 6-month safety follow-up
Population: The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 137 Participants |
| ActHIB Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 54 Participants |
Secondary
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.
Time frame: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
Population: The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 \& Cohort 3) in the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 217 Participants |
| ActHIB Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 72 Participants |
Secondary
Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits
Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.
Time frame: From the fourth dose through the end of the 6-month safety follow-up
Population: The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits | 668 Participants |
| ActHIB Group | Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits | 205 Participants |
Secondary
Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits.
Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.
Time frame: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
Population: The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 \& Cohort 3) in the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits. | 1336 Participants |
| ActHIB Group | Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits. | 433 Participants |
Secondary
Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit
Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).
Time frame: In the 4-day (Day0-3) follow-up period after the fourth dose
Population: The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit | 18 Participants |
| ActHIB Group | Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit | 5 Participants |
Secondary
Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit
Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).
Time frame: In the 4-day (Day 0-3) follow-up period after primary vaccination course
Population: The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 \& Cohort 3) in the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit | 46 Participants |
| ActHIB Group | Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit | 16 Participants |
Secondary
Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination
Symptoms assessed were fever, rash/exanthem, parotid/salivary gland swelling, and any suspected signs of meningism including febrile convulsions. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.
Time frame: Within 43 days (Day 0 through Day 42) after vaccination
Population: The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination | Meningismus | 0 Participants |
| Menhibrix Group | Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination | Parotiditis | 0 Participants |
| Menhibrix Group | Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination | Rash | 59 Participants |
| Menhibrix Group | Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination | Fever | 211 Participants |
| ActHIB Group | Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination | Fever | 70 Participants |
| ActHIB Group | Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination | Meningismus | 0 Participants |
| ActHIB Group | Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination | Rash | 19 Participants |
| ActHIB Group | Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination | Parotiditis | 0 Participants |
Secondary
Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s)
Increased circumferential swelling defined as either swelling with a diameter of \>50 mm or a \>50 mm increase in the circumference of the mid-limb when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interferes with or prevents everyday activities (for example, active playing, eating, sleeping).
Time frame: Within 4 days (Day 0 to Day 3) after fourth dose vaccination
Population: The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s) | 1489 Participants |
| ActHIB Group | Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s) | 503 Participants |
Secondary
Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
Population: The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 \& Cohort 3) in the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs) | 163 Participants |
| ActHIB Group | Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs) | 52 Participants |
Secondary
Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From the fourth dose through the end of the 6-month safety follow-up
Population: The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs) | 85 Participants |
| ActHIB Group | Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs) | 33 Participants |
Secondary
Number of Subjects Reporting Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
Time frame: From the fourth dose through the end of the 6-month safety follow-up
Population: The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Rash | 265 Participants |
| ActHIB Group | Number of Subjects Reporting Rash | 94 Participants |
Secondary
Number of Subjects Reporting Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
Time frame: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose
Population: The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 \& Cohort 3) in the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Rash | 470 Participants |
| ActHIB Group | Number of Subjects Reporting Rash | 154 Participants |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: From the fourth dose through the end of the 6-month safety follow-up
Population: The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 47 Participants |
| ActHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 18 Participants |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: From Dose 0 through 6 months after the last primary dose or untill administration of the fourth dose
Population: The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 \& Cohort 3) in the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 126 Participants |
| ActHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 50 Participants |
Secondary
Number of Subjects Reporting Solicited Local and General Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Solicited genral symptoms assessed were fever, irritability/fussiness, drowsiness and loss of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.
Time frame: Within the 4 days (Day 0-3) following each dose of the primary vaccination course
Population: The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 \& Cohort 3) in the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Drowsiness, Dose 3 | 1260 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Redness, Dose 1 | 1152 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Drowsiness, Across doses | 2418 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Swelling, Dose 1 | 893 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Temperature, Dose 1 | 688 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Pain, Dose 2 | 1679 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Temperature, Dose 2 | 803 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Swelling, Dose 2 | 1091 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Temperature, Dose 3 | 609 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Redness, Dose 2 | 1455 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Temperature, Across doses | 1434 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Swelling, Dose 3 | 1110 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Irritability, Dose 1 | 2156 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Pain, Across doses | 2419 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Irritability, Dose 2 | 2074 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Swelling, Across doses | 1707 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Irritability, Dose 3 | 1771 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Redness, Dose 3 | 1409 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Irritability, Across doses | 2740 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Drowsiness, Dose 1 | 1864 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Loss of appetite, Dose 1 | 1024 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Pain, Dose 3 | 1454 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Loss of appetite, Dose 2 | 921 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Drowsiness, Dose 2 | 1588 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Loss of appetite, Dose 3 | 828 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Redness, Across doses | 2052 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Loss of appetite, Across doses | 1764 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Pain, Dose 1 | 1849 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Loss of appetite, Across doses | 609 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Pain, Dose 1 | 672 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Pain, Dose 2 | 596 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Pain, Dose 3 | 522 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Pain, Across doses | 819 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Redness, Dose 1 | 401 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Redness, Dose 2 | 483 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Redness, Dose 3 | 495 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Redness, Across doses | 691 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Swelling, Dose 1 | 281 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Swelling, Dose 2 | 350 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Swelling, Dose 3 | 381 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Swelling, Across doses | 568 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Drowsiness, Dose 1 | 655 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Drowsiness, Dose 2 | 552 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Drowsiness, Dose 3 | 444 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Drowsiness, Across doses | 804 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Temperature, Dose 1 | 228 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Temperature, Dose 2 | 276 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Temperature, Dose 3 | 206 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Temperature, Across doses | 463 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Irritability, Dose 1 | 782 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Irritability, Dose 2 | 708 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Irritability, Dose 3 | 600 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Irritability, Across doses | 926 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Loss of appetite, Dose 1 | 375 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Loss of appetite, Dose 2 | 317 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Any Loss of appetite, Dose 3 | 285 Participants |
Secondary
Number of Subjects Reporting Solicited Local and General Symptoms
Solicited local symptoms assessed were pain, redness, swelling and an increase in limb circumference. Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness and lost of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C
Time frame: Within the 4 days (Day 0-3) post-vaccination period following the fourth dose
Population: The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Pain | 1319 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Redness | 1213 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Swelling | 936 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Increase in limb circumference | 1489 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Drowsiness | 1088 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fever | 341 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Irritability | 1482 Participants |
| Menhibrix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Loss of appetite | 825 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Loss of appetite | 287 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Pain | 494 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Drowsiness | 381 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Redness | 463 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Irritability | 534 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Swelling | 334 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fever | 134 Participants |
| ActHIB Group | Number of Subjects Reporting Solicited Local and General Symptoms | Increase in limb circumference | 503 Participants |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE 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: Within 31 days (Day 0-30) following the fourth dose
Population: The Fourth dose Total Vaccinated cohort included all vaccinated subjects in the fourth dose vaccination phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 1010 Participants |
| ActHIB Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 334 Participants |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE 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: Within 31 days (Day 0-30) following the primary vaccination course
Population: The Primary Total Vaccinated cohort included all vaccinated subjects (Cohort 1, Cohort 2 \& Cohort 3) in the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 1820 Participants |
| ActHIB Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 602 Participants |
Secondary
Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values
Anti-PSC and anti-PSY antibody cut-off values assessed were \>=0.3 microgram per milliliter (µg/mL) and \>=2.0 µg/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after primary vaccination
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values | Anti-PSC >=0.3 µg/mL | 418 Participants |
| Menhibrix Group | Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values | Anti-PSY >=0.3 µg/mL | 402 Participants |
| Menhibrix Group | Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values | Anti-PSC >=2.0 µg/mL | 379 Participants |
| Menhibrix Group | Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values | Anti-PSY >=2.0 µg/mL | 396 Participants |
| ActHIB Group | Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values | Anti-PSY >=2.0 µg/mL | 0 Participants |
| ActHIB Group | Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values | Anti-PSC >=0.3 µg/mL | 5 Participants |
| ActHIB Group | Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values | Anti-PSC >=2.0 µg/mL | 2 Participants |
| ActHIB Group | Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values | Anti-PSY >=0.3 µg/mL | 1 Participants |
Secondary
Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40
anti-H1N1, anti-H3N2 and anti-influenza-B (anti B) antibody were measured by hemagglutination inhibition assay (HIA), in subjects who received 2 doses of influenza vaccine within the same influenza season of which at least one dose is concomitant with the study vaccine. For the purposes of this study, concomitant administration of influenza vaccine was defined as administration within 28 days before to 7 days after administration of study vaccines. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based.
Time frame: Prior to the fourth dose vaccination and one month after the fourth dose vaccination
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40 | Anti-H1N1 pre-dose 4 | 0 Participants |
| Menhibrix Group | Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40 | Anti-H1N1 post-dose 4 | 2 Participants |
| Menhibrix Group | Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40 | Anti-H3N2 pre-dose 4 | 0 Participants |
| Menhibrix Group | Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40 | Anti-H3N2 post-dose 4 | 3 Participants |
| Menhibrix Group | Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40 | Anti-B pre-dose 4 | 0 Participants |
| Menhibrix Group | Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40 | Anti-B post-dose 4 | 1 Participants |
| ActHIB Group | Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40 | Anti-B pre-dose 4 | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40 | Anti-H1N1 pre-dose 4 | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40 | Anti-H3N2 post-dose 4 | 1 Participants |
| ActHIB Group | Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40 | Anti-H1N1 post-dose 4 | 1 Participants |
| ActHIB Group | Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40 | Anti-B post-dose 4 | 1 Participants |
| ActHIB Group | Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40 | Anti-H3N2 pre-dose 4 | 0 Participants |
Secondary
Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)
Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after primary vaccination
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL) | Anti-HBs with Hepatitis B at birth | 193 Participants |
| Menhibrix Group | Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL) | Anti-HBs without Hepatitis B at birth | 17 Participants |
| ActHIB Group | Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL) | Anti-HBs with Hepatitis B at birth | 47 Participants |
| ActHIB Group | Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL) | Anti-HBs without Hepatitis B at birth | 8 Participants |
Secondary
Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: 42 days after fourth vaccination
Population: The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL) | 812 Participants |
| ActHIB Group | Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL) | 273 Participants |
Secondary
Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values
Anti-mumps antibody cut-off values assessed were \>=28 estimated dose 50 (ED50) and \>=51 ED50. The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 24 ED50. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: 42 days after fourth vaccination
Population: The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values | Anti-mumps >=28 ED50 | 532 Participants |
| Menhibrix Group | Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values | Anti-mumps >=51 ED50 | 490 Participants |
| ActHIB Group | Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values | Anti-mumps >=28 ED50 | 176 Participants |
| ActHIB Group | Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values | Anti-mumps >=51 ED50 | 160 Participants |
Secondary
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after primary vaccination
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL) | Anti-PT | 327 Participants |
| Menhibrix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL) | Anti-FHA | 324 Participants |
| Menhibrix Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL) | Anti-PRN | 321 Participants |
| ActHIB Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL) | Anti-PT | 100 Participants |
| ActHIB Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL) | Anti-FHA | 97 Participants |
| ActHIB Group | Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL) | Anti-PRN | 99 Participants |
Secondary
Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after primary vaccination
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50) | Anti-Polio 1 | 285 Participants |
| Menhibrix Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50) | Anti-Polio 2 | 285 Participants |
| Menhibrix Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50) | Anti-Polio 3 | 285 Participants |
| ActHIB Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50) | Anti-Polio 1 | 90 Participants |
| ActHIB Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50) | Anti-Polio 2 | 90 Participants |
| ActHIB Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50) | Anti-Polio 3 | 89 Participants |
Secondary
Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth dose vaccination
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL). | 227 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL). | 52 Participants |
Secondary
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth dose vaccination and 42 days after fourth vaccination
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL) | Anti-PRP [post-dose 4] | 361 Participants |
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL) | Anti-PRP [pre-dose 4] | 329 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL) | Anti-PRP [post-dose 4] | 126 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL) | Anti-PRP [pre-dose 4] | 98 Participants |
Secondary
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value
Anti-PRP antibody cut-off values assessed were \>=0.15 µg/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after the primary vaccination course
Population: The Primary ATP cohort for immunogenicity included evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures and met no elimination criteria) for whom assay results were available for antibodies against at least 1 study vaccine antigen for the blood sample taken during primary vaccination (after the 3rd vaccine dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value | 518 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value | 168 Participants |
| Menhibrix C Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value | 162 Participants |
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value | 180 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value | 176 Participants |
Secondary
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PRP antibody cut-off values assessed were \>=0.15 microgram per milliliter (µg/mL) and \>=1.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP pre-dose 4 >=0.15 µg/mL | 38 Participants |
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP pre-dose 4 >=1.0 µg/mL | 33 Participants |
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP post-dose 4 >=0.15 µg/mL | 40 Participants |
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP post-dose 4 >=1.0 µg/mL | 40 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP post-dose 4 >=1.0 µg/mL | 13 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP pre-dose 4 >=0.15 µg/mL | 12 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP post-dose 4 >=0.15 µg/mL | 13 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP pre-dose 4 >=1.0 µg/mL | 11 Participants |
Secondary
Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PRP antibody cut-off values assessed were \>=0.15 microgram per milliliter (µg/mL) and \>=1.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Time frame: One month after the primary vaccination course
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP >=0.15 µg/mL | 49 Participants |
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP >=1.0 µg/mL | 49 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP >=0.15 µg/mL | 42 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP >=1.0 µg/mL | 42 Participants |
| Menhibrix C Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP >=0.15 µg/mL | 43 Participants |
| Menhibrix C Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP >=1.0 µg/mL | 43 Participants |
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP >=1.0 µg/mL | 134 Participants |
| Menhibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP >=0.15 µg/mL | 134 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP >=0.15 µg/mL | 46 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PRP >=1.0 µg/mL | 46 Participants |
Secondary
Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PSC and anti-PSY antibody cut-off values assessed were \>=0.3 µg/mL and \>=2.0 µg/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth dose vaccination and 42 days after fourth dose vaccination
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC pre-dose 4 >=0.3 µg/mL | 300 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC pre-dose 4 >=2.0 µg/mL | 73 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC post-dose 4 >=0.3 µg/mL | 313 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC post-dose 4 >=2.0 µg/mL | 262 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY pre-dose 4 >=0.3 µg/mL | 320 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY pre-dose 4 >=2.0 µg/mL | 235 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY post-dose 4 >=0.3 µg/mL | 332 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY post-dose 4 >=2.0 µg/mL | 325 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY post-dose 4 >=2.0 µg/mL | 4 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC pre-dose 4 >=0.3 µg/mL | 3 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY pre-dose 4 >=0.3 µg/mL | 1 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC pre-dose 4 >=2.0 µg/mL | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY post-dose 4 >=0.3 µg/mL | 6 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC post-dose 4 >=0.3 µg/mL | 9 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY pre-dose 4 >=2.0 µg/mL | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC post-dose 4 >=2.0 µg/mL | 6 Participants |
Secondary
Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PSC and anti-PSY antibody cut-off values assessed were \>=0.3 µg/mL and \>=2.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC pre-dose 4 >=0.3 µg/mL | 40 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC pre-dose 4 >=2.0 µg/mL | 22 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC post-dose 4 >=0.3 µg/mL | 39 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC post-dose 4 >=2.0 µg/mL | 39 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY pre-dose 4 >=0.3 µg/mL | 40 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY pre-dose 4 >=2.0 µg/mL | 36 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY post-dose 4 >=0.3 µg/mL | 40 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY post-dose 4 >=2.0 µg/mL | 40 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY post-dose 4 >=2.0 µg/mL | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC pre-dose 4 >=0.3 µg/mL | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY pre-dose 4 >=0.3 µg/mL | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC pre-dose 4 >=2.0 µg/mL | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY post-dose 4 >=0.3 µg/mL | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC post-dose 4 >=0.3 µg/mL | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY pre-dose 4 >=2.0 µg/mL | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC post-dose 4 >=2.0 µg/mL | 0 Participants |
Secondary
Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PSC and anti-PSY antibody cut-off values assessed were \>=0.3 microgram per milliliter (µg/mL) and \>=2.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Time frame: One month after the primary vaccination course
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC >=0.3 µg/mL | 134 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC >=2.0 µg/mL | 134 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY >=0.3 µg/mL | 130 Participants |
| Menhibrix Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY >=2.0 µg/mL | 130 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY >=2.0 µg/mL | 1 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC >=0.3 µg/mL | 2 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSY >=0.3 µg/mL | 1 Participants |
| ActHIB Group | Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values | Anti-PSC >=2.0 µg/mL | 1 Participants |
Secondary
Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: 42 days after fourth vaccination
Population: The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL) | 850 Participants |
| ActHIB Group | Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL) | 285 Participants |
Secondary
Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after primary vaccination
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL) | Anti-D | 365 Participants |
| Menhibrix Group | Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL) | Anti-T | 365 Participants |
| ActHIB Group | Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL) | Anti-D | 120 Participants |
| ActHIB Group | Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL) | Anti-T | 120 Participants |
Secondary
Number of Subjects With Anti-varicella Titer Equal to or Above 1:40
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 1:5 This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: 42 days after fourth vaccination
Population: The Pooled cohort consisted of all evaluable subjects in the Fourth dose ATP cohort for immunogenicity, HibMenCY-TT-008 and Cohort 1 from HibMenCY-TT-010
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Menhibrix Group | Number of Subjects With Anti-varicella Titer Equal to or Above 1:40 | 722 Participants |
| ActHIB Group | Number of Subjects With Anti-varicella Titer Equal to or Above 1:40 | 223 Participants |
Secondary
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth dose vaccination and 42 days after fourth vaccination
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4 | hSBA-MenC [post-dose 4] | 326 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4 | hSBA-MenY [post-dose 4] | 338 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4 | hSBA-MenC [pre-dose 4] | 318 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4 | hSBA-MenY [pre-dose 4] | 309 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4 | hSBA-MenY [pre-dose 4] | 6 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4 | hSBA-MenC [post-dose 4] | 26 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4 | hSBA-MenC [pre-dose 4] | 12 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4 | hSBA-MenY [post-dose 4] | 87 Participants |
Secondary
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8.
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth dose vaccination
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8. | hSBA-MenC [pre-dose 4] | 318 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8. | hSBA-MenY [pre-dose 4] | 306 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8. | hSBA-MenC [pre-dose 4] | 12 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8. | hSBA-MenY [pre-dose 4] | 6 Participants |
Secondary
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
hSBA-MenC and hSBA-MenY antibody cut-off values assessed were \>=1:4 and \>=1:8. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Time frame: One month after the primary vaccination course
Population: The Primary ATP cohort for immunogenicity included evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures and met no elimination criteria ) for whom assay results were available for antibodies against at least 1 study vaccine antigen for the blood sample taken during primary vaccination (after the 3rd vaccine dose
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:4 | 485 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:8 | 485 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:4 | 463 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:8 | 461 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:4 | 11 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:8 | 3 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:8 | 11 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:4 | 3 Participants |
| Menhibrix C Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:8 | 140 Participants |
| Menhibrix C Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:8 | 156 Participants |
| Menhibrix C Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:4 | 141 Participants |
| Menhibrix C Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:4 | 156 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:4 | 167 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:8 | 167 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:8 | 165 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:4 | 165 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:8 | 156 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:4 | 157 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:8 | 162 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:4 | 162 Participants |
Secondary
Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values
hSBA-MenC/Y antibody cut-off values assessed were \>=1:4 and \>=1:8 The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Time frame: One month after the primary vaccination course
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol and met no elimination criteria during the study) for whom results were available for antibodies against the vaccine antigens after the third vaccine dose.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:4 | 47 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:8 | 47 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:4 | 48 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:8 | 48 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:4 | 42 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:8 | 42 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:8 | 42 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:4 | 42 Participants |
| Menhibrix C Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:8 | 44 Participants |
| Menhibrix C Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:8 | 44 Participants |
| Menhibrix C Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:4 | 44 Participants |
| Menhibrix C Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:4 | 44 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:4 | 133 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:8 | 133 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:8 | 134 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:4 | 134 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:8 | 1 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY >=1:4 | 1 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:8 | 2 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC >=1:4 | 2 Participants |
Secondary
Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values
hSBA-MenC/Y antibody cut-off values assessed were \>=1:4 and \>=1:8. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.
Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination
Population: The Fourth dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those who met eligibility criteria, complied with the procedures defined in the protocol, with no elimination criteria during the study) for whom results were available for antibodies against vaccine antigens for the blood sample taken 43 days post-vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC pre-dose 4 >=1:4 | 39 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC pre-dose 4 >=1:8 | 39 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC post-dose 4 >=1:4 | 39 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC post-dose 4 >=1:8 | 39 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY pre-dose 4 >=1:4 | 39 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY pre-dose 4 >=1:8 | 39 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY post-dose 4 >=1:4 | 40 Participants |
| Menhibrix Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY post-dose 4 >=1:8 | 40 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY post-dose 4 >=1:8 | 7 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC pre-dose 4 >=1:4 | 2 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY pre-dose 4 >=1:4 | 3 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC pre-dose 4 >=1:8 | 2 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY post-dose 4 >=1:4 | 7 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC post-dose 4 >=1:4 | 1 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenY pre-dose 4 >=1:8 | 3 Participants |
| ActHIB Group | Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values | hSBA-MenC post-dose 4 >=1:8 | 1 Participants |