Haemophilus Influenzae Type b, Neisseria Meningitidis
Conditions
Keywords
Immunogenicity, Primary & booster vaccination, Infants, Meningococcal vaccine, Safety, Children, Hib disease, Meningococcal disease
Brief summary
This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age. The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.
Detailed description
The non-inferiority of the immunogenicity, safety, and antibody persistence of Hib-MenCY-TT vaccine will be compared to ActHIB®, a monovalent Hib conjugate vaccine licensed in the US. All subjects will be vaccinated at 2, 4, 6, and 12 to 15 months. The immunogenicity of the MenC and MenY antigens will be summarized. MenC and MenY immunogenicity will be compared to Menomune® (a quadrivalent meningococcal A, C, Y, and W-135 plain polysaccharide vaccine licensed in the US) administered to children 3 to 5 years of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALGSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine
Primary phase: 3 IM doses Booster phase: 1 IM dose
BIOLOGICALActHIB
Primary phase: 3 IM doses Booster phase: 1 IM dose
BIOLOGICALPediarix
Primary phase: 3 IM doses
BIOLOGICALPrevnar
Primary phase: 3 IM doses Booster phase: 1 IM dose
BIOLOGICALMenomune
Primary phase: 1 SC dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 15 Months
Healthy volunteers
Yes
Inclusion criteria
* For Groups A and B * Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol. * Healthy male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering the study. * Born after a gestation period between 36 and 42 weeks. * 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. * For Group C * Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol. * Healthy male or female between, and including, 3 and 5 years of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering the study.
Exclusion criteria
-For Groups A and B * 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 within six months prior to the first vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). * Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine. * History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and/or Streptococcus pneumoniae disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including dry natural latex rubber. * 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. For Group C * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the 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 within six months prior to the vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the dose of study vaccine. * Previous vaccination against Neisseria meningitidis. * History of Neisseria meningitidis disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including dry natural latex rubber * Major congenital defects or serious chronic illness. * Acute disease at time of enrollment. * Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value. | One month after the 3-dose primary vaccination course (at Month 5) | The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | One month after the 3-dose primary vaccination course (at Month 5) | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | One month after the 3-dose primary vaccination course (at Month 5) | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Number of Subjects Reporting Any Grade 3 Symptoms | During the 4-day follow-up period after each primary vaccine dose | Symptoms were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A Grade 3 symptom was defined as any symptom that prevented normal everyday activity. Any was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value | One month after the fourth dose (at Month 11-14) | The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4 | One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group) | A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (\<) 1:128. |
| Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4 | One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group) | A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (\<) 1:128. |
| Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | Anti-PSC antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL. |
| Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). |
| Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | Anti-PSY antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL. |
| Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL) |
| Number of Subjects Reporting Medically Attended Visits | During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0 | A medically attended visit was defined as an hospitalization, an emergency room visit or a visit to or from medical personnel. This Outcome Measure only concerns subjects in the Menomune Group. |
| Number of Subjects Reporting Rash | During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0 | An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns subjects in the Menomune Group. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0 | 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 subject . This Outcome Measure only concerns subjects in the Menomune Group. |
| Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | Anti-PRP antibody cut-off values for this outcome were 0.15 µg/mL and 1.0 µg/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | The anti-diphtheria and anti-tetanus antibody cut-off value for this outcome was ≥ 0.1 IU/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups. |
| Anti-diphtheria and Anti-tetanus Antibody Concentrations | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL) | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations | Prior to the primary vaccination course (at Day 0) | Concentrations of antibodies are presented as GMCs expressed as EL.U/mL. Results for one month after the 3-dose primary vaccination course (at Month 5) are presented under the Primary Outcome Measures section. This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | Titers are presented as geometric mean titers (GMTs). This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Number of Subjects With Vaccine Response to PT, FHA and PRN | One month after the 3-dose primary vaccination course (at Month 5) | Vaccine response to PT/FHA/PRN was defined as, for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month post-primary vaccination course, and, for initially seropositive subjects, antibody concentration one month post-primary vaccination course ≥ 1-fold the pre-vaccination antibody concentration. A seronegative/seronegative subject was defined as a subject with antibody concentration \</≥ 5 EL.U/mL for anti-PT/FHA/PRN prior to vaccination. This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Within 4 days (Day 0-3) after the 3-dose primary vaccination | Solicited local symptoms were pain, redness and swelling at injection site. Any = any report of the specified symptom irrespective of intensity grade; Grade 2 pain = cried/protested on touch; Grade 3 pain = cried when limb was moved/spontaneously painful; Grade 2 or 3 redness/swelling = redness/swelling larger than (\>) 10 millimeters (mm); Grade 3 redness/swelling = redness/swelling \> 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Within 4 days (Day 0-3) after the 3-dose primary vaccination | Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Any = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. Grade 2 for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; Grade 3 for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); Grade 2 or 3 fever = rectal temperature higher than (\>) 39°C; Grade 3 fever = rectal temperature \> 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group). | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs) | From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses | From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine. | Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups. |
| Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | One month post fourth dose vaccination (at Month 11-14) | Fourth dose responses to rSBA-MenC and rSBA-MenY were defined as follows (Definition 1): * Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: \< 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after fourth dose (post-fourth dose antibody titer ≥1:32), * Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after fourth dose. |
| Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | One month post fourth dose vaccination (at Month 11-14) | Fourth dose responses to hSBA-MenC and hSBA-MenY were defined as follows (Definition 1): * Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: \< 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after the fourth dose (post-fourth dose antibody titer ≥1:16), * Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after the fourth dose. |
| Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | One month after fourth dose vaccination (at Month 11-14) | Streptococcus pneumoniae antibody cut-off values assessed was ≥0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. |
| Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | One month after fourth dose vaccination (at Month 11-14) | Streptococcus pneumoniae antibody cut-off values assessed was ≥0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. |
| Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | One month after fourth dose vaccination (at Month 11-14) | Streptococcus pneumoniae antibody cut-off values assessed was ≥0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. |
| Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | One month post fourth dose vaccination (at Month 11-14) | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. |
| Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | Anti-PRP antibody cut-off values assessed were ≥0.15 µg/mL and ≥1.0 µg/mL. |
| Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | rSBA-MenC antibody cut-off values assessed were ≥1:8 and ≥1:128 |
| rSBA-MenC Antibody Titers | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | Titers are presented as geometric mean titers (GMTs). |
| Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | rSBA-MenY antibody cut-off values assesse were ≥1:8 and ≥1:128. |
| rSBA-MenY Antibody Titers | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | Titers are presented as geometric mean titers (GMTs). |
| Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | hSBA-MenC antibody cut-off values assessed were ≥1:4 and ≥1:8. |
| hSBA-MenC Antibody Titers | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | Titers are presented as geometric mean titers (GMTs). |
| Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | hSBA-MenY antibody cut-off values assessed were ≥1:4 and ≥1:8. |
| hSBA-MenY Antibody Titers | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | Titers are presented as geometric mean titers (GMTs). |
| Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | Anti-PSC antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL. |
| Anti-PSC Antibody Concentrations | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). |
| Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | Anti-PSY antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL. |
| Anti-PSY Antibody Concentrations | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL) |
| Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | — |
| Anti-tetanus Antibody Concentrations | Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14) | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL). |
| Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | rSBA-MenC antibody cut-off values for this outcome were 1:8 and 1:128. |
| Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses | From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up | Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups. |
| Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s) | Within 4 days (Day 0-3) and within 8 days (Day 0-7) following the fourth dose | Large injection site reactions were defined as either swelling with a diameter of \> 30 mm or a \> 30 mm increase in the circumference of the mid-thigh when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interfered with or prevented everyday activities (for example, active playing, eating, sleeping). |
| Number of Subjects Reporting New Onset of Chronic Illness(es) | From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Anti-PRP Antibody Concentrations | Prior to and one month after the primary vaccination course (at Day 0 and Month 5) | Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups . |
| Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | Titers are presented as geometric mean titers (GMTs). |
| Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | rSBA-MenY antibody cut-off values for this outcome measure were 1:8 and 1:128. |
| Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers | Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group) | Titers are presented as geometric mean titers (GMTs). |
Countries
United States
Participant flow
Recruitment details
In a Primary Phase (study 101858), 3 groups, MenHibrix, ActiHIB and Menomune, were followed from Day 0 to either Month (M) 7 or 10, depending on vaccination. Then, in a Fourth-Dose Phase (study 102015), 3 groups (MenHibrix, ActiHIB/ActHIB and ActiHIB/MenHibrix) were followed from M10-13 to study end (M16-19). Treatment allocation: primary phase:
Pre-assignment details
MenHibrix Group was followed during the entire study period, from Day 0 to M16-19). ActiHIB Group was followed as ActiHIB Group up to M10-13, when it was split into the ActHIB/ActHIB and ActHIB/MenHibrix groups, these latter being followed from M10-13 to study end. Menomune Group was followed up to M7.
Participants by arm
| Arm | Count |
|---|---|
| MenHibrix Group Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.. | 287 |
| ActHIB Group During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively. | 319 |
| Menomune Group Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region. | 150 |
| Total | 756 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Fourth Dose Phase | Lost to Follow-up | 4 | 0 | 0 | 2 | 2 |
| Fourth Dose Phase | Migration from study area | 0 | 0 | 0 | 0 | 2 |
| Fourth Dose Phase | Other | 0 | 0 | 0 | 1 | 1 |
| Fourth Dose Phase | Protocol Violation | 0 | 0 | 0 | 1 | 0 |
| Fourth Dose Phase | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 |
| Primary Phase | Adverse Event | 2 | 1 | 0 | 0 | 0 |
| Primary Phase | Lost to Follow-up | 8 | 6 | 0 | 0 | 0 |
| Primary Phase | Migration from study area | 1 | 3 | 0 | 0 | 0 |
| Primary Phase | Other | 2 | 5 | 0 | 0 | 0 |
| Primary Phase | Withdrawal by Subject | 12 | 10 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | MenHibrix Group | ActHIB Group | Menomune Group | Total |
|---|---|---|---|---|
| Age, Continuous | 64.2 Days STANDARD_DEVIATION 8.05 | 64.0 Days STANDARD_DEVIATION 7.52 | 1554.1 Days STANDARD_DEVIATION 338.4 | 560.8 Days STANDARD_DEVIATION 118 |
| Sex: Female, Male Female | 141 Participants | 166 Participants | 70 Participants | 377 Participants |
| Sex: Female, Male Male | 146 Participants | 153 Participants | 80 Participants | 379 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 263 / 287 | 302 / 319 | 18 / 150 | 62 / 132 | 67 / 130 |
| serious Total, serious adverse events | 16 / 287 | 20 / 319 | 0 / 150 | 1 / 132 | 2 / 130 |
Outcome results
Primary
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: One month after the 3-dose primary vaccination course (at Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-PT (N=198;215) | 57.1 EL.U/mL |
| MenHibrix Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-FHA (N=200;213) | 208.9 EL.U/mL |
| MenHibrix Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-PRN (N=200;217) | 86.3 EL.U/mL |
| ActHIB Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-PRN (N=200;217) | 93.8 EL.U/mL |
| ActHIB Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-PT (N=198;215) | 66.4 EL.U/mL |
| ActHIB Group | Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations | Anti-FHA (N=200;213) | 252.2 EL.U/mL |
Primary
Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: One month after the 3-dose primary vaccination course (at Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Anti-14 (N=167;172) | 4.79 µg/mL |
| MenHibrix Group | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Anti-18C (N=172;169) | 2.5 µg/mL |
| MenHibrix Group | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Anti-9V (N=174;180) | 2.17 µg/mL |
| MenHibrix Group | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Anti-19F (N=167;169) | 1.62 µg/mL |
| MenHibrix Group | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Anti-6B (N=166;162) | 1.31 µg/mL |
| MenHibrix Group | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Anti-23F (N=174;177) | 2.25 µg/mL |
| MenHibrix Group | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Anti-4 (N=173;177) | 1.72 µg/mL |
| ActHIB Group | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Anti-23F (N=174;177) | 2.46 µg/mL |
| ActHIB Group | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Anti-4 (N=173;177) | 1.9 µg/mL |
| ActHIB Group | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Anti-6B (N=166;162) | 1.59 µg/mL |
| ActHIB Group | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Anti-9V (N=174;180) | 2.32 µg/mL |
| ActHIB Group | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Anti-14 (N=167;172) | 4.64 µg/mL |
| ActHIB Group | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Anti-18C (N=172;169) | 2.56 µg/mL |
| ActHIB Group | Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes | Anti-19F (N=167;169) | 1.74 µg/mL |
Primary
Number of Subjects Reporting Any Grade 3 Symptoms
Symptoms were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A Grade 3 symptom was defined as any symptom that prevented normal everyday activity. Any was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: During the 4-day follow-up period after each primary vaccine dose
Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Any Grade 3 Symptoms | 33 Participants |
| ActHIB Group | Number of Subjects Reporting Any Grade 3 Symptoms | 79 Participants |
Primary
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value
The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups .
Time frame: One month after the fourth dose (at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies 1 month (31 to 48 days) after the administration of the fourth dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value | 174 Participants |
| ActHIB Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value | 92 Participants |
Primary
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value.
The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: One month after the 3-dose primary vaccination course (at Month 5)
Population: The Primary According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures, with no elimination criteria) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value. | 186 Participants |
| ActHIB Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value. | 181 Participants |
Secondary
Anti-diphtheria and Anti-tetanus Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti-diphtheria and Anti-tetanus Antibody Concentrations | Anti-diphtheria [prior to vaccination] (N=118;140) | 0.173 IU/mL |
| MenHibrix Group | Anti-diphtheria and Anti-tetanus Antibody Concentrations | Anti-diphtheria [after vaccination] (N=201;220) | 2.060 IU/mL |
| MenHibrix Group | Anti-diphtheria and Anti-tetanus Antibody Concentrations | Anti-tetanus [prior to vaccination] (N=118;139) | 0.565 IU/mL |
| MenHibrix Group | Anti-diphtheria and Anti-tetanus Antibody Concentrations | Anti-tetanus [after vaccination] (N=199;216) | 3.618 IU/mL |
| ActHIB Group | Anti-diphtheria and Anti-tetanus Antibody Concentrations | Anti-tetanus [after vaccination] (N=199;216) | 1.986 IU/mL |
| ActHIB Group | Anti-diphtheria and Anti-tetanus Antibody Concentrations | Anti-diphtheria [prior to vaccination] (N=118;140) | 0.155 IU/mL |
| ActHIB Group | Anti-diphtheria and Anti-tetanus Antibody Concentrations | Anti-tetanus [prior to vaccination] (N=118;139) | 0.497 IU/mL |
| ActHIB Group | Anti-diphtheria and Anti-tetanus Antibody Concentrations | Anti-diphtheria [after vaccination] (N=201;220) | 2.277 IU/mL |
Secondary
Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations | [prior to vaccination] (N=91;108) | 13.5 mIU/mL |
| MenHibrix Group | Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations | [after vaccination] (N=171;169) | 1567.5 mIU/mL |
| ActHIB Group | Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations | [prior to vaccination] (N=91;108) | 11.3 mIU/mL |
| ActHIB Group | Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations | [after vaccination] (N=171;169) | 1555.1 mIU/mL |
Secondary
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Titers are presented as geometric mean titers (GMTs). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-polio 2 [after vaccination] (N=91;83) | 398.2 Titers |
| MenHibrix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-polio 3 [prior to vaccination] (N=61;64) | 4.7 Titers |
| MenHibrix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-polio 3 [after vaccination] (N=84;79) | 923.7 Titers |
| MenHibrix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-polio 1 [prior to vaccination] (N=61;60) | 12.3 Titers |
| MenHibrix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-polio 1 [after vaccination] (N=87;82) | 530.7 Titers |
| MenHibrix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-polio 2 [prior to vaccination] (N=60;63) | 9.4 Titers |
| ActHIB Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-polio 1 [after vaccination] (N=87;82) | 651.5 Titers |
| ActHIB Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-polio 2 [after vaccination] (N=91;83) | 330.4 Titers |
| ActHIB Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-polio 1 [prior to vaccination] (N=61;60) | 17.3 Titers |
| ActHIB Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-polio 3 [prior to vaccination] (N=61;64) | 6.2 Titers |
| ActHIB Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-polio 2 [prior to vaccination] (N=60;63) | 13.5 Titers |
| ActHIB Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-polio 3 [after vaccination] (N=84;79) | 1055.8 Titers |
Secondary
Anti-polysaccharide C (Anti-PSC) Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | [prior to vaccination] (N=161;185;138) | 0.19 µg/mL |
| MenHibrix Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | [1 month post-vaccination] (N=197;207;136) | 4.41 µg/mL |
| ActHIB Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | [prior to vaccination] (N=161;185;138) | 0.18 µg/mL |
| ActHIB Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | [1 month post-vaccination] (N=197;207;136) | 0.16 µg/mL |
| Menomune Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | [prior to vaccination] (N=161;185;138) | 0.17 µg/mL |
| Menomune Group | Anti-polysaccharide C (Anti-PSC) Antibody Concentrations | [1 month post-vaccination] (N=197;207;136) | 7.37 µg/mL |
Secondary
Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations | [prior to vaccination] (N=157;187;137) | 0.20 µg/mL |
| MenHibrix Group | Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations | [1 month post-vaccination] (N=189;181;129) | 19.82 µg/mL |
| ActHIB Group | Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations | [1 month post-vaccination] (N=189;181;129) | 0.15 µg/mL |
| ActHIB Group | Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations | [prior to vaccination] (N=157;187;137) | 0.20 µg/mL |
| Menomune Group | Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations | [1 month post-vaccination] (N=189;181;129) | 7.21 µg/mL |
| Menomune Group | Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations | [prior to vaccination] (N=157;187;137) | 0.17 µg/mL |
Secondary
Anti-PRP Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti-PRP Antibody Concentrations | [prior to vaccination] (N=112;132) | 0.155 µg/mL |
| MenHibrix Group | Anti-PRP Antibody Concentrations | [1 month post-vaccination] (N=199;211) | 7.992 µg/mL |
| ActHIB Group | Anti-PRP Antibody Concentrations | [prior to vaccination] (N=112;132) | 0.142 µg/mL |
| ActHIB Group | Anti-PRP Antibody Concentrations | [1 month post-vaccination] (N=199;211) | 4.392 µg/mL |
Secondary
Anti-PRP Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti-PRP Antibody Concentrations | [pre-fourth dose] (N=160;89;95) | 1.073 µg/mL |
| MenHibrix Group | Anti-PRP Antibody Concentrations | [post-fourth dose] (N=176;93;103) | 28.596 µg/mL |
| ActHIB Group | Anti-PRP Antibody Concentrations | [pre-fourth dose] (N=160;89;95) | 0.810 µg/mL |
| ActHIB Group | Anti-PRP Antibody Concentrations | [post-fourth dose] (N=176;93;103) | 19.029 µg/mL |
| Menomune Group | Anti-PRP Antibody Concentrations | [pre-fourth dose] (N=160;89;95) | 0.695 µg/mL |
| Menomune Group | Anti-PRP Antibody Concentrations | [post-fourth dose] (N=176;93;103) | 10.650 µg/mL |
Secondary
Anti-PSC Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti-PSC Antibody Concentrations | [pre-fourth dose] (N=159;89;89) | 0.88 µg/mL |
| MenHibrix Group | Anti-PSC Antibody Concentrations | [post-fourth dose] (N=174;89;104) | 4.32 µg/mL |
| ActHIB Group | Anti-PSC Antibody Concentrations | [pre-fourth dose] (N=159;89;89) | 0.16 µg/mL |
| ActHIB Group | Anti-PSC Antibody Concentrations | [post-fourth dose] (N=174;89;104) | 0.16 µg/mL |
| Menomune Group | Anti-PSC Antibody Concentrations | [pre-fourth dose] (N=159;89;89) | 0.16 µg/mL |
| Menomune Group | Anti-PSC Antibody Concentrations | [post-fourth dose] (N=174;89;104) | 6.81 µg/mL |
Secondary
Anti-PSY Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti-PSY Antibody Concentrations | [post-fourth dose] (N=173;87;101) | 22.27 µg/mL |
| MenHibrix Group | Anti-PSY Antibody Concentrations | [pre-fourth dose] (N=157;82;85) | 3.83 µg/mL |
| ActHIB Group | Anti-PSY Antibody Concentrations | [post-fourth dose] (N=173;87;101) | 0.16 µg/mL |
| ActHIB Group | Anti-PSY Antibody Concentrations | [pre-fourth dose] (N=157;82;85) | 0.15 µg/mL |
| Menomune Group | Anti-PSY Antibody Concentrations | [pre-fourth dose] (N=157;82;85) | NA µg/mL |
| Menomune Group | Anti-PSY Antibody Concentrations | [post-fourth dose] (N=173;87;101) | 5.57 µg/mL |
Secondary
Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations
Concentrations of antibodies are presented as GMCs expressed as EL.U/mL. Results for one month after the 3-dose primary vaccination course (at Month 5) are presented under the Primary Outcome Measures section. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: Prior to the primary vaccination course (at Day 0)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT [prior to vaccination] (N=116;140) | 3.4 EL.U/mL |
| MenHibrix Group | Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA [prior to vaccination] (N=118;140) | 10.0 EL.U/mL |
| MenHibrix Group | Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN [prior to vaccination] (N=117;139) | 4.8 EL.U/mL |
| ActHIB Group | Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT [prior to vaccination] (N=116;140) | 3.9 EL.U/mL |
| ActHIB Group | Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA [prior to vaccination] (N=118;140) | 10.5 EL.U/mL |
| ActHIB Group | Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN [prior to vaccination] (N=117;139) | 5.1 EL.U/mL |
Secondary
Anti-tetanus Antibody Concentrations
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL).
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Anti-tetanus Antibody Concentrations | [pre-fourth dose] (N=164;92;95) | 0.782 IU/mL |
| MenHibrix Group | Anti-tetanus Antibody Concentrations | [post-fourth dose] (N=178;95;104) | 2.559 IU/mL |
| ActHIB Group | Anti-tetanus Antibody Concentrations | [pre-fourth dose] (N=164;92;95) | 0.461 IU/mL |
| ActHIB Group | Anti-tetanus Antibody Concentrations | [post-fourth dose] (N=178;95;104) | 1.785 IU/mL |
| Menomune Group | Anti-tetanus Antibody Concentrations | [post-fourth dose] (N=178;95;104) | 1.794 IU/mL |
| Menomune Group | Anti-tetanus Antibody Concentrations | [pre-fourth dose] (N=164;92;95) | 0.488 IU/mL |
Secondary
Concentration of Antibodies Against Streptococcus Pneumonia Serotypes
Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.
Time frame: One month post fourth dose vaccination (at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-23F (N=176;90;102) | 7.23 µg/mL |
| MenHibrix Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-18C (N=175;88;102) | 4.57 µg/mL |
| MenHibrix Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-14 (N=174;87;100) | 6.12 µg/mL |
| MenHibrix Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-19F (N=173;89;96) | 1.81 µg/mL |
| MenHibrix Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-4 (N=174;89;102) | 2.38 µg/mL |
| MenHibrix Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-6B (N=174;89;101) | 3.91 µg/mL |
| MenHibrix Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-9V (N=175;90;102) | 3.84 µg/mL |
| ActHIB Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-4 (N=174;89;102) | 2.69 µg/mL |
| ActHIB Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-6B (N=174;89;101) | 4.07 µg/mL |
| ActHIB Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-9V (N=175;90;102) | 3.85 µg/mL |
| ActHIB Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-14 (N=174;87;100) | 7.00 µg/mL |
| ActHIB Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-18C (N=175;88;102) | 5.23 µg/mL |
| ActHIB Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-19F (N=173;89;96) | 1.93 µg/mL |
| ActHIB Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-23F (N=176;90;102) | 8.02 µg/mL |
| Menomune Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-18C (N=175;88;102) | 5.45 µg/mL |
| Menomune Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-6B (N=174;89;101) | 5.04 µg/mL |
| Menomune Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-23F (N=176;90;102) | 9.08 µg/mL |
| Menomune Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-19F (N=173;89;96) | 2.04 µg/mL |
| Menomune Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-14 (N=174;87;100) | 7.87 µg/mL |
| Menomune Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-9V (N=175;90;102) | 4.60 µg/mL |
| Menomune Group | Concentration of Antibodies Against Streptococcus Pneumonia Serotypes | Anti-4 (N=174;89;102) | 2.92 µg/mL |
Secondary
hSBA-MenC Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | hSBA-MenC Antibody Titers | [post-fourth dose] (N=65;37;35) | 657.1 Titers |
| MenHibrix Group | hSBA-MenC Antibody Titers | [pre-fourth dose] (N=59;38;35) | 68.1 Titers |
| ActHIB Group | hSBA-MenC Antibody Titers | [post-fourth dose] (N=65;37;35) | 2.1 Titers |
| ActHIB Group | hSBA-MenC Antibody Titers | [pre-fourth dose] (N=59;38;35) | NA Titers |
| Menomune Group | hSBA-MenC Antibody Titers | [pre-fourth dose] (N=59;38;35) | 2.0 Titers |
| Menomune Group | hSBA-MenC Antibody Titers | [post-fourth dose] (N=65;37;35) | 72.5 Titers |
Secondary
hSBA-MenY Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | hSBA-MenY Antibody Titers | [pre-fourth dose] (N=62;38;35) | 11.3 Titers |
| MenHibrix Group | hSBA-MenY Antibody Titers | [post-fourth dose] (N=65;37;35) | 246.6 Titers |
| ActHIB Group | hSBA-MenY Antibody Titers | [pre-fourth dose] (N=62;38;35) | NA Titers |
| ActHIB Group | hSBA-MenY Antibody Titers | [post-fourth dose] (N=65;37;35) | 2.2 Titers |
| Menomune Group | hSBA-MenY Antibody Titers | [pre-fourth dose] (N=62;38;35) | NA Titers |
| Menomune Group | hSBA-MenY Antibody Titers | [post-fourth dose] (N=65;37;35) | 11.1 Titers |
Secondary
Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers | [1 month post-vaccination] (N=177;194;136) | 1096.5 Titers |
| MenHibrix Group | Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers | [Prior to vaccination] (N=153;183;133) | 4.8 Titers |
| ActHIB Group | Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers | [1 month post-vaccination] (N=177;194;136) | 4.4 Titers |
| ActHIB Group | Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers | [Prior to vaccination] (N=153;183;133) | 5.1 Titers |
| Menomune Group | Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers | [Prior to vaccination] (N=153;183;133) | 9 Titers |
| Menomune Group | Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers | [1 month post-vaccination] (N=177;194;136) | 284.2 Titers |
Secondary
Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers | [prior to vaccination] (N=156;186;140) | 6.1 Titers |
| MenHibrix Group | Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers | [1 month post-vaccination] (N=174;186;139) | 495.3 Titers |
| ActHIB Group | Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers | [prior to vaccination] (N=156;186;140) | 5.7 Titers |
| ActHIB Group | Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers | [1 month post-vaccination] (N=174;186;139) | 6.8 Titers |
| Menomune Group | Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers | [prior to vaccination] (N=156;186;140) | 54.9 Titers |
| Menomune Group | Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers | [1 month post-vaccination] (N=174;186;139) | 685.1 Titers |
Secondary
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Any = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. Grade 2 for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; Grade 3 for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); Grade 2 or 3 fever = rectal temperature higher than (\>) 39°C; Grade 3 fever = rectal temperature \> 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups
Time frame: Within 8 days (Day 0-7) after the 3-dose primary vaccination
Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 irritability | 25 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 drowsiness | 85 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 drowsiness | 10 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever ≥38.0°C | 115 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever >39.0°C | 19 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever >40.0°C | 0 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any irritability | 222 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 irritability | 127 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any loss of appetite | 127 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 loss of appetite | 35 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite | 4 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any drowsiness | 187 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any loss of appetite | 164 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any drowsiness | 227 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any irritability | 272 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 drowsiness | 116 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite | 5 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 drowsiness | 21 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 irritability | 168 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever ≥38.0°C | 158 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 irritability | 51 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever >39.0°C | 19 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 loss of appetite | 56 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever >40.0°C | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. Any= any report of the specified symptom irrespective of intensity and relationship to vaccination. Grade 2 for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; Grade 3 for Drowsiness, Irritability/Fussiness = prevented normal activity; Grade 3 Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); Grade 2 or 3 for fever = T \>39.0°C; Grade 3 for fever = T \>40.0°C
Time frame: Within 8 days (Day 0-7) after fourth dose vaccination
Population: The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 irritability | 51 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any drowsiness | 79 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 irritability | 13 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any loss of appetite | 56 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 loss of appetite | 13 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 drowsiness | 3 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever > 40.0°C | 3 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever ≥ 38.0°C | 54 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite | 2 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever > 39.0°C | 9 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any irritability | 125 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 drowsiness | 27 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 drowsiness | 1 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 irritability | 27 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever > 39.0°C | 2 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever > 40.0°C | 0 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 irritability | 1 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any drowsiness | 48 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever ≥ 38.0°C | 24 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any loss of appetite | 35 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 drowsiness | 8 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite | 0 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 loss of appetite | 1 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any irritability | 67 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 loss of appetite | 4 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 drowsiness | 8 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever > 39.0°C | 9 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite | 0 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 drowsiness | 1 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever ≥ 38.0°C | 19 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever > 40.0°C | 2 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any irritability | 62 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 irritability | 28 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 irritability | 4 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any loss of appetite | 33 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any drowsiness | 43 Participants |
Secondary
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. Any= any report of the specified symptom irrespective of intensity and relationship to vaccination. Grade 2 for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; Grade 3 for Drowsiness, Irritability/Fussiness = prevented normal activity; Grade 3 Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); Grade 2 or 3 for fever = T \>39.0°C; Grade 3 for fever = T \>40.0°C
Time frame: Within 4 days (Day 0-3) after fourth dose vaccination
Population: The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 drowsiness | 2 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any loss of appetite | 46 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any irratibility | 114 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 drowsiness | 21 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 irritability | 10 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 irritability | 42 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any drowsinnes | 72 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite | 1 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever > 39.0°C | 4 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever ≥ 38.0°C | 40 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 loss of appetite | 10 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever > 40.0°C | 1 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 irritability | 25 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any drowsinnes | 48 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 drowsiness | 1 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever ≥ 38.0°C | 19 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever > 39.0°C | 1 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever > 40.0°C | 0 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any irratibility | 65 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 irritability | 0 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any loss of appetite | 34 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 loss of appetite | 1 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite | 0 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 drowsiness | 7 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any drowsinnes | 41 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any loss of appetite | 30 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever > 39.0°C | 5 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 drowsiness | 1 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 loss of appetite | 4 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever ≥ 38.0°C | 14 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 drowsiness | 7 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 irritability | 23 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any irratibility | 58 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite | 0 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 irritability | 4 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever > 40.0°C | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms
Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Any = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. Grade 2 for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; Grade 3 for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); Grade 2 or 3 fever = rectal temperature higher than (\>) 39°C; Grade 3 fever = rectal temperature \> 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: Within 4 days (Day 0-3) after the 3-dose primary vaccination
Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite | 3 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 drowsiness | 84 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 drowsiness | 9 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever ≥38.0°C | 110 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever >39.0°C | 14 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever >40.0°C | 0 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any irritability | 217 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 irritability | 125 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 irritability | 22 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any loss of appetite | 123 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 loss of appetite | 32 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any drowsiness | 185 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 loss of appetite | 51 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any drowsiness | 224 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any irritability | 268 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 drowsiness | 112 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Any loss of appetite | 159 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 drowsiness | 20 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 2 or 3 irritability | 161 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever ≥38.0°C | 150 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 loss of appetite | 4 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever >39.0°C | 13 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Grade 3 irritability | 48 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms | Fever >40.0°C | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
Solicited local symptoms were pain, redness and swelling at injection site. Any = any report of the specified symptom irrespective of intensity grade; Grade 2 pain = cried/protested on touch; Grade 3 pain = cried when limb was moved/spontaneously painful; Grade 2 or 3 redness/swelling = redness/swelling larger than (\>) 10 millimeters (mm); Grade 3 redness/swelling = redness/swelling \> 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: Within 4 days (Day 0-3) after the 3-dose primary vaccination
Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 2 or 3 pain | 62 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >30 mm | 1 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any redness | 112 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any swelling | 90 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 3 pain | 13 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling >10 mm | 27 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >10 mm | 22 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling >30 mm | 1 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any pain | 129 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling >30 mm | 11 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any pain | 171 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 2 or 3 pain | 90 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 3 pain | 31 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any redness | 148 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >10 mm | 31 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >30 mm | 11 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any swelling | 110 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling >10 mm | 27 Participants |
Secondary
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. Any= any report of the specified symptom irrespective of intensity grade; Grade 2 pain = cried/protested on touch; Grade 3 pain = cried when limb was moved/spontaneously painful; Grade 2 or 3 redness/swelling = redness/swelling \>10 millimeters (mm); Grade 3 redness/swelling = redness/swelling \>30 mm; Grade 2 limb circumference (LC) = LC \>20 mm; Grade 3 LC = LC \>40 mm
Time frame: Within 4 days (Day 0-3) after fourth dose vaccination
Population: The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling >30 mm | 3 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Limb circumference >20 mm | 2 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any pain | 79 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 3 pain | 3 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >30 mm | 4 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling >10 mm | 9 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Limb circumference >40 mm | 0 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 2 or 3 pain | 26 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any redness | 81 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >10 mm | 12 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any swelling | 49 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any limb circumference | 59 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling >10 mm | 1 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any limb circumference | 44 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any redness | 40 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >10 mm | 10 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Limb circumference >20 mm | 5 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling >30 mm | 0 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Limb circumference >40 mm | 0 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 3 pain | 2 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any pain | 42 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any swelling | 19 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 2 or 3 pain | 15 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >30 mm | 3 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 2 or 3 pain | 12 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 3 pain | 3 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >30 mm | 3 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any swelling | 20 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any redness | 38 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling >10 mm | 6 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling >30 mm | 0 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Limb circumference >40 mm | 0 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any limb circumference | 36 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Limb circumference >20 mm | 5 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any pain | 48 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >10 mm | 10 Participants |
Secondary
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. Any= any report of the specified symptom irrespective of intensity grade; Grade 2 pain = cried/protested on touch; Grade 3 pain = cried when limb was moved/spontaneously painful; Grade 2 or 3 redness/swelling = redness/swelling \>10 millimeters (mm); Grade 3 redness/swelling = redness/swelling \>30 mm; Grade 2 limb circumference (LC) = LC \>20 mm; Grade 3 LC = LC \>40 mm
Time frame: Within 8 days (Day 0-7) after fourth dose vaccination
Population: The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >30 mm | 4 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling > 30 mm | 3 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any pain | 79 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any limb circumference | 61 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Limb circumference >20 mm | 2 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling > 10 mm | 9 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any swelling | 49 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 3 pain | 3 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any redness | 81 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 2 or 3 pain | 26 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >10 mm | 12 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Limb circumference >40 mm | 0 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any limb circumference | 46 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Limb circumference >20 mm | 5 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Limb circumference >40 mm | 0 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >10 mm | 10 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >30 mm | 3 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any pain | 42 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 2 or 3 pain | 15 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 3 pain | 2 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any redness | 40 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any swelling | 19 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling > 10 mm | 1 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling > 30 mm | 0 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling > 30 mm | 0 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling > 10 mm | 6 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >10 mm | 11 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any pain | 48 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any limb circumference | 36 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Limb circumference >20 mm | 5 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >30 mm | 4 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any swelling | 20 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any redness | 39 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Limb circumference >40 mm | 0 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 2 or 3 pain | 12 Participants |
| Menomune Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 3 pain | 3 Participants |
Secondary
Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms
Solicited local symptoms were pain, redness and swelling at injection site. Any = any report of the specified symptom irrespective of intensity grade; Grade 2 pain = cried/protested on touch; Grade 3 pain = cried when limb was moved/spontaneously painful; Grade 2 or 3 redness/swelling = redness/swelling larger than (\>) 10 millimeters (mm); Grade 3 redness/swelling = redness/swelling \> 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: Within 8 days (Day 0-7) after the 3-dose primary vaccination
Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 2 or 3 pain | 63 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >30 mm | 1 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any redness | 113 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any swelling | 90 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 3 pain | 13 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling >10 mm | 27 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >10 mm | 22 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling >30 mm | 1 Participants |
| MenHibrix Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any pain | 129 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling >30 mm | 11 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any pain | 171 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 2 or 3 pain | 90 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Grade 3 pain | 31 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any redness | 148 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >10 mm | 31 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Redness >30 mm | 11 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Any swelling | 111 Participants |
| ActHIB Group | Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms | Swelling >10 mm | 27 Participants |
Secondary
Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses
Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.
Time frame: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up
Population: The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses | Physician's office visit | 75 Participants |
| MenHibrix Group | Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses | ER visit | 6 Participants |
| MenHibrix Group | Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses | Physician's o. visit not related to common illness | 13 Participants |
| ActHIB Group | Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses | Physician's office visit | 31 Participants |
| ActHIB Group | Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses | ER visit | 1 Participants |
| ActHIB Group | Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses | Physician's o. visit not related to common illness | 8 Participants |
| Menomune Group | Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses | ER visit | 7 Participants |
| Menomune Group | Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses | Physician's o. visit not related to common illness | 13 Participants |
| Menomune Group | Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses | Physician's office visit | 43 Participants |
Secondary
Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses
Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.
Time frame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.
Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses | Emergency room visit | 25 Participants |
| MenHibrix Group | Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses | Physician's office visit | 181 Participants |
| MenHibrix Group | Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses | Physician's o. v. not related to common illnesses | 51 Participants |
| ActHIB Group | Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses | Emergency room visit | 31 Participants |
| ActHIB Group | Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses | Physician's office visit | 190 Participants |
| ActHIB Group | Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses | Physician's o. v. not related to common illnesses | 46 Participants |
Secondary
Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s)
Large injection site reactions were defined as either swelling with a diameter of \> 30 mm or a \> 30 mm increase in the circumference of the mid-thigh when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interfered with or prevented everyday activities (for example, active playing, eating, sleeping).
Time frame: Within 4 days (Day 0-3) and within 8 days (Day 0-7) following the fourth dose
Population: The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s) | [within Day 0-3 following the fourth dose] | 3 Participants |
| MenHibrix Group | Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s) | [within Day 0-7 following the fourth dose] | 3 Participants |
| ActHIB Group | Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s) | [within Day 0-3 following the fourth dose] | 0 Participants |
| ActHIB Group | Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s) | [within Day 0-7 following the fourth dose] | 0 Participants |
| Menomune Group | Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s) | [within Day 0-3 following the fourth dose] | 0 Participants |
| Menomune Group | Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s) | [within Day 0-7 following the fourth dose] | 0 Participants |
Secondary
Number of Subjects Reporting Medically Attended Visits
A medically attended visit was defined as an hospitalization, an emergency room visit or a visit to or from medical personnel. This Outcome Measure only concerns subjects in the Menomune Group.
Time frame: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0
Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Medically Attended Visits | Emergency room visit | 1 Participants |
| MenHibrix Group | Number of Subjects Reporting Medically Attended Visits | Physician's office visit | 18 Participants |
Secondary
Number of Subjects Reporting New Onset of Chronic Illness(es)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up
Population: The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Reporting New Onset of Chronic Illness(es) | 2 Participants |
| ActHIB Group | Number of Subjects Reporting New Onset of Chronic Illness(es) | 1 Participants |
| Menomune Group | Number of Subjects Reporting New Onset of Chronic Illness(es) | 0 Participants |
Secondary
Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine
Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs) | 2 Participants |
| ActHIB Group | Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs) | 5 Participants |
Secondary
Number of Subjects Reporting Rash
An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.
Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Rash | 50 Participants |
| ActHIB Group | Number of Subjects Reporting Rash | 55 Participants |
Secondary
Number of Subjects Reporting Rash
An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae.
Time frame: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up
Population: The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Rash | 10 Participants |
| ActHIB Group | Number of Subjects Reporting Rash | 10 Participants |
| Menomune Group | Number of Subjects Reporting Rash | 10 Participants |
Secondary
Number of Subjects Reporting Rash
An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns subjects in the Menomune Group.
Time frame: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0
Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Rash | 1 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. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.
Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 16 Participants |
| ActHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 20 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: During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).
Population: The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 6 Participants |
| ActHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 2 Participants |
| Menomune Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 3 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: During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).
Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 16 Participants |
| ActHIB Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 20 Participants |
| Menomune Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 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 subject . This Outcome Measure only concerns subjects in the Menomune Group.
Time frame: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0
Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 31-day follow-up period following the fourth dose
Population: The Fourth Dose Total Vaccinated cohort included all vaccinated subjects during the fourth dose phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 102 Participants |
| ActHIB Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 39 Participants |
| Menomune Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 58 Participants |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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: From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group).
Population: The Primary Total Vaccinated cohort included all vaccinated subjects with at least one vaccine administration documented during the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 213 Participants |
| ActHIB Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 230 Participants |
| Menomune Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 37 Participants |
Secondary
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL)
The anti-diphtheria and anti-tetanus antibody cut-off value for this outcome was ≥ 0.1 IU/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups.
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) | Anti-diphtheria [prior to vaccination] (N=118;140) | 81 Participants |
| MenHibrix Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) | Anti-diphtheria [after vaccination] (N=201;220) | 201 Participants |
| MenHibrix Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) | Anti-tetanus [prior to vaccination] (N=118;139) | 109 Participants |
| MenHibrix Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) | Anti-tetanus [after vaccination] (N=199;216) | 198 Participants |
| ActHIB Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) | Anti-tetanus [after vaccination] (N=199;216) | 216 Participants |
| ActHIB Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) | Anti-diphtheria [prior to vaccination] (N=118;140) | 89 Participants |
| ActHIB Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) | Anti-tetanus [prior to vaccination] (N=118;139) | 130 Participants |
| ActHIB Group | Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL) | Anti-diphtheria [after vaccination] (N=201;220) | 219 Participants |
Secondary
Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL)
This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL) | [prior to vaccination] (N=91;108) | 28 Participants |
| MenHibrix Group | Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL) | [after vaccination] (N=171;169) | 167 Participants |
| ActHIB Group | Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL) | [prior to vaccination] (N=91;108) | 27 Participants |
| ActHIB Group | Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL) | [after vaccination] (N=171;169) | 166 Participants |
Secondary
Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8
This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 | Anti-polio 1 [prior to vaccination] (N=61;60) | 34 Participants |
| MenHibrix Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 | Anti-polio 1 [after vaccination] (N=87;82) | 86 Participants |
| MenHibrix Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 | Anti-polio 2 [prior to vaccination] (N=60;63) | 31 Participants |
| MenHibrix Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 | Anti-polio 2 [after vaccination] (N=91;83) | 91 Participants |
| MenHibrix Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 | Anti-polio 3 [prior to vaccination] (N=61;64) | 7 Participants |
| MenHibrix Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 | Anti-polio 3 [after vaccination] (N=84;79) | 84 Participants |
| ActHIB Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 | Anti-polio 3 [prior to vaccination] (N=61;64) | 13 Participants |
| ActHIB Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 | Anti-polio 1 [prior to vaccination] (N=61;60) | 41 Participants |
| ActHIB Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 | Anti-polio 2 [after vaccination] (N=91;83) | 82 Participants |
| ActHIB Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 | Anti-polio 1 [after vaccination] (N=87;82) | 82 Participants |
| ActHIB Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 | Anti-polio 3 [after vaccination] (N=84;79) | 79 Participants |
| ActHIB Group | Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8 | Anti-polio 2 [prior to vaccination] (N=60;63) | 39 Participants |
Secondary
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PRP antibody cut-off values assessed were ≥0.15 µg/mL and ≥1.0 µg/mL.
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values | ≥1.0 µg/mL [pre-4th dose] (N=160;89;95) | 90 Participants |
| MenHibrix Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.15 µg/mL [post-4th dose] (N=176;93;103) | 176 Participants |
| MenHibrix Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.15 µg/mL [pre-4th dose] (N=160;89;95) | 152 Participants |
| MenHibrix Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values | ≥1.0 µg/mL [post-4th dose] (N=176;93;103) | 174 Participants |
| ActHIB Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.15 µg/mL [post-4th dose] (N=176;93;103) | 93 Participants |
| ActHIB Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.15 µg/mL [pre-4th dose] (N=160;89;95) | 78 Participants |
| ActHIB Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values | ≥1.0 µg/mL [post-4th dose] (N=176;93;103) | 92 Participants |
| ActHIB Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values | ≥1.0 µg/mL [pre-4th dose] (N=160;89;95) | 41 Participants |
| Menomune Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.15 µg/mL [pre-4th dose] (N=160;89;95) | 85 Participants |
| Menomune Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values | ≥1.0 µg/mL [post-4th dose] (N=176;93;103) | 101 Participants |
| Menomune Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values | ≥1.0 µg/mL [pre-4th dose] (N=160;89;95) | 40 Participants |
| Menomune Group | Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.15 µg/mL [post-4th dose] (N=176;93;103) | 103 Participants |
Secondary
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values
Anti-PSC antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values | ≥0.3 µg/mL [prior to vaccination] (N=161;185;138) | 24 Participants |
| MenHibrix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values | ≥0.3 µg/mL [after vaccination] (N=197;207;136) | 196 Participants |
| MenHibrix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values | ≥2.0 µg/mL [prior to vaccination] (N=161;185;138) | 1 Participants |
| MenHibrix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values | ≥2.0 µg/mL [after vaccination] (N=197;207;136) | 172 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values | ≥2.0 µg/mL [after vaccination] (N=197;207;136) | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values | ≥0.3 µg/mL [prior to vaccination] (N=161;185;138) | 16 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values | ≥2.0 µg/mL [prior to vaccination] (N=161;185;138) | 6 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values | ≥0.3 µg/mL [after vaccination] (N=197;207;136) | 8 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values | ≥2.0 µg/mL [after vaccination] (N=197;207;136) | 122 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values | ≥0.3 µg/mL [after vaccination] (N=197;207;136) | 134 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values | ≥2.0 µg/mL [prior to vaccination] (N=161;185;138) | 3 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values | ≥0.3 µg/mL [prior to vaccination] (N=161;185;138) | 10 Participants |
Secondary
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PSC antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.3 µg/mL [pre-fourth dose] (N=159;89;89) | 150 Participants |
| MenHibrix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.3 µg/mL [post-fourth dose] (N=174;89;104) | 173 Participants |
| MenHibrix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values | ≥2.0 µg/mL [pre-fourth dose] (N=159;89;89) | 20 Participants |
| MenHibrix Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values | ≥2.0 µg/mL [post-fourth dose] (N=174;89;104) | 142 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values | ≥2.0 µg/mL [post-fourth dose] (N=174;89;104) | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.3 µg/mL [pre-fourth dose] (N=159;89;89) | 3 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values | ≥2.0 µg/mL [pre-fourth dose] (N=159;89;89) | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.3 µg/mL [post-fourth dose] (N=174;89;104) | 3 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values | ≥2.0 µg/mL [post-fourth dose] (N=174;89;104) | 98 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.3 µg/mL [post-fourth dose] (N=174;89;104) | 104 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values | ≥2.0 µg/mL [pre-fourth dose] (N=159;89;89) | 1 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.3 µg/mL [pre-fourth dose] (N=159;89;89) | 5 Participants |
Secondary
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values
Anti-PSY antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values | ≥2.0 µg/mL [after vaccination] (N=189;181;129) | 186 Participants |
| MenHibrix Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values | ≥0.3 µg/mL [after vaccination] (N=189;181;129) | 188 Participants |
| MenHibrix Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values | ≥0.3 µg/mL [prior to vaccination] (N=157;187;137) | 23 Participants |
| MenHibrix Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values | ≥2.0 µg/mL [prior to vaccination] (N=157;187;137) | 5 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values | ≥2.0 µg/mL [after vaccination] (N=189;181;129) | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values | ≥2.0 µg/mL [prior to vaccination] (N=157;187;137) | 6 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values | ≥0.3 µg/mL [prior to vaccination] (N=157;187;137) | 28 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values | ≥0.3 µg/mL [after vaccination] (N=189;181;129) | 5 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values | ≥0.3 µg/mL [prior to vaccination] (N=157;187;137) | 6 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values | ≥0.3 µg/mL [after vaccination] (N=189;181;129) | 125 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values | ≥2.0 µg/mL [prior to vaccination] (N=157;187;137) | 2 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values | ≥2.0 µg/mL [after vaccination] (N=189;181;129) | 108 Participants |
Secondary
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values
Anti-PSY antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.3 µg/mL [pre-fourth dose] (N=157;82;85) | 155 Participants |
| MenHibrix Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.3 µg/mL [post-fourth dose] (N=173;87;101) | 172 Participants |
| MenHibrix Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values | ≥2.0 µg/mL [pre-fourth dose] (N=157;82;85) | 116 Participants |
| MenHibrix Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values | ≥2.0 µg/mL [post-fourth dose] (N=173;87;101) | 168 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values | ≥2.0 µg/mL [post-fourth dose] (N=173;87;101) | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.3 µg/mL [pre-fourth dose] (N=157;82;85) | 1 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values | ≥2.0 µg/mL [pre-fourth dose] (N=157;82;85) | 0 Participants |
| ActHIB Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.3 µg/mL [post-fourth dose] (N=173;87;101) | 3 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values | ≥2.0 µg/mL [post-fourth dose] (N=173;87;101) | 87 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.3 µg/mL [post-fourth dose] (N=173;87;101) | 101 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values | ≥2.0 µg/mL [pre-fourth dose] (N=157;82;85) | 0 Participants |
| Menomune Group | Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values | ≥0.3 µg/mL [pre-fourth dose] (N=157;82;85) | 0 Participants |
Secondary
Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values
Anti-PRP antibody cut-off values for this outcome were 0.15 µg/mL and 1.0 µg/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values | ≥0.15 µg/mL [prior to vaccination] (N=112;132) | 43 Participants |
| MenHibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values | ≥1.0 µg/mL [after vaccination] (N=199;211) | 186 Participants |
| MenHibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values | ≥0.15 µg/mL [after vaccination] (N=199;211) | 196 Participants |
| MenHibrix Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values | ≥1.0 µg/mL [prior to vaccination] (N=112;132) | 9 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values | ≥1.0 µg/mL [prior to vaccination] (N=112;132) | 10 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values | ≥0.15 µg/mL [after vaccination] (N=199;211) | 202 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values | ≥1.0 µg/mL [after vaccination] (N=199;211) | 181 Participants |
| ActHIB Group | Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values | ≥0.15 µg/mL [prior to vaccination] (N=112;132) | 42 Participants |
Secondary
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL
This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL | Anti-FHA [after vaccination] (N=200;213) | 200 Participants |
| MenHibrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL | Anti-PRN [after vaccination] (N=200;217) | 199 Participants |
| MenHibrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL | Anti-FHA [prior to vaccination] (N=118;140) | 91 Participants |
| MenHibrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL | Anti-PT [prior to vaccination] (N=116;140) | 21 Participants |
| MenHibrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL | Anti-PRN [prior to vaccination] (N=117;139) | 40 Participants |
| MenHibrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL | Anti-PT [after vaccination] (N=198;215) | 196 Participants |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL | Anti-PRN [prior to vaccination] (N=117;139) | 56 Participants |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL | Anti-FHA [prior to vaccination] (N=118;140) | 103 Participants |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL | Anti-FHA [after vaccination] (N=200;213) | 213 Participants |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL | Anti-PT [after vaccination] (N=198;215) | 214 Participants |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL | Anti-PRN [after vaccination] (N=200;217) | 215 Participants |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL | Anti-PT [prior to vaccination] (N=116;140) | 37 Participants |
Secondary
Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL)
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | [post-fourth dose] (N=178;95;104) | 178 Participants |
| MenHibrix Group | Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | [pre-fourth dose] (N=164;92;95) | 164 Participants |
| ActHIB Group | Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | [post-fourth dose] (N=178;95;104) | 95 Participants |
| ActHIB Group | Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | [pre-fourth dose] (N=164;92;95) | 89 Participants |
| Menomune Group | Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | [pre-fourth dose] (N=164;92;95) | 93 Participants |
| Menomune Group | Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL) | [post-fourth dose] (N=178;95;104) | 104 Participants |
Secondary
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)
Fourth dose responses to hSBA-MenC and hSBA-MenY were defined as follows (Definition 1): * Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: \< 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after the fourth dose (post-fourth dose antibody titer ≥1:16), * Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after the fourth dose.
Time frame: One month post fourth dose vaccination (at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | hSBA-MenC (N=58;36;33) | 44 Participants |
| MenHibrix Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | hSBA-MenY (N=61;36;33) | 52 Participants |
| ActHIB Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | hSBA-MenC (N=58;36;33) | 0 Participants |
| ActHIB Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | hSBA-MenY (N=61;36;33) | 1 Participants |
| Menomune Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | hSBA-MenC (N=58;36;33) | 29 Participants |
| Menomune Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | hSBA-MenY (N=61;36;33) | 15 Participants |
Secondary
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)
Fourth dose responses to hSBA-MenC and hSBA-MenY were also assessed using a second definition (Definition 2): * Post-fourth dose hSBA antibody titers ≥1:16 in subjects seronegative at the pre-fourth dose time point (hSBA antibody titers \< 1:8), * At least (i.e., greater than or equal to) a 4-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:4 but \< 1: 8, * At least (i.e., greater than or equal to) a 2-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8.
Time frame: One month post fourth dose vaccination (at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | hSBA-MenC (N=58;36;33) | 52 Participants |
| MenHibrix Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | hSBA-MenY (N=61;36;33) | 56 Participants |
| ActHIB Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | hSBA-MenC (N=58;36;33) | 0 Participants |
| ActHIB Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | hSBA-MenY (N=61;36;33) | 1 Participants |
| Menomune Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | hSBA-MenC (N=58;36;33) | 29 Participants |
| Menomune Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y) | hSBA-MenY (N=61;36;33) | 15 Participants |
Secondary
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)
Fourth dose responses to rSBA-MenC and rSBA-MenY were defined as follows (Definition 1): * Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: \< 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after fourth dose (post-fourth dose antibody titer ≥1:32), * Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after fourth dose.
Time frame: One month post fourth dose vaccination (at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | rSBA-MenC (N=149;72;77) | 131 Participants |
| MenHibrix Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | rSBA-MenY (N=147;67;79) | 119 Participants |
| ActHIB Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | rSBA-MenC (N=149;72;77) | 2 Participants |
| ActHIB Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | rSBA-MenY (N=147;67;79) | 10 Participants |
| Menomune Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | rSBA-MenC (N=149;72;77) | 71 Participants |
| Menomune Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | rSBA-MenY (N=147;67;79) | 76 Participants |
Secondary
Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)
Fourth dose responses to rSBA-MenC and rSBA-MenY were also assessed using a second definition (Definition 2): * Post-fourth dose rSBA antibody titers ≥1:32 in subjects seronegative at the pre-fourth dose time point (rSBA antibody titers \< 1:8), * At least (i.e., greater than or equal to) a 4-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8 but \< 1:128, * At least (i.e., greater than or equal to) a 2-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:128.
Time frame: One month post fourth dose vaccination (at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | rSBA-MenC (N=149;72;77) | 140 Participants |
| MenHibrix Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | rSBA-MenY (N=147;67;79) | 134 Participants |
| ActHIB Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | rSBA-MenC (N=149;72;77) | 2 Participants |
| ActHIB Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | rSBA-MenY (N=147;67;79) | 11 Participants |
| Menomune Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | rSBA-MenC (N=149;72;77) | 71 Participants |
| Menomune Group | Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y) | rSBA-MenY (N=147;67;79) | 78 Participants |
Secondary
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4
A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (\<) 1:128.
Time frame: One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4 | 2 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4 | 1 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4 | 3 Participants |
Secondary
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values
hSBA-MenC antibody cut-off values assessed were ≥1:4 and ≥1:8.
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [pre-fourth dose] (N=59;38;35) | 54 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:4 [pre-fourth dose] (N=59;38;35) | 54 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:4 [post-fourth dose] (N=65;37;35) | 63 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [post-fourth dose] (N=65;37;35) | 63 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:4 [pre-fourth dose] (N=59;38;35) | 0 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [post-fourth dose] (N=65;37;35) | 0 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:4 [post-fourth dose] (N=65;37;35) | 1 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [pre-fourth dose] (N=59;38;35) | 0 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:4 [post-fourth dose] (N=65;37;35) | 33 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:4 [pre-fourth dose] (N=59;38;35) | 1 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [pre-fourth dose] (N=59;38;35) | 0 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [post-fourth dose] (N=65;37;35) | 33 Participants |
Secondary
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values
rSBA-MenC antibody cut-off values assessed were ≥1:8 and ≥1:128
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥ 1:8 [pre-fourth dose] (N=157;83;89) | 147 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [post-fourth dose] (N=163;82;92) | 161 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥ 1:128 [pre-fourth dose] (N=157;83;89) | 104 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:128 [post-fourth dose] (N=163;82;92) | 159 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:128 [post-fourth dose] (N=163;82;92) | 1 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥ 1:8 [pre-fourth dose] (N=157;83;89) | 5 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥ 1:128 [pre-fourth dose] (N=157;83;89) | 1 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [post-fourth dose] (N=163;82;92) | 8 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:128 [post-fourth dose] (N=163;82;92) | 74 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [post-fourth dose] (N=163;82;92) | 90 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥ 1:128 [pre-fourth dose] (N=157;83;89) | 2 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values | ≥ 1:8 [pre-fourth dose] (N=157;83;89) | 9 Participants |
Secondary
Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values
rSBA-MenC antibody cut-off values for this outcome were 1:8 and 1:128.
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values | ≥1:8 [Prior to vaccination] (N=153;183;133) | 10 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values | ≥1:128 [Prior to vaccination] (N=153;183;133) | 3 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values | ≥1:8 [1 month post-vaccination] (N=177;194;136) | 173 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values | ≥1:128 [1 month post-vaccination] (N=177;194;136) | 171 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values | ≥1:128 [1 month post-vaccination] (N=177;194;136) | 2 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values | ≥1:8 [Prior to vaccination] (N=153;183;133) | 13 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values | ≥1:8 [1 month post-vaccination] (N=177;194;136) | 7 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values | ≥1:128 [Prior to vaccination] (N=153;183;133) | 5 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values | ≥1:128 [1 month post-vaccination] (N=177;194;136) | 105 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values | ≥1:128 [Prior to vaccination] (N=153;183;133) | 20 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values | ≥1:8 [1 month post-vaccination] (N=177;194;136) | 126 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values | ≥1:8 [Prior to vaccination] (N=153;183;133) | 27 Participants |
Secondary
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4
A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (\<) 1:128.
Time frame: One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4 | 13 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4 | 0 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4 | 0 Participants |
Secondary
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values
hSBA-MenY antibody cut-off values assessed were ≥1:4 and ≥1:8.
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:4 [pre-fourth dose] (N=62;38;35) | 33 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:4 [post-fourth dose] (N=65;37;35) | 62 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [pre-fourth dose] (N=62;38;35) | 30 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [post-fourth dose] (N=65;37;35) | 62 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [post-fourth dose] (N=65;37;35) | 1 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:4 [pre-fourth dose] (N=62;38;35) | 0 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [pre-fourth dose] (N=62;38;35) | 0 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:4 [post-fourth dose] (N=65;37;35) | 1 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [post-fourth dose] (N=65;37;35) | 20 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:4 [post-fourth dose] (N=65;37;35) | 21 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [pre-fourth dose] (N=62;38;35) | 0 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:4 [pre-fourth dose] (N=62;38;35) | 0 Participants |
Secondary
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values
rSBA-MenY antibody cut-off values assesse were ≥1:8 and ≥1:128.
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [pre-fourth dose] (N=158;79;90) | 142 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [post-fourth dose] (N=162;80;93) | 160 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:128 [pre-fourth dose] (N=158;79;90) | 96 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:128 [post-fourth dose] (N=162;80;93) | 158 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:128 [post-fourth dose] (N=162;80;93) | 16 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [pre-fourth dose] (N=158;79;90) | 26 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:128 [pre-fourth dose] (N=158;79;90) | 10 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [post-fourth dose] (N=162;80;93) | 30 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:128 [post-fourth dose] (N=162;80;93) | 92 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [post-fourth dose] (N=162;80;93) | 93 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:128 [pre-fourth dose] (N=158;79;90) | 17 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values | ≥1:8 [pre-fourth dose] (N=158;79;90) | 37 Participants |
Secondary
Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values
rSBA-MenY antibody cut-off values for this outcome measure were 1:8 and 1:128.
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values | ≥1:8 [Prior to vaccination] (N=156;186;140) | 29 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values | ≥1:128 [Prior to vaccination] (N=156;186;140) | 4 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values | ≥1:8 [1 month post-vaccination] (N=174;186;139) | 171 Participants |
| MenHibrix Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values | ≥1:128 [1 month post-vaccination] (N=174;186;139) | 154 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values | ≥1:128 [1 month post-vaccination] (N=174;186;139) | 6 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values | ≥1:8 [Prior to vaccination] (N=156;186;140) | 28 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values | ≥1:8 [1 month post-vaccination] (N=174;186;139) | 35 Participants |
| ActHIB Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values | ≥1:128 [Prior to vaccination] (N=156;186;140) | 3 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values | ≥1:128 [1 month post-vaccination] (N=174;186;139) | 131 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values | ≥1:128 [Prior to vaccination] (N=156;186;140) | 61 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values | ≥1:8 [1 month post-vaccination] (N=174;186;139) | 134 Participants |
| Menomune Group | Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values | ≥1:8 [Prior to vaccination] (N=156;186;140) | 92 Participants |
Secondary
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-6B [after vaccination] (N=166;162) | 155 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-19F [prior to vaccination] (N=88;99) | 47 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-4 [prior to vaccination] (N=87;100) | 9 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-19F [after vaccination] (N=167;169) | 166 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-23F [prior to vaccination] (N=86;103) | 13 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-9V [prior to vaccination] (N=88;100) | 19 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-23F [after vaccination] (N=174;177) | 171 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-6B [prior to vaccination] (N=84;96) | 12 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-9V [after vaccination] (N=174;180) | 173 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-14 [after vaccination] (N=167;172) | 166 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-4 [after vaccination] (N=173;177) | 173 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-18C [prior to vaccination] (N=85;97) | 19 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-14 [prior to vaccination] (N=75;90) | 46 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-18C [after vaccination] (N=172;169) | 172 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-19F [after vaccination] (N=167;169) | 169 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-4 [prior to vaccination] (N=87;100) | 3 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-4 [after vaccination] (N=173;177) | 177 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-6B [prior to vaccination] (N=84;96) | 15 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-6B [after vaccination] (N=166;162) | 155 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-9V [prior to vaccination] (N=88;100) | 19 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-9V [after vaccination] (N=174;180) | 180 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-18C [after vaccination] (N=172;169) | 167 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-19F [prior to vaccination] (N=88;99) | 52 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-23F [prior to vaccination] (N=86;103) | 15 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-23F [after vaccination] (N=174;177) | 174 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-14 [prior to vaccination] (N=75;90) | 62 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-14 [after vaccination] (N=167;172) | 171 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-18C [prior to vaccination] (N=85;97) | 24 Participants |
Secondary
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-9V [prior to vaccination] (N=88;100) | 5 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-19F [after vaccination] (N=167;169) | 156 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-23F [prior to vaccination] (N=86;103) | 7 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-6B [prior to vaccination] (N=84;96) | 10 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-23F [after vaccination] (N=174;177) | 155 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-9V [after vaccination] (N=174;180) | 169 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-6B [after vaccination] (N=166;162) | 130 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-14 [prior to vaccination] (N=75;90) | 32 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-18C [after vaccination] (N=172;169) | 168 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-14 [after vaccination] (N=167;172) | 164 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-4 [after vaccination] (N=173;177) | 162 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-18C [prior to vaccination] (N=85;97) | 5 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-19F [prior to vaccination] (N=88;99) | 27 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-4 [prior to vaccination] (N=87;100) | 1 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-19F [after vaccination] (N=167;169) | 160 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-4 [prior to vaccination] (N=87;100) | 0 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-4 [after vaccination] (N=173;177) | 168 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-6B [after vaccination] (N=166;162) | 139 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-9V [prior to vaccination] (N=88;100) | 9 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-9V [after vaccination] (N=174;180) | 175 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-18C [after vaccination] (N=172;169) | 166 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-19F [prior to vaccination] (N=88;99) | 20 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-23F [prior to vaccination] (N=86;103) | 8 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-23F [after vaccination] (N=174;177) | 167 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-6B [prior to vaccination] (N=84;96) | 8 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-14 [prior to vaccination] (N=75;90) | 33 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-14 [after vaccination] (N=167;172) | 167 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-18C [prior to vaccination] (N=85;97) | 8 Participants |
Secondary
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off
The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-14 [prior to vaccination] (N=75;90) | 70 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-6B [after vaccination] (N=166;162) | 163 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-4 [prior to vaccination] (N=87;100) | 23 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-14 [after vaccination] (N=167;172) | 167 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-4 [after vaccination] (N=173;177) | 173 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-6B [prior to vaccination] (N=84;96) | 40 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-19F [prior to vaccination] (N=88;99) | 76 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-9V [after vaccination] (N=174;180) | 174 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-19F [after vaccination] (N=167;169) | 167 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-18C [prior to vaccination] (N=85;97) | 41 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-23F [prior to vaccination] (N=86;103) | 44 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-9V [prior to vaccination] (N=88;100) | 45 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-23F [after vaccination] (N=174;177) | 173 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-18C [after vaccination] (N=172;169) | 172 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-23F [after vaccination] (N=174;177) | 176 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-6B [after vaccination] (N=166;162) | 162 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-9V [prior to vaccination] (N=88;100) | 54 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-9V [after vaccination] (N=174;180) | 180 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-14 [prior to vaccination] (N=75;90) | 80 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-14 [after vaccination] (N=167;172) | 172 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-18C [prior to vaccination] (N=85;97) | 55 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-18C [after vaccination] (N=172;169) | 169 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-4 [after vaccination] (N=173;177) | 177 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-4 [prior to vaccination] (N=87;100) | 18 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-19F [prior to vaccination] (N=88;99) | 82 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-19F [after vaccination] (N=167;169) | 169 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-23F [prior to vaccination] (N=86;103) | 47 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off | Anti-6B [prior to vaccination] (N=84;96) | 41 Participants |
Secondary
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL)
Streptococcus pneumoniae antibody cut-off values assessed was ≥0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.
Time frame: One month after fourth dose vaccination (at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-9V (N=175;90;102) | 175 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-23F (N=176;90;102) | 175 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-18C (N=175;88;102) | 175 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-14 (N=174;87;100) | 174 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-6B (N=174;89;101) | 174 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-4 (N=174;89;102) | 174 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-19F (N=173;89;96) | 173 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-18C (N=175;88;102) | 88 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-4 (N=174;89;102) | 89 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-6B (N=174;89;101) | 89 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-9V (N=175;90;102) | 90 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-14 (N=174;87;100) | 87 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-19F (N=173;89;96) | 89 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-23F (N=176;90;102) | 90 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-18C (N=175;88;102) | 102 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-6B (N=174;89;101) | 101 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-23F (N=176;90;102) | 101 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-19F (N=173;89;96) | 96 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-4 (N=174;89;102) | 102 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-14 (N=174;87;100) | 100 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL) | Anti-9V (N=175;90;102) | 102 Participants |
Secondary
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL)
Streptococcus pneumoniae antibody cut-off values assessed was ≥0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.
Time frame: One month after fourth dose vaccination (at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-6B (N=174;89;101) | 174 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-18C (N=175;88;102) | 175 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-14 (N=174;87;100) | 174 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-4 (N=174;89;102) | 174 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-23F (N=176;90;102) | 175 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-19F (N=173;89;96) | 171 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-9V (N=175;90;102) | 175 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-14 (N=174;87;100) | 87 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-4 (N=174;89;102) | 89 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-6B (N=174;89;101) | 89 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-9V (N=175;90;102) | 90 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-18C (N=175;88;102) | 88 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-19F (N=173;89;96) | 89 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-23F (N=176;90;102) | 90 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-18C (N=175;88;102) | 102 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-6B (N=174;89;101) | 101 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-23F (N=176;90;102) | 101 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-19F (N=173;89;96) | 96 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-14 (N=174;87;100) | 100 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-9V (N=175;90;102) | 102 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL) | Anti-4 (N=174;89;102) | 102 Participants |
Secondary
Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL)
Streptococcus pneumoniae antibody cut-off values assessed was ≥0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.
Time frame: One month after fourth dose vaccination (at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-23F (N=176;90;102) | 175 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-4 (N=174;89;102) | 165 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-14 (N=174;87;100) | 172 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-6B (N=174;89;101) | 171 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-18C (N=175;88;102) | 174 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-19F (N=173;89;96) | 157 Participants |
| MenHibrix Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-9V (N=175;90;102) | 174 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-14 (N=174;87;100) | 87 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-23F (N=176;90;102) | 90 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-9V (N=175;90;102) | 90 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-18C (N=175;88;102) | 88 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-4 (N=174;89;102) | 86 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-19F (N=173;89;96) | 83 Participants |
| ActHIB Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-6B (N=174;89;101) | 89 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-18C (N=175;88;102) | 102 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-6B (N=174;89;101) | 100 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-9V (N=175;90;102) | 102 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-14 (N=174;87;100) | 100 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-19F (N=173;89;96) | 91 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-23F (N=176;90;102) | 101 Participants |
| Menomune Group | Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL) | Anti-4 (N=174;89;102) | 99 Participants |
Secondary
Number of Subjects With Vaccine Response to PT, FHA and PRN
Vaccine response to PT/FHA/PRN was defined as, for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month post-primary vaccination course, and, for initially seropositive subjects, antibody concentration one month post-primary vaccination course ≥ 1-fold the pre-vaccination antibody concentration. A seronegative/seronegative subject was defined as a subject with antibody concentration \</≥ 5 EL.U/mL for anti-PT/FHA/PRN prior to vaccination. This Outcome Measure only concerns the MenHibrix and ActHIB groups .
Time frame: One month after the 3-dose primary vaccination course (at Month 5)
Population: The Primary ATP cohort for immunogenicity included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) and for whom the data concerning the immunogenicity of at least one vaccine antigen were available during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenHibrix Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-PT (N=111;135) | 109 Participants |
| MenHibrix Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-FHA (N=116;132) | 113 Participants |
| MenHibrix Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-PRN (N=115;133) | 103 Participants |
| ActHIB Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-PT (N=111;135) | 132 Participants |
| ActHIB Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-FHA (N=116;132) | 128 Participants |
| ActHIB Group | Number of Subjects With Vaccine Response to PT, FHA and PRN | Anti-PRN (N=115;133) | 126 Participants |
Secondary
rSBA-MenC Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | rSBA-MenC Antibody Titers | [pre-fourth dose] (N=157;83;89) | 167.1 Titers |
| MenHibrix Group | rSBA-MenC Antibody Titers | [post-fourth dose] (N=163;82;92)) | 2443.9 Titers |
| ActHIB Group | rSBA-MenC Antibody Titers | [pre-fourth dose] (N=157;83;89) | 4.7 Titers |
| ActHIB Group | rSBA-MenC Antibody Titers | [post-fourth dose] (N=163;82;92)) | 5.3 Titers |
| Menomune Group | rSBA-MenC Antibody Titers | [pre-fourth dose] (N=157;83;89) | 5.3 Titers |
| Menomune Group | rSBA-MenC Antibody Titers | [post-fourth dose] (N=163;82;92)) | 321.8 Titers |
Secondary
rSBA-MenY Antibody Titers
Titers are presented as geometric mean titers (GMTs).
Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)
Population: The Fourth Dose ATP cohort for immunogenicity included evaluable subjects (i.e. those meeting eligibility criteria, complying with the procedures, with no elimination criteria) from the Fourth Dose ATP cohort for safety for whom assay results were available for antibodies against study vaccine antigen at 31 to 48 days post fourth dose vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenHibrix Group | rSBA-MenY Antibody Titers | [pre-fourth dose] (N=158;79;90) | 128.6 Titers |
| MenHibrix Group | rSBA-MenY Antibody Titers | [post-fourth dose] (N=162;80;93) | 1424.6 Titers |
| ActHIB Group | rSBA-MenY Antibody Titers | [pre-fourth dose] (N=158;79;90) | 11.3 Titers |
| ActHIB Group | rSBA-MenY Antibody Titers | [post-fourth dose] (N=162;80;93) | 16.1 Titers |
| Menomune Group | rSBA-MenY Antibody Titers | [pre-fourth dose] (N=158;79;90) | 15.6 Titers |
| Menomune Group | rSBA-MenY Antibody Titers | [post-fourth dose] (N=162;80;93) | 1454.0 Titers |